NCT03887247

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,234

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

June 6, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

May 19, 2021

Status Verified

April 1, 2021

Enrollment Period

2.1 years

First QC Date

March 19, 2019

Last Update Submit

May 18, 2021

Conditions

Adverse Drug Effect of OpioidsAdverse Drug Effect of Benzodiazepines

Keywords

Care coordinationOpioidBenzodiazepineBehavioral scienceBehavioral economicsNudgeFragmentation of careConcurrent prescribing

Outcome Measures

Primary Outcomes (3)

  • Overlapping 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

    Days of opioids received

    90 days

  • Benzodiazepine Days

    Days of benzodiazepines received

    90 days

Study Arms (2)

E-Mail Alert

ACTIVE COMPARATOR

Send email to the patient's opioid prescriber(s), benzodiazepine prescriber(s), and/or primary care manager.

Behavioral: E-mail Alert

As-Usual

NO INTERVENTION

As-usual (no email) approach.

Interventions

E-mail AlertBEHAVIORAL

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.

E-Mail Alert

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient has a cancer diagnosis
  • Patient is receiving palliative care
  • Patient is under 18
  • Patient was previously allocated to a study condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (1)

  • 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.

    PMID: 36218952DERIVED

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2019

First Posted

March 22, 2019

Study Start

June 6, 2019

Primary Completion

July 29, 2021

Study Completion

June 1, 2022

Last Updated

May 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)