Reducing Concurrent Opioid-Benzodiazepine Prescriptions

May 18, 2021 updated by: Walter Reed National Military Medical Center

Reducing Concurrent Opioid-Benzodiazepine Prescriptions Through Provider Intervention

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2234

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
90 days
Opioid Days
Time Frame: 90 days
Days of opioids received
90 days
Benzodiazepine Days
Time Frame: 90 days
Days of benzodiazepines received
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Walter Reed National Military Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Defense
General Services Administration (GSA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 29, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REDUCE-CONCURRENT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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