<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/NCT03825549</url>
  </required_header>
  <id_info>
    <org_study_id>829269</org_study_id>
    <nct_id>NCT03825549</nct_id>
  </id_info>
  <brief_title>A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing</brief_title>
  <acronym>REDUCE</acronym>
  <official_title>A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Donaghue Medical Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sutter Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</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>
      In this study, the investigators will evaluate the effect of a health system initiative&#xD;
      aiming to change clinician opioid prescribing behaviors using two behavioral economic&#xD;
      interventions - individual audit feedback and peer comparison feedback of clinicians.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Opioid-related abuse and overdose represent a growing national epidemic in the United States.&#xD;
      Clinician practice patterns play an important role: opioid prescriptions impact the&#xD;
      likelihood that patients will misuse or become dependent on these medications, with longer&#xD;
      prescriptions leading to greater sustained use. In this study, we will evaluate a Sutter&#xD;
      Health System quality improvement initiative using monthly individual audit feedback and/or&#xD;
      monthly peer comparison feedback to clinicians to change opioid prescribing patterns. In&#xD;
      partnership with Sutter Health System, this will be conducted using randomization to evaluate&#xD;
      its effect. We will also conduct a process evaluation to understand factors associated with&#xD;
      better or worse performance at the clinician level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 3, 2019</start_date>
  <completion_date type="Actual">March 2, 2020</completion_date>
  <primary_completion_date type="Actual">March 2, 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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the mean number of pills per opioid prescription</measure>
    <time_frame>Six months</time_frame>
    <description>The primary outcome is the change in the mean number of pills prescribed per opioid prescription from baseline to the intervention period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in proportion of patient visits with an opioid prescription</measure>
    <time_frame>Six months</time_frame>
    <description>The secondary outcome is the change in proportion of patient visits in which an opioid is prescribed from baseline to the intervention period.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in morphine milligram equivalents per opioid prescription</measure>
    <time_frame>Six months</time_frame>
    <description>The change in morphine milligram equivalents per opioid prescription from baseline to the intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in mean number of opioid pills per patient-visit</measure>
    <time_frame>Six months</time_frame>
    <description>The change in the mean number of opioid pills per patient-visit from baseline to the intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in proportion of patient-visits with non-opioid pain prescription</measure>
    <time_frame>Six months</time_frame>
    <description>The change in proportion of patient-visits with non-opioid pain prescriptions (e.g., ibuprofen, acetaminophen, celecoxib, or muscle relaxants such as cyclobenzaprine, baclofen or tizanidine) from baseline to the intervention period.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">452</enrollment>
  <condition>Acute Pain</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individual Audit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinicians will receive individual audit feedback informing them of their performance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peer Comparison</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinicians will receive peer comparison feedback informing them of how their performance compares to their peers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individual Audit and Peer Comparison</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinicians will receive individual audit feedback informing them of their performance and peer comparison feedback informing them of how their performance compares to their peers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Individual audit feedback</intervention_name>
    <description>Practice sites randomly assigned to have individual audit feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period. The email will inform the clinician that the health system is doing monthly audits and provide them the number of patients in the last month for whom they prescribed 30 opioid pills per prescription or higher.</description>
    <arm_group_label>Individual Audit</arm_group_label>
    <arm_group_label>Individual Audit and Peer Comparison</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peer comparison feedback</intervention_name>
    <description>Practice sites randomly assigned to have peer comparison feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period. Data on the mean number of opioid pills per prescription and the proportion of visits with an opioid prescription will be delivered using a 3-month rolling average as follows: a) If clinician is above median: informed how their data compares to the median; b) If clinician is below median but above 10th percentile: informed how their data compares to the 10th percentile; c) If clinician is 10th percentile or below: informed of their data and commended for being a &quot;low prescriber.&quot;</description>
    <arm_group_label>Individual Audit and Peer Comparison</arm_group_label>
    <arm_group_label>Peer Comparison</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinicians&#xD;
&#xD;
             1. Practiced primarily at participating emergency department or urgent care center&#xD;
&#xD;
          -  Patients&#xD;
&#xD;
               1. Presented to a participating emergency department or urgent care center during&#xD;
                  the study period&#xD;
&#xD;
               2. Discharged to home from the visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinicians&#xD;
&#xD;
               1. Saw less than 100 patients in the prior year&#xD;
&#xD;
               2. Practiced primarily at another site that is not in the main trial&#xD;
&#xD;
               3. Did not practice at Sutter Health in the prior 90 days&#xD;
&#xD;
          -  Patients&#xD;
&#xD;
               1. Currently pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mitesh Patel, MD, MBA, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amol Navathe, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sutter Heath</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94596</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>March 4, 2020</last_update_submitted>
  <last_update_submitted_qc>March 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Opioids</keyword>
  <keyword>Nudges</keyword>
  <keyword>Emergency Medicine</keyword>
  <keyword>Urgent Care</keyword>
  <keyword>Feedback</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <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/NCT03825549
org study id: 829269
nct id: NCT03825549
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, the investigators will evaluate the effect of a health system initiative
      aiming to change clinician opioid prescribing behaviors using two behavioral economic
      interventions - individual audit feedback and peer comparison feedback of clinicians.
Opioid-related abuse and overdose represent a growing national epidemic in the United States.
      Clinician practice patterns play an important role: opioid prescriptions impact the
      likelihood that patients will misuse or become dependent on these medications, with longer
      prescriptions leading to greater sustained use. In this study, we will evaluate a Sutter
      Health System quality improvement initiative using monthly individual audit feedback and/or
      monthly peer comparison feedback to clinicians to change opioid prescribing patterns. In
      partnership with Sutter Health System, this will be conducted using randomization to evaluate
      its effect. We will also conduct a process evaluation to understand factors associated with
      better or worse performance at the clinician level.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
measure: Change in the mean number of pills per opioid prescription
time frame: Six months
description: The primary outcome is the change in the mean number of pills prescribed per opioid prescription from baseline to the intervention period.
measure: Change in proportion of patient visits with an opioid prescription
time frame: Six months
description: The secondary outcome is the change in proportion of patient visits in which an opioid is prescribed from baseline to the intervention period.
measure: Change in morphine milligram equivalents per opioid prescription
time frame: Six months
description: The change in morphine milligram equivalents per opioid prescription from baseline to the intervention period.
measure: Change in mean number of opioid pills per patient-visit
time frame: Six months
description: The change in the mean number of opioid pills per patient-visit from baseline to the intervention period.
measure: Change in proportion of patient-visits with non-opioid pain prescription
time frame: Six months
description: The change in proportion of patient-visits with non-opioid pain prescriptions (e.g., ibuprofen, acetaminophen, celecoxib, or muscle relaxants such as cyclobenzaprine, baclofen or tizanidine) from baseline to the intervention period.
arm group label: Control
arm group type: No Intervention
description: No intervention
arm group label: Individual Audit
arm group type: Experimental
description: Clinicians will receive individual audit feedback informing them of their performance.
arm group label: Peer Comparison
arm group type: Experimental
description: Clinicians will receive peer comparison feedback informing them of how their performance compares to their peers.
arm group label: Individual Audit and Peer Comparison
arm group type: Experimental
description: Clinicians will receive individual audit feedback informing them of their performance and peer comparison feedback informing them of how their performance compares to their peers.
intervention type: Behavioral
intervention name: Individual audit feedback
description: Practice sites randomly assigned to have individual audit feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period. The email will inform the clinician that the health system is doing monthly audits and provide them the number of patients in the last month for whom they prescribed 30 opioid pills per prescription or higher.
arm group label: Individual Audit
arm group label: Individual Audit and Peer Comparison
intervention type: Behavioral
intervention name: Peer comparison feedback
description: Practice sites randomly assigned to have peer comparison feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period. Data on the mean number of opioid pills per prescription and the proportion of visits with an opioid prescription will be delivered using a 3-month rolling average as follows: a) If clinician is above median: informed how their data compares to the median; b) If clinician is below median but above 10th percentile: informed how their data compares to the 10th percentile; c) If clinician is 10th percentile or below: informed of their data and commended for being a "low prescriber."
arm group label: Individual Audit and Peer Comparison
arm group label: Peer Comparison
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mitesh Patel, MD, MBA, MS
role: Principal Investigator
affiliation: University of Pennsylvania
last name: Amol Navathe, MD, PhD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acute Pain
sharing ipd: No