Patient Priorities Aligned Discrete Decision Making for Older Adults With Multiple Chronic Conditions.

NCT07848386 | Recruiting

• 1 other identifier: HSC-SPH-22-0586
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Priorities

Outcome Measures

Primary Outcomes (2)

• Decision regret as assessed by the Decision regret scale

  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)

  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

Secondary Outcomes (9)

• Decision-making quality in surgical consultations using the Shared Decision-Making Process (SDMP)Scale

  24 hours-72 hours after the intervention

• Perceived involvement in care using the Perceived Involvement in Care Scale (PICS, binary format)

  24 hours-72 hours after the intervention

• Decisional confidence using the SURE scale

  24 hours-72 hours after the intervention

• Acceptability as assessed by the Acceptability of Intervention Measure (AIM)

  24 hours-72 hours after the intervention

• Appropriateness as assessed by the Intervention Appropriateness Measure (IAM),

  24 hours-72 hours after the intervention

Study Arms (2)

AI Chatbot

EXPERIMENTAL

Behavioral: AI Chatbot

Control arm

ACTIVE COMPARATOR

Behavioral: Control Arm (Educational Preparation Guide)

Interventions

AI Chatbot BEHAVIORAL

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,

AI Chatbot

Control Arm (Educational Preparation Guide) BEHAVIORAL

Participants will receive a Portable Document Format(PDF) educational preparation guide ("Preparing for Your Surgical Consultation") by email, with sufficient time before the scheduled surgical consultation to review the materials. Participants review the materials independently on their own schedule.

Control arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Aanand D Naik, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aanand D Naik, MD

CONTACT

713-500-9000; Aanand.Naik@uth.tmc.edu

Geethika Yalavarthy

CONTACT

(713) 500-4040; Geethika.Yalavarthy@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to the existence of alternative study arms. Each arm is presented as a standalone study evaluating a specific approach to surgical preparation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 30, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)