Encouraging Judicious Prescribing of Opioids in Los Angeles County

Substance-Related Disorders Clinical Trial

Official title:

Comparative Effectiveness of Two Letters to Encourage Judicious Prescribing of Opioids: A County-wide Project in Los Angeles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03856593
• Other study ID #: UP-19-00172
• Secondary ID: P30AG024968
• Status: Completed
• Phase: N/A
• Start date: April 5, 2019
• Est. completion date: August 8, 2021

Study information

• Verified date: March 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 541
• Est. completion date: August 8, 2021
• Est. primary completion date: August 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Los Angeles 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)
• Prescriptions with unknown Drug Enforcement Agency (DEA) number

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

Behavioral:
• Standard letter
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.
• Comparator letter
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.

Locations

Country	Name	City	State
United States	Los Angeles County Medical Examiner's Office	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Average Weekly Change in Valium Milligram Equivalents (VME) Dispensed.	Difference in average weekly VME 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 and 4-52 weeks post-letter (excludes 0-3 weeks for washout)