E-mails to Nudge Safer and Better-Informed Prescribing of Risky Drugs

Not Applicable

Active, not recruiting

• Conditions: Opioid Prescribing; Prescription Drug Misuse
• Interventions: Behavioral: PDMP Clinical Benefit E-mail; Behavioral: PDMP Legal Mandate E-mail

• Registration Number: NCT06443385
• Lead Sponsor: Columbia University

Brief Summary

This study will test e-mails to encourage engagement with the Minnesota prescription monitoring program (PMP/PDMP) and will evaluate the effect of these e-mails on PMP/PDMP use and controlled substance prescribing.

Detailed Description

Drug overdose deaths have skyrocketed in recent years, and many overdoses continue to involve prescribed medications like opioids and stimulants. At the same time, state prescription drug monitoring programs (PDMPs), which help clinicians prescribe these medications safely, remain underused. In Minnesota, 32% of opioid prescriptions are written by clinicians who do not use the PDMP. In many states, including Minnesota, policymakers have limited tools to raise PDMP use even though it is often required under state law. To address this policy dilemma, this study will test e-mails designed to facilitate PDMP use and evaluate their effects on PDMP use and controlled substance prescribing. This study will include a projected 7,126 physician and physician assistant prescribers of opioids and other controlled substances who lack active PDMP accounts, never query the PDMP, or query the PDMP infrequently relative to their prescribing volume. To generate evidence on clinician motivation for responding to encouragement, the study will randomly vary messaging to focus on legal requirements to use the PDMP vs. clinical benefits of the PDMP.

Study Timeline

• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-05
• Study Start: 2024-07-17
• Primary Completion: 2024-09-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-04
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 7126

Inclusion Criteria

• Minnesota physician or physician assistant
• Controlled substance prescriber not following state requirements to maintain an active PDMP account, or opioid prescriber not searching the PDMP or infrequently searching the PDMP

Exclusion Criteria

• No e-mail address available

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinical Benefit Messaging	PDMP Clinical Benefit E-mail	-
Legal Mandate Messaging	PDMP Legal Mandate E-mail	-

Primary Outcome Measures

Name	Time	Method
Rate of PDMP Engagement	2 months	An indicator for increased PDMP engagement during the 2-month period after the first e-mails were sent. It will indicate whether the level of engagement rose from the baseline level that resulted in the clinician's enrollment into the study. For clinicians who lacked an account, the outcome will indicate whether they created one; for clinicians with an inactive account, the outcome will indicate whether they reactivated it. For those who never searched, it will indicate any search, and for those who rarely searched, it will indicate whether their search rate rose.
Volume of Potentially Guideline-discordant Opioid Prescribing	2 months	A composite of several measures of potentially guideline-discordant opioid prescribing. These will include: 1. Opioid co-prescriptions with other opioids; 2. Opioid co-prescriptions with benzodiazepines; 3. Opioid co-prescriptions with gabapentinoids; 4. High daily opioid doses; 5. Long-duration opioid prescriptions to opioid-naïve individuals

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States