Reducing Concurrent Opioid-Benzodiazepine Prescriptions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03887247|
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : December 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Adverse Drug Effect of Opioids Adverse Drug Effect of Benzodiazepines||Behavioral: E-mail Alert||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 two conditions:
- 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
- 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 :||3500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reducing Concurrent Opioid-Benzodiazepine Prescriptions Through Provider Intervention|
|Actual Study Start Date :||June 6, 2019|
|Estimated Primary Completion Date :||June 5, 2020|
|Estimated Study Completion Date :||June 5, 2021|
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.
- 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
- Opioid Days [ Time Frame: 90 days ]Days of opioids received
- Benzodiazepine Days [ Time Frame: 90 days ]Days of benzodiazepines 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,PhDemail@example.com|
|United States, Maryland|
|Walter Reed National Military Medical Center||Recruiting|
|Bethesda, Maryland, United States, 20889|
|Contact: Robert E Brutcher, PharmD,PhD 301-295-2113 firstname.lastname@example.org|
|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|