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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Aanand D Naik, MD
- 電話番号：713-500-9000
- メール：Aanand.Naik@uth.tmc.edu
研究連絡先のバックアップ
- 名前：Geethika Yalavarthy
- 電話番号：(713) 500-4040
- メール：Geethika.Yalavarthy@uth.tmc.edu
研究場所
-
-
Texas
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Houston、Texas、アメリカ、77030
- 募集
- The University of Texas Health Science Center at Houston
-
コンタクト：
- Aanand D Naik, MD
- 電話番号：713-500-9000
- メール：Aanand.Naik@uth.tmc.edu
-
コンタクト：
- Geethika Yalavarthy
- 電話番号：(713) 500-4040
- メール：Geethika.Yalavarthy@uth.tmc.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：コントロールアーム
|
|
|
実験的：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, |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Decision regret as assessed by the Decision regret scale
時間枠：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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Decision-making quality in surgical consultations using the Shared Decision-Making Process (SDMP)Scale
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Aanand D Naik, MD、The University of Texas Health Science Center, Houston
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- HSC-SPH-22-0586
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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