- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06443385
E-mails to Nudge Safer and Better-Informed Prescribing of Risky Drugs
February 8, 2026 updated by: Adam Sacarny, PhD, Columbia University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
7872
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Irving Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Legal Mandate Messaging
|
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.
|
|
Experimental: Clinical Benefit Messaging
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 months
|
|
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:
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Adam Sacarny, PhD, Columbia University
- Principal Investigator: Mireille Jacobson, PhD, University of Southern California
- Principal Investigator: Tatyana Avilova, PhD, Bowdoin College
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2024
Primary Completion (Actual)
September 14, 2024
Study Completion (Actual)
September 24, 2025
Study Registration Dates
First Submitted
May 30, 2024
First Submitted That Met QC Criteria
June 4, 2024
First Posted (Actual)
June 5, 2024
Study Record Updates
Last Update Posted (Actual)
February 11, 2026
Last Update Submitted That Met QC Criteria
February 8, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAV1928
- AEARCTR-0013549 (Registry Identifier: AEA RCT Registry (socialscienceregistry.org))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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