Error DisclosureNCT06234085
Optimizing Video Communication Assessment for Teaching Error Disclosure Skills
A study testing VCA feedback report available in people with Error Disclosure, run by University of Washington at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Error Disclosure
- What is being tested?
- VCA feedback report available
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Jul 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Enrolled in the second post-graduate year (PGY2) of an Internal Medicine or Family Medicine Residency
Who cannot join
- Declines research use of audio recordings
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Washington at Boise
Boise, Idaho, 83702
Beaumont Health
Dearborn, Michigan, 48124
Washington State University at Everett
Everett, Washington, 98201
Dartmouth Hitchcock Medica Center
Lebanon, New Hampshire, 03756
University of Washington
Seattle, Washington, 98105
Washington University in St. Louis
St Louis, Missouri, 63141
University of Massachussets
Worcester, Massachusetts, 01655
About this study
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.
Read the 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.
- Conditions
- Error Disclosure
- Being tested
- VCA feedback report available
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCA feedback report availableOther
Access to feedback report described in the intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: VCA feedback report available |
| Control | No intervention | Participants will not have access to a feedback report. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The second of two time points for VCA use (4 weeks after first use)
Secondary outcomes (2)
Survey about prior disclosure experience
Survey with items asking about prior experience with error disclosure, provided to all participants.
Measured: Before the first VCA use
Survey about VCA feedback use in intervention arm
Survey asking about self-reported use of feedback components, provided to the intervention arm participants only.
Measured: Before the second VCA use (4 weeks after first use)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Jul 2022
- Primary completion15 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Error DisclosureStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial of an educational intervention or control.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- The National Board of Medical Examiners
- Responsible party
- Principal investigator, Andrew Austin White, University of Washington
- Investigators
- Andrew A White, MD, SFHM, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234085
- Sponsor's protocol ID
- STUDY00015707
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The primary data is confidential audio recordings, which we do not have participant permission to share with other researchers.
Publications
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.
PubMed 39110461
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Video Communication Assessment for Teaching Error Disclosure Skills
- ClinicalTrials.gov ID
- NCT06234085
- Acronym / sponsor ID
- STUDY00015707
- Conditions
- Error Disclosure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- The National Board of Medical Examiners
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized trial of an educational intervention or control.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: VCA feedback report availableParticipants 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. |
| Control | No intervention | –Participants will not have access to a feedback report. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Enrolled in the second post-graduate year (PGY2) of an Internal Medicine or Family Medicine Residency
Key exclusion criteria (1 listed)
- Declines research use of audio recordings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VCA feedback report availableAccess to feedback report described in the intervention | Other | Intervention |
Primary outcome
Summary crowdsourced rating
Time frame: The second of two time points for VCA use (4 weeks after first use)
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.
2 secondary outcomes
Survey about prior disclosure experience
Time frame: Before the first VCA use
Survey about VCA feedback use in intervention arm
Time frame: Before the second VCA use (4 weeks after first use)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Derived from this study: PubMed 39110461White 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.
- Individual participant dataSharing planned: No. The primary data is confidential audio recordings, which we do not have participant permission to share with other researchers.
Related trials for Error Disclosure
Recruiting
DECIDE Just Culture: Conceptualization of Clinical Error
Error Disclosure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew A White, MD, SFHM principal investigator
University of Washington
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VCA feedback report available in people with Error Disclosure, run by University of Washington at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary crowdsourced rating (time frame: The second of two time points for VCA use (4 weeks after first use)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06234085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.