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

NCT07812337 | Not Yet Recruiting

• 4 other identifiers: 2026-1045R00AG083131NRL NeurologyProtocol Version 8/14/26
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Abnormality

Keywords

Alzheimer's Disease; Blood Biomarker Testing; Shared Decision-Making

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  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

  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.

Study Arms (1)

Simulation clinical encounters

EXPERIMENTAL

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

Interventions

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.

Simulation clinical encounters

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

School of Medicine and Public Health, University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (3)

• 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.

  PMID: 25956069 BACKGROUND

• 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.

  PMID: 19879711 BACKGROUND

• Brooke, John. (1995). SUS: A quick and dirty usability scale. Usability Eval. Ind.. 189.

  BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Fred Ketchum, M.D., Ph.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

608-265-5523; BiomarkersInPrimarycare@neurology.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: September 10, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)