ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized Study of Electronic Health Record Defaults and Comparison Feedback to Effectively Decrease Opioid Prescription Pill Burden (REDUCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03825549
Recruitment Status : Not yet recruiting
First Posted : January 31, 2019
Last Update Posted : February 5, 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 - default options and social comparison feedback on performance to clinicians.

Condition or disease Intervention/treatment Phase
Acute Pain Behavioral: Opioid prescription default Behavioral: Social 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 electronic health record default options and monthly social 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.

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 Study of Electronic Health Record Defaults and Using Social Comparison Feedback to Effectively Decrease Opioid Prescription Pill Burden
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
No Intervention: Control
No intervention
Experimental: Default
Clinicians' electronic health record will be updated with a preference list which includes an opioid prescription default of 10 pills per prescription.
Behavioral: Opioid prescription default
Clinicians randomly assigned to have changes to opioid prescription default will have prescriptions for short-acting opioids that are set to 10 pills displayed at the top of their electronic preference list. Their initial preference list of opioids will remain but be shown below the new list of prescriptions that have 10 pills as the default.

Experimental: Comparison
Clinicians will receive social comparison feedback informing them of how their performance compares to their peers.
Behavioral: Social comparison feedback
Practice sites randomly assigned to have social comparison feedback will be sent information by email to each clinician at the site each month for one year. 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 below median: informed how their data compares to the median; b) If clinician is above median but below 90th percentile: informed how their data compares to the 90th percentile; c) If clinician is 90th percentile or above: informed of their data and commended for being a "low prescriber."

Experimental: Default and Comparison
Clinicians' electronic health record will be updated with a preference list which includes an opioid prescription default of 10 pills per prescription. Clinicians will receive social comparison feedback informing them of how their performance compares to their peers.
Behavioral: Opioid prescription default
Clinicians randomly assigned to have changes to opioid prescription default will have prescriptions for short-acting opioids that are set to 10 pills displayed at the top of their electronic preference list. Their initial preference list of opioids will remain but be shown below the new list of prescriptions that have 10 pills as the default.

Behavioral: Social comparison feedback
Practice sites randomly assigned to have social comparison feedback will be sent information by email to each clinician at the site each month for one year. 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 below median: informed how their data compares to the median; b) If clinician is above median but below 90th percentile: informed how their data compares to the 90th percentile; c) If clinician is 90th percentile or above: 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: One year ]
    The primary outcome is the change in the mean number of pills prescribed per opioid prescription from baseline to the end of the intervention period.


Secondary Outcome Measures :
  1. Change in proportion of patient visits with an opioid prescription [ Time Frame: One year ]
    The secondary outcome is the change in proportion of patient visits in which an opioid is prescribed from baseline to the end of the intervention period.


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

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

  3. Change in proportion of patient-visits with non-opioid pain prescription [ Time Frame: One year ]
    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 end of the intervention period.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

Clinicians

- 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


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


Contacts
Contact: Mitesh Patel, MD, MBA, MS 215-898-3367 mpatel@pennmedicine.upenn.edu

Locations
United States, California
Sutter Heath Not yet recruiting
Walnut Creek, California, United States, 94596
Contact: Sherry Yan, Phd       YanSX@sutterhealth.org   
Sponsors and Collaborators
University of Pennsylvania
Donaghue Medical Research Foundation
Sutter Health
Investigators
Principal Investigator: Mitesh Patel, MD, MBA, MS University of Pennsylvania
Principal Investigator: Amol Navathe, MD, PhD University of Pennsylvania

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: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents