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Reducing Concurrent Opioid-Benzodiazepine Prescriptions

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03887247
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : December 9, 2019
Sponsor:
Collaborators:
United States Department of Defense
General Services Administration (GSA)
Information provided by (Responsible Party):
Walter Reed National Military Medical Center

Brief Summary:
The purpose of this effort is to use informative e-mails to improve the process of prescribing of opioids and benzodiazepines within the National Capital Region/Military Health System (NCR/MHS), with the aim of decreasing concurrent opioid and benzodiazepine prescribing.

Condition or disease Intervention/treatment Phase
Adverse Drug Effect of Opioids Adverse Drug Effect of Benzodiazepines Behavioral: E-mail Alert Not Applicable

Detailed Description:

The purpose of this effort is to use low-cost informative e-mails to improve the process of prescribing of opioids and benzodiazepines within the National Capital Region/Military Health System (NCR/MHS), with the aim of decreasing concurrent opioid and benzodiazepine prescribing. Both the VA/DoD Clinical Practice Guideline for Opioid Therapy for Chronic Pain (2017) and the CDC Guideline for Prescribing Opioids for Chronic Pain (2016) strongly recommend against the concurrent use of opioids and benzodiazepines. Taken together, these drugs could cause respiratory depression, enhanced sedation, and death. The intervention population will be prescribers and primary care managers associated with patients who have recently received concurrent prescriptions of opioids and benzodiazepines. Using a randomized approach, we will allocate the NCR/MHS providers associated with patients with concurrent prescriptions for opioids and benzodiazepines to one of two conditions:

  1. E-mail alert - A messaging approach, in which we will send encrypted emails to the patient's opioid and benzodiazepine prescriber(s) and primary care manager that identify the concurrent prescriptions and detail the patient's prescription history, inform them of the VA/DoD guideline and risk to patient, and provide action steps and relevant resources. When multiple providers are involved, the email message will also encourage coordination across providers and provide relevant contact information
  2. As-Usual - An as-usual approach, in which providers are not sent messages. These providers can access patient information through the MHS Opioid Registry as before.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Reducing Concurrent Opioid-Benzodiazepine Prescriptions Through Provider Intervention
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : June 5, 2020
Estimated Study Completion Date : June 5, 2021

Arm Intervention/treatment
Active Comparator: E-Mail Alert
Send email to the patient's opioid prescriber(s), benzodiazepine prescriber(s), and/or primary care manager.
Behavioral: E-mail Alert
Encrypted email to the following providers: the patient's opioid prescriber(s), benzodiazepine prescriber(s), and/or primary care manager. If there is more than one provider, they are copied together on the same message. The email identifies the concurrent prescriptions, details the patient's prescription history, includes relevant VA/DoD guidelines, states the risk of concurrent prescribing to patient, and provides action steps and relevant resources. When multiple providers are involved, the message encourages the providers to coordinate with each other and provides provider contact information to facilitate this communication.

No Intervention: As-Usual
As-usual (no email) approach.



Primary Outcome Measures :
  1. Overlapping Days [ Time Frame: 90 days ]
    Overlapping days of opioids and benzodiazepines, determined using the dates of service and days supply of the prescription drug fills

  2. Opioid Days [ Time Frame: 90 days ]
    Days of opioids received

  3. Benzodiazepine Days [ Time Frame: 90 days ]
    Days of benzodiazepines received



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient had an overlapping opioid-benzodiazepine prescription
  • At least one of the patient's providers (opioid prescribers, benzodiazepine prescribers, and/or PCM) is in the NCR

Exclusion Criteria:

  • Patient has a cancer diagnosis
  • Patient is receiving palliative care
  • Patient is under 18
  • Patient was previously allocated to a study condition

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): NCT03887247


Contacts
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Contact: Robert E Brutcher, PharmD,PhD 301-295-2113 robert.e.brutcher.mil@mail.mil

Locations
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United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Contact: Robert E Brutcher, PharmD,PhD    301-295-2113    robert.e.brutcher.mil@mail.mil   
Sponsors and Collaborators
Walter Reed National Military Medical Center
United States Department of Defense
General Services Administration (GSA)
Investigators
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Principal Investigator: Robert E Brutcher, PharmD,PhD Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences
Principal Investigator: Alan Sim, PhD Defense Health Agency
Principal Investigator: Elana Safran, MPP General Services Administration (GSA)
Principal Investigator: Adam Sacarny, PhD General Services Administration and Columbia University
Principal Investigator: Mary Steffel, PhD General Services Administration and Northeastern University
Principal Investigator: Christopher J Spevak, MD, MPH, JD Walter Reed National Medical Medical Center
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Responsible Party: Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT03887247    
Other Study ID Numbers: REDUCE-CONCURRENT
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 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 Walter Reed National Military Medical Center:
Care coordination
Opioid
Benzodiazepine
Behavioral science
Behavioral economics
Nudge
Fragmentation of care
Concurrent prescribing
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders