Reducing Concurrent Opioid-Benzodiazepine Prescriptions

NCT ID: NCT03887247

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-06
• Study Completion Date: 2022-06-01

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:

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.

Conditions

Adverse Drug Effect of Opioids; Adverse Drug Effect of Benzodiazepines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

E-Mail Alert

Send email to the patient's opioid prescriber(s), benzodiazepine prescriber(s), and/or primary care manager.

Group Type: ACTIVE_COMPARATOR

E-mail Alert

Intervention Type: BEHAVIORAL

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.

As-Usual

As-usual (no email) approach.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

General Services Administration (GSA)

FED

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert E Brutcher, PharmD,PhD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences

Alan Sim, PhD

Role: PRINCIPAL_INVESTIGATOR

Defense Health Agency

Elana Safran, MPP

Role: PRINCIPAL_INVESTIGATOR

General Services Administration (GSA)

Adam Sacarny, PhD

Role: PRINCIPAL_INVESTIGATOR

General Services Administration and Columbia University

Mary Steffel, PhD

Role: PRINCIPAL_INVESTIGATOR

General Services Administration and Northeastern University

Christopher J Spevak, MD, MPH, JD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Medical Medical Center

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36218952 (View on PubMed)

Other Identifiers

REDUCE-CONCURRENT

Identifier Type: -

Identifier Source: org_study_id