CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 541 enrolled
Drug / intervention
Standard letter +1 morebehavioral
Likely dose
Not stated in record
Key inclusion· 3
  • Prescriber must be licensed in California
  • Prescriber had at least one prescription filled by a patient who died of opioid poisoning in Los Angeles County
  • Prescriber must have a CURES report on record
Key exclusion· 4
  • Prescriber licensed only outside California (without California license) even if prescription was filled in California
  • Prescriber does not have a CURES report on record
  • Prescriber issued only one opioid prescription in the last 12 months since the time of the deceased death, and that prescription was to the deceased
  • Prescriptions with unknown Drug Enforcement Agency (DEA) number

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03856593
NCT03856593N/ACompleted

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

University of Southern California·interventional·Posted Feb 27, 2019·Updated Mar 28, 2023

In Brief

A clinical study evaluating Standard letter and Comparator letter for Substance-Related Disorders. Completed, enrolled 541 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 27, 2019
Enrollment StartApr 5, 2019
Primary CompletionAug 8, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.3 years ago

Interventions

Standard letterbehavioral

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 letterbehavioral

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.