Reducing Concurrent Opioid-Benzodiazepine Prescriptions
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|ClinicalTrials.gov Identifier: NCT03887247|
Recruitment Status : Not yet recruiting
First Posted : March 22, 2019
Last Update Posted : March 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Adverse Drug Effect of Opioids Adverse Drug Effect of Benzodiazepines||Behavioral: Basic Email Behavioral: Coordinated Email||Not Applicable|
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 three conditions:
- Basic Notification - A basic message, 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
- Coordinated Notification - A coordinated message, in which the email message will also encourage coordination across providers and provide relevant contact information
- 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 (Clinical Trial)|
|Estimated Enrollment :||2500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reducing Concurrent Opioid-Benzodiazepine Prescriptions Through Provider Intervention|
|Estimated Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 31, 2021|
Active Comparator: Basic
Send basic email to the patient's opioid prescriber(s), benzodiazepine prescriber(s), and/or primary care manager.
Behavioral: Basic Email
Encrypted emails sent separately to each of: the patient's opioid prescriber(s), benzodiazepine prescriber(s), and/or primary care manager. The emails identify the concurrent prescriptions, detail the patient's prescription history, include relevant VA/DoD guidelines, state the risk of concurrent prescribing to patient, and provide action steps and relevant resources.
Active Comparator: Coordinated
Send coordinated email to the patient's opioid prescriber(s), benzodiazepine prescriber(s), and/or primary care manager.
Behavioral: Coordinated Email
Encrypted email with the following providers copied together on one message: the patient's opioid prescriber(s), benzodiazepine prescriber(s), and/or primary care manager. 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. The message encourages the prescribers to coordinate with each other and provides provider contact information to facilitate this communication.
No Intervention: As-Usual
As-usual (no email) approach.
- 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
- Morphine milligram equivalents [ Time Frame: 90 days ]Morphine milligram equivalents (MME) received
- Diazepam milligram equivalents [ Time Frame: 90 days ]Diazepam milligram equivalents (DME) received
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887247
|Contact: Robert E Brutcher, PharmD,PhDfirstname.lastname@example.org|
|Principal Investigator:||Robert E Brutcher, PharmD,PhD||Walter Reed National Military Medical Center-Bethesda|
|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|