Behavioral Insights to Encourage Judicious Prescribing of Opioids

NCT ID: NCT02790476

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 851 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-27
• Study Completion Date: 2018-02-27

Brief Summary

In collaboration with the San Diego Medical Examiner's Office and the State of California's controlled Substance Utilization Review and Evaluation System (CURES), the investigators propose to review opioid poisonings over the past 12 months and will send letters to prescribers in California when at least one of the provider's prescription(s) was filled by a patient who died of an opioid poisoning in San Diego County. The letters will be non-judgmental and factual, explaining that a patient of the provider who was being treated with prescription narcotics died of an opioid poisoning. The letter will also encourage judicious prescribing including use of the CURES system before prescribing. The investigators will evaluate physician prescribing practices over 24 months 12 months pre- and 12 months post-letter using data from the CURES database. The investigators' hypothesis is that letters will make the risk of opioids more cognitively available and that physicians will respond by prescribing opioids more carefully. This will result in fewer deaths due to misuse and more frequent use of the CURES system.

Conditions

Substance-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Letter intervention

The intervention arm will involve letters sent to prescribers in San Diego County.

Group Type: EXPERIMENTAL

Letters

Intervention Type: OTHER

The letters will be factual and nonjudgmental, signed by the County Medical Examiner, and would state that a patient they had treated with controlled substances died of an opioid poisoning. The letter will encourage judicious prescribing, and will provide information developed by an advisory group: how to identify and taper unsafe regimens (high dose, polypharmacy, or use of multiple prescribers); how to identify addiction and compassionately refer patients for medication-assisted treatment; and recommendations to avoid bad outcomes (e.g. "do not fire your patient for signs of addiction.") The letter would also encourage use of the CURES system before prescribing, as well as co-prescribing of naloxone.

Control

The control group will involve prescribers not receiving letters

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Letters

The letters will be factual and nonjudgmental, signed by the County Medical Examiner, and would state that a patient they had treated with controlled substances died of an opioid poisoning. The letter will encourage judicious prescribing, and will provide information developed by an advisory group: how to identify and taper unsafe regimens (high dose, polypharmacy, or use of multiple prescribers); how to identify addiction and compassionately refer patients for medication-assisted treatment; and recommendations to avoid bad outcomes (e.g. "do not fire your patient for signs of addiction.") The letter would also encourage use of the CURES system before prescribing, as well as co-prescribing of naloxone.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Prescribers in California for whom at least one of their prescription(s) was filled by a patient who died of an opioid poisoning in San Diego County

Exclusion Criteria

• Prescriber is licensed outside the State of California and does not hold a California license, but the prescription was filled in California
• The prescriber does not have a CURES report on record
• The prescriber has issued only one opioid prescription in the last 12 months since the time of the deceased death (and the prescription was to the deceased)
• Prescribers with unknown Drug Enforcement Agency number

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Jason Doctor

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Doctor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

San Diego County Medical Examiner's Office

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CHCF-16-00053

Identifier Type: -

Identifier Source: org_study_id