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.
Visão geral do estudo
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Aanand D Naik, MD
- Número de telefone: 713-500-9000
- E-mail: Aanand.Naik@uth.tmc.edu
Estude backup de contato
- Nome: Geethika Yalavarthy
- Número de telefone: (713) 500-4040
- E-mail: Geethika.Yalavarthy@uth.tmc.edu
Locais de estudo
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Texas
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Houston, Texas, Estados Unidos, 77030
- Recrutamento
- The University of Texas Health Science Center at Houston
-
Contato:
- Aanand D Naik, MD
- Número de telefone: 713-500-9000
- E-mail: Aanand.Naik@uth.tmc.edu
-
Contato:
- Geethika Yalavarthy
- Número de telefone: (713) 500-4040
- E-mail: Geethika.Yalavarthy@uth.tmc.edu
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Braço de controle
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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, |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Decision regret as assessed by the Decision regret scale
Prazo: 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)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Decision-making quality in surgical consultations using the Shared Decision-Making Process (SDMP)Scale
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
|
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Assigned preparation approach on health-related quality of life using the Short Form (SF-12) Quality of Life Scale
Prazo: 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)
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Aanand D Naik, MD, The University of Texas Health Science Center, Houston
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HSC-SPH-22-0586
Plano para dados de participantes individuais (IPD)
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