Innovative Cognitive Impairment Case Finding and Engagement for Diverse Participation in Alzheimer's Disease Care, Treatment, And Research (INCLUDE)

Indiana University

Status: Completed

Conditions: Mild Cognitive Impairment (MCI); Alzheimer Disease; Cognitive Decline; Dementia; Alzheimer's Disease (Incl Subtypes)

Treatments: Behavioral: Acceptability and Feasibility of Twistle messaging for PDM+ patients

Study type: Interventional

Funder types: Other

Identifiers

NCT07016178

25818

Details and patient eligibility

About

Recent studies have highlighted the potential use of electronic health record (EHR) data for scalable and less biased identification of people who may have or be at risk of developing MCI or ADRD at the population level.8,9 Using data from the EHR in advance of PC visits can systematically identify patients with undetected MCI and ADRD. At Indiana University (IU), researchers developed a Passive Digital Marker (PDM) to enable early detection of ADRD with an 80% accuracy for one-year and three-year prediction horizons.8,9 Despite the accuracy of the PDM, the feasibility, acceptability, and overall effectiveness of its use for early detection of ADRD in PC remains unclear.

Building on this innovative tool and the ongoing engagement in IUH PC for early detection of ADRD, we propose a project to test the acceptability and feasibility of implementing the PDM in IUH PC to identify people with and at risk of MCI and ADRD and measure if we can increase patient engagement in research and evidence-based follow-up care with the IUH Brain Health Navigator (BHN). The BHN, is primary care based registered nurse with special training to conduct additional assessments of patients following a positive ADRD screen to identify possible underlying causes of cognitive impairment and assist the PCP to facilitate the patient's next steps for diagnostic assessment.

Enrollment: 3,454 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 65 years and older; established patients of 12 selected clinics at IU Health PC who are identified by the PDM as high risk for developing or having undetected MCI or ADRD.

Exclusion criteria

• Patients younger than 65 years; new patients to IUH (less than 12 months); individuals whose primary language is neither English nor Spanish; and current diagnosis of ADRD or MCI.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,454 participants in 1 patient group

PDM+

Experimental group

Description:

Patients at participating clinics identified through the Passive Digital Marker (PDM) as at risk will be contacted for clinical follow up via Twistle, a secure text message platform prior to their next schedule primary care visit. Patients identified as at risk, PDM+, who confirm a cognitive concern via Twistle will be referred to the IU Health Brain Health Navigator (BHN), a clinical nurse embedded in primary care. . The BHN will deliver the IUH Brain Health Protocol to assess for reversible causes, initiate shared decision-making processes for care and treatment, assess for treatment eligibility, and complete a warm hand-off when appropriate. Additionally, the BHN will facilitate patient enrollment in the Indiana CTSI ALL IN research registry and/or the IU Biobank.

Treatment:

Behavioral: Acceptability and Feasibility of Twistle messaging for PDM+ patients