Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:16 AM
Study NCT ID:
NCT07475104
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-16
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Redesigning Surgical Care for Patients in Wisconsin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 660}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of surgeons trained to competence', 'timeFrame': 'At completion of the assessment phase (after 10 training recordings and 5 assessment recordings per surgeon), approximately 3-12 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Surgeon assessment score', 'timeFrame': 'At completion of the assessment phase (after 10 training recordings and 5 assessment recordings per surgeon), approximately 3-12 months', 'description': "For each treatment group, the mean and standard deviation of surgeons' assessment scores (range 0-10) will be reported. Higher scores indicate higher competence."}, {'measure': 'Feeling Heard and Understood', 'timeFrame': "Within 7 days of each patient's surgical consultation; analyzed relative to each surgeon's training completion (pre vs post)", 'description': '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.'}, {'measure': 'Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surgical Care survey', 'timeFrame': "Within 7 days of each patient's surgical consultation; analyzed relative to surgeon training completion (pre vs post)", 'description': '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.'}, {'measure': 'Surgeon Acceptability (Practitioner Opinion Survey)', 'timeFrame': 'At completion of the assessment phase (after 10 training recordings and 5 assessment recordings per surgeon), approximately 3-12 months', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['informed consent', 'health literacy', 'surgical training', 'shared decision making', 'surgical communication'], 'conditions': ['Communication', 'Surgery', 'Shared Decision Making']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nApproximately 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.\n\nFindings 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.", 'detailedDescription': "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.\n\nThis 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.\n\nThe study also evaluates feasibility and acceptability of training a large number of surgeons across two institutions. Feasibility is defined as training at least 85% 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.\n\nSixty 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 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria (Surgeons):\n\n* Surgeons who work in the University of Wisconsin-Madison and Medical College of Wisconsin Departments of Surgery who have an outpatient surgical clinic and treat adult patients at UW Health or Froedtert Hospital and MCW\n\nInclusion Criteria (Patients):\n\n* Adult patients with decision making capacity\n* Presenting to an enrolled surgeon's clinic with a surgical problem to discuss treatment\n\nExclusion Criteria (Surgeons):\n\n* 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.\n* Surgeons at UWH who have previously been trained to use Better Conversations (25 surgeons) are excluded.\n\nExclusion Criteria (Patients):\n\n* Adult patients who do not have decision making capacity will be excluded.\n* Individuals who do not speak English will be excluded."}, 'identificationModule': {'nctId': 'NCT07475104', 'briefTitle': 'Redesigning Surgical Care for Patients in Wisconsin', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Redesigning Surgical Care to Support the Health Outcome Goals and Care Preferences for Older Adults: Better Conversations for Better Informed Consent', 'orgStudyIdInfo': {'id': '2025-1648'}, 'secondaryIdInfos': [{'id': 'SMPH / Surgery / WiSOR', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 12/16/2025', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control - Education Specialist Delivered Training', 'description': '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.', 'interventionNames': ['Behavioral: Education Specialist Delivered Training']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention A - Automated Training', 'description': '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.', 'interventionNames': ['Behavioral: Automated Training']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention B - Automated Training with Disclosure Messaging', 'description': '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.', 'interventionNames': ['Behavioral: Automated Training']}], 'interventions': [{'name': 'Education Specialist Delivered Training', 'type': 'BEHAVIORAL', 'otherNames': ['Better Conversations', 'Better Conversations for Better Informed Consent'], 'description': '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.', 'armGroupLabels': ['Control - Education Specialist Delivered Training']}, {'name': 'Automated Training', 'type': 'BEHAVIORAL', 'otherNames': ['Better Conversations', 'Better Conversations for Better Informed Consent'], 'description': 'Training in the Better Conversations framework supported by computerized automation. Procedures match the education-specialist approach (didactic session; 10 training recordings; 5 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.', 'armGroupLabels': ['Intervention A - Automated Training', 'Intervention B - Automated Training with Disclosure Messaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'UW Health', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Margaret (Gretchen) L Schwarze, MD, MPP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UW School of Medicine and Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wisconsin Partnership Program', 'class': 'OTHER'}, {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}