Optimizing Video Communication Assessment for Teaching Error Disclosure Skills

NCT ID: NCT06234085

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participating residency programs assigned all eligible post-graduate year 2 (PGY2s) to attend a 75-minute teaching session at Time 1, consisting of 50 minutes of lecture about communication with patients after medical harm, 20 minutes of VCA practice with two cases (containing 4 and 3 sequenced vignettes, respectively), and 5 minutes of debrief. At Time 2, residents attended a session consisting of 25 minutes of lecture about institutional programs to support clinicians with error disclosure and 20 minutes of VCA practice with two additional cases (3 sequenced vignettes each). The recommended duration between Time 1 and Time 2 was four weeks, although the conference schedule at two residencies required an interval of 5 to 8 weeks for some residents.

Residents who completed the VCA at Time 1 were randomized in 1:1 fashion to either receive feedback before Time 2 (intervention) or after Time 2 (control). Intervention residents received emails when their feedback was available, instructing them to review it in the app before the next teaching session and VCA practice. Feedback was typically provided two weeks after VCA use to allow for completion of rating and data quality checks. Reports presented an interactive feedback display within the VCA app for each vignette.

Residents provided audio responses to each vignette through the VCA software. Audio responses were bundled into rating tasks on MTurk for raters who were US residents over 18 years old and able to speak and read English. Raters answered demographic questions, read a vignette description in lay language, viewed the patient video, and listened to resident responses. They rated each response on six items covering domains of error disclosure. We averaged ratings across items and raters to create an overall rating of each response. We then averaged response ratings across all 7 vignettes at Time 1 to create an overall Time 1 score, and across all 6 vignettes at Time 2 to create a Time 2 score.

Residents completed questionnaires in the VCA application before proceeding to cases. The survey at Time 1 asked about age, gender, race, the number of times the resident had personally participated in disclosure of a harmful error to a patient or family, and the highest level of involvement they've had during disclosure of a harmful medical error. Before Time 2, residents who had received feedback were asked "approximately how many minutes did you spend reviewing your feedback" (response options in 5-min ranges), and "how many of your own responses did you replay", "how many of the exemplar (highly rated peer) responses did you play", (response options of none, 1-2, 3-4, 5 or more). Residents responded to four additional items (Table 2) about the usefulness of each feedback component (scores, personal recordings, exemplar recordings, learning points) using a 5-point scale with labels from "not at all" to "extremely"

To address our primary study question about the effect of the intervention, i.e., access to VCA feedback, we conducted a factorial analysis of covariance (ANCOVA) examining the impact that the intervention and prior disclosure exposure had on Time 2 scores, while adjusting for Time 1 scores. We used logistic regression to investigate whether Time 1 scores could predict the likelihood participants returned for Time 2.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Error Disclosure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized trial of an educational intervention or control.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators
Investigators are blinded; participants can not be blinded to the intervention.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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.

Group Type EXPERIMENTAL

VCA feedback report available

Intervention Type OTHER

Access to feedback report described in the intervention

Control

Participants will not have access to a feedback report.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VCA feedback report available

Access to feedback report described in the intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Declines research use of audio recordings
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The National Board of Medical Examiners

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andrew Austin White

Professor: School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrew A White, MD, SFHM

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Washington at Boise

Boise, Idaho, United States

Site Status

University of Massachussets

Worcester, Massachusetts, United States

Site Status

Beaumont Health

Dearborn, Michigan, United States

Site Status

Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Dartmouth Hitchcock Medica Center

Lebanon, New Hampshire, United States

Site Status

Washington State University at Everett

Everett, Washington, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39110461 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00015707

Identifier Type: -

Identifier Source: org_study_id