Skip to main content
Clinical Trials/NCT03856593
NCT03856593CompletedNot Applicable

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

University of Southern California1 site in 1 country541 target enrollmentStarted: April 5, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
541
Locations
1
Primary Endpoint
Average Weekly Change in Morphine Milligram Equivalents (MME) Dispensed

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Arms & Interventions

Standard letter

Experimental

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

Intervention: Standard letter (Behavioral)

Comparator letter

Experimental

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

Intervention: Comparator letter (Behavioral)

Outcomes

Primary Outcomes

Average Weekly Change in Morphine Milligram Equivalents (MME) Dispensed

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

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).

Secondary Outcomes

  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jason Doctor

Professor

University of Southern California

Study Sites (1)

Loading locations...

Similar Trials