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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Shared decision-making support tool

    Other intervention

    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.

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Simulation clinical encountersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.
2

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.

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.

Secondary outcomes

1

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.

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.
2

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.

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

National Institute on Aging (NIA)

Collaborator