<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03834025</url>
  </required_header>
  <id_info>
    <org_study_id>18-2236</org_study_id>
    <secondary_id>R21DA047286</secondary_id>
    <nct_id>NCT03834025</nct_id>
  </id_info>
  <brief_title>Nudges and Incentives to Enhance the Opioid Treatment Workforce</brief_title>
  <official_title>Nudges and Incentives to Enhance the Opioid Treatment Workforce</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project seeks to examine a critical barrier to optimizing the health care workforce for&#xD;
      the treatment of opioid use disorders. Without a dramatic increase in the number of primary&#xD;
      care providers trained and comfortable with the many nuances of prescribing&#xD;
      medication-assisted treatment (MAT), the staggering increases in opioid overdose deaths will&#xD;
      continue to skyrocket. However, Drug Addiction Treatment Act (DATA) 2000 waiver training&#xD;
      alone is not enough to facilitate prescribing for patients who desperately need services; an&#xD;
      estimated 40% of physicians with waivers do not initiate MAT prescriptions. To address this&#xD;
      problem, North Carolina developed a learning collaborative framework to promote MAT training.&#xD;
      Learning collaboratives have been shown to be an efficacious approach to increase utilization&#xD;
      of MAT, but engagement among providers in North Carolina has been low. To date, the need to&#xD;
      encourage provider collaborative participation at scale has not been addressed. This is the&#xD;
      critical problem focused on in this proposal.&#xD;
&#xD;
      The death rate from accidental opioid overdoses continues to climb at an alarming rate, with&#xD;
      overdose deaths in 2016 almost five times the number from 1999. The daily death rate from&#xD;
      opioid overdoses in the U.S. alone is now estimated at 115, so every day that evidence-based&#xD;
      treatment is not available leads to more preventable deaths. North Carolina is one of the&#xD;
      states with both an opioid overdose death rate greater than the national average (11.9 vs&#xD;
      10.4 deaths per 100,000, age-adjusted) and a rate of increase in opioid overdose deaths&#xD;
      greater than the national average (19% vs. 16%). North Carolina is also one of four states&#xD;
      with an Agency for Healthcare Research and Quality (AHRQ) funded Extension for Community&#xD;
      Healthcare Outcomes (ECHO) MAT learning collaborative available to primary care practices,&#xD;
      but engagement among providers is low. While the main barriers to engagement are incompletely&#xD;
      understood, recent evidence from provider interviews conducted by the study team in December&#xD;
      2017 and January 2018 suggest that one substantial barrier is the time required for weekly&#xD;
      ECHO clinics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to assess how to effectively recruit and enroll primary care providers&#xD;
      into participation into an ECHO MAT learning collaborative. For study participants that&#xD;
      enroll in the learning collaborative, the study team will track participation over 6 months.&#xD;
&#xD;
      The study is designed to be implemented in two phases. Phase 1 is the recruitment phase.&#xD;
      Providers will be randomized to receive recruitment letters and emails from 1 of 4&#xD;
      conditions. Randomization for this phase will occur at the practice level, as determined by&#xD;
      provider address.&#xD;
&#xD;
      Participants that contact the study team and enroll in the study will begin Phase 2 of the&#xD;
      study. In Phase 2 of the study participants will be randomly assigned to rewards for&#xD;
      participation in ECHO MAT learning collaborative. Their participation in the learning&#xD;
      collaborative will be tracked. Phase 2 of the study is a pilot.&#xD;
&#xD;
      Recruitment:&#xD;
&#xD;
      Primary care providers will receive recruitment letters, and may receive emails and phone&#xD;
      calls based on the recruitment condition they are assigned to.&#xD;
&#xD;
      Informed Consent:&#xD;
&#xD;
      Since it is not possible to consent before recruitment, participants will complete the&#xD;
      informed consent process at the beginning of Phase 2 of the study. The consent form will be&#xD;
      shared with eligible participants when they contact the study team to enroll. Before&#xD;
      enrolling in the ECHO MAT learning collaborative, participants will be asked to provide&#xD;
      consent in order to enroll in the study.&#xD;
&#xD;
      Randomization:&#xD;
&#xD;
      Phase 1: Primary care providers will be randomized by practice to 1 of 4 study arms.&#xD;
      Computerized randomization will assign practices to study arms, practices and primary care&#xD;
      providers will have an equal chance of being randomized to each study arm .&#xD;
&#xD;
      Phase 2: Eligible participants will be randomized to the Phase 2 study arm upon enrollment in&#xD;
      the study. Randomization will be assigned using a predetermined randomly ordered list of&#xD;
      study condition assignments. Upon enrolling in the study, the participants will be assigned&#xD;
      to the condition that is next on the list. Participants will have an equal chance of being&#xD;
      randomized to each study arm.&#xD;
&#xD;
      Assessment:&#xD;
&#xD;
      Assessment for Phase 1 will occur when participants contact study staff with interest in the&#xD;
      study or to enroll. Any primary care providers that are sent letters but do not contact study&#xD;
      staff will be included in study analyses as 'No' for outcomes for Phase 1.&#xD;
&#xD;
      Assessment for Phase 2 will occur throughout the 6 months after participants enroll in the&#xD;
      study. Outcomes for this study phase are related to participation in ECHO MAT learning&#xD;
      collaboratives, which is tracked for each training by study staff.&#xD;
&#xD;
      Detailed Description of the Intervention:&#xD;
&#xD;
      Phase 1 recruitment letters are designed in a 2 (prosocial mention of need for primary care&#xD;
      providers trained in opioid use disorder treatment vs. none) x 2 (mention of additional&#xD;
      practice supports available for participation in training vs. none). This yields 4 study&#xD;
      conditions for recruitment letters: 1) Letter including prosocial messages and additional&#xD;
      mention of practice supports available for participation, 2) Letter including prosocial&#xD;
      messages but no additional mention of practice support available for participation, 3) Letter&#xD;
      including an additional mention of practice support available for participation but no&#xD;
      prosocial messages, and 4) Recruitment as usual letter that does not include prosocial&#xD;
      messages or an additional mention of practice support available for participation.&#xD;
&#xD;
      Phase 2 examines participation in the learning community by group. Participants will be&#xD;
      randomly assigned to 1 of 3 groups. At this time the investigators are not disclosing the&#xD;
      Phase 2 conditions, and will disclose these at the end of the study, as approved by UNC's&#xD;
      institutional review board (IRB).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Actual">August 28, 2020</completion_date>
  <primary_completion_date type="Actual">August 28, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Participants are unaware of other study arms.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Recruited Providers That Contact Staff for Information About Enrolling in the Study</measure>
    <time_frame>From start of recruitment to end of data collection for last participant, up to 1.5 years</time_frame>
    <description>Phase 1 recruitment interventions will be compared based on the number of recruited providers that reach out to study staff via email, phone, or any other method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Number of UNC ECHO Clinic Sessions a Participant Attends</measure>
    <time_frame>From enrollment to 6 months afterwards, enrollment to 9 months afterwards.</time_frame>
    <description>Phase 2 study interventions will be compared based on the number of UNC ECHO clinic sessions that a participant attends.&#xD;
Subsequent to COVID-19, the number of ECHO clinic sessions was decreased and the assessment period was extended by 3 additional months for those who had not completed the Follow up period as of 3/9/2020.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Recruited Providers That Complete Enrollment in the Phase 2 Study</measure>
    <time_frame>From start of recruitment to enrollment fulfillment, up to 1 year</time_frame>
