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Evaluation of a Decision-Support Tool for Blood Biomarker Testing for Alzheimer's Disease in Primary Care

3. september 2026 oppdatert av: University of Wisconsin, Madison

Pilot Evaluation of a Tool to Support Communication About Blood Biomarker Testing for Cognitive Complaints in Primary Care

The goal of the current study is to evaluate a decision-support tool intended to help primary care providers (PCPs) communicate with patients about blood biomarker testing for Alzheimer's Disease, enhancing shared-decision making and information sharing in the clinical space. The main questions it aims to answer are:

  • Is the decision-support tool accepted and easy to use for PCPs?
  • Does using the tool improve shared decision-making during clinical encounters? Researchers will compare clinical encounters between PCPs who do not use the tool to discuss blood biomarker testing for Alzheimer's Disease, versus PCPs who have been trained to utilize the tool during clinical encounters to see whether the tool effectively facilitates shared-decision making.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This pilot study will determine the acceptability and usability of a decision-support tool for primary care providers (PCPs) and assess the feasibility of recruitment techniques in preparation for a later trial. The study includes two high-fidelity simulation components.

Simulation 1: The investigators will assess the usability and acceptability of the decision-support tool through direct observation and surveys of PCPs participating in high-fidelity simulations of clinical encounters (N=15). The hypothesis is that the decision-support tool will be acceptable and usable by PCPs.

Simulation 2: The investigators will compare the effect of the decision-support tool on shared decision-making (SDM) in high-fidelity simulated clinical encounters conducted with the tool versus without the tool (N=25 per arm). The hypothesis is that shared decision-making will increase in encounters using the intervention.

Studietype

Intervensjonell

Registrering (Antatt)

70

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Forente stater
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53705
        • School of Medicine and Public Health, University of Wisconsin
        • Ta kontakt med:

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Simulation 1 and Simulation 2: PCPs with experience and interest in cognitive diagnosis.
  • Simulation 2: community dwelling older adults age 50 or older are eligible.

Exclusion Criteria (PCP): none

Participant Exclusion Criteria:

  • Not fluent in English
  • age <50 years
  • pre-existing diagnosis of cognitive impairment
  • having an activated medical decision-make r or not living independently in the community.

There will be no exclusion based upon sex/gender, race, or ethnicity.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Simulation clinical encounters
In Simulation 1, 15 PCPs will complete simulated clinical encounters with standardized patients after completing trainings on how to use the decision-support tool. In Simulation 2, a different group of 3-5 PCPs will see patients during simulated clinical encounters without using the decision-support too for the first half. In the second half, these PCPs will complete trainings on how to use the tool and then see the second half of the participants using the tool.
Annen: Shared decision-making support tool
Based on previous data analysis, the decision-support tool is intended to facilitate discussions between the patients and their providers regarding the Phospho-Tau blood test. It functions as a flowchart to provide clear, accessible information about the blood test that will assist providers in discussions around guide the patients through navigating a diagnostic workups for memory problems.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Effectiveness of the tool on shared decision-making as measured by OPTION-5 Score
Tidsramme: This is a single time point outcome measure. In Simulation 2, providers participants will complete OPTION-5 immediately after they participate in the high fidelity clinical encounter session.
Effectiveness of the tool on shared decision-making will be measured by OPTION-5 score, a validated measurement to quantitatively evaluated shared decision-making process from the observers' perspective. The total range of scores is from 0-100 where higher scores indicate greater patient involvement
This is a single time point outcome measure. In Simulation 2, providers participants will complete OPTION-5 immediately after they participate in the high fidelity clinical encounter session.
Effectiveness of the tool on shared decision-making assessed by SDM-Q-9.
Tidsramme: This is a single time point outcome measure. In Simulation 2, patients participants will complete SDM-Q-9 immediately after they participate in the high fidelity clinical encounter session.
SDM-Q-9 is a 9-item questionnaire that evaluates the shared decision-making (SDM) process from the patient's perspective. Individual items range from "completely disagree" (0) to "completely agree" (5), yielding a raw sum score between 0 and 45, where higher scores demonstrate increased effectiveness.
This is a single time point outcome measure. In Simulation 2, patients participants will complete SDM-Q-9 immediately after they participate in the high fidelity clinical encounter session.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Acceptability and usability of the tool as measured by an adapted System Usability Scale (SUS)
Tidsramme: In both simulation 1 and simulation 2, provider participants complete the SUS immediately after they have completed the high fidelity clinical encounter session with a patient participant or a standardized patient.
The System Usability Scale (SUS) is a short 10-item questionnaire that presents a subjective assessments of usability. The scores are calculated by adjusting odd- and even-numbered item responses, summing the adjusted scores (0-40), and multiplying the total by 2.5 to produce a final score ranging from 0 to 100, where higher scores indicate increased acceptability and usability.
In both simulation 1 and simulation 2, provider participants complete the SUS immediately after they have completed the high fidelity clinical encounter session with a patient participant or a standardized patient.
Acceptability and usability of the tool as measured by Practitioner Opinion Survey
Tidsramme: In both simulation 1 and simulation 2, provider participants complete the POS immediately after they have completed the high fidelity clinical encounter session with a patient participant or a standardized patient.
The Practitioner opinion survey (POS) is a questionnaire that contains 15 items that assess the usability and acceptability of the shared decision-making tool. The total score range is from 15-75, with higher summed score indicating higher usability and acceptability from the perspective of the providers.
In both simulation 1 and simulation 2, provider participants complete the POS immediately after they have completed the high fidelity clinical encounter session with a patient participant or a standardized patient.

Samarbeidspartnere og etterforskere

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

Sponsor

University of Wisconsin, Madison

Samarbeidspartnere

National Institute on Aging (NIA)

Etterforskere

  • Hovedetterforsker: Fred Ketchum, M.D., Ph.D., University of Wisconsin, Madison

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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 (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

15. november 2027

Studiet fullført (Antatt)

15. november 2027

Datoer for studieregistrering

Først innsendt

18. august 2026

Først innsendt som oppfylte QC-kriteriene

3. september 2026

Først lagt ut (Faktiske)

10. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026-1045
  • R00AG083131 (U.S. NIH-stipend/kontrakt)
  • NRL Neurology (Annen identifikator: UW Madison)
  • Protocol Version 8/14/26 (Annen identifikator: UW Madison)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

There is currently not a plan to make IPD available.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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