Encouraging Judicious Prescribing of Opioids in Los Angeles County
Primary Purpose
Substance-Related Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard letter
Comparator letter
Sponsored by
About this trial
This is an interventional other trial for Substance-Related Disorders focused on measuring Opioids, Safe prescribing
Eligibility 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
Sites / Locations
- Los Angeles County Medical Examiner's Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Standard letter
Comparator letter
Arm Description
Prescribers randomized to this arm will be sent the standard letter.
Prescribers randomized to this arm will be sent the comparator letter.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT03856593
First Posted
February 25, 2019
Last Updated
March 27, 2023
Sponsor
University of Southern California
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT03856593
Brief Title
Encouraging Judicious Prescribing of Opioids in Los Angeles County
Official Title
Comparative Effectiveness of Two Letters to Encourage Judicious Prescribing of Opioids: A County-wide Project in Los Angeles
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 5, 2019 (Actual)
Primary Completion Date
August 8, 2021 (Actual)
Study Completion Date
August 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders
Keywords
Opioids, Safe prescribing
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
541 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard letter
Arm Type
Experimental
Arm Description
Prescribers randomized to this arm will be sent the standard letter.
Arm Title
Comparator letter
Arm Type
Experimental
Arm Description
Prescribers randomized to this arm will be sent the comparator letter.
Intervention Type
Behavioral
Intervention Name(s)
Standard letter
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Comparator letter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average Weekly Change in Morphine Milligram Equivalents (MME) Dispensed
Description
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).
Time Frame
52 weeks pre-letter to 4-52 weeks post-letter (excludes 0-3 weeks for washout)
Secondary Outcome Measure Information:
Title
Average Weekly Change in Valium Milligram Equivalents (VME) Dispensed.
Description
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).
Time Frame
52 weeks pre-letter and 4-52 weeks post-letter (excludes 0-3 weeks for washout)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Doctor, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles County Medical Examiner's Office
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Encouraging Judicious Prescribing of Opioids in Los Angeles County
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