    <description>Phase 1 recruitment interventions will be compared based on the number of recruited providers that enroll in the Phase 2 study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Amount of Time a Participant Attends a UNC ECHO Clinic Session</measure>
    <time_frame>From enrollment to 6 months afterwards, enrollment to 9 months afterwards.</time_frame>
    <description>Phase 2 study interventions will be compared based on the total amount of time that a participant attends a UNC ECHO clinic session (P2).&#xD;
Subsequent to COVID-19, the number of ECHO clinic sessions was decreased and the assessment period was extended by 3 additional months for those who had not completed the Follow up period as of 3/9/2020.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Receive a DATA 2000 Waiver</measure>
    <time_frame>From enrollment to 6 months afterwards, enrollment to 9 months afterwards.</time_frame>
    <description>Phase 2 study interventions will be compared based on the number of participants that receive a DATA 2000 waiver. MAT waiver training is an 8 hour course for physicians and a 24 hour course for advanced practitioners that is required for providers to prescribe and dispense MAT.&#xD;
Subsequent to COVID-19, the number of ECHO clinic sessions was decreased and the assessment period was extended by 3 additional months for those who had not completed the Follow up period as of 3/9/2020.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Begin Prescribing MAT Paid by Medicaid Within One Year of Phase 2 Start</measure>
    <time_frame>One year</time_frame>
    <description>Phase 2 study interventions will be compared based on the number of participants that begin prescribing MAT paid by Medicaid within one year of enrolling in Phase 2.</description>
  </secondary_outcome>
  <number_of_arms>12</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Opioid Abuse (Disorder)</condition>
  <arm_group>
    <arm_group_label>Phase 1 Condition 1, Phase 2 Condition 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual' (Phase 1 Condition 1). These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation. If they enroll, in Phase 2 of the study these participants will be in condition 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 Condition 1, Phase 2 Condition 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual' (Phase 1 Condition 1). These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation. If they enroll, in Phase 2 of the study these participants will be in condition 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 Condition 1, Phase 2 Condition 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual' (Phase 1 Condition 1). These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation. If they enroll, in Phase 2 of the study these participants will be in condition 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 Condition 2, Phase 2 Condition 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging (Phase 1 Condition 2). If they enroll, in Phase 2 of the study these participants will be in condition 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 Condition 2, Phase 2 Condition 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging (Phase 1 Condition 2). If they enroll, in Phase 2 of the study these participants will be in condition 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 Condition 2, Phase 2 Condition 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging (Phase 1 Condition 2). If they enroll, in Phase 2 of the study these participants will be in condition 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 Condition 3, Phase 2 Condition 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation (Phase 1 Condition 3). If they enroll, in Phase 2 of the study these participants will be in condition 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 Condition 3, Phase 2 Condition 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation (Phase 1 Condition 3). If they enroll, in Phase 2 of the study these participants will be in condition 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 Condition 3, Phase 2 Condition 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation (Phase 1 Condition 3). If they enroll, in Phase 2 of the study these participants will be in condition 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 Condition 4, Phase 2 Condition 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of financial support available for participation (Phase 1 Condition 4). If they enroll, in Phase 2 of the study these participants will be in condition 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 Condition 4, Phase 2 Condition 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of financial support available for participation (Phase 1 Condition 4). If they enroll, in Phase 2 of the study these participants will be in condition 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 Condition 4, Phase 2 Condition 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of financial support available for participation (Phase 1 Condition 4). If they enroll, in Phase 2 of the study these participants will be in condition 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Phase 1 Condition 1</intervention_name>
    <description>Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual' (Phase 1 Condition 1). These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.</description>
    <arm_group_label>Phase 1 Condition 1, Phase 2 Condition 1</arm_group_label>
    <arm_group_label>Phase 1 Condition 1, Phase 2 Condition 2</arm_group_label>
    <arm_group_label>Phase 1 Condition 1, Phase 2 Condition 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Phase 1 Condition 2</intervention_name>
    <description>Providers assigned to this condition will be sent recruitment materials that include an additional mention of financial support available for participation, but will not include prosocial messaging (Phase 1 Condition 2).</description>
    <arm_group_label>Phase 1 Condition 2, Phase 2 Condition 1</arm_group_label>
    <arm_group_label>Phase 1 Condition 2, Phase 2 Condition 2</arm_group_label>
    <arm_group_label>Phase 1 Condition 2, Phase 2 Condition 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Phase 1 Condition 3</intervention_name>
    <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation (Phase 1 Condition 3).</description>
    <arm_group_label>Phase 1 Condition 3, Phase 2 Condition 1</arm_group_label>
    <arm_group_label>Phase 1 Condition 3, Phase 2 Condition 2</arm_group_label>
    <arm_group_label>Phase 1 Condition 3, Phase 2 Condition 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Phase 1 Condition 4</intervention_name>
    <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of financial support available for participation (Phase 1 Condition 4).</description>
    <arm_group_label>Phase 1 Condition 4, Phase 2 Condition 1</arm_group_label>
    <arm_group_label>Phase 1 Condition 4, Phase 2 Condition 2</arm_group_label>
    <arm_group_label>Phase 1 Condition 4, Phase 2 Condition 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Phase 2 Condition 1</intervention_name>
    <description>Providers who enroll in the study and are assigned to this condition will be in this group. Other than the opportunity to participate in a learning collaborative, participants receive no compensation.</description>
    <arm_group_label>Phase 1 Condition 1, Phase 2 Condition 1</arm_group_label>
    <arm_group_label>Phase 1 Condition 2, Phase 2 Condition 1</arm_group_label>
    <arm_group_label>Phase 1 Condition 3, Phase 2 Condition 1</arm_group_label>
    <arm_group_label>Phase 1 Condition 4, Phase 2 Condition 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Phase 2 Condition 2</intervention_name>
    <description>Providers who enroll in the study and are assigned to this condition will be in this group. In addition to the opportunity to participate in the learning collaborative, participants receive a reimbursement at 30% of the NC Medicaid rate for a patient visit.</description>
    <arm_group_label>Phase 1 Condition 1, Phase 2 Condition 2</arm_group_label>
    <arm_group_label>Phase 1 Condition 2, Phase 2 Condition 2</arm_group_label>
    <arm_group_label>Phase 1 Condition 3, Phase 2 Condition 2</arm_group_label>
    <arm_group_label>Phase 1 Condition 4, Phase 2 Condition 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Phase 2 Condition 3</intervention_name>
    <description>Providers who enroll in the study and are assigned to this condition will be in this group. In addition to the opportunity to participate in the learning collaborative, participants receive a reimbursement at 100 percent of the NC Medicaid rate for a patient visit for their time participating in the learning collaborative.</description>
