Clinical trial NCT06234085: Optimizing Video Communication Assessment for Teaching Error Disclosure Skills
Official title: Optimizing Video Communication Assessment for Teaching Error Disclosure Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Error Disclosure
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: The National Board of Medical Examiners
First posted: 2024-01-31
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial of an educational intervention or control.
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Summary crowdsourced rating
timeFrame: The second of two time points for VCA use (4 weeks after first use)
Secondary outcomes:
measure: Survey about prior disclosure experience
timeFrame: Before the first VCA use
measure: Survey about VCA feedback use in intervention arm
timeFrame: Before the second VCA use (4 weeks after first use)
Other outcomes:
Locations:
city: Boise
country: United States
facility: University of Washington at Boise
state: Idaho
city: Worcester
country: United States
facility: University of Massachussets
state: Massachusetts
city: Dearborn
country: United States
facility: Beaumont Health
state: Michigan
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medica Center
state: New Hampshire
city: Everett
country: United States
facility: Washington State University at Everett
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Andrew A White, MD, SFHM
role: PRINCIPAL_INVESTIGATOR
References: