Redesigning Surgical Care to Support the Health Outcome Goals and Care Preferences for Older Adults: Better Conversations for Better Informed Consent
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 660
- 试验地点
- 2
- 主要终点
- Percentage of surgeons trained to competence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Surgeons):
- •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
- •Inclusion Criteria (Patients):
- •Adult patients with decision making capacity
- •Presenting to an enrolled surgeon's clinic with a surgical problem to discuss treatment
排除标准
- •(Surgeons):
- •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.
- •Exclusion Criteria (Patients):
- •Adult patients who do not have decision making capacity will be excluded.
- •Individuals who do not speak English will be excluded.
研究组 & 干预措施
Control - Education Specialist Delivered Training
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.
干预措施: Education Specialist Delivered Training (Behavioral)
Intervention A - Automated Training
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.
干预措施: Automated Training (Behavioral)
Intervention B - Automated Training with Disclosure Messaging
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.
干预措施: Automated Training (Behavioral)
结局指标
主要结局
Percentage of surgeons trained to competence
时间窗: 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.
次要结局
- 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)