E-mail Nudges for Prescribing Risky Drugs

Opioid Prescribing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06443385
• Other study ID #: AAAV1928
• Secondary ID: AEARCTR-0013549
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Columbia University
• Contact: Adam Sacarny, PhD
• Phone: 914-715-0217
• Email: ajs2102[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 7126
• Est. completion date: December 31, 2025
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Misuse
• Opioid Prescribing

Intervention

Behavioral:
• PDMP Legal Mandate E-mail
E-mails highlighting the state's legal requirements to use the PDMP. There will be one initial email and one follow-up email one month later.
• PDMP Clinical Benefit E-mail
E-mails highlighting the clinical benefits of having access to the PDMP and checking the PDMP before prescribing opioids. There will be one initial email and one follow-up email one month later.

Locations

Country	Name	City	State
United States	Minnesota Board of Pharmacy	Minneapolis	Minnesota
United States	Columbia University Irving Medical Center	New York	New York
United States	Minnesota Management and Budget	Saint Paul	Minnesota

Sponsors (6)

Lead Sponsor	Collaborator
Columbia University	Abdul Latif Jameel Poverty Action Lab, Bowdoin College, Minnesota Board of Pharmacy, Minnesota Management and Budget, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of PDMP Engagement	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.	2 months
Primary	Volume of Potentially Guideline-discordant Opioid Prescribing	A composite of several measures of potentially guideline-discordant opioid prescribing. These will include: Opioid co-prescriptions with other opioids; Opioid co-prescriptions with benzodiazepines, gabapentinoids, and stimulants; High daily opioid doses; Long-duration opioid prescriptions to opioid-naïve individuals	2 months