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

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: Opioid Use
• Intervention / Treatment: Behavioral: PMP Use Mandate Letter; Behavioral: Prescribing Information Letter; Behavioral: Prescribing Information + PMP Use Mandate Letter

• Study Type: Interventional
• Enrollment (Actual): 12000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Minnesota Board of Pharmacy
    • Saint Paul, Minnesota, United States, 55155
      • Minnesota Management and Budget Agency

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of Patients with Co-Prescriptions	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	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

• Sponsor: Columbia University
• Collaborators: University of Southern California; Minnesota Management and Budget Agency; Minnesota Board of Pharmacy
• 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

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: benzodiazepines; opioids; clinical guidelines; prescribing; gabapentinoids; overprescribing; Benzodiazepine Use; Gabapentin Use
• 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