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 — BEHAVIORAL
    Training 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 — BEHAVIORAL
    Training 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 Training
    Surgeons 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 Training
    Surgeons 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 Messaging
    Identical 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)

FacilityCityStateZIPSite coordinators
UW HealthMadisonWisconsin53792-
Medical College of WisconsinMilwaukeeWisconsin53226-

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