CommunicationNCT07475104
Redesigning Surgical Care for Patients in Wisconsin
A study testing Education Specialist Delivered Training and Automated Training in people with Communication and Surgery, run by University of Wisconsin, Madison at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication, Surgery, Shared Decision Making
- What is being tested?
- Education Specialist Delivered Training and Automated Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Feb 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
UW Health
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Redesigning Surgical Care to Support the Health Outcome Goals and Care Preferences for Older Adults: Better Conversations for Better Informed Consent
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.
Read more
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.
Read the detailed description
This study evaluates two training strategies to help surgeons use Better Conversations, an evidence-based communication framework that improves informed consent by supporting patient understanding, deliberation, and preparation for surgery. Prior work by the investigative team shows that Better Conversations addresses shortcomings in traditional consent practices, aligns with quality improvement standards, and is well-received by surgeons and patients.
This is a non-inferiority trial comparing (1) audit-and-feedback training delivered by an education specialist and (2) an automated training approach that uses natural language processing and active machine learning to identify key elements of Better Conversations in de-identified transcripts of surgical consultations. Automated output is reviewed and finalized by the education specialist before being shared with surgeons. The hypothesis is that automated training will be non-inferior to specialist-delivered training, with a 5% non-inferiority margin.
The study also evaluates feasibility and acceptability of training a large number of surgeons across two institutions. Feasibility is defined as training at least 80% of surgeons to competence. Acceptability will be assessed using surgeon surveys and exit interviews, and patient-reported outcomes. Patients will complete validated surveys (Feeling Heard and Understood; CAHPS Surgical Care items) before and after their surgeon's training. A subset of patients will participate in interviews regarding their consultation experience. A separate group of patients will consent to have their consultations audio recorded solely for surgeon training or assessment purposes.
Sixty surgeons from UW Health and the Medical College of Wisconsin will be randomized, stratified by site, to one of the two training groups. All surgeons will begin with a 30-minute didactic session, followed by 10 training recordings with corresponding feedback, and 5-7 assessment recordings used to evaluate competence. Consultations will be audio recorded, transcribed, and de-identified prior to feedback and analysis. Competence will be evaluated using a standardized adherence checklist developed by the study team, assessing both the presence and quality of required communication elements.
This study will generate estimates of within- and between-surgeon variation in communication performance and patient-reported outcomes. These data will inform analytic planning and power calculations for a future pragmatic trial examining the broader impact of Better Conversations on patient decision making, satisfaction, and health outcomes.
- Conditions
- Communication, Surgery, Shared Decision Making
- Being tested
- Education Specialist Delivered Training, Automated Training
- Keywords
- informed consent, health literacy, surgical training, shared decision making, surgical communication
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education Specialist Delivered TrainingBehavioural
Also called Better Conversations, Better Conversations for Better Informed Consent
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 TrainingBehavioural
Also called Better Conversations, Better Conversations for Better Informed Consent
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Automated Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
For each treatment group, the mean and standard deviation of surgeons' assessment scores (range 0-10) will be reported. Higher scores indicate higher competence.
Measured: At completion of the assessment phase (after 10 training recordings and 5 assessment recordings per surgeon), approximately 3-12 months
Feeling Heard and Understood
The mean and standard deviation of Feeling Heard and Understood scores before and after surgeon training will be reported. This patient-survey item uses a 5-point Likert scale (1 = Not at all true to 5 = Completely true), with higher scores indicating better perceived communication. It is used to assess acceptability to patients and preliminary changes associated with surgeon training. For each surgeon, a change score defined as the difference between post-training and pre-training scores will be computed. Surgeon-level change scores will be compared between groups using 95% confidence intervals.
Measured: 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
CAHPS Surgical Care survey items from 5 patients per surgeon pre-training and 5 patients post-training, aggregated per surgeon and by arm, to characterize patient experience of communication. Items include Yes/No responses (0-1), 3-point responses (0-2), and 4-point responses (0-3). Higher values indicate better experience and scores are expressed as a continuous percent, 0-100. Surgeon-level change scores will be compared between groups using 95% confidence intervals.
Measured: Within 7 days of each patient's surgical consultation; analyzed relative to surgeon training completion (pre vs post)
Surgeon Acceptability (Practitioner Opinion Survey)
Practitioner Opinion Survey administered after training and assessment to evaluate surgeons' perspectives on the training and use of Better Conversations (e.g., usefulness and feasibility). Items use a 0-5 response scale, and higher scores indicate greater acceptability. Summarized overall and by arm. Scores are expressed as a continuous percent, 0-100.
Measured: At completion of the assessment phase (after 10 training recordings and 5 assessment recordings per surgeon), approximately 3-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start27 Feb 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Wisconsin Partnership Program, Medical College of Wisconsin
- Responsible party
- Sponsor
- Investigators
- Margaret (Gretchen) L Schwarze, MD, MPP, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475104
- Sponsor's protocol ID
- 2025-1648
- Other IDs
- SMPH / Surgery / WiSOR, Protocol Version 4/8/2026
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redesigning Surgical Care to Support the Health Outcome Goals and Care Preferences for Older Adults: Better Conversations for Better Informed Consent
- ClinicalTrials.gov ID
- NCT07475104
- Acronym / sponsor ID
- 2025-1648
- Conditions
- Communication, Surgery, Shared Decision Making
- Keywords
- informed consent, health literacy, surgical training, shared decision making, surgical communication
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Wisconsin Partnership Program, Medical College of Wisconsin
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study evaluates two training strategies to help surgeons use Better Conversations, an evidence-based communication framework that improves informed consent by supporting patient understanding, deliberation, and preparation for surgery. Prior work by the investigative team shows that Better Conversations addresses shortcomings in traditional consent practices, aligns with quality improvement standards, and is well-received by surgeons and patients.
This is a non-inferiority trial comparing (1) audit-and-feedback training delivered by an education specialist and (2) an automated training approach that uses natural language processing and active machine learning to identify key elements of Better Conversations in de-identified transcripts of surgical consultations. Automated output is reviewed and finalized by the education specialist before being shared with surgeons. The hypothesis is that automated training will be non-inferior to specialist-delivered training, with a 5% non-inferiority margin.
The study also evaluates feasibility and acceptability of training a large number of surgeons across two institutions. Feasibility is defined as training at least 80% of surgeons to competence. Acceptability will be assessed using surgeon surveys and exit interviews, and patient-reported outcomes. Patients will complete validated surveys (Feeling Heard and Understood; CAHPS Surgical Care items) before and after their surgeon's training. A subset of patients will participate in interviews regarding their consultation experience. A separate group of patients will consent to have their consultations audio recorded solely for surgeon training or assessment purposes.
Sixty surgeons from UW Health and the Medical College of Wisconsin will be randomized, stratified by site, to one of the two training groups. All surgeons will begin with a 30-minute didactic session, followed by 10 training recordings with corresponding feedback, and 5-7 assessment recordings used to evaluate competence. Consultations will be audio recorded, transcribed, and de-identified prior to feedback and analysis. Competence will be evaluated using a standardized adherence checklist developed by the study team, assessing both the presence and quality of required communication elements.
This study will generate estimates of within- and between-surgeon variation in communication performance and patient-reported outcomes. These data will inform analytic planning and power calculations for a future pragmatic trial examining the broader impact of Better Conversations on patient decision making, satisfaction, and health outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control - Education Specialist Delivered Training | Active comparator | Behavioral: 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. |
| Intervention A - Automated Training | Experimental | Behavioral: 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. |
| Intervention B - Automated Training with Disclosure Messaging | Experimental | Behavioral: Automated TrainingIdentical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education Specialist Delivered TrainingAlso: Better Conversations, Better Conversations for Better Informed ConsentTraining 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. | Behavioural | Control - Education Specialist Delivered Training |
| Automated TrainingAlso: Better Conversations, Better Conversations for Better Informed ConsentTraining 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. | Behavioural | Intervention A - Automated Training, Intervention B - Automated Training with Disclosure Messaging |
Primary outcome
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
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.
4 secondary outcomes
Surgeon assessment score
Time frame: At completion of the assessment phase (after 10 training recordings and 5 assessment recordings per surgeon), approximately 3-12 months
Feeling Heard and Understood
Time frame: 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
Time frame: Within 7 days of each patient's surgical consultation; analyzed relative to surgeon training completion (pre vs post)
Surgeon Acceptability (Practitioner Opinion Survey)
Time frame: At completion of the assessment phase (after 10 training recordings and 5 assessment recordings per surgeon), approximately 3-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margaret (Gretchen) L Schwarze, MD, MPP principal investigator
UW School of Medicine and Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Specialist Delivered Training and Automated Training in people with Communication and Surgery, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.