Clinical trial NCT06647303: Improving Surgical Communication for Patients in Wisconsin
Official title: Better Conversations for Better Informed Consent: A Pilot Study to Automate Surgeon Training and Evaluate Patient-Reported Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgeons
Surgical Procedure, Unspecified
Keywords: decision making
communication
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate a new training program to support communication between surgeons and their patients. The goal of the training program is to help patients get the information they need to make treatment decisions that are right for them.

Participants will complete surveys, attend a focus group, or receive training on Better Conversations, depending on the type of participant.

Detailed description: Observational research shows that surgeons translate informed consent and shared decision-making standards into an overly complicated technical explanation of the patient's disease and treatment, and an overly simplified narrative that surgery will "fix" the patient's problem. They omit critical information about the goals and downsides of surgery and struggle to actualize the patient's role in medical decisions, while unintentionally concealing professional expertise. "Better Conversations" is a novel communication framework designed to address these problems. With this framework, surgeons provide context about clinical norms, clearly establish the goals of surgery, and comprehensively delineate the downsides of surgery as experienced by the patient to generate a deliberative space for patients to consider whether surgery is right for them. This paradigm-shifting framework meets the legal and ethical standards for informed consent, supports deliberation, and allows patients to anticipate and prepare for the experience of surgery.

The present study supports optimization of surgeon training and study procedures (Phase II) that is needed before large scale testing and dissemination (Phase III). Although this intervention is evidence based, collaborative efforts are needed to ultimately test and disseminate a major clinical shift. The long-term goal is for every surgeon to use Better Conversations with every patient, every time. The present study has two main objectives: 1) To make the education program scalable with automated assessment and feedback to surgeons using audio recordings from their clinical conversations, and 2) to evaluate patient and family reported outcome measures regarding surgeon communication.

Eligibility criteria: Inclusion Criteria:

Surgeons:

* Surgeons from University of Wisconsin - Madison Department of Surgery who have an outpatient surgical clinic and treat adult patients at UW Health

Surgical candidates:

* Age 18 or older
* Present to an enrolled surgeon's clinic with a surgical problem
* Decision making ability
* Speak English

Stakeholders:

* Must have previous experience with surgery (within 10 years)
* Speak English

Exclusion Criteria:

Surgeons:

* Solely treat minors (under age 18)

Surgical candidates:

* Lacking decision making capacity
* Unable to speak English

Stakeholders:

* Unable to speak English

Primary outcomes:
measure: Effect of automated training program
timeFrame: Up to 4 years
measure: Compare effectiveness of specialist-delivered training versus automated training on participant-reported measures of surgeon communication
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
measure: To identify survey measures that have a strong baseline variance, the number of participants who evaluate communication skills of the surgeon in the top 10 percentile of scoring
timeFrame: Up to 4 years
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Margaret (Gretchen) Schwarze, MD, MPP
role: PRINCIPAL_INVESTIGATOR
References: