NCT06234085

Brief Summary

The goal of this randomized, single-blinded, educational study is to test the effect of providing crowdsourced ratings and feedback to second-year (PGY2) internal medicine (IM) and family medicine (FM) resident physicians' about their adverse event communication skills. The main question it aims to answer is: \- Is the intervention of providing reports with personal performance feedback and recommendations for effective error disclosure associated with higher ratings of resident error disclosure skills? Participants will perform simulated error disclosure with a software tool called the Video-based Communication Assessment (VCA). Participants will be randomized to receive feedback reports (intervention) or not (control). Participants receiving the intervention will be asked to review their feedback and all participants will use the VCA again approximately 4 weeks later with different patient cases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

7 active sites

Status
completed

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

Study Start

First participant enrolled

July 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

January 22, 2024

Last Update Submit

January 30, 2024

Conditions

Error Disclosure

Outcome Measures

Primary Outcomes (1)

  • Summary crowdsourced rating

    A numerical score representing an average of scores of a participant's communication skills provided by panels of crowdsourced laypeople who listened to audio recordings of participants responding to a VCA case.

    The second of two time points for VCA use (4 weeks after first use)

Secondary Outcomes (2)

  • Survey about prior disclosure experience

    Before the first VCA use

  • Survey about VCA feedback use in intervention arm

    Before the second VCA use (4 weeks after first use)

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will be provided with access to a feedback report in the VCA app that contains 1) crowdsourced ratings of their error disclosure communication, 2) access to recordings of their responses to the completed VCA cases, 3) a recording of a highly-rated peer response and 4) learning points summarizing what laypeople would like the doctor to say in response to the case.

Other: VCA feedback report available

Control

NO INTERVENTION

Participants will not have access to a feedback report.

Interventions

VCA feedback report availableOTHER

Access to feedback report described in the intervention

Intervention

Eligibility Criteria

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

You may qualify if:

  • Enrolled in the second post-graduate year (PGY2) of an Internal Medicine or Family Medicine Residency

You may not qualify if:

  • Declines research use of audio recordings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Washington at Boise

Boise, Idaho, 83702, United States

Location

University of Massachussets

Worcester, Massachusetts, 01655, United States

Location

Beaumont Health

Dearborn, Michigan, 48124, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63141, United States

Location

Dartmouth Hitchcock Medica Center

Lebanon, New Hampshire, 03756, United States

Location

Washington State University at Everett

Everett, Washington, 98201, United States

Location

University of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (1)

  • White AA, King AM, D'Addario AE, Brigham KB, Bradley JM, Gallagher TH, Mazor KM. Crowdsourced Feedback to Improve Resident Physician Error Disclosure Skills: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2425923. doi: 10.1001/jamanetworkopen.2024.25923.

    PMID: 39110461DERIVED

Study Officials

  • Andrew A White, MD, SFHM

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Investigators are blinded; participants can not be blinded to the intervention.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized trial of an educational intervention or control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor: School of Medicine

Study Record Dates

First Submitted

January 22, 2024

First Posted

January 31, 2024

Study Start

July 1, 2022

Primary Completion

May 15, 2023

Study Completion

June 30, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

The primary data is confidential audio recordings, which we do not have participant permission to share with other researchers.

Locations

US(7)