    <arm_group_label>Phase 1 Condition 1, Phase 2 Condition 3</arm_group_label>
    <arm_group_label>Phase 1 Condition 2, Phase 2 Condition 3</arm_group_label>
    <arm_group_label>Phase 1 Condition 3, Phase 2 Condition 3</arm_group_label>
    <arm_group_label>Phase 1 Condition 4, Phase 2 Condition 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Licensed Primary Care Provider (Doctor of Medicine (MD), Doctor of Osteopathic&#xD;
             Medicine (DO), Physician Assistant (PA), Nurse Practitioner (NP))&#xD;
&#xD;
          -  Currently practice in North Carolina&#xD;
&#xD;
          -  For Nurse practitioners, the following specialties were included:&#xD;
&#xD;
               -  Addiction Psychiatry&#xD;
&#xD;
               -  Addiction/Chemical Dependency&#xD;
&#xD;
               -  Adolescent Medicine&#xD;
&#xD;
               -  Emergency Medicine&#xD;
&#xD;
               -  Family Practice&#xD;
&#xD;
               -  Family Practice, Geriatric&#xD;
&#xD;
               -  General Practice&#xD;
&#xD;
               -  General Preventive Medicine&#xD;
&#xD;
               -  Geriatrics&#xD;
&#xD;
               -  Gerontology&#xD;
&#xD;
               -  Gynecology&#xD;
&#xD;
               -  Infectious Disease&#xD;
&#xD;
               -  Internal Medicine&#xD;
&#xD;
               -  Internal Medicine/Immunology Diagnostic&#xD;
&#xD;
               -  Internal Medicine/Pulmonary Dis. &amp; Crit&#xD;
&#xD;
               -  Medicine/Pediatrics&#xD;
&#xD;
               -  Medicine/Psychiatry&#xD;
&#xD;
               -  Obstetrics&#xD;
&#xD;
               -  Obstetrics and Gynecology/Critical Care&#xD;
&#xD;
               -  Obstetrics/Gynecology&#xD;
&#xD;
               -  Other Specialty&#xD;
&#xD;
               -  Pain Management (phys med)&#xD;
&#xD;
               -  Pain Medicine&#xD;
&#xD;
               -  Pediatrics&#xD;
&#xD;
               -  Psychiatry&#xD;
&#xD;
               -  Psychiatry, Child&#xD;
&#xD;
               -  Psychiatry/Geriatric&#xD;
&#xD;
               -  Public Health&#xD;
&#xD;
               -  Unspecified&#xD;
&#xD;
               -  Hospitalist&#xD;
&#xD;
          -  For MD/DOs practitioners that were considered primary by the medical board care were&#xD;
             included except those specializing in sports, addiction, alcohol, and surgery&#xD;
&#xD;
          -  For PAs practitioners were included that are considered primary care by the medical&#xD;
             board&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Another member of the same practice is already enrolled in the study (one provider per&#xD;
             practice in Phase 2)&#xD;
&#xD;
          -  Active participation in University of North Carolina at Chapel Hill (UNC) ECHO&#xD;
             Collaborative at beginning of study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marisa Domino, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina At Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7411</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <results_first_submitted>June 23, 2021</results_first_submitted>
  <results_first_submitted_qc>July 27, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 20, 2021</results_first_posted>
  <last_update_submitted>July 27, 2021</last_update_submitted>
  <last_update_submitted_qc>July 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Opioid Abuse Disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication. Some of the outcomes proposed by the study are covered by data use agreements, we will not share measures restricted by data use agreements. We will share data, as allowed, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.</ipd_description>
    <ipd_time_frame>9 to 36 months following publication</ipd_time_frame>
    <ipd_access_criteria>We will share data, as allowed, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 20, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03834025/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment materials were determined by the randomization of Phase 1. There were four types of recruitment materials: (1) recruitment as usual (no prosocial messaging, no reference to compensation); (2) no prosocial messaging, no reference to compensation; (3) prosocial messaging, reference to compensation; (4) prosocial messaging, reference to compensation.</recruitment_details>
      <pre_assignment_details>Once a participant was enrolled, then they were randomized for Phase 2. Phase 2 involved three levels of compensation: no compensation, 30% compensation, 100% compensation. Participants were compensated for each learning collaborative attended based on the Phase 2 randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Phase 1 Condition 1 (Recruitment as Usual)</title>
          <description>Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.</description>
        </group>
        <group group_id="P2">
          <title>Phase 1 Condition 2 (no Prosocial Messaging, Compensation)</title>
          <description>Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging.</description>
        </group>
        <group group_id="P3">
          <title>Phase 1 Condition 3 (Prosocial Messaging, no Compensation)</title>
          <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
        </group>
        <group group_id="P4">
          <title>Phase 1 Condition 4 (Prosocial Messaging, Compensation)</title>
          <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
        </group>
        <group group_id="P5">
          <title>Phase 2 Condition 1 (no Compensation)</title>
          <description>Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.</description>
        </group>
        <group group_id="P6">
          <title>Phase 2 Condition 2 (30% Compensation)</title>
          <description>Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.</description>
        </group>
        <group group_id="P7">
          <title>Phase 2 Condition 3 (100% Compensation)</title>
          <description>Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Sent Recruitment Letter (Phase 1)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4150"/>
                <participants group_id="P2" count="3871"/>
                <participants group_id="P3" count="4121"/>
                <participants group_id="P4" count="3693"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Sent Letter</title>
              <participants_list>
                <participants group_id="P1" count="4150"/>
                <participants group_id="P2" count="3871"/>
                <participants group_id="P3" count="4121"/>
                <participants group_id="P4" count="3693"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Responded to Letter</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="36"/>
                <participants group_id="P3" count="44"/>
                <participants group_id="P4" count="44"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="36"/>
                <participants group_id="P3" count="44"/>
                <participants group_id="P4" count="44"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4114"/>
                <participants group_id="P2" count="3835"/>
                <participants group_id="P3" count="4077"/>
                <participants group_id="P4" count="3649"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Randomized to Payment Condition(Phase 2)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="24"/>
                <participants group_id="P6" count="21"/>
                <participants group_id="P7" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="24"/>
                <participants group_id="P6" count="21"/>
                <participants group_id="P7" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Investigators did not have access to baseline demographic information for study participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Phase 1 Condition 1 (Recruitment as Usual)</title>
          <description>Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.</description>
        </group>
        <group group_id="B2">
          <title>Phase 1 Condition 2 (no Prosocial Messaging, Compensation)</title>
          <description>Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging.</description>
        </group>
        <group group_id="B3">
          <title>Phase 1 Condition 3 (Prosocial Messaging, no Compensation)</title>
          <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
        </group>
        <group group_id="B4">
          <title>Phase 1 Condition 4 (Prosocial Messaging, Compensation)</title>
