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

21. oktober 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

60 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Kontrollarm
Eksperimentell: AI Chatbot
Atferdsmessig: 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,

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The University of Texas Health Science Center, Houston

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. april 2026

Primær fullføring (Antatt)

30. oktober 2027

Studiet fullført (Antatt)

30. oktober 2027

Datoer for studieregistrering

Først innsendt

22. september 2026

Først innsendt som oppfylte QC-kriteriene

22. september 2026

Først lagt ut (Faktiske)

30. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. oktober 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HSC-SPH-22-0586

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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