Encouraging Judicious Prescribing of Opioids in Los Angeles County

NCT03856593 | Completed Results

• 2 other identifiers: UP-19-00172P30AG024968
• Study Type: interventional
• Target: 541
• Locations: 1 country
• Sites: 1

Brief Summary

In collaboration with the Los Angeles County 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 12 months and 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 Los Angeles 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 letters 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, resulting in fewer deaths due to misuse and more frequent use of the CURES system.

Conditions

Substance-Related Disorders

Keywords

Opioids; Safe prescribing

Outcome Measures

Primary Outcomes (1)

• Average Weekly Change in Morphine Milligram Equivalents (MME) Dispensed

  Difference in average weekly MME dispensed 52 weeks pre-letter to 4-52 (excludes 0-3 weeks for washout) post-letter. Measure of interest is the difference in the above measure between prescribers randomized to the standard letter and the comparator letter, referred to as the difference-in-difference (interaction coefficient).

  52 weeks pre-letter to 4-52 weeks post-letter (excludes 0-3 weeks for washout)

Secondary Outcomes (1)

• Average Weekly Change in Valium Milligram Equivalents (VME) Dispensed.

  52 weeks pre-letter and 4-52 weeks post-letter (excludes 0-3 weeks for washout)

Study Arms (2)

Standard letter

EXPERIMENTAL

Prescribers randomized to this arm will be sent the standard letter.

Behavioral: Standard letter

Comparator letter

EXPERIMENTAL

Prescribers randomized to this arm will be sent the comparator letter.

Behavioral: Comparator letter

Interventions

Standard letter BEHAVIORAL

The standard letter will be signed by the Chief Medical Examiner-Coroner and County Health Officer of Los Angeles County to notify prescribers of the death in their practice. The letter includes the decedent's name, date of birth and date of death, and outlines the annual number and types of prescription drug deaths seen by the medical examiner, discusses the value of and way to access the State's prescription drug monitoring program and includes five Centers for Disease Control and Prevention (CDC) guideline-recommended safe prescribing strategies: 1) Avoid co-prescribing of opioids with benzodiazepines, 2) prescribe minimal dose necessary for acute pain, 3) consider slow tapers with pauses to below 50 morphine milligram equivalents (MME) per day, 4) avoid prescriptions lasting greater than 3-months for pain, and 5) prescribe naloxone in conjunction with opioids for patients taking \> 50 MME per day. The letter also states that CURES review is required by law as of October 2, 2018.

Standard letter

Comparator letter BEHAVIORAL

The comparator letter includes all the details in the standard letter plus additional text involving an "if/when/then statement" along with an injunction to providers to share safety information with patients so that they identify as a "safe prescriber." Specifically, the additional text reads as follows: When your next patient presents with pain, keep the above 5 recommendations close at hand to assist with their safe care. Also, be comfortable voicing your concern about prescribing safety with them so that they are also aware of the dangers scheduled drugs may carry. "If/when/then" is a form of "pre-suasion" that provides simple rules that tie goals to specific actions and has been used successfully to encourage behavior in many areas including medication adherence and drug abuse rehabilitation.

Comparator letter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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 Los Angeles 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)
• Prescriptions with unknown Drug Enforcement Agency (DEA) number

Sponsors & Collaborators

• University of Southern California: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Los Angeles County Medical Examiner's Office

Los Angeles, California, 90033, United States

Location

Related Publications (1)

• Doctor JN, Kelley MA, Goldstein NJ, Lucas J, Knight T, Stewart EP. A randomized trial looking at planning prompts to reduce opioid prescribing. Nat Commun. 2024 Jan 12;15(1):263. doi: 10.1038/s41467-023-44573-5.

  PMID: 38216566 DERIVED

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: Yes

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: Professor

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 27, 2019
• Study Start: April 5, 2019
• Primary Completion: August 8, 2021
• Study Completion: August 8, 2021
• Last Updated: March 28, 2023
• Results First Posted: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)