Clinical trial NCT03887247: Reducing Concurrent Opioid-Benzodiazepine Prescriptions
Official title: Reducing Concurrent Opioid-Benzodiazepine Prescriptions Through Provider Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
Collaborators: name: United States Department of Defense
name: General Services Administration (GSA)
First posted: 2019-03-22
Enrollment: 2234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Overlapping Days
timeFrame: 90 days
measure: Opioid Days
timeFrame: 90 days
measure: Benzodiazepine Days
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences
name: Robert E Brutcher, PharmD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Defense Health Agency
name: Alan Sim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: General Services Administration (GSA)
name: Elana Safran, MPP
role: PRINCIPAL_INVESTIGATOR
affiliation: General Services Administration and Columbia University
name: Adam Sacarny, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: General Services Administration and Northeastern University
name: Mary Steffel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Walter Reed National Medical Medical Center
name: Christopher J Spevak, MD, MPH, JD
role: PRINCIPAL_INVESTIGATOR
References:
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.