Reducing Concurrent Opioid-Benzodiazepine Prescriptions

Reducing Concurrent Opioid-Benzodiazepine Prescriptions Through Provider Intervention

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Adverse Drug Effect of Opioids; Adverse Drug Effect of Benzodiazepines
• Intervention / Treatment: Behavioral: E-mail Alert

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 Type: Interventional
• Enrollment (Actual): 2234
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overlapping Days	Overlapping days of opioids and benzodiazepines, determined using the dates of service and days supply of the prescription drug fills	90 days
Opioid Days	Days of opioids received	90 days
Benzodiazepine Days	Days of benzodiazepines received	90 days

Collaborators and Investigators

• Sponsor: Walter Reed National Military Medical Center
• Collaborators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2019
• Primary Completion (Anticipated): July 29, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Opioid; Benzodiazepine; Behavioral economics; Nudge; Care coordination; Behavioral science; Fragmentation of care; Concurrent prescribing
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: REDUCE-CONCURRENT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No