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

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04628832
• Other study ID #: AAAT2489
• Status: Completed
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: July 12, 2021

Study information

• Verified date: September 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12000
• Est. completion date: July 12, 2021
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Specialization in oncology or palliative medicine

Related Conditions & MeSH terms

• Opioid Use

Intervention

Behavioral:
• PMP Use Mandate Letter
A letter with reminders about the mandate to check the PMP when prescribing opioids.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Minnesota Board of Pharmacy	Minneapolis	Minnesota
United States	Minnesota Management and Budget Agency	Saint Paul	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Columbia University	Minnesota Board of Pharmacy, Minnesota Management and Budget Agency, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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