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Trial record 46 of 46 for:    CYCLOBENZAPRINE

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

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ClinicalTrials.gov Identifier: NCT03825549
Recruitment Status : Enrolling by invitation
First Posted : January 31, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborators:
Donaghue Medical Research Foundation
Sutter Health
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Acute Pain Behavioral: Individual audit feedback Behavioral: Peer comparison feedback Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing
Actual Study Start Date : September 3, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
No Intervention: Control
No intervention
Experimental: Individual Audit
Clinicians will receive individual audit feedback informing them of their performance.
Behavioral: Individual audit feedback
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.

Experimental: Peer Comparison
Clinicians will receive peer comparison feedback informing them of how their performance compares to their peers.
Behavioral: Peer comparison feedback
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."

Experimental: Individual Audit and Peer Comparison
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.
Behavioral: Individual audit feedback
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.

Behavioral: Peer comparison feedback
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 Measures :
  1. Change in the mean number of pills per opioid prescription [ Time Frame: Six months ]
    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 :
  1. Change in proportion of patient visits with an opioid prescription [ Time Frame: Six months ]
    The secondary outcome is the change in proportion of patient visits in which an opioid is prescribed from baseline to the intervention period.


Other Outcome Measures:
  1. Change in morphine milligram equivalents per opioid prescription [ Time Frame: Six months ]
    The change in morphine milligram equivalents per opioid prescription from baseline to the intervention period.

  2. Change in mean number of opioid pills per patient-visit [ Time Frame: Six months ]
    The change in the mean number of opioid pills per patient-visit from baseline to the intervention period.

  3. Change in proportion of patient-visits with non-opioid pain prescription [ Time Frame: Six months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825549


Locations
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United States, California
Sutter Heath
Walnut Creek, California, United States, 94596
Sponsors and Collaborators
University of Pennsylvania
Donaghue Medical Research Foundation
Sutter Health
Investigators
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Principal Investigator: Mitesh Patel, MD, MBA, MS University of Pennsylvania
Principal Investigator: Amol Navathe, MD, PhD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03825549     History of Changes
Other Study ID Numbers: 829269
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
Opioids
Nudges
Emergency Medicine
Urgent Care
Feedback
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents