Hernia
Conditions
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.
Interventions
BEHAVIORALAI Chatbot
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,
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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: 1. Patients scheduled for an upcoming outpatient consultation with one of our partner surgeons specifically to discuss a potential surgical procedure 2. Patients who have undergone a surgical procedure performed one of our partner surgeons after January 1, 2025 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decision regret as assessed by the Decision regret scale | 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 |
| Self-identified health goals following elective hernia surgery, as measured by the Goal Attainment Scale (GAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decision-making quality in surgical consultations using the Shared Decision-Making Process (SDMP)Scale | 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. |
| Perceived involvement in care using the Perceived Involvement in Care Scale (PICS, binary format) | 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. |
| Decisional confidence using the SURE scale | 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 |
| Acceptability as assessed by the Acceptability of Intervention Measure (AIM) | 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 |
| Appropriateness as assessed by the Intervention Appropriateness Measure (IAM) | 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 |
| Feasibility as assessed by the Feasibility of Intervention Measure (FIM) | 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 |
| Assigned preparation approach on health-related quality of life using the Short Form (SF-12) Quality of Life Scale | 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. |
| Comfort and function following surgery using the Carolina's Comfort Scale (CCS) | 4 months after surgery | 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 |
| Satisfaction as assessed by the Satisfaction Measure | 24 hours-72 hours after the intervention | This is a 1 item questionnaire and scored from 0(worst visit possible)-10 ( best visit possible) , higher value means better outcome |
Countries
United States
Contacts
CONTACTAanand D Naik, MD
CONTACTGeethika Yalavarthy
PRINCIPAL_INVESTIGATORAanand D Naik, MD
The University of Texas Health Science Center, Houston
Outcome results
None listed