- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04628832
Nudging Providers to Curtail Dangerous Opioid Prescribing: A Trial to Investigate Mechanisms
September 16, 2022 updated by: Columbia University
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
12000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55414
- Minnesota Board of Pharmacy
-
Saint Paul, Minnesota, United States, 55155
- Minnesota Management and Budget Agency
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Wrote concurrent prescription for opioids and benzodiazepines OR opioids and gabapentinoids
Exclusion Criteria:
- Specialization in oncology or palliative medicine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PMP Use Mandate
|
A letter with reminders about the mandate to check the PMP when prescribing opioids.
|
Experimental: Prescribing Information
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Count of Patients with Co-Prescriptions
Time Frame: 60 days
|
The number of patients with co-prescriptions from the prescriber in the 60 days after the letters are sent.
|
60 days
|
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.
|
60 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Adam Sacarny, PhD, Columbia University
- Principal Investigator: Mireille Jacobson, PhD, University of Southern California
- Principal Investigator: David Powell, PhD, RAND
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2021
Primary Completion (Actual)
July 12, 2021
Study Completion (Actual)
July 12, 2021
Study Registration Dates
First Submitted
November 9, 2020
First Submitted That Met QC Criteria
November 9, 2020
First Posted (Actual)
November 16, 2020
Study Record Updates
Last Update Posted (Actual)
September 19, 2022
Last Update Submitted That Met QC Criteria
September 16, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AAAT2489
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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