Evaluation of a Decision-Support Tool for Blood Biomarker Testing for Alzheimer's Disease in Primary Care
3. september 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
70
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Fred Ketchum, M.D., Ph.D.
- Telefonnummer: 608-265-5523
- E-mail: BiomarkersInPrimarycare@neurology.wisc.edu
Studiesteder
-
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53705
- School of Medicine and Public Health, University of Wisconsin
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Kontakt:
- Fred Ketchum, M.D., PhD
- Telefonnummer: 608-265-5523
- E-mail: fketchum@wisc.edu
-
-
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
- Voksen
- Ældre voksen
Tager imod sunde 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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
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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
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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.
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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.
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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.
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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.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
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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.
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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.
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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.
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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.
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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.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Fred Ketchum, M.D., Ph.D., University of Wisconsin, Madison
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.
- Barr PJ, O'Malley AJ, Tsulukidze M, Gionfriddo MR, Montori V, Elwyn G. The psychometric properties of Observer OPTION(5), an observer measure of shared decision making. Patient Educ Couns. 2015 Aug;98(8):970-6. doi: 10.1016/j.pec.2015.04.010. Epub 2015 Apr 29.
- Brooke, John. (1995). SUS: A quick and dirty usability scale. Usability Eval. Ind.. 189.
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 (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
15. november 2027
Studieafslutning (Anslået)
15. november 2027
Datoer for studieregistrering
Først indsendt
18. august 2026
Først indsendt, der opfyldte QC-kriterier
3. september 2026
Først opslået (Faktiske)
10. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026-1045
- R00AG083131 (U.S. NIH-bevilling/kontrakt)
- NRL Neurology (Anden identifikator: UW Madison)
- Protocol Version 8/14/26 (Anden identifikator: UW Madison)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
There is currently not a plan to make IPD available.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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