Reducing Concurrent Opioid-Benzodiazepine Prescriptions

• ClinicalTrials.gov Identifier: NCT03887247
• Recruitment Status: Unknown
• First Posted: March 22, 2019
• Last Update Posted: May 19, 2021
• Sponsor: Walter Reed National Military Medical Center
• Collaborators: United States Department of Defense; General Services Administration (GSA)
• Information provided by (Responsible Party): Walter Reed National Military Medical Center

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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2234 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: July 29, 2021
• Estimated Study Completion Date: June 1, 2022

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Maryland

Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20889

Sponsors and Collaborators

Walter Reed National Military Medical Center

United States Department of Defense

General Services Administration (GSA)

Investigators

• 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Walter Reed National Military Medical Center
• ClinicalTrials.gov Identifier: NCT03887247
• Other Study ID Numbers: REDUCE-CONCURRENT
• First Posted: March 22, 2019
• Last Update Posted: May 19, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders