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Behavioral Insights to Encourage Judicious Prescribing of Opioids

Primary Purpose

Substance-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Letters
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Substance-Related Disorders focused on measuring Safe, Prescribing, Opioids

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 San Diego 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 DEA

Sites / Locations

  • San Diego County Medical Examiner's Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Letter intervention

Control

Arm Description

The intervention arm will involve letters sent to prescribers in San Diego County.

The control group will involve prescribers not receiving letters

Outcomes

Primary Outcome Measures

Average change over time in dispensed narcotics
The hypothesis is that the average change over time in dispensed narcotic represented as monthly morphine milligram equivalent (MME) dose will be larger for prescribers receiving the letter intervention, compared to the average change over time for the control prescribers not receiving the letter intervention.
Number of opioid prescriptions for ≥ 90 morphine milligram equivalent (MME) and > 50 MME
The hypothesis is that there will be fewer opioid prescriptions both at a dose ≥ 90 morphine milligram equivalent (MME) and at a dose > 50 MME among prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention.
Number of opioid and benzodiazepine co-prescriptions
The hypothesis is that there will be fewer opioid and benzodiazepine co-prescriptions for prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention.

Secondary Outcome Measures

Frequency of CURES use
The hypothesis is that there will be more frequent use of CURES among prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention.
Number of "new start" prescriptions
The hypothesis is that there will be fewer prescriptions for opioid naïve patients by prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention.

Full Information

First Posted
May 27, 2016
Last Updated
February 6, 2019
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT02790476
Brief Title
Behavioral Insights to Encourage Judicious Prescribing of Opioids
Official Title
Use of Behavioral Insights to Encourage Judicious Prescribing of Opioids
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 27, 2017 (Actual)
Primary Completion Date
May 27, 2017 (Actual)
Study Completion Date
February 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

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 San Diego 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 the past 12 months and will 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 San Diego 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 letter 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. This will result 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
Safe, Prescribing, Opioids

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
805 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Letter intervention
Arm Type
Experimental
Arm Description
The intervention arm will involve letters sent to prescribers in San Diego County.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will involve prescribers not receiving letters
Intervention Type
Other
Intervention Name(s)
Letters
Intervention Description
The letters will be factual and nonjudgmental, signed by the County Medical Examiner, and would state that a patient they had treated with controlled substances died of an opioid poisoning. The letter will encourage judicious prescribing, and will provide information developed by an advisory group: how to identify and taper unsafe regimens (high dose, polypharmacy, or use of multiple prescribers); how to identify addiction and compassionately refer patients for medication-assisted treatment; and recommendations to avoid bad outcomes (e.g. "do not fire your patient for signs of addiction.") The letter would also encourage use of the CURES system before prescribing, as well as co-prescribing of naloxone.
Primary Outcome Measure Information:
Title
Average change over time in dispensed narcotics
Description
The hypothesis is that the average change over time in dispensed narcotic represented as monthly morphine milligram equivalent (MME) dose will be larger for prescribers receiving the letter intervention, compared to the average change over time for the control prescribers not receiving the letter intervention.
Time Frame
12 months
Title
Number of opioid prescriptions for ≥ 90 morphine milligram equivalent (MME) and > 50 MME
Description
The hypothesis is that there will be fewer opioid prescriptions both at a dose ≥ 90 morphine milligram equivalent (MME) and at a dose > 50 MME among prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention.
Time Frame
12 months
Title
Number of opioid and benzodiazepine co-prescriptions
Description
The hypothesis is that there will be fewer opioid and benzodiazepine co-prescriptions for prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Frequency of CURES use
Description
The hypothesis is that there will be more frequent use of CURES among prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention.
Time Frame
12 months
Title
Number of "new start" prescriptions
Description
The hypothesis is that there will be fewer prescriptions for opioid naïve patients by prescribers receiving the letter intervention, compared to control prescribers not receiving the letter intervention.
Time Frame
12 months

10. Eligibility

Sex
All
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 San Diego 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 DEA
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
San Diego County Medical Examiner's Office
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Behavioral Insights to Encourage Judicious Prescribing of Opioids

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