NCT04628832

Brief Summary

Despite an enormous policy response, opioid prescribing remains well above historical levels and harms from opioids continue to mount. Nearly all states have Prescription Monitoring Programs (PMPs) to facilitate safer prescribing of opioids and other drugs, but research suggests these systems only deliver benefits when health care professionals are required to use them. Even with PMP mandates in place, providers may be unaware of the dangers of co-prescribing opioids with benzodiazepines or gabapentinoids, which include increased risk of overdose and death. Working with the Minnesota state government, the investigators will mail letters to guideline-discordant opioid prescribers that either highlight an upcoming legally mandated requirement to check the PMP before prescribing an opioid, inform and educate providers about patients filling concurrent prescriptions and the dangers of such co-prescribing, or both. Study participants will be randomized to receive no intervention or one of the three treatment letters. Using administrative data, the investigators will track effects of the letters on not only prescribing but also PMP usage and queries. Findings form the multiplicity of treatment messages and outcomes will shed light on the mechanisms driving overprescribing. Results will inform future work by state and local policymakers to make opioid prescribing safer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2021

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

November 9, 2020

Last Update Submit

September 16, 2022

Conditions

Opioid Use

Keywords

opioidsprescribingbenzodiazepinesgabapentinoidsclinical guidelinesoverprescribingBenzodiazepine UseGabapentin Use

Outcome Measures

Primary Outcomes (2)

  • Count of Patients with Co-Prescriptions

    The number of patients with co-prescriptions from the prescriber in the 60 days after the letters are sent.

    60 days

  • Rate of Prescribers Checking PMP

    Indicator for whether the prescriber checks the PMP at least once in the 60 days after the letters are sent.

    60 days

Study Arms (4)

PMP Use Mandate

EXPERIMENTAL
Behavioral: PMP Use Mandate Letter

Prescribing Information

EXPERIMENTAL
Behavioral: Prescribing Information Letter

Prescribing Information + PMP Use Mandate

EXPERIMENTAL
Behavioral: Prescribing Information + PMP Use Mandate Letter

Control / As-Usual

NO INTERVENTION

Interventions

PMP Use Mandate LetterBEHAVIORAL

A letter with reminders about the mandate to check the PMP when prescribing opioids.

PMP Use Mandate
Prescribing Information LetterBEHAVIORAL

A letter with information about the prescriber's patients who received co-prescriptions. The letters will provide clinical background on the harms of co-prescribing and encourage prescribers to avoid co-prescribing in the future.

Prescribing Information
Prescribing Information + PMP Use Mandate LetterBEHAVIORAL

A letter combining the content of the PMP Use Mandate Letter and the Prescribing Information Letter. This letter will remind prescribers about the PMP use mandate and provide information about the prescriber's patients who received co-prescriptions.

Prescribing Information + PMP Use Mandate

Eligibility Criteria

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

You may qualify if:

  • Wrote concurrent prescription for opioids and benzodiazepines OR opioids and gabapentinoids

You may not qualify if:

  • Specialization in oncology or palliative medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Minnesota Board of Pharmacy

Minneapolis, Minnesota, 55414, United States

Location

Minnesota Management and Budget Agency

Saint Paul, Minnesota, 55155, United States

Location

Study Officials

  • Adam Sacarny, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Mireille Jacobson, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

  • David Powell, PhD

    RAND

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 16, 2020

Study Start

April 15, 2021

Primary Completion

July 12, 2021

Study Completion

July 12, 2021

Last Updated

September 19, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)