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Nudging Providers to Curtail Dangerous Opioid Prescribing: A Trial to Investigate Mechanisms

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: NCT04628832
Recruitment Status : Not yet recruiting
First Posted : November 16, 2020
Last Update Posted : November 17, 2020
Sponsor:
Collaborators:
University of Southern California
Minnesota Management and Budget Agency
Minnesota Board of Pharmacy
Information provided by (Responsible Party):
Columbia University

Brief Summary:
Despite an enormous policy response, opioid prescribing remains well above historical levels and harms from opioids continue to mount. Nearly all states have Prescription Monitoring Programs (PMPs) to facilitate safer prescribing of opioids and other drugs, but research suggests these systems only deliver benefits when health care professionals are required to use them. Even with PMP mandates in place, providers may be unaware of the dangers of co-prescribing opioids with benzodiazepines or gabapentinoids, which include increased risk of overdose and death. Working with the Minnesota state government, the investigators will mail letters to guideline-discordant opioid prescribers that either highlight an upcoming legally mandated requirement to check the PMP before prescribing an opioid, inform and educate providers about patients filling concurrent prescriptions and the dangers of such co-prescribing, or both. Study participants will be randomized to receive no intervention or one of the three treatment letters. Using administrative data, the investigators will track effects of the letters on not only prescribing but also PMP usage and queries. Findings form the multiplicity of treatment messages and outcomes will shed light on the mechanisms driving overprescribing. Results will inform future work by state and local policymakers to make opioid prescribing safer.

Condition or disease Intervention/treatment Phase
Opioid Use Behavioral: PMP Use Mandate Letter Behavioral: Prescribing Information Letter Behavioral: Prescribing Information + PMP Use Mandate Letter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Nudging Providers to Curtail Dangerous Opioid Prescribing: A Trial to Investigate Mechanisms
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Experimental: PMP Use Mandate Behavioral: PMP Use Mandate Letter
A letter with reminders about the mandate to check the PMP when prescribing opioids.

Experimental: Prescribing Information Behavioral: Prescribing Information Letter
A letter with information about the prescriber's patients who received co-prescriptions. The letters will provide clinical background on the harms of co-prescribing and encourage prescribers to avoid co-prescribing in the future.

Experimental: Prescribing Information + PMP Use Mandate Behavioral: Prescribing Information + PMP Use Mandate Letter
A letter combining the content of the PMP Use Mandate Letter and the Prescribing Information Letter. This letter will remind prescribers about the PMP use mandate and provide information about the prescriber's patients who received co-prescriptions.

No Intervention: Control / As-Usual



Primary Outcome Measures :
  1. Rate of Prescribers Checking PMP [ Time Frame: 60 days ]
    Indicator for whether the prescriber checks the PMP at least once in the 60 days after the letters are sent.

  2. Rate of Prescribers Avoiding Co-prescriptions [ Time Frame: 60 days ]
    Indicator for whether the prescriber is responsible for zero co-prescriptions in the 60 days after the letters are sent.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Wrote concurrent prescription for opioids and benzodiazepines OR opioids and gabapentinoids

Exclusion Criteria:

  • Specialization in oncology or palliative medicine

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): NCT04628832


Contacts
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Contact: Adam Sacarny, PhD 212-305-7084 ajs2102@columbia.edu

Locations
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United States, Minnesota
Minnesota Board of Pharmacy
Minneapolis, Minnesota, United States, 55414
Contact: Barbara A Carter       barbara.a.carter@state.mn.us   
Minnesota Management and Budget Agency
Saint Paul, Minnesota, United States, 55155
Contact: Weston Merrick, MPA       weston.merrick@state.mn.us   
Sub-Investigator: Ian Williamson, MBA         
Sponsors and Collaborators
Columbia University
University of Southern California
Minnesota Management and Budget Agency
Minnesota Board of Pharmacy
Investigators
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Principal Investigator: Adam Sacarny, PhD Columbia University
Principal Investigator: Mireille Jacobson, PhD University of Southern California
Principal Investigator: David Powell, PhD RAND
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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT04628832    
Other Study ID Numbers: AAAT2489
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
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 Columbia University:
opioids
prescribing
benzodiazepines
gabapentinoids
clinical guidelines
overprescribing
Benzodiazepine Use
Gabapentin Use