Behavioral Insights to Encourage Judicious Prescribing of Opioids

NCT02790476 | Completed Results

• 1 other identifier: CHCF-16-00053
• Study Type: interventional
• Target: 851
• Locations: 1 country
• Sites: 1

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

Keywords

Safe; Prescribing; Opioids

Outcome Measures

Primary Outcomes (3)

• Average Change Over Time in Dispensed Narcotics

  The hypothesis is that the average change over time in dispensed narcotic represented as monthly morphine milligram equivalent (MME) dose will be larger for prescribers receiving the letter intervention, compared to the average change over time for the control prescribers not receiving the letter intervention.

  12 months

• Number of Opioid Prescriptions for > 90 Morphine Milligram Equivalent (MME) and ≥ 50 MME

  The hypothesis is that there will be fewer opioid prescriptions both at a dose \> 90 morphine milligram equivalent (MME) and at a dose ≥ 50 MME among prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention.

  12 months

• Number of Opioid and Benzodiazepine Co-prescriptions

  The hypothesis is that there will be fewer opioid and benzodiazepine co-prescriptions for prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention.

  12 months

Secondary Outcomes (2)

• Frequency of CURES Use

  12 months

• Number of "New Start" Prescriptions

  12 months

Study Arms (2)

Letter intervention

EXPERIMENTAL

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

Other: Letters

Control

NO INTERVENTION

The control group will involve prescribers not receiving letters

Interventions

Letters 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.

Letter intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

San Diego County Medical Examiner's Office

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Jason Doctor
• Organization: University of Southern California

jdoctor@usc.edu

213.821.8142

Study Officials

• Jason Doctor, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 6, 2016
• Study Start: January 27, 2017
• Primary Completion: May 27, 2017
• Study Completion: February 27, 2018
• Last Updated: April 29, 2024
• Results First Posted: April 29, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)