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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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,

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: AI ChatbotExperimental treatment 1 intervention
Group B: Control armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
4 months after surgery
2

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.

Time frame
4 months after surgery

Secondary outcomes

1

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

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.

Time frame
24 hours-72 hours after the intervention
2

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

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.

Time frame
24 hours-72 hours after the intervention
3

Decisional confidence using the SURE scale

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

Time frame
24 hours-72 hours after the intervention
4

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

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

Time frame
24 hours-72 hours after the intervention

Other outcomes

Sponsors and contacts

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