NCT04628832

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

Completed NA Last updated 19 September 2022

What this trial tests

NA trial testing PMP Use Mandate Letter in Opioid Use in 12,000 participants. Completed in 12 July 2021.

Timeline

15 April 2021

Primary endpoint
12 July 2021

12 July 2021

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	12,000
Start date	15 April 2021
Primary completion	12 July 2021
Estimated completion	12 July 2021
Sites	2 locations across United States

Drugs / interventions tested

• PMP Use Mandate Letter
• Prescribing Information Letter
• Prescribing Information + PMP Use Mandate Letter

Conditions studied

• Opioid Use — all drugs for Opioid Use →

Sponsor

Columbia University

Who can join

Eligibility, any sex, with Opioid Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Healthcare Practitioner and Other Professionals' Perspectives on Gabapentinoid Misuse and Dependence: A Systematic Review of Qualitative Studies.
   McNeilage AG, Browne E, Nielsen S, Ashton-James CE, et al · · 2025 · cited 1× · PMID 40891219 · DOI 10.1002/ejp.70116