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OpenTrials
Completed

NCT Number: NCT04628832

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minnesota Board of Pharmacy, Minneapolis, Minnesota, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Specialization in oncology or palliative medicine

Treatment and study plan

PMP Use Mandate Letter

Behavioral

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

Prescribing Information Letter

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 Letter

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.

Primary outcomes

  1. Count of Patients with Co-Prescriptions

    Time frame: 60 days

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

  2. Rate of Prescribers Checking PMP

    Time frame: 60 days

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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Minnesota Board of Pharmacy
  • Minnesota Management and Budget Agency
  • University of Southern California

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 16, 2020
Registry last updated
Sep 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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