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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Abnormality
• Intervention / Treatment: Other: Shared decision-making support tool

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fred Ketchum, M.D., Ph.D.; Phone Number: 608-265-5523; Email: BiomarkersInPrimarycare@neurology.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • School of Medicine and Public Health, University of Wisconsin
      • Contact: Fred Ketchum, M.D., PhD; Phone Number: 608-265-5523; Email: fketchum@wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of the tool on shared decision-making as measured by OPTION-5 Score	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability and usability of the tool as measured by an adapted System Usability Scale (SUS)	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	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.

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Fred Ketchum, M.D., Ph.D., University of Wisconsin, Madison

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2027

Study Registration Dates

• First Submitted: August 18, 2026
• First Submitted That Met QC Criteria: September 3, 2026
• First Posted (Actual): September 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; Shared Decision-Making; Blood Biomarker Testing
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: 2026-1045; R00AG083131 (U.S. NIH Grant/Contract); NRL Neurology (Other Identifier: UW Madison); Protocol Version 8/14/26 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is currently not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No