          <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
        </group>
        <group group_id="B5">
          <title>Phase 2 Condition 1 (no Compensation)</title>
          <description>Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.</description>
        </group>
        <group group_id="B6">
          <title>Phase 2 Condition 2 (30% Compensation)</title>
          <description>Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.</description>
        </group>
        <group group_id="B7">
          <title>Phase 2 Condition 3 (100% Compensation)</title>
          <description>Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.</description>
        </group>
        <group group_id="B8">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
            <count group_id="B4" value="0"/>
            <count group_id="B5" value="0"/>
            <count group_id="B6" value="0"/>
            <count group_id="B7" value="0"/>
            <count group_id="B8" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Data not collected</population>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Data not collected</population>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Recruited Providers That Contact Staff for Information About Enrolling in the Study</title>
        <description>Phase 1 recruitment interventions will be compared based on the number of recruited providers that reach out to study staff via email, phone, or any other method.</description>
        <time_frame>From start of recruitment to end of data collection for last participant, up to 1.5 years</time_frame>
        <population>This outcome is not relevant for Phase 2</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1 Condition 1 (Recruitment as Usual)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1 Condition 2 (no Prosocial Messaging, Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1 Condition 3 (Prosocial Messaging, no Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O4">
            <title>Phase 1 Condition 4 (Prosocial Messaging, Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2 Condition 1 (no Compensation)</title>
            <description>Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 Condition 2 (30% Compensation)</title>
            <description>Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 Condition 3 (100% Compensation)</title>
            <description>Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Recruited Providers That Contact Staff for Information About Enrolling in the Study</title>
          <description>Phase 1 recruitment interventions will be compared based on the number of recruited providers that reach out to study staff via email, phone, or any other method.</description>
          <population>This outcome is not relevant for Phase 2</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4150"/>
                <count group_id="O2" value="3871"/>
                <count group_id="O3" value="4121"/>
                <count group_id="O4" value="3693"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="36"/>
                    <measurement group_id="O3" value="44"/>
                    <measurement group_id="O4" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Number of UNC ECHO Clinic Sessions a Participant Attends</title>
        <description>Phase 2 study interventions will be compared based on the number of UNC ECHO clinic sessions that a participant attends.&#xD;
Subsequent to COVID-19, the number of ECHO clinic sessions was decreased and the assessment period was extended by 3 additional months for those who had not completed the Follow up period as of 3/9/2020.</description>
        <time_frame>From enrollment to 6 months afterwards, enrollment to 9 months afterwards.</time_frame>
        <population>This outcome is only relevant to Phase 2 completers.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1 Condition 1 (Recruitment as Usual)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1 Condition 2 (no Prosocial Messaging, Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1 Condition 3 (Prosocial Messaging, no Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O4">
            <title>Phase 1 Condition 4 (Prosocial Messaging, Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2 Condition 1 (no Compensation)</title>
            <description>Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 Condition 2 (30% Compensation)</title>
            <description>Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 Condition 3 (100% Compensation)</title>
            <description>Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Number of UNC ECHO Clinic Sessions a Participant Attends</title>
          <description>Phase 2 study interventions will be compared based on the number of UNC ECHO clinic sessions that a participant attends.&#xD;
Subsequent to COVID-19, the number of ECHO clinic sessions was decreased and the assessment period was extended by 3 additional months for those who had not completed the Follow up period as of 3/9/2020.</description>
          <population>This outcome is only relevant to Phase 2 completers.</population>
          <units>Number of clinic sessions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="24"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="1.00" spread="2.23"/>
                    <measurement group_id="O6" value="6.95" spread="8.60"/>
                    <measurement group_id="O7" value="12.04" spread="13.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Recruited Providers That Complete Enrollment in the Phase 2 Study</title>
        <description>Phase 1 recruitment interventions will be compared based on the number of recruited providers that enroll in the Phase 2 study.</description>
        <time_frame>From start of recruitment to enrollment fulfillment, up to 1 year</time_frame>
        <population>This outcome is only relevant for Phase I participants</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1 Condition 1 (Recruitment as Usual)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1 Condition 2 (no Prosocial Messaging, Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1 Condition 3 (Prosocial Messaging, no Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O4">
            <title>Phase 1 Condition 4 (Prosocial Messaging, Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2 Condition 1 (no Compensation)</title>
            <description>Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 Condition 2 (30% Compensation)</title>
            <description>Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 Condition 3 (100% Compensation)</title>
            <description>Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Recruited Providers That Complete Enrollment in the Phase 2 Study</title>
          <description>Phase 1 recruitment interventions will be compared based on the number of recruited providers that enroll in the Phase 2 study.</description>
          <population>This outcome is only relevant for Phase I participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4150"/>
                <count group_id="O2" value="3871"/>
                <count group_id="O3" value="4121"/>
                <count group_id="O4" value="3693"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Amount of Time a Participant Attends a UNC ECHO Clinic Session</title>
        <description>Phase 2 study interventions will be compared based on the total amount of time that a participant attends a UNC ECHO clinic session (P2).&#xD;
Subsequent to COVID-19, the number of ECHO clinic sessions was decreased and the assessment period was extended by 3 additional months for those who had not completed the Follow up period as of 3/9/2020.</description>
        <time_frame>From enrollment to 6 months afterwards, enrollment to 9 months afterwards.</time_frame>
        <population>This outcome is only relevant to those who completed the Phase 2 study</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1 Condition 1 (Recruitment as Usual)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1 Condition 2 (no Prosocial Messaging, Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1 Condition 3 (Prosocial Messaging, no Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O4">
            <title>Phase 1 Condition 4 (Prosocial Messaging, Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2 Condition 1 (no Compensation)</title>
            <description>Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 Condition 2 (30% Compensation)</title>
            <description>Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 Condition 3 (100% Compensation)</title>
