Nudging Providers to Curtail Dangerous Opioid Prescribing: A Trial to Investigate Mechanisms

NCT ID: NCT04628832

Last Updated: 2022-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2021-07-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PMP Use Mandate

Group Type EXPERIMENTAL

PMP Use Mandate Letter

Intervention Type BEHAVIORAL

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

Prescribing Information

Group Type EXPERIMENTAL

Prescribing Information Letter

Intervention Type BEHAVIORAL

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 + PMP Use Mandate

Group Type EXPERIMENTAL

Prescribing Information + PMP Use Mandate Letter

Intervention Type BEHAVIORAL

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.

Control / As-Usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PMP Use Mandate Letter

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

Intervention Type BEHAVIORAL

Prescribing Information Letter

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.

Intervention Type BEHAVIORAL

Prescribing Information + PMP Use Mandate Letter

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Specialization in oncology or palliative medicine
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Southern California

OTHER

Sponsor Role collaborator

Minnesota Management and Budget Agency

UNKNOWN

Sponsor Role collaborator

Minnesota Board of Pharmacy

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Adam Sacarny, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Mireille Jacobson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

David Powell, PhD

Role: PRINCIPAL_INVESTIGATOR

RAND

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Minnesota Board of Pharmacy

Minneapolis, Minnesota, United States

Site Status

Minnesota Management and Budget Agency

Saint Paul, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AAAT2489

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Over-the-Counter Medication Usage
NCT00439348 COMPLETED NA
Safe Prescription of Opioids in Primary Care
NCT05577026 ACTIVE_NOT_RECRUITING NA
Medication Use and Quality of Life Among Older People
NCT05123313 ACTIVE_NOT_RECRUITING NA
RxConnect User Testing Study
NCT05493072 COMPLETED NA