Behavioral Insights to Encourage Judicious Prescribing of Opioids

Use of Behavioral Insights to Encourage Judicious Prescribing of Opioids

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.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders
• Intervention / Treatment: Other: Letters

• Study Type: Interventional
• Enrollment (Actual): 851
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • San Diego County Medical Examiner's Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

The investigators will not be enrolling subjects. This is an evaluation of a public health intervention involving sending prescriber's factual and nonjudgmental letters, signed by the County Medical Examiner, that would state that a patient the provider had treated with controlled substances died of an opioid poisoning.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Letter intervention; The intervention arm will involve letters sent to prescribers in San Diego County.	Other: 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.
No Intervention: Control; The control group will involve prescribers not receiving letters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of CURES Use	The hypothesis is that there will be more frequent use of CURES among prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention.	12 months
Number of "New Start" Prescriptions	The hypothesis is that there will be fewer prescriptions for opioid naïve patients by prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention.	12 months

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Principal Investigator: Jason Doctor, PhD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2017
• Primary Completion (Actual): May 27, 2017
• Study Completion (Actual): February 27, 2018

Study Registration Dates

• First Submitted: May 27, 2016
• First Submitted That Met QC Criteria: June 1, 2016
• First Posted (Estimated): June 6, 2016

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Opioids; Prescribing; Safe
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: CHCF-16-00053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No