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NCT Number: NCT07812337

Evaluation of a Decision-Support Tool for Blood Biomarker Testing for Alzheimer's Disease 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.

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Key information

Conditions

Cognitive Abnormality Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Medicine and Public Health, University of Wisconsin

Madison, Wisconsin, 53705, United States

Location contact

Fred Ketchum, M.D., PhD

CONTACT

[email protected]

608-265-5523

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shared decision-making support tool

Other

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.

Primary outcomes

  1. Effectiveness of the tool on shared decision-making as measured by OPTION-5 Score

    Time frame: 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

  2. Effectiveness of the tool on shared decision-making assessed by SDM-Q-9.

    Time frame: 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.

Secondary outcomes

  1. Acceptability and usability of the tool as measured by an adapted System Usability Scale (SUS)

    Time frame: 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.

  2. Acceptability and usability of the tool as measured by Practitioner Opinion Survey

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fred Ketchum, M.D., Ph.D.

CONTACT

[email protected]

608-265-5523

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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