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

• ClinicalTrials.gov Identifier: NCT04628832
• Recruitment Status: Completed
• First Posted: November 16, 2020
• Last Update Posted: September 19, 2022
• Sponsor: Columbia University
• Collaborators: University of Southern California; Minnesota Management and Budget Agency; Minnesota Board of Pharmacy
• Information provided by (Responsible Party): Columbia University

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Study Start Date: April 15, 2021
• Actual Primary Completion Date: July 12, 2021
• Actual Study Completion Date: July 12, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Minnesota

Minnesota Board of Pharmacy

Minneapolis, Minnesota, United States, 55414

Minnesota Management and Budget Agency

Saint Paul, Minnesota, United States, 55155

Sponsors and Collaborators

Columbia University

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

More Information

• Responsible Party: Columbia University
• ClinicalTrials.gov Identifier: NCT04628832
• Other Study ID Numbers: AAAT2489
• First Posted: November 16, 2020
• Last Update Posted: September 19, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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