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

21. oktober 2026 opdateret af: Aanand Dinkar Naik, The University of Texas Health Science Center, Houston

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Kontrolarm
Eksperimentel: AI Chatbot
Adfærdsmæssigt: AI 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,

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Decision regret as assessed by the Decision regret scale
Tidsramme: 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
Self-identified health goals following elective hernia surgery, as measured by the Goal Attainment Scale (GAS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Decision-making quality in surgical consultations using the Shared Decision-Making Process (SDMP)Scale
Tidsramme: 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)
Tidsramme: 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
Decisional confidence using the SURE scale
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Assigned preparation approach on health-related quality of life using the Short Form (SF-12) Quality of Life Scale
Tidsramme: 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
Comfort and function following surgery using the Carolina's Comfort Scale (CCS)
Tidsramme: 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
4 months after surgery
Satisfaction as assessed by the Satisfaction Measure
Tidsramme: 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
24 hours-72 hours after the intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The University of Texas Health Science Center, Houston

Efterforskere

  • Ledende efterforsker: Aanand D Naik, MD, The University of Texas Health Science Center, Houston

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. april 2026

Primær færdiggørelse (Anslået)

30. oktober 2027

Studieafslutning (Anslået)

30. oktober 2027

Datoer for studieregistrering

Først indsendt

22. september 2026

Først indsendt, der opfyldte QC-kriterier

22. september 2026

Først opslået (Faktiske)

30. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. oktober 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HSC-SPH-22-0586

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