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Application of Economics & Social Psychology to Improve Opioid Prescribing Safety (AESOPS): R21 Pilot Phase (AESOPS)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773484
Recruitment Status : Enrolling by invitation
First Posted : December 12, 2018
Last Update Posted : April 4, 2019
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Northwestern University
RAND
Sutter Health
Asante Health System
AltaMed Health Services
The Children's Clinic
Information provided by (Responsible Party):
Jason Doctor, University of Southern California

Brief Summary:
There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and an abundance of evidence of harm. The objective of the R21 pilot phase of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS) is to develop and test novel behavioral nudges to encourage adherence to pain and CDC guidelines for opioid prescribing for persons with noncancer pain. Interventions will leverage the electronic health record (EHR): Accountable Justification alerts triggered by discordant prescriptions that populate the note with provider's rationale for guideline exceptions and Active Choice (SmartSet) that are triggered by EHR workflow containing exclusively guideline concordant choices. Clinicians will also receive audit and feedback on their performance during the prior quarter as well as in comparison to other clinicians on CDC quality measures.

Condition or disease Intervention/treatment Phase
Opioid Use, Unspecified Behavioral: Accountable Justification Behavioral: Active Choice (SmartSet) Behavioral: Audit and Feedback Not Applicable

Detailed Description:
There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and an abundance of evidence of harm. In 2017, the Centers for Disease Control and Prevention (CDC) issued the "CDC Guideline for Prescribing Opioids for Chronic Pain" to encourage safe and effective alternatives to opioids, discontinuation of opioids when patients do not resume normal activities and prudent dosing strategies. However, poor guideline adherence is a general concern and may impede uptake. Our prior studies have used insights from behavioral economics and social psychology to increase guideline adherence. The objective of the R21 pilot phase of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS) is to develop and test the following novel behavioral nudges to encourage adherence to pain and CDC guidelines for opioid prescribing for persons with noncancer pain: 1) Accountable Justification alert will have clinicians enter a brief statement justifying their opioid prescription for new orders or refills. The note will then be added to the patient's medical record, 2) The Active Choice (SmartSet) alert will encourage clinicians to engage in a taper discussion with the patient and either begin a taper or justify a reason for continuing medication, 3) Audit and Feedback will provide clinicians with aggregate data on their performance relative to top-performing peers on CDC measures of interest. This information will be reported back to the clinician by mail, email or within the electronic health record. Peer comparison encourages clinician to follow the lead of top performers, as we often follow the lead of others similar to ourselves.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Application of Economics & Social Psychology to Improve Opioid Prescribing Safety (AESOPS): R21 Pilot Phase
Actual Study Start Date : March 25, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: Clinical Decision Support/Audit & Feedback
Clinical decision support nudges (Accountable Justification and Active Choice (SmartSet)) within the electronic health record and Audit and Feedback on performance. Participating clinicians will receive any of three nudges when eligibility criteria are met within a patient's chart.
Behavioral: Accountable Justification
Accountable Justification is triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions.

Behavioral: Active Choice (SmartSet)
Active Choice (SmartSet) will be triggered within the EHR for patients with long-term opioid to encourage taper discussion, increase use of nonopioid alternatives, naloxone prescriptions and urine drug testing

Behavioral: Audit and Feedback
Clinicians will receive feedback on their performance during the prior quarter as well as how they compare to other clinicians on CDC measures of interest.




Primary Outcome Measures :
  1. Changes in daily milligram morphine equivalent [ Time Frame: 6 months ]
    We will estimate daily milligram morphine equivalent for each clinician and observe the change each month. This will capture CDC guideline prescribing endpoints.


Secondary Outcome Measures :
  1. Rate of dose escalation [ Time Frame: 6 months ]
    Evaluate the transition from low to high dose prescribing



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • NM clinic that sees patients ≥ 18 years old whose leadership agrees to participate

Exclusion Criteria:

  • None

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): NCT03773484


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
University of Southern California
National Institute on Aging (NIA)
Northwestern University
RAND
Sutter Health
Asante Health System
AltaMed Health Services
The Children's Clinic
Investigators
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Principal Investigator: Jason N Doctor, PhD University of Southern California
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Responsible Party: Jason Doctor, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT03773484    
Other Study ID Numbers: HS-CG-17-00019
R21AG057395-01 ( U.S. NIH Grant/Contract )
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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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 Jason Doctor, University of Southern California:
Opioids
Behavioral Research