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A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing (REDUCE)

Primary Purpose

Acute Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Individual audit feedback
Peer comparison feedback
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Pain focused on measuring Opioids, Nudges, Emergency Medicine, Urgent Care, Feedback

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinicians

    1. Practiced primarily at participating emergency department or urgent care center

  • Patients

    1. Presented to a participating emergency department or urgent care center during the study period
    2. Discharged to home from the visit

Exclusion Criteria:

  • Clinicians

    1. Saw less than 100 patients in the prior year
    2. Practiced primarily at another site that is not in the main trial
    3. Did not practice at Sutter Health in the prior 90 days
  • Patients

    1. Currently pregnant

Sites / Locations

  • Sutter Heath

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

Individual Audit

Peer Comparison

Individual Audit and Peer Comparison

Arm Description

No intervention

Clinicians will receive individual audit feedback informing them of their performance.

Clinicians will receive peer comparison feedback informing them of how their performance compares to their peers.

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.

Outcomes

Primary Outcome Measures

Change in the mean number of pills per opioid prescription
The primary outcome is the change in the mean number of pills prescribed per opioid prescription from baseline to the intervention period.

Secondary Outcome Measures

Change in proportion of patient visits with an opioid prescription
The secondary outcome is the change in proportion of patient visits in which an opioid is prescribed from baseline to the intervention period.

Full Information

First Posted
January 17, 2019
Last Updated
March 4, 2020
Sponsor
University of Pennsylvania
Collaborators
Donaghue Medical Research Foundation, Sutter Health
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1. Study Identification

Unique Protocol Identification Number
NCT03825549
Brief Title
A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing
Acronym
REDUCE
Official Title
A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
March 2, 2020 (Actual)
Study Completion Date
March 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Donaghue Medical Research Foundation, Sutter Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
Opioids, Nudges, Emergency Medicine, Urgent Care, Feedback

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
452 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Individual Audit
Arm Type
Experimental
Arm Description
Clinicians will receive individual audit feedback informing them of their performance.
Arm Title
Peer Comparison
Arm Type
Experimental
Arm Description
Clinicians will receive peer comparison feedback informing them of how their performance compares to their peers.
Arm Title
Individual Audit and Peer Comparison
Arm Type
Experimental
Arm 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(s)
Individual audit feedback
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Peer comparison feedback
Intervention 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."
Primary Outcome Measure Information:
Title
Change in the mean number of pills per opioid prescription
Description
The primary outcome is the change in the mean number of pills prescribed per opioid prescription from baseline to the intervention period.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Change in proportion of patient visits with an opioid prescription
Description
The secondary outcome is the change in proportion of patient visits in which an opioid is prescribed from baseline to the intervention period.
Time Frame
Six months
Other Pre-specified Outcome Measures:
Title
Change in morphine milligram equivalents per opioid prescription
Description
The change in morphine milligram equivalents per opioid prescription from baseline to the intervention period.
Time Frame
Six months
Title
Change in mean number of opioid pills per patient-visit
Description
The change in the mean number of opioid pills per patient-visit from baseline to the intervention period.
Time Frame
Six months
Title
Change in proportion of patient-visits with non-opioid pain prescription
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.
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinicians 1. Practiced primarily at participating emergency department or urgent care center Patients Presented to a participating emergency department or urgent care center during the study period Discharged to home from the visit Exclusion Criteria: Clinicians Saw less than 100 patients in the prior year Practiced primarily at another site that is not in the main trial Did not practice at Sutter Health in the prior 90 days Patients Currently pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitesh Patel, MD, MBA, MS
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amol Navathe, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sutter Heath
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing

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