HerniaNCT07848386
Patient Priorities Aligned Discrete Decision Making for Older Adults With Multiple Chronic Conditions.
A study testing AI Chatbot in people with Hernia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hernia
- What is being tested?
- AI Chatbot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2026to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Aanand D Naik, MD, 713-500-9000, Aanand.Naik@uth.tmc.edu
Geethika Yalavarthy, (713) 500-4040, Geethika.Yalavarthy@uth.tmc.edu
About this study
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
- Hernia
- Being tested
- AI Chatbot
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI ChatbotBehavioural
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,
| Study group | Role | What they receive |
|---|---|---|
| AI Chatbot | Experimental | Not described Receives: Behavioral: AI Chatbot |
| Control arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 4 months after surgery
Secondary outcomes (9)
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.
Measured: 24 hours-72 hours after the intervention
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.
Measured: 24 hours-72 hours after the intervention
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
Measured: 24 hours-72 hours after the intervention
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
Measured: 24 hours-72 hours after the intervention
Appropriateness as assessed by the Intervention Appropriateness Measure (IAM)
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
Measured: 24 hours-72 hours after the intervention
Feasibility as assessed by the Feasibility of Intervention Measure (FIM)
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
Measured: 24 hours-72 hours after the intervention
Assigned preparation approach on health-related quality of life using the Short Form (SF-12) Quality of Life Scale
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.
Measured: 4 months after surgery
Comfort and function following surgery using the Carolina's Comfort Scale (CCS)
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
Measured: 4 months after surgery
Satisfaction as assessed by the Satisfaction Measure
This is a 1 item questionnaire and scored from 0(worst visit possible)-10 ( best visit possible) , higher value means better outcome
Measured: 24 hours-72 hours after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start30 Apr 2026
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aanand Dinkar Naik, The University of Texas Health Science Center, Houston
- Investigators
- Aanand D Naik, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848386
- Sponsor's protocol ID
- HSC-SPH-22-0586
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Priorities Aligned Discrete Decision Making for Older Adults With Multiple Chronic Conditions.
- ClinicalTrials.gov ID
- NCT07848386
- Acronym / sponsor ID
- HSC-SPH-22-0586
- Conditions
- Hernia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI Chatbot | Experimental | Behavioral: AI Chatbot |
| Control arm | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI ChatbotParticipants 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, | Behavioural | AI Chatbot |
Primary outcome
Decision regret as assessed by the Decision regret scale
Time frame: 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)
Time frame: 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.
9 secondary outcomes
Decision-making quality in surgical consultations using the Shared Decision-Making Process (SDMP)Scale
Time frame: 24 hours-72 hours after the intervention
Perceived involvement in care using the Perceived Involvement in Care Scale (PICS, binary format)
Time frame: 24 hours-72 hours after the intervention
Decisional confidence using the SURE scale
Time frame: 24 hours-72 hours after the intervention
Acceptability as assessed by the Acceptability of Intervention Measure (AIM)
Time frame: 24 hours-72 hours after the intervention
Appropriateness as assessed by the Intervention Appropriateness Measure (IAM)
Time frame: 24 hours-72 hours after the intervention
Feasibility as assessed by the Feasibility of Intervention Measure (FIM)
Time frame: 24 hours-72 hours after the intervention
Assigned preparation approach on health-related quality of life using the Short Form (SF-12) Quality of Life Scale
Time frame: 4 months after surgery
Comfort and function following surgery using the Carolina's Comfort Scale (CCS)
Time frame: 4 months after surgery
Satisfaction as assessed by the Satisfaction Measure
Time frame: 24 hours-72 hours after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aanand D Naik, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI Chatbot in people with Hernia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aanand D Naik, MD (713-500-9000, Aanand.Naik@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision regret as assessed by the Decision regret scale (time frame: 4 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.