Patient Priorities Aligned Discrete Decision Making for Older Adults With Multiple Chronic Conditions.
The purpose of the study is to to evaluate an artificial intelligence (AI) powered large language model (LLM) chatbot -PrioritiesAI -that assists patients in understanding, clarifying, and communicating their health priorities and desired outcomes related to elective hernia surgery.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Aanand D Naik, MD
- 电话号码:713-500-9000
- 邮箱:Aanand.Naik@uth.tmc.edu
研究联系人备份
- 姓名:Geethika Yalavarthy
- 电话号码:(713) 500-4040
- 邮箱:Geethika.Yalavarthy@uth.tmc.edu
学习地点
-
-
Texas
-
Houston、Texas、美国、77030
- 招聘中
- The University of Texas Health Science Center at Houston
-
接触:
- Aanand D Naik, MD
- 电话号码:713-500-9000
- 邮箱:Aanand.Naik@uth.tmc.edu
-
接触:
- Geethika Yalavarthy
- 电话号码:(713) 500-4040
- 邮箱:Geethika.Yalavarthy@uth.tmc.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Capacity to provide informed consent
- Ability to communicate effectively by phone in English
- Access to a working email address that the participant checks regularly
- Scheduled for an upcoming outpatient consultation with one of our partner surgeons to discuss elective hernia surgery (femoral, ventral, inguinal, or umbilical)
- No significant cognitive impairment that would interfere with meaningful participation
To ensure focus on surgical decisions, participants must fall into one of these categories:
- Patients scheduled for an upcoming outpatient consultation with one of our partner surgeons specifically to discuss a potential surgical procedure
- Patients who have undergone a surgical procedure performed one of our partner surgeons after January 1, 2025
- Participants must meet criteria #1 or #2 above and must not have participated in Phase 1 of the study
Exclusion Criteria:
- Cognitive impairment sufficient to interfere with meaningful participation in Patient Priorities Care (PPC) discussions
- Communication challenges that cannot be reasonably accommodated within the study protocol
- Inability to complete patient-reported outcome measures independently or with minimal assistance
- Lack of decision-making capacity regarding surgical care
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预:控制臂
|
|
|
实验性的:AI Chatbot
|
Participants receive a personalized web link by email .The link provides access to the Priorities AI chatbot on any internet-connected device. The chatbot guides participants through a structured conversation to identify their health priorities and goals related to their surgical decision, |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Decision regret as assessed by the Decision regret scale
大体时间:4 months after surgery
|
This is a 5 item questionnaire and each is scored from 0(no regret)-5 (high regret). Average of the item scores are calculated then 1 is subtracted and the final score is multiplied by 25 for a final metric from 0 to 100. Higher scores indicating worse outcome |
4 months after surgery
|
|
Self-identified health goals following elective hernia surgery, as measured by the Goal Attainment Scale (GAS)
大体时间:4 months after surgery
|
This is rated on a 5-point scale from -2 (much less than expected) to +2 (much better than expected), with 0 representing the expected level of goal attainment. Higher scores indicate greater attainment of individualized goals. |
4 months after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Decision-making quality in surgical consultations using the Shared Decision-Making Process (SDMP)Scale
大体时间:24 hours-72 hours after the intervention
|
The Shared Decision-Making Process (SDMP) Scale is a 4-item, patient-reported measure. Maximum scores range from 0 to 4, with higher scores indicating greater shared decision-making. |
24 hours-72 hours after the intervention
|
|
Perceived involvement in care using the Perceived Involvement in Care Scale (PICS, binary format)
大体时间:24 hours-72 hours after the intervention
|
This is a 13 item questionnaire and each is scored as 1(agree) or 0(disagree) for a total score 0-13, with higher scores indicating greater perceived involvement in care. |
24 hours-72 hours after the intervention
|
|
Decisional confidence using the SURE scale
大体时间:24 hours-72 hours after the intervention
|
This is a 4 item questionnaire and each is scored as a 1(yes) or 0(no) for a maximum score of 0-4,higher score indicating greater decisional confidence |
24 hours-72 hours after the intervention
|
|
Acceptability as assessed by the Acceptability of Intervention Measure (AIM)
大体时间:24 hours-72 hours after the intervention
|
This is a 4 item questionnaire and each is scored on a 5-point Likert scale from 1( completely disagree) to 5 (completely agree) for a maximum score of 4-20, higher scores indicate greater perceived acceptability |
24 hours-72 hours after the intervention
|
|
Appropriateness as assessed by the Intervention Appropriateness Measure (IAM)
大体时间:24 hours-72 hours after the intervention
|
This is a 4 item questionnaire and each is scored on a 5-point Likert scale from 1( completely disagree) to 5 (completely agree) for a maximum score of 4-20, higher scores indicate greater perceived appropriateness |
24 hours-72 hours after the intervention
|
|
Feasibility as assessed by the Feasibility of Intervention Measure (FIM)
大体时间:24 hours-72 hours after the intervention
|
This is a 4 item questionnaire and each is scored on a 5-point Likert scale from 1( completely disagree) to 5 (completely agree) for a maximum score of 4-20, higher scores indicate greater perceived feasibility |
24 hours-72 hours after the intervention
|
|
Assigned preparation approach on health-related quality of life using the Short Form (SF-12) Quality of Life Scale
大体时间:4 months after surgery
|
The SF-12 assesses physical and mental health across eight health concepts and generates two summary scores: the Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12). Both scores are calculated using responses to all 12 items and are typically reported on a 0-100 scale, with higher scores indicating better health-related quality of life. |
4 months after surgery
|
|
Comfort and function following surgery using the Carolina's Comfort Scale (CCS)
大体时间:4 months after surgery
|
This is a 23 item questionnaire and each is scored from 0(no symptoms) to 5( disabling symptoms) for a score range of 0-115, higher score indicating worse postoperative comfort |
4 months after surgery
|
|
Satisfaction as assessed by the Satisfaction Measure
大体时间:24 hours-72 hours after the intervention
|
This is a 1 item questionnaire and scored from 0(worst visit possible)-10 ( best visit possible) , higher value means better outcome |
24 hours-72 hours after the intervention
|
合作者和调查者
调查人员
- 首席研究员:Aanand D Naik, MD、The University of Texas Health Science Center, Houston
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- HSC-SPH-22-0586
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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