            <description>Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Amount of Time a Participant Attends a UNC ECHO Clinic Session</title>
          <description>Phase 2 study interventions will be compared based on the total amount of time that a participant attends a UNC ECHO clinic session (P2).&#xD;
Subsequent to COVID-19, the number of ECHO clinic sessions was decreased and the assessment period was extended by 3 additional months for those who had not completed the Follow up period as of 3/9/2020.</description>
          <population>This outcome is only relevant to those who completed the Phase 2 study</population>
          <units>Hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="24"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0.94" spread="2.03"/>
                    <measurement group_id="O6" value="6.61" spread="8.30"/>
                    <measurement group_id="O7" value="11.89" spread="13.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Receive a DATA 2000 Waiver</title>
        <description>Phase 2 study interventions will be compared based on the number of participants that receive a DATA 2000 waiver. MAT waiver training is an 8 hour course for physicians and a 24 hour course for advanced practitioners that is required for providers to prescribe and dispense MAT.&#xD;
Subsequent to COVID-19, the number of ECHO clinic sessions was decreased and the assessment period was extended by 3 additional months for those who had not completed the Follow up period as of 3/9/2020.</description>
        <time_frame>From enrollment to 6 months afterwards, enrollment to 9 months afterwards.</time_frame>
        <population>This outcome is only relevant for Phase 2 completers.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1 Condition 1 (Recruitment as Usual)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1 Condition 2 (no Prosocial Messaging, Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1 Condition 3 (Prosocial Messaging, no Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O4">
            <title>Phase 1 Condition 4 (Prosocial Messaging, Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2 Condition 1 (no Compensation)</title>
            <description>Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 Condition 2 (30% Compensation)</title>
            <description>Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 Condition 3 (100% Compensation)</title>
            <description>Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Receive a DATA 2000 Waiver</title>
          <description>Phase 2 study interventions will be compared based on the number of participants that receive a DATA 2000 waiver. MAT waiver training is an 8 hour course for physicians and a 24 hour course for advanced practitioners that is required for providers to prescribe and dispense MAT.&#xD;
Subsequent to COVID-19, the number of ECHO clinic sessions was decreased and the assessment period was extended by 3 additional months for those who had not completed the Follow up period as of 3/9/2020.</description>
          <population>This outcome is only relevant for Phase 2 completers.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="24"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="16"/>
                    <measurement group_id="O6" value="11"/>
                    <measurement group_id="O7" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Begin Prescribing MAT Paid by Medicaid Within One Year of Phase 2 Start</title>
        <description>Phase 2 study interventions will be compared based on the number of participants that begin prescribing MAT paid by Medicaid within one year of enrolling in Phase 2.</description>
        <time_frame>One year</time_frame>
        <population>This outcome is only relevant for Phase 2 completers.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1 Condition 1 (Recruitment as Usual)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1 Condition 2 (no Prosocial Messaging, Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1 Condition 3 (Prosocial Messaging, no Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O4">
            <title>Phase 1 Condition 4 (Prosocial Messaging, Compensation)</title>
            <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
          </group>
          <group group_id="O5">
            <title>Phase 2 Condition 1 (no Compensation)</title>
            <description>Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.</description>
          </group>
          <group group_id="O6">
            <title>Phase 2 Condition 2 (30% Compensation)</title>
            <description>Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.</description>
          </group>
          <group group_id="O7">
            <title>Phase 2 Condition 3 (100% Compensation)</title>
            <description>Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Begin Prescribing MAT Paid by Medicaid Within One Year of Phase 2 Start</title>
          <description>Phase 2 study interventions will be compared based on the number of participants that begin prescribing MAT paid by Medicaid within one year of enrolling in Phase 2.</description>
          <population>This outcome is only relevant for Phase 2 completers.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="24"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="7"/>
                    <measurement group_id="O7" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs not collected</time_frame>
      <desc>Phase 1 is a very low risk intervention, involving only mailing or emailing an invitation. No mortality, serious adverse event, or other adverse event data were collected. Phase 2 is a very low risk intervention, involving only participating in on-line training sessions (via zoom). No mortality, serious adverse event, or other adverse event data were collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>Phase 1 Condition 1 (Recruitment as Usual)</title>
          <description>Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.</description>
        </group>
        <group group_id="E2">
          <title>Phase 1 Condition 2 (no Prosocial Messaging, Compensation)</title>
          <description>Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging.</description>
        </group>
        <group group_id="E3">
          <title>Phase 1 Condition 3 (Prosocial Messaging, no Compensation)</title>
          <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
        </group>
        <group group_id="E4">
          <title>Phase 1 Condition 4 (Prosocial Messaging, Compensation)</title>
          <description>Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation.</description>
        </group>
        <group group_id="E5">
          <title>Phase 2 Condition 1 (no Compensation)</title>
          <description>Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.</description>
        </group>
        <group group_id="E6">
          <title>Phase 2 Condition 2 (30% Compensation)</title>
          <description>Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.</description>
        </group>
        <group group_id="E7">
          <title>Phase 2 Condition 3 (100% Compensation)</title>
          <description>Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Marisa Domino, PhD</name_or_title>
      <organization>University of North Carolina at Chapel Hill</organization>
      <phone>919-966-3891</phone>
      <email>domino@unc.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03834025
org study id: 18-2236
secondary id: R21DA047286
nct id: NCT03834025
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project seeks to examine a critical barrier to optimizing the health care workforce for
      the treatment of opioid use disorders. Without a dramatic increase in the number of primary
      care providers trained and comfortable with the many nuances of prescribing
      medication-assisted treatment (MAT), the staggering increases in opioid overdose deaths will
      continue to skyrocket. However, Drug Addiction Treatment Act (DATA) 2000 waiver training
      alone is not enough to facilitate prescribing for patients who desperately need services; an
      estimated 40% of physicians with waivers do not initiate MAT prescriptions. To address this
      problem, North Carolina developed a learning collaborative framework to promote MAT training.
      Learning collaboratives have been shown to be an efficacious approach to increase utilization
      of MAT, but engagement among providers in North Carolina has been low. To date, the need to
      encourage provider collaborative participation at scale has not been addressed. This is the
      critical problem focused on in this proposal.

      The death rate from accidental opioid overdoses continues to climb at an alarming rate, with
      overdose deaths in 2016 almost five times the number from 1999. The daily death rate from
      opioid overdoses in the U.S. alone is now estimated at 115, so every day that evidence-based
      treatment is not available leads to more preventable deaths. North Carolina is one of the
      states with both an opioid overdose death rate greater than the national average (11.9 vs
      10.4 deaths per 100,000, age-adjusted) and a rate of increase in opioid overdose deaths
      greater than the national average (19% vs. 16%). North Carolina is also one of four states
      with an Agency for Healthcare Research and Quality (AHRQ) funded Extension for Community
      Healthcare Outcomes (ECHO) MAT learning collaborative available to primary care practices,
      but engagement among providers is low. While the main barriers to engagement are incompletely
      understood, recent evidence from provider interviews conducted by the study team in December
      2017 and January 2018 suggest that one substantial barrier is the time required for weekly
      ECHO clinics.
This study is designed to assess how to effectively recruit and enroll primary care providers
      into participation into an ECHO MAT learning collaborative. For study participants that
      enroll in the learning collaborative, the study team will track participation over 6 months.

      The study is designed to be implemented in two phases. Phase 1 is the recruitment phase.
      Providers will be randomized to receive recruitment letters and emails from 1 of 4
      conditions. Randomization for this phase will occur at the practice level, as determined by
      provider address.

      Participants that contact the study team and enroll in the study will begin Phase 2 of the
      study. In Phase 2 of the study participants will be randomly assigned to rewards for
      participation in ECHO MAT learning collaborative. Their participation in the learning
      collaborative will be tracked. Phase 2 of the study is a pilot.

      Recruitment:

      Primary care providers will receive recruitment letters, and may receive emails and phone
      calls based on the recruitment condition they are assigned to.

      Informed Consent:

      Since it is not possible to consent before recruitment, participants will complete the
      informed consent process at the beginning of Phase 2 of the study. The consent form will be
      shared with eligible participants when they contact the study team to enroll. Before
      enrolling in the ECHO MAT learning collaborative, participants will be asked to provide
      consent in order to enroll in the study.

      Randomization:

      Phase 1: Primary care providers will be randomized by practice to 1 of 4 study arms.
      Computerized randomization will assign practices to study arms, practices and primary care
      providers will have an equal chance of being randomized to each study arm .

      Phase 2: Eligible participants will be randomized to the Phase 2 study arm upon enrollment in
      the study. Randomization will be assigned using a predetermined randomly ordered list of
      study condition assignments. Upon enrolling in the study, the participants will be assigned
      to the condition that is next on the list. Participants will have an equal chance of being
      randomized to each study arm.

      Assessment:

      Assessment for Phase 1 will occur when participants contact study staff with interest in the
      study or to enroll. Any primary care providers that are sent letters but do not contact study
      staff will be included in study analyses as 'No' for outcomes for Phase 1.

      Assessment for Phase 2 will occur throughout the 6 months after participants enroll in the
      study. Outcomes for this study phase are related to participation in ECHO MAT learning
      collaboratives, which is tracked for each training by study staff.

      Detailed Description of the Intervention:

      Phase 1 recruitment letters are designed in a 2 (prosocial mention of need for primary care
      providers trained in opioid use disorder treatment vs. none) x 2 (mention of additional
      practice supports available for participation in training vs. none). This yields 4 study
      conditions for recruitment letters: 1) Letter including prosocial messages and additional
      mention of practice supports available for participation, 2) Letter including prosocial
      messages but no additional mention of practice support available for participation, 3) Letter
      including an additional mention of practice support available for participation but no
      prosocial messages, and 4) Recruitment as usual letter that does not include prosocial
      messages or an additional mention of practice support available for participation.

      Phase 2 examines participation in the learning community by group. Participants will be
      randomly assigned to 1 of 3 groups. At this time the investigators are not disclosing the
      Phase 2 conditions, and will disclose these at the end of the study, as approved by UNC's
      institutional review board (IRB).
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Health Services Research
masking: None (Open Label)
masking description: Participants are unaware of other study arms.
measure: Number of Recruited Providers That Contact Staff for Information About Enrolling in the Study
time frame: From start of recruitment to end of data collection for last participant, up to 1.5 years
description: Phase 1 recruitment interventions will be compared based on the number of recruited providers that reach out to study staff via email, phone, or any other method.
measure: Mean Number of UNC ECHO Clinic Sessions a Participant Attends
time frame: From enrollment to 6 months afterwards, enrollment to 9 months afterwards.
description: Phase 2 study interventions will be compared based on the number of UNC ECHO clinic sessions that a participant attends.
Subsequent to COVID-19, the number of ECHO clinic sessions was decreased and the assessment period was extended by 3 additional months for those who had not completed the Follow up period as of 3/9/2020.
measure: Number of Recruited Providers That Complete Enrollment in the Phase 2 Study
time frame: From start of recruitment to enrollment fulfillment, up to 1 year
description: Phase 1 recruitment interventions will be compared based on the number of recruited providers that enroll in the Phase 2 study.
measure: Total Amount of Time a Participant Attends a UNC ECHO Clinic Session
time frame: From enrollment to 6 months afterwards, enrollment to 9 months afterwards.
description: Phase 2 study interventions will be compared based on the total amount of time that a participant attends a UNC ECHO clinic session (P2).
Subsequent to COVID-19, the number of ECHO clinic sessions was decreased and the assessment period was extended by 3 additional months for those who had not completed the Follow up period as of 3/9/2020.
measure: Number of Participants That Receive a DATA 2000 Waiver
time frame: From enrollment to 6 months afterwards, enrollment to 9 months afterwards.
description: Phase 2 study interventions will be compared based on the number of participants that receive a DATA 2000 waiver. MAT waiver training is an 8 hour course for physicians and a 24 hour course for advanced practitioners that is required for providers to prescribe and dispense MAT.
Subsequent to COVID-19, the number of ECHO clinic sessions was decreased and the assessment period was extended by 3 additional months for those who had not completed the Follow up period as of 3/9/2020.
measure: Number of Participants That Begin Prescribing MAT Paid by Medicaid Within One Year of Phase 2 Start
time frame: One year
description: Phase 2 study interventions will be compared based on the number of participants that begin prescribing MAT paid by Medicaid within one year of enrolling in Phase 2.
arm group label: Phase 1 Condition 1, Phase 2 Condition 1
arm group type: Experimental
description: Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual' (Phase 1 Condition 1). These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation. If they enroll, in Phase 2 of the study these participants will be in condition 1.
arm group label: Phase 1 Condition 1, Phase 2 Condition 2
arm group type: Experimental
description: Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual' (Phase 1 Condition 1). These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation. If they enroll, in Phase 2 of the study these participants will be in condition 2.
arm group label: Phase 1 Condition 1, Phase 2 Condition 3
arm group type: Experimental
description: Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual' (Phase 1 Condition 1). These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation. If they enroll, in Phase 2 of the study these participants will be in condition 3.
arm group label: Phase 1 Condition 2, Phase 2 Condition 1
arm group type: Experimental
description: Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging (Phase 1 Condition 2). If they enroll, in Phase 2 of the study these participants will be in condition 1.
arm group label: Phase 1 Condition 2, Phase 2 Condition 2
arm group type: Experimental
description: Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging (Phase 1 Condition 2). If they enroll, in Phase 2 of the study these participants will be in condition 2.
arm group label: Phase 1 Condition 2, Phase 2 Condition 3
arm group type: Experimental
description: Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging (Phase 1 Condition 2). If they enroll, in Phase 2 of the study these participants will be in condition 3.
arm group label: Phase 1 Condition 3, Phase 2 Condition 1
arm group type: Experimental
description: Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation (Phase 1 Condition 3). If they enroll, in Phase 2 of the study these participants will be in condition 1.
arm group label: Phase 1 Condition 3, Phase 2 Condition 2
arm group type: Experimental
description: Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation (Phase 1 Condition 3). If they enroll, in Phase 2 of the study these participants will be in condition 2.
arm group label: Phase 1 Condition 3, Phase 2 Condition 3
arm group type: Experimental
description: Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation (Phase 1 Condition 3). If they enroll, in Phase 2 of the study these participants will be in condition 3.
arm group label: Phase 1 Condition 4, Phase 2 Condition 1
arm group type: Experimental
description: Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of financial support available for participation (Phase 1 Condition 4). If they enroll, in Phase 2 of the study these participants will be in condition 1.
arm group label: Phase 1 Condition 4, Phase 2 Condition 2
arm group type: Experimental
description: Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of financial support available for participation (Phase 1 Condition 4). If they enroll, in Phase 2 of the study these participants will be in condition 2.
arm group label: Phase 1 Condition 4, Phase 2 Condition 3
arm group type: Experimental
description: Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of financial support available for participation (Phase 1 Condition 4). If they enroll, in Phase 2 of the study these participants will be in condition 3.
intervention type: Behavioral
intervention name: Phase 1 Condition 1
description: Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual' (Phase 1 Condition 1). These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.
arm group label: Phase 1 Condition 1, Phase 2 Condition 1
arm group label: Phase 1 Condition 1, Phase 2 Condition 2
arm group label: Phase 1 Condition 1, Phase 2 Condition 3
intervention type: Behavioral
intervention name: Phase 1 Condition 2
description: Providers assigned to this condition will be sent recruitment materials that include an additional mention of financial support available for participation, but will not include prosocial messaging (Phase 1 Condition 2).
arm group label: Phase 1 Condition 2, Phase 2 Condition 1
arm group label: Phase 1 Condition 2, Phase 2 Condition 2
arm group label: Phase 1 Condition 2, Phase 2 Condition 3
intervention type: Behavioral
intervention name: Phase 1 Condition 3
description: Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation (Phase 1 Condition 3).
arm group label: Phase 1 Condition 3, Phase 2 Condition 1
arm group label: Phase 1 Condition 3, Phase 2 Condition 2
arm group label: Phase 1 Condition 3, Phase 2 Condition 3
intervention type: Behavioral
intervention name: Phase 1 Condition 4
description: Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of financial support available for participation (Phase 1 Condition 4).
arm group label: Phase 1 Condition 4, Phase 2 Condition 1
arm group label: Phase 1 Condition 4, Phase 2 Condition 2
arm group label: Phase 1 Condition 4, Phase 2 Condition 3
intervention type: Behavioral
intervention name: Phase 2 Condition 1
description: Providers who enroll in the study and are assigned to this condition will be in this group. Other than the opportunity to participate in a learning collaborative, participants receive no compensation.
arm group label: Phase 1 Condition 1, Phase 2 Condition 1
arm group label: Phase 1 Condition 2, Phase 2 Condition 1
arm group label: Phase 1 Condition 3, Phase 2 Condition 1
arm group label: Phase 1 Condition 4, Phase 2 Condition 1
intervention type: Behavioral
intervention name: Phase 2 Condition 2
description: Providers who enroll in the study and are assigned to this condition will be in this group. In addition to the opportunity to participate in the learning collaborative, participants receive a reimbursement at 30% of the NC Medicaid rate for a patient visit.
arm group label: Phase 1 Condition 1, Phase 2 Condition 2
arm group label: Phase 1 Condition 2, Phase 2 Condition 2
arm group label: Phase 1 Condition 3, Phase 2 Condition 2
arm group label: Phase 1 Condition 4, Phase 2 Condition 2
intervention type: Behavioral
intervention name: Phase 2 Condition 3
description: Providers who enroll in the study and are assigned to this condition will be in this group. In addition to the opportunity to participate in the learning collaborative, participants receive a reimbursement at 100 percent of the NC Medicaid rate for a patient visit for their time participating in the learning collaborative.
arm group label: Phase 1 Condition 1, Phase 2 Condition 3
arm group label: Phase 1 Condition 2, Phase 2 Condition 3
arm group label: Phase 1 Condition 3, Phase 2 Condition 3
arm group label: Phase 1 Condition 4, Phase 2 Condition 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marisa Domino, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
sharing ipd: Yes
ipd description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication. Some of the outcomes proposed by the study are covered by data use agreements, we will not share measures restricted by data use agreements. We will share data, as allowed, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
ipd time frame: 9 to 36 months following publication
ipd access criteria: We will share data, as allowed, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 