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Clinical Trials/NCT06443385
NCT06443385
Completed
N/A

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

Columbia University1 site in 1 country7,872 target enrollmentJuly 17, 2024

Overview

Phase
N/A
Intervention
PDMP Legal Mandate E-mail
Conditions
Opioid Prescribing
Sponsor
Columbia University
Enrollment
7872
Locations
1
Primary Endpoint
Rate of PDMP Engagement
Status
Completed
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 17, 2024
End Date
September 24, 2025
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adam Sacarny, PhD

Associate Professor of Health Policy and Management

Columbia University

Eligibility Criteria

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

Arms & Interventions

Legal Mandate Messaging

Intervention: PDMP Legal Mandate E-mail

Clinical Benefit Messaging

Intervention: PDMP Clinical Benefit E-mail

Control

Outcomes

Primary Outcomes

Rate of PDMP Engagement

Time Frame: 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

Time Frame: 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

Study Sites (1)

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