NCT04069403

Brief Summary

Analyze baseline concurrent opioid prescribing metrics at the individual prescriber level in the Duke Health System on the identified three main outcome measures. Test the impact of reports on opioid prescriber behaviors with the following primary measures: number of prescriptions with concurrent benzo within reporting period, number of prescriptions with concurrent muscle relaxants within reporting period, and number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis within reporting period. Create a blueprint to implement the concurrent opioid prescribing nudge intervention in other settings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
427

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

September 10, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

June 30, 2020

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

August 23, 2019

Last Update Submit

June 29, 2020

Conditions

Keywords

OpioidsPrescriptionPatternsNudgePractices

Outcome Measures

Primary Outcomes (4)

  • Change in Opioid prescribing habits

    Using baseline concurrent opioid prescribing metrics obtained (at the individual prescriber level) during their initial month and month prior in the Duke Health System, measure changes in Opioid n prescription orders as measured by provider prescriptions

    Baseline, 6 Months

  • number of prescriptions with concurrent benzo within reporting period

    Identify the number of prescriptions with concurrent benzo over 6 months

    6 Months

  • number of prescriptions with concurrent muscle relaxants within reporting period

    Identify the number of prescriptions with concurrent muscle relaxants over 6 months

    6 Months

  • number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis within reporting period

    Identify the number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis over 6 months

    6 Months

Study Arms (2)

Intervention Arm- Automated Reports

EXPERIMENTAL

Receives automated reports on prescription patterns monthly

Other: Automated Reports on prescription patterns for their patients

Control Arm: Usual clinical education and feedback

NO INTERVENTION

Receive no reports

Interventions

de-identified aggregate reports

Also known as: de-identified reports, prescribers' prescribing patterns
Intervention Arm- Automated Reports

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The primary population of focus for this study is:
  • attending physicians
  • residents
  • advanced practice providers
  • hereby referred to as opioid prescribers in Duke University Health System and may include these departments and clinics:
  • Emergency Department
  • Neurology, Pain Management
  • Primary Care
  • Psychiatry, Sleep Disorder Clinic
  • Spine
  • All opioid prescribers in these settings will be identified in partnership with Duke University Health System.

You may not qualify if:

  • Providers not identified above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersHealth Behavior

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehavior

Study Officials

  • Charlene Wong, MD

    Duke University

    PRINCIPAL INVESTIGATOR
  • Charles Scales, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Analyze baseline concurrent opioid prescribing metrics at the individual prescriber level in the Duke Health System on the identified three main outcome measures. Test the impact of reports on opioid prescriber behaviors with the following primary measures: number of prescriptions with concurrent or benzo within reporting period, number of prescriptions with concurrent muscle relaxants within reporting period, and number of encounters with naloxone prescriptions for patients with any opioid-related diagnosis within reporting period. Create a blueprint to implement the concurrent opioid prescribing nudge intervention in other settings.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

September 10, 2019

Primary Completion

June 15, 2020

Study Completion

June 15, 2020

Last Updated

June 30, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations