University of Wisconsin
Madison, Wisconsin, 53705, United States
Location status: Recruiting
Location contact
Kyle J Bushaw, MA
CONTACT
Margaret (Gretchen) Schwarze, MD, MPP
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06647303
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Madison, Wisconsin, 53705, United States
Location status: Recruiting
Kyle J Bushaw, MA
CONTACT
Margaret (Gretchen) Schwarze, MD, MPP
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Surgeons:
Surgical candidates:
Stakeholders:
Exclusion criteria
Surgeons:
Surgical candidates:
Stakeholders:
Surgeons will receive training on the Better Conversations framework
Participants will attend a focus group to discuss the survey instruments used in this study which will help with future study design
Participants will complete surveys regarding the surgeon's communication skills
Time frame: Up to 4 years
Specialists will train 10 surgeons, audio recording 150 surgical consultations with surgical candidates. 100 audio recordings will be used as a training set to develop an automated assessment and feedback program. 50 recordings will be used to measure fidelity to the intervention with a summative assessment. 10 additional surgeons will be trained using the automated training and researchers will audio record 150 more surgical consultations with surgical candidates. Automated feedback will be provided for 100 of the consultations and researchers will measure fidelity to the automated intervention with a summative assessment of 50 consultations. The effect of the automated training program will be tested by comparing summative assessments of surgeon performance between the two differently-trained groups. Summative assessments to identify strengths and weaknesses of the automated training program will be used to revise the training iteratively for future study.
Time frame: Up to 4 years
Researchers will compare surgical candidate participant survey results between surgeons who received specialist-delivered training versus those who received automated training.
Time frame: Up to 4 years
Data from the "Feeling Heard and Understood", "Preparation for Decision Making Scale", and the "Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surgical Care Survey" instruments will be collected from patient participants, scored, and compared for their ceiling effects. Survey scores will be transformed from 1-100 with higher scores indicating better surgeon communication. The number of participants with scores in the top 10 percentile (90-100) will be reported for each survey, surveys with higher numbers of participants in the top 10th percentile have less baseline variance.
Contact information is provided by the study sponsor or research team.
Kyle J Bushaw, MA
CONTACT
Margaret (Gretchen) L Schwarze, MD, MPP
CONTACT
University of Wisconsin, Madison
Other
Better Conversations for Better Informed Consent: A Pilot Study to Automate Surgeon Training and Evaluate Patient-Reported Outcomes
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06739005
Artificial Intelligence (AI), CABG
Beijing, Beijing Municipality, China
View Trial DetailsNCT03265873
Head and Neck Cancer, Head and Neck Neoplasms
Clamart, France
View Trial DetailsNCT03361488
Anesthesia, Behavior
Basel, Switzerland
View Trial DetailsNCT07663539
Behavior, Communication
Memphis, Tennessee, United States
View Trial Details