Reducing Concurrent Opioid-Benzodiazepine Prescriptions
Primary Purpose
Adverse Drug Effect of Opioids, Adverse Drug Effect of Benzodiazepines
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
E-mail Alert
Sponsored by
About this trial
This is an interventional other trial for Adverse Drug Effect of Opioids focused on measuring Care coordination, Opioid, Benzodiazepine, Behavioral science, Behavioral economics, Nudge, Fragmentation of care, Concurrent prescribing
Eligibility 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
Sites / Locations
- Walter Reed National Military Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
E-Mail Alert
As-Usual
Arm Description
Send email to the patient's opioid prescriber(s), benzodiazepine prescriber(s), and/or primary care manager.
As-usual (no email) approach.
Outcomes
Primary Outcome Measures
Overlapping Days
Overlapping days of opioids and benzodiazepines, determined using the dates of service and days supply of the prescription drug fills
Opioid Days
Days of opioids received
Benzodiazepine Days
Days of benzodiazepines received
Secondary Outcome Measures
Full Information
NCT ID
NCT03887247
First Posted
March 19, 2019
Last Updated
May 18, 2021
Sponsor
Walter Reed National Military Medical Center
Collaborators
United States Department of Defense, General Services Administration (GSA)
1. Study Identification
Unique Protocol Identification Number
NCT03887247
Brief Title
Reducing Concurrent Opioid-Benzodiazepine Prescriptions
Official Title
Reducing Concurrent Opioid-Benzodiazepine Prescriptions Through Provider Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
July 29, 2021 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Walter Reed National Military Medical Center
Collaborators
United States Department of Defense, General Services Administration (GSA)
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
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.
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:
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Drug Effect of Opioids, Adverse Drug Effect of Benzodiazepines
Keywords
Care coordination, Opioid, Benzodiazepine, Behavioral science, Behavioral economics, Nudge, Fragmentation of care, Concurrent prescribing
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2234 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E-Mail Alert
Arm Type
Active Comparator
Arm Description
Send email to the patient's opioid prescriber(s), benzodiazepine prescriber(s), and/or primary care manager.
Arm Title
As-Usual
Arm Type
No Intervention
Arm Description
As-usual (no email) approach.
Intervention Type
Behavioral
Intervention Name(s)
E-mail Alert
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overlapping Days
Description
Overlapping days of opioids and benzodiazepines, determined using the dates of service and days supply of the prescription drug fills
Time Frame
90 days
Title
Opioid Days
Description
Days of opioids received
Time Frame
90 days
Title
Benzodiazepine Days
Description
Days of benzodiazepines received
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert E Brutcher, PharmD,PhD
Organizational Affiliation
Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan Sim, PhD
Organizational Affiliation
Defense Health Agency
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elana Safran, MPP
Organizational Affiliation
General Services Administration (GSA)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam Sacarny, PhD
Organizational Affiliation
General Services Administration and Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary Steffel, PhD
Organizational Affiliation
General Services Administration and Northeastern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher J Spevak, MD, MPH, JD
Organizational Affiliation
Walter Reed National Medical Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36218952
Citation
Sacarny A, Safran E, Steffel M, Dunham JR, Abili OD, Mohajeri L, Oh PT, Sim A, Brutcher RE, Spevak C. Effect of Pharmacist Email Alerts on Concurrent Prescribing of Opioids and Benzodiazepines by Prescribers and Primary Care Managers: A Randomized Clinical Trial. JAMA Health Forum. 2022 Sep 2;3(9):e223378. doi: 10.1001/jamahealthforum.2022.3378.
Results Reference
derived
Learn more about this trial
Reducing Concurrent Opioid-Benzodiazepine Prescriptions
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