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Behavioral Insights to Encourage Judicious Prescribing of Opioids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02790476
Recruitment Status : Completed
First Posted : June 6, 2016
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Jason Doctor, University of Southern California

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.

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Other: Letters Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 805 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Use of Behavioral Insights to Encourage Judicious Prescribing of Opioids
Actual Study Start Date : January 27, 2017
Actual Primary Completion Date : May 27, 2017
Actual Study Completion Date : February 27, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Letter intervention
The intervention arm will involve letters sent to prescribers in San Diego County.
Other: Letters
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.

No Intervention: Control
The control group will involve prescribers not receiving letters



Primary Outcome Measures :
  1. Average change over time in dispensed narcotics [ Time Frame: 12 months ]
    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.

  2. Number of opioid prescriptions for ≥ 90 morphine milligram equivalent (MME) and > 50 MME [ Time Frame: 12 months ]
    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.

  3. Number of opioid and benzodiazepine co-prescriptions [ Time Frame: 12 months ]
    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 :
  1. Frequency of CURES use [ Time Frame: 12 months ]
    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.

  2. Number of "new start" prescriptions [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790476


Locations
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United States, California
San Diego County Medical Examiner's Office
San Diego, California, United States, 92123
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Jason Doctor, PhD University of Southern California
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Responsible Party: Jason Doctor, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02790476    
Other Study ID Numbers: CHCF-16-00053
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jason Doctor, University of Southern California:
Safe
Prescribing
Opioids
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders