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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04628832
Enrollment
12000
Registered
2020-11-16
Start date
2021-04-15
Completion date
2021-07-12
Last updated
2022-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use

Keywords

opioids, prescribing, benzodiazepines, gabapentinoids, clinical guidelines, overprescribing, Benzodiazepine Use, Gabapentin Use

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.

Interventions

BEHAVIORALPMP Use Mandate Letter

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

BEHAVIORALPrescribing 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.

BEHAVIORALPrescribing 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.

Sponsors

University of Southern California
CollaboratorOTHER
Minnesota Management and Budget Agency
CollaboratorUNKNOWN
Minnesota Board of Pharmacy
CollaboratorOTHER
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Specialization in oncology or palliative medicine

Design outcomes

Primary

MeasureTime frameDescription
Count of Patients with Co-Prescriptions60 daysThe number of patients with co-prescriptions from the prescriber in the 60 days after the letters are sent.
Rate of Prescribers Checking PMP60 daysIndicator for whether the prescriber checks the PMP at least once in the 60 days after the letters are sent.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026