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.
Aperçu de l'étude
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Aanand D Naik, MD
- Numéro de téléphone: 713-500-9000
- E-mail: Aanand.Naik@uth.tmc.edu
Sauvegarde des contacts de l'étude
- Nom: Geethika Yalavarthy
- Numéro de téléphone: (713) 500-4040
- E-mail: Geethika.Yalavarthy@uth.tmc.edu
Lieux d'étude
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Texas
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Houston, Texas, États-Unis, 77030
- Recrutement
- The University of Texas Health Science Center at Houston
-
Contact:
- Aanand D Naik, MD
- Numéro de téléphone: 713-500-9000
- E-mail: Aanand.Naik@uth.tmc.edu
-
Contact:
- Geethika Yalavarthy
- Numéro de téléphone: (713) 500-4040
- E-mail: Geethika.Yalavarthy@uth.tmc.edu
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Bras de commande
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Expérimental: AI Chatbot
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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, |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Decision regret as assessed by the Decision regret scale
Délai: 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
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Self-identified health goals following elective hernia surgery, as measured by the Goal Attainment Scale (GAS)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Decision-making quality in surgical consultations using the Shared Decision-Making Process (SDMP)Scale
Délai: 24 hours-72 hours after the intervention
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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
|
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Perceived involvement in care using the Perceived Involvement in Care Scale (PICS, binary format)
Délai: 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
|
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Decisional confidence using the SURE scale
Délai: 24 hours-72 hours after the intervention
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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)
Délai: 24 hours-72 hours after the intervention
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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)
Délai: 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)
Délai: 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
Délai: 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
|
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Comfort and function following surgery using the Carolina's Comfort Scale (CCS)
Délai: 4 months after surgery
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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
|
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Satisfaction as assessed by the Satisfaction Measure
Délai: 24 hours-72 hours after the intervention
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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
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Aanand D Naik, MD, The University of Texas Health Science Center, Houston
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HSC-SPH-22-0586
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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