NCT06443385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,872

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

July 17, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2025

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

May 30, 2024

Last Update Submit

February 8, 2026

Conditions

Keywords

opioidsprescribingoverprescribingprescription drug monitoring programscontrolled substances

Outcome Measures

Primary Outcomes (2)

  • 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

  • Volume of Potentially Guideline-discordant Opioid Prescribing

    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

    2 months

Study Arms (3)

Legal Mandate Messaging

EXPERIMENTAL
Behavioral: PDMP Legal Mandate E-mail

Clinical Benefit Messaging

EXPERIMENTAL
Behavioral: PDMP Clinical Benefit E-mail

Control

NO INTERVENTION

Interventions

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.

Legal Mandate 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.

Clinical Benefit Messaging

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No e-mail address available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • Sacarny A, Avilova T, Williamson I, Merrick W, Jacobson M. Prescription Drug Monitoring Program Reminder Emails, Program Use, and Prescribing: A Randomized Clinical Trial. JAMA Health Forum. 2025 Dec 5;6(12):e255623. doi: 10.1001/jamahealthforum.2025.5623.

MeSH Terms

Conditions

Prescription Drug Misuse

Condition Hierarchy (Ancestors)

Drug MisuseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Adam Sacarny, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR
  • Mireille Jacobson, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR
  • Tatyana Avilova, PhD

    Bowdoin College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Clinicians will be assigned at random to one of three arms: PDMP legal mandate e-mails, PDMP clinical benefit emails, or a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Health Policy and Management

Study Record Dates

First Submitted

May 30, 2024

First Posted

June 5, 2024

Study Start

July 17, 2024

Primary Completion

September 14, 2024

Study Completion

September 24, 2025

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations