Recruiting

Decision-Support Tool

Sponsor:

University of Wisconsin, Madison

Code:

NCT07812337

Conditions

Cognitive Abnormality

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Shared decision-making support tool

Study Details

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

Study ID

NCT07812337

Start date

Oct 1, 2026

Status verified date

Sep, 2026

Completion date

Nov 15, 2027

Anticipated

Primary completion date

Nov 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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 Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • 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 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. ]

Central Contacts and Locations

Central contacts

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

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

Locations

School of Medicine and Public Health, University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Fred Ketchum, M.D., PhD

608-265-5523fketchum@wisc.edu

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.