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

Not Applicable

Completed

• Conditions: Opioid Use
• Interventions: Behavioral: PMP Use Mandate Letter; Behavioral: Prescribing Information Letter; Behavioral: Prescribing Information + PMP Use Mandate Letter

• Registration Number: NCT04628832
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-16
• Study Start: 2021-04-15
• Primary Completion: 2021-07-12
• Study Completion: 2021-07-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12000

Inclusion Criteria

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

Exclusion Criteria

• Specialization in oncology or palliative medicine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PMP Use Mandate	PMP Use Mandate Letter	-
Prescribing Information	Prescribing Information Letter	-
Prescribing Information + PMP Use Mandate	Prescribing Information + PMP Use Mandate Letter	-

Primary Outcome Measures

Name	Time	Method
Count of Patients with Co-Prescriptions	60 days	The number of patients with co-prescriptions from the prescriber in the 60 days after the letters are sent.
Rate of Prescribers Checking PMP	60 days	Indicator for whether the prescriber checks the PMP at least once in the 60 days after the letters are sent.

Trial Locations

Locations (2)

Minnesota Management and Budget Agency; 🇺🇸 Saint Paul, Minnesota, United States

Minnesota Board of Pharmacy; 🇺🇸 Minneapolis, Minnesota, United States