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.
Descripción general del estudio
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Aanand D Naik, MD
- Número de teléfono: 713-500-9000
- Correo electrónico: Aanand.Naik@uth.tmc.edu
Copia de seguridad de contactos de estudio
- Nombre: Geethika Yalavarthy
- Número de teléfono: (713) 500-4040
- Correo electrónico: Geethika.Yalavarthy@uth.tmc.edu
Ubicaciones de estudio
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Texas
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Houston, Texas, Estados Unidos, 77030
- Reclutamiento
- The University of Texas Health Science Center at Houston
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Contacto:
- Aanand D Naik, MD
- Número de teléfono: 713-500-9000
- Correo electrónico: Aanand.Naik@uth.tmc.edu
-
Contacto:
- Geethika Yalavarthy
- Número de teléfono: (713) 500-4040
- Correo electrónico: Geethika.Yalavarthy@uth.tmc.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Brazo de control
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Experimental: 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, |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Decision regret as assessed by the Decision regret scale
Periodo de tiempo: 4 months after surgery
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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)
Periodo de tiempo: 4 months after surgery
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Decision-making quality in surgical consultations using the Shared Decision-Making Process (SDMP)Scale
Periodo de tiempo: 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)
Periodo de tiempo: 24 hours-72 hours after the intervention
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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
Periodo de tiempo: 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
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Acceptability as assessed by the Acceptability of Intervention Measure (AIM)
Periodo de tiempo: 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
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Appropriateness as assessed by the Intervention Appropriateness Measure (IAM)
Periodo de tiempo: 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 appropriateness |
24 hours-72 hours after the intervention
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Feasibility as assessed by the Feasibility of Intervention Measure (FIM)
Periodo de tiempo: 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 feasibility |
24 hours-72 hours after the intervention
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Assigned preparation approach on health-related quality of life using the Short Form (SF-12) Quality of Life Scale
Periodo de tiempo: 4 months after surgery
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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)
Periodo de tiempo: 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
Periodo de tiempo: 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
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Aanand D Naik, MD, The University of Texas Health Science Center, Houston
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HSC-SPH-22-0586
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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