Redesigning Surgical Care for Patients in Wisconsin
Part of paid clinical trials in Madison, Wisconsin.
- Sponsor
- University of Wisconsin, Madison
- Study ID
- NCT07475104
- Status
- Enrolling By Invitation
Conditions
- Communication
- Shared Decision Making
- Surgery
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Education Specialist Delivered Training — BEHAVIORALTraining in the Better Conversations framework delivered by an education specialist, including a brief didactic session and audit-and-feedback based on 10 de-identified outpatient consultations, followed by assessment using five additional recordings scored with an adherence checklist.
- Automated Training — BEHAVIORALTraining in the Better Conversations framework supported by computerized automation. Procedures match the education-specialist approach (didactic session; 10 training recordings; 5-7 assessment recordings). For each training consultation, the de-identified transcript is processed using previously developed natural language processing with active/supervised machine learning to identify elements of Better Conversations that are present or absent and common errors. An education specialist reviews and edits the automated output and emails feedback and a score sheet within one week using the same standardized format. In one half of the automated-training arm, surgeons also receive intermittent disclosure messages indicating that some feedback is computer-generated.
Study Details
This study evaluates strategies to train surgeons to use Better Conversations, an evidence-based communication framework designed to improve informed consent by helping patients understand the goals of surgery, the downsides of treatment, and what to expect. Better Conversations supports deliberation, patient preparation, and alignment of decisions with patient goals, addressing known shortcomings in traditional informed consent. The purpose of this study is to compare two methods of surgeon training: (1) training delivered by an education specialist using audit and feedback, and (2) training supported by computerized automation that identifies elements of Better Conversations in de-identified transcripts of surgical consultations. The central question is whether the automated training program is non-inferior to the specialist-delivered program. Approximately 60 surgeons from two academic health systems will be randomized to one of these training approaches. Each surgeon will complete a didactic session, have outpatient surgical consultations audio-recorded for feedback, and complete assessment recordings after training. Patients of enrolled surgeons will complete surveys before and after their surgeon's training to evaluate patient-reported communication outcomes. Findings from this study will assess the effectiveness, feasibility, and acceptability of automated training and support the development of a larger pragmatic study to evaluate the broader effects of Better Conversations on patient outcomes.
Key Dates
- Start date
- Feb 27, 2026
- Status verified
- Apr 2026
- Primary completion
- Mar 31, 2028
- Completion
- Aug 31, 2028
Study Design
- Enrollment
- 660 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Active Comparator: Control - Education Specialist Delivered TrainingSurgeons receive standard audit-and-feedback training delivered by an education specialist, including a brief didactic session and feedback on 10 de-identified outpatient consultations. Five additional recordings are used to assess performance with an adherence checklist.
- Experimental: Intervention A - Automated TrainingSurgeons receive automated audit-and-feedback training. De-identified transcripts from 10 consultations are processed with previously developed natural language processing, and an education specialist reviews and edits the automated output. Five additional recordings are assessed using the same checklist.
- Experimental: Intervention B - Automated Training with Disclosure MessagingIdentical to Intervention A with the addition that surgeons receive intermittent disclosure messages indicating that some feedback is computer-generated. Assessment and scoring procedures match the other arms and use the adherence checklist with a competence threshold.
Primary Outcome Measure
Percentage of surgeons trained to competence [ Time Frame: At completion of the assessment phase (after 10 training recordings and 5 assessment recordings per surgeon), approximately 3-12 months ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UW Health | Madison | Wisconsin | 53792 | - |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | - |
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