<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/NCT02974335</url>
  </required_header>
  <id_info>
    <org_study_id>14-01948</org_study_id>
    <nct_id>NCT02974335</nct_id>
  </id_info>
  <brief_title>A Phased-Implementation Feasibility and Proof-of-Concept Study to Assess Incorporating the NIDA CTN Common Data Elements (CDEs) Into the Electronic Health Record (EHR) in Large Primary Care Settings (&quot;CDE-EHR-PC&quot; Study), Phase 1</brief_title>
  <official_title>A Phased-Implementation Feasibility and Proof-of-Concept Study to Assess Incorporating the NIDA CTN Common Data Elements (CDEs) Into the Electronic Health Record (EHR) in Large Primary Care Settings (&quot;CDE-EHR-PC&quot; Study), Phase 1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</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 is a 4-phase study to implement the NIDA CDEs in primary care settings. Collecting and&#xD;
      utilizing the CDEs in clinical practice requires a strategy for implementing screening to&#xD;
      collect substance use information that populates the CDEs, and assisting primary care&#xD;
      providers to offer appropriate interventions by providing clinical decision support (CDS) and&#xD;
      a mechanism for making referrals to addiction treatment. We aim to maximize the efficient&#xD;
      adoption of screening, CDS, and treatment referrals by integrating all of these activities&#xD;
      into the electronic health record (EHR).&#xD;
&#xD;
      The study will be conducted at three sites, representing three large health systems. Each&#xD;
      phase will include deliverables essential to move to the next phase, and an independent&#xD;
      Advisory Committee will review progress and make recommendations at each transition about how&#xD;
      best to progress to each subsequent phase. Based on progress during earlier phases, the&#xD;
      Advisory Committee may recommend expansion to additional clinics or health systems during the&#xD;
      second part of Phase 4.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 1 involves identifying the optimal screening tools and approaches for capturing CDE&#xD;
      data, programming the screening tools and CDEs into the Epic EHR, and soliciting stakeholder&#xD;
      input regarding implementation strategies for screening and clinical interventions (including&#xD;
      treatment referrals) to address substance use.&#xD;
&#xD;
      In the KTA framework, Phase 1 addresses the first steps in the action cycle, which are to&#xD;
      identify, review, and select the tools that are to be implemented; adapt tools to the local&#xD;
      context; assess barriers to use of the tools; and begin the process of implementation by&#xD;
      programming these tools into the Epic EHR. We will accomplish these steps primarily through&#xD;
      interviews and focus groups with key stakeholders. The information gained from stakeholders&#xD;
      will be applied in an iterative process to develop a best-practice approach to screening&#xD;
      patients, and to build the EHR tools (CDEs and CDS) that will be further tailored and tested&#xD;
      in Phase 2, and then implemented in one clinic in Phase 3.&#xD;
&#xD;
      Research Questions and Aims&#xD;
&#xD;
      The research questions that Phase 1 seeks to address are:&#xD;
&#xD;
        1. Where should screening and initial assessment occur, and who should administer the&#xD;
           screening and assessment questionnaires?&#xD;
&#xD;
        2. Is it better to screen for drugs only, or for drugs and alcohol, or for drugs, alcohol&#xD;
           and tobacco? Should screening also include depression (e.g., PHQ2 and PHQ9)? Should&#xD;
           screening be embedded in a broad behavioral health screen (e.g., a comprehensive health&#xD;
           risk assessment such as My Own Health Report (30))?&#xD;
&#xD;
      The specific aim that corresponds to Phase 1 is Aim 1: To program the NIDA CTN CDEs and a&#xD;
      lean decision support module into Epic. This phase will also define potential barriers and&#xD;
      facilitators to the adoption of the CDEs and CDS, which is a component of Specific Aim 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 25, 2017</start_date>
  <completion_date type="Actual">April 5, 2019</completion_date>
  <primary_completion_date type="Actual">April 5, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Patient level outcomes: diagnosis, and treatment referral</measure>
    <time_frame>1 Year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Provider level outcomes: screening and assessment, and clinical interventions including counseling and treatment referral.</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Systems level outcomes: logistics and costs of introducing the CDEs.</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">67</enrollment>
  <condition>Addiction</condition>
  <arm_group>
    <arm_group_label>Primary Care Providers (PCPs)</arm_group_label>
    <description>Key stakeholders including: informatics/Epic leaders, medical providers, and patients from the two health systems that will be involved in the study, as well as national health information technology leaders from other large health systems.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medical Assistants (MAs) + Registered Nurses (RNs)</arm_group_label>
    <description>Key stakeholders including: informatics/Epic leaders, medical providers, and patients from the two health systems that will be involved in the study, as well as national health information technology leaders from other large health systems.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Key stakeholders including: informatics/Epic leaders, medical providers, and patients from the two health systems that will be involved in the study, as well as national health information technology leaders from other large health systems.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interviews with Stakeholders</intervention_name>
    <description>The information gained from stakeholders will be applied in an iterative process to develop a best-practice approach to screening patients, and to build the EHR tools (CDEs and CDS) that will be further tailored and tested in Phase 2, and then implemented in one clinic in Phase 3.</description>
    <arm_group_label>Medical Assistants (MAs) + Registered Nurses (RNs)</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_label>Primary Care Providers (PCPs)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be recruited from the three clinics where we plan to implement study Phases&#xD;
        2-4. Clinic staff will give recruitment flyers to all patients registering for appointments&#xD;
        in the week prior to each focus group. Potential participants who are interested in&#xD;
        participating will call the Research Coordinator, who will assess eligibility and schedule&#xD;
        them for the appropriate group. Groups will be divided based on age; one group will include&#xD;
        participants under age 50, and a second group will include those age 50 and over. This&#xD;
        grouping strategy is chosen because individuals in these age groups are anticipated to&#xD;
        differ in their substance use patterns, medical needs, and concerns about screening&#xD;
        procedures.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be a current primary care clinic patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer McNeely</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York University Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusettes General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>McNeely J, Kumar PC, Rieckmann T, Sedlander E, Farkas S, Chollak C, Kannry JL, Vega A, Waite EA, Peccoralo LA, Rosenthal RN, McCarty D, Rotrosen J. Barriers and facilitators affecting the implementation of substance use screening in primary care clinics: a qualitative study of patients, providers, and staff. Addict Sci Clin Pract. 2018 Apr 9;13(1):8. doi: 10.1186/s13722-018-0110-8.</citation>
    <PMID>29628018</PMID>
  </results_reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>August 24, 2022</last_update_submitted>
  <last_update_submitted_qc>August 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Behavior, Addictive</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02974335
org study id: 14-01948
nct id: NCT02974335
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a 4-phase study to implement the NIDA CDEs in primary care settings. Collecting and
      utilizing the CDEs in clinical practice requires a strategy for implementing screening to
      collect substance use information that populates the CDEs, and assisting primary care
      providers to offer appropriate interventions by providing clinical decision support (CDS) and
      a mechanism for making referrals to addiction treatment. We aim to maximize the efficient
      adoption of screening, CDS, and treatment referrals by integrating all of these activities
      into the electronic health record (EHR).

      The study will be conducted at three sites, representing three large health systems. Each
      phase will include deliverables essential to move to the next phase, and an independent
      Advisory Committee will review progress and make recommendations at each transition about how
      best to progress to each subsequent phase. Based on progress during earlier phases, the
      Advisory Committee may recommend expansion to additional clinics or health systems during the
      second part of Phase 4.
Phase 1 involves identifying the optimal screening tools and approaches for capturing CDE
      data, programming the screening tools and CDEs into the Epic EHR, and soliciting stakeholder
      input regarding implementation strategies for screening and clinical interventions (including
      treatment referrals) to address substance use.

      In the KTA framework, Phase 1 addresses the first steps in the action cycle, which are to
      identify, review, and select the tools that are to be implemented; adapt tools to the local
      context; assess barriers to use of the tools; and begin the process of implementation by
      programming these tools into the Epic EHR. We will accomplish these steps primarily through
      interviews and focus groups with key stakeholders. The information gained from stakeholders
      will be applied in an iterative process to develop a best-practice approach to screening
      patients, and to build the EHR tools (CDEs and CDS) that will be further tailored and tested
      in Phase 2, and then implemented in one clinic in Phase 3.

      Research Questions and Aims

      The research questions that Phase 1 seeks to address are:

        1. Where should screening and initial assessment occur, and who should administer the
           screening and assessment questionnaires?

        2. Is it better to screen for drugs only, or for drugs and alcohol, or for drugs, alcohol
           and tobacco? Should screening also include depression (e.g., PHQ2 and PHQ9)? Should
           screening be embedded in a broad behavioral health screen (e.g., a comprehensive health
           risk assessment such as My Own Health Report (30))?

      The specific aim that corresponds to Phase 1 is Aim 1: To program the NIDA CTN CDEs and a
      lean decision support module into Epic. This phase will also define potential barriers and
      facilitators to the adoption of the CDEs and CDS, which is a component of Specific Aim 2.
observational model: Other
time perspective: Other
measure: Patient level outcomes: diagnosis, and treatment referral
time frame: 1 Year
measure: Provider level outcomes: screening and assessment, and clinical interventions including counseling and treatment referral.
time frame: 1 year
measure: Systems level outcomes: logistics and costs of introducing the CDEs.
time frame: 1 year
arm group label: Primary Care Providers (PCPs)
description: Key stakeholders including: informatics/Epic leaders, medical providers, and patients from the two health systems that will be involved in the study, as well as national health information technology leaders from other large health systems.
arm group label: Medical Assistants (MAs) + Registered Nurses (RNs)
description: Key stakeholders including: informatics/Epic leaders, medical providers, and patients from the two health systems that will be involved in the study, as well as national health information technology leaders from other large health systems.
arm group label: Patients
description: Key stakeholders including: informatics/Epic leaders, medical providers, and patients from the two health systems that will be involved in the study, as well as national health information technology leaders from other large health systems.
intervention type: Behavioral
intervention name: Interviews with Stakeholders
description: The information gained from stakeholders will be applied in an iterative process to develop a best-practice approach to screening patients, and to build the EHR tools (CDEs and CDS) that will be further tailored and tested in Phase 2, and then implemented in one clinic in Phase 3.
arm group label: Medical Assistants (MAs) + Registered Nurses (RNs)
arm group label: Patients
arm group label: Primary Care Providers (PCPs)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer McNeely
role: Principal Investigator
affiliation: New York University Medical School
facility: 
facility: 
facility: 
country: United States
citation: McNeely J, Kumar PC, Rieckmann T, Sedlander E, Farkas S, Chollak C, Kannry JL, Vega A, Waite EA, Peccoralo LA, Rosenthal RN, McCarty D, Rotrosen J. Barriers and facilitators affecting the implementation of substance use screening in primary care clinics: a qualitative study of patients, providers, and staff. Addict Sci Clin Pract. 2018 Apr 9;13(1):8. doi: 10.1186/s13722-018-0110-8.
PMID: 29628018
responsible party type: Sponsor
mesh term: Behavior, Addictive