Reducing Concurrent Opioid-Benzodiazepine Prescriptions

Adverse Drug Effect of Benzodiazepines Clinical Trial

Official title:

Reducing Concurrent Opioid-Benzodiazepine Prescriptions Through Provider Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03887247
• Other study ID #: REDUCE-CONCURRENT
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 6, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: April 2021
• Source: Walter Reed National Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2234
• Est. completion date: June 1, 2022
• Est. primary completion date: July 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Drug Effect of Benzodiazepines
• Adverse Drug Effect of Opioids
• Drug-Related Side Effects and Adverse Reactions

Intervention

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.

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center	General Services Administration (GSA), United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overlapping Days	Overlapping days of opioids and benzodiazepines, determined using the dates of service and days supply of the prescription drug fills	90 days
Primary	Opioid Days	Days of opioids received	90 days
Primary	Benzodiazepine Days	Days of benzodiazepines received	90 days