Redesigning Surgical Care for Patients in Wisconsin

NCT07475104 | Enrolling By Invitation

• 3 other identifiers: 2025-1648SMPH / Surgery / WiSORProtocol Version 4/8/2026
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Communication; Surgery; Shared Decision Making

Keywords

informed consent; health literacy; surgical training; shared decision making; surgical communication

Outcome Measures

Primary Outcomes (1)

• Percentage of surgeons trained to competence

  Competence is assessed using the established 10-item adherence checklist, yielding a total possible score ranging from 0 to 10, applied to the five assessment audio recordings obtained after each surgeon completes the 10 training recordings. Higher scores indicate greater fidelity to the Better Conversations framework, competence is 6 or higher. The performance of surgeons in the automated-training group will be compared with those in the education-specialist training group, and non-inferiority will be evaluated using a 5% non-inferiority margin. Feasibility is defined as greater than or equal to 80 percent of surgeons trained to competence.

  At completion of the assessment phase (after 10 training recordings and 5 assessment recordings per surgeon), approximately 3-12 months

Secondary Outcomes (4)

• Surgeon assessment score

  At completion of the assessment phase (after 10 training recordings and 5 assessment recordings per surgeon), approximately 3-12 months

• Feeling Heard and Understood

  Within 7 days of each patient's surgical consultation; analyzed relative to each surgeon's training completion (pre vs post)

• Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surgical Care survey

  Within 7 days of each patient's surgical consultation; analyzed relative to surgeon training completion (pre vs post)

• Surgeon Acceptability (Practitioner Opinion Survey)

  At completion of the assessment phase (after 10 training recordings and 5 assessment recordings per surgeon), approximately 3-12 months

Study Arms (3)

Control - Education Specialist Delivered Training

ACTIVE COMPARATOR

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.

Behavioral: Education Specialist Delivered Training

Intervention A - Automated Training

EXPERIMENTAL

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.

Behavioral: Automated Training

Intervention B - Automated Training with Disclosure Messaging

EXPERIMENTAL

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.

Behavioral: Automated Training

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.

Also known as: Better Conversations, Better Conversations for Better Informed Consent

Control - Education Specialist Delivered Training

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.

Also known as: Better Conversations, Better Conversations for Better Informed Consent

Intervention A - Automated Training; Intervention B - Automated Training with Disclosure Messaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgeons who work in the University of Wisconsin-Madison and Medical College of Wisconsin who have an outpatient surgical clinic and treat adult patients at UW Health or Froedtert Hospital and MCW
• Adult patients with decision making capacity
• Presenting to an enrolled surgeon's clinic with a surgical problem to discuss treatment

You may not qualify if:

• Surgeons who solely treat minors (under age 18), i.e., pediatric surgeons, will be excluded from this study, but training will be made available to them outside of this study.
• Surgeons at UWH who have previously been trained to use Better Conversations (25 surgeons) are excluded.
• Adult patients who do not have decision making capacity will be excluded.
• Individuals who do not speak English will be excluded.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Wisconsin Partnership Program: collaborator
• Medical College of Wisconsin: collaborator

Study Sites (2)

UW Health

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Margaret (Gretchen) L Schwarze, MD, MPP

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Surgeons will be blinded to the type of training received, except for one-half of the automated training group, who will get intermittent messaging that the feedback was generated via computer automation to test how they feel about the training type they are receiving.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel, three-arm, cluster-randomized design at the surgeon level with a 2:1:1 allocation ratio. Surgeons are randomized by site to (1) education-specialist audit-and-feedback (control), (2) automated audit-and-feedback without disclosure messaging, or (3) automated audit-and-feedback with intermittent disclosure messaging indicating that some feedback is computer-generated. All surgeons complete the same training sequence (didactic session; 10 training consultations with feedback; 5 assessment consultations). Study patients are nested within surgeons and provide pre- and post-training outcomes; patients do not cross arms.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)