<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/NCT04425668</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00175142</org_study_id>
    <nct_id>NCT04425668</nct_id>
  </id_info>
  <brief_title>Effect of Academic Detailing to Reduce Opioid Prescribing in Dentistry</brief_title>
  <official_title>Effect of Academic Detailing to Reduce Opioid Prescribing in Dentistry: a Randomized Quality Improvement Effort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Michigan Department of Health and Human Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to improve quality of care for dental patients in the state of&#xD;
      Michigan. This will be achieved through educating dentists about best practices for opioid&#xD;
      prescribing and includes three continuing education (CE) credits and one (or two) academic&#xD;
      detailing (AD) visits. The cohort of 90 dentists who are enrolled to the CE will be&#xD;
      randomized into two groups upon enrollment. One of these groups, half of the cohort, will&#xD;
      receive the academic detailing. A report will be written highlighting key findings from this&#xD;
      project and best practices for treating patients after dental care.The quality of care for&#xD;
      dental patients will be improved by sharing this information with both participating and&#xD;
      non-participating dental providers statewide through reports, manuscripts, and presentations.&#xD;
      These data will inform best practice with the potential for future academic detailing and&#xD;
      educational interventions for dentists and oral surgeons.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 29, 2020</start_date>
  <completion_date type="Actual">May 29, 2021</completion_date>
  <primary_completion_date type="Actual">May 29, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Single blinded- dentists to be blinded; Analyses will be done by blinded analyst</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the amount of opioid prescribed measured in the total oral morphine equivalents</measure>
    <time_frame>baseline, up to 3 months</time_frame>
    <description>Opioid data from the Michigan Automated Prescription Service (MAPS), state prescription drug monitoring program (PDMP) will be used. These periods yield 63 working weekdays in each period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the number of opioid prescriptions</measure>
    <time_frame>baseline, up to 3 months</time_frame>
    <description>Number of opioid prescription details through PDMP data pulled from MAPS.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Opioid Prescribing</condition>
  <condition>Pain Management</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Academic detailing intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Academic detailing (AD)</intervention_name>
    <description>In addition to continuing educational (CE) videos this group will receive up to two personalized, one-on-one, education sessions from an academic detailer. The sessions will last between 15-30 minutes. Each AD visit will consist of: an introduction, a brief needs assessment, key educational messages, a discussion of challenges the provider faces, and giving the provider leave-behind educational materials. The AD visit key educational messages are specific recommendations for opioid-prescribing practice change. When appropriate the detailer will suggest a phone call with Dr. Romesh Nalliah to discuss specific dentistry questions. There may also be a second AD visit if agreed upon by the dentist.</description>
    <arm_group_label>Academic detailing intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Continuing educational</intervention_name>
    <description>Dentists enrolled in the CE program will serve as the control group. They will have access to the 3 hours of CE content online similar to the AD group; however, they will not receive academic detailing or the opportunity to connect via phone with Dr. Nalliah.&#xD;
In this group, if the dentists have content-specific questions after participating in the CE program, they may contact MichiganOPENdental@umich.edu for responses appropriately directed to Dr. Nalliah.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Dentists in the state of Michigan with an active drug enforcement agency (DEA)&#xD;
             license.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All oral Surgeons in Michigan. Michigan dentists who have a significant (&gt;5%)&#xD;
             population living outside of Michigan (self-reported), as the prescription drug&#xD;
             monitoring program (PDMP) data we will obtain from Michigan Automated Prescription&#xD;
             Service (MAPS) will only cover those prescriptions filled in the state of Michigan.&#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>Chad Brummett, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chad Brummett</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>May 29, 2021</last_update_submitted>
  <last_update_submitted_qc>May 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Chad Brummett</investigator_full_name>
    <investigator_title>Professor of Anesthesiology Research, Senior Associate Chair for Research</investigator_title>
  </responsible_party>
  <keyword>Dentist</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04425668
org study id: HUM00175142
nct id: NCT04425668
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this project is to improve quality of care for dental patients in the state of
      Michigan. This will be achieved through educating dentists about best practices for opioid
      prescribing and includes three continuing education (CE) credits and one (or two) academic
      detailing (AD) visits. The cohort of 90 dentists who are enrolled to the CE will be
      randomized into two groups upon enrollment. One of these groups, half of the cohort, will
      receive the academic detailing. A report will be written highlighting key findings from this
      project and best practices for treating patients after dental care.The quality of care for
      dental patients will be improved by sharing this information with both participating and
      non-participating dental providers statewide through reports, manuscripts, and presentations.
      These data will inform best practice with the potential for future academic detailing and
      educational interventions for dentists and oral surgeons.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
masking description: Single blinded- dentists to be blinded; Analyses will be done by blinded analyst
measure: Change in the amount of opioid prescribed measured in the total oral morphine equivalents
time frame: baseline, up to 3 months
description: Opioid data from the Michigan Automated Prescription Service (MAPS), state prescription drug monitoring program (PDMP) will be used. These periods yield 63 working weekdays in each period.
measure: Change in the number of opioid prescriptions
time frame: baseline, up to 3 months
description: Number of opioid prescription details through PDMP data pulled from MAPS.
arm group label: Control Group
arm group type: Active Comparator
arm group label: Academic detailing intervention
arm group type: Experimental
intervention type: Behavioral
intervention name: Academic detailing (AD)
description: In addition to continuing educational (CE) videos this group will receive up to two personalized, one-on-one, education sessions from an academic detailer. The sessions will last between 15-30 minutes. Each AD visit will consist of: an introduction, a brief needs assessment, key educational messages, a discussion of challenges the provider faces, and giving the provider leave-behind educational materials. The AD visit key educational messages are specific recommendations for opioid-prescribing practice change. When appropriate the detailer will suggest a phone call with Dr. Romesh Nalliah to discuss specific dentistry questions. There may also be a second AD visit if agreed upon by the dentist.
arm group label: Academic detailing intervention
intervention type: Other
intervention name: Continuing educational
description: Dentists enrolled in the CE program will serve as the control group. They will have access to the 3 hours of CE content online similar to the AD group; however, they will not receive academic detailing or the opportunity to connect via phone with Dr. Nalliah.
In this group, if the dentists have content-specific questions after participating in the CE program, they may contact MichiganOPENdental@umich.edu for responses appropriately directed to Dr. Nalliah.
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chad Brummett, M.D.
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Chad Brummett
investigator title: Professor of Anesthesiology Research, Senior Associate Chair for Research
sharing ipd: No