Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

21 oktober 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

80

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

60 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Kontrollarm
Experimentell: AI Chatbot
Beteende: 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,

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Decision regret as assessed by the Decision regret scale
Tidsram: 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)
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The University of Texas Health Science Center, Houston

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 april 2026

Primärt slutförande (Beräknad)

30 oktober 2027

Avslutad studie (Beräknad)

30 oktober 2027

Studieregistreringsdatum

Först inskickad

22 september 2026

Först inskickad som uppfyllde QC-kriterierna

22 september 2026

Första postat (Faktisk)

30 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 oktober 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HSC-SPH-22-0586

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera