Clinical trial NCT05607732: Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Official title: Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Cognitive Impairment
Cognitive Decline
Alzheimer Disease
Keywords: Detect
Manage
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Oak Street Health
name: University of Illinois at Chicago
First posted: 2022-11-07
Enrollment: 45257
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Our study intends to offer 'real world' evidence of a viable, sustainable means to mobilize primary care via a comprehensive strategy for detecting cognitive impairment and dementias, advancing next steps for referral, and participating in the care planning and management of affected patients and caregivers. We will conduct a clinic-randomized, pragmatic trial testing the effectiveness and fidelity of our NIH Toolbox-derived paradigm to improve early detection and management of cognitive impairment/dementia in primary care settings serving health disparate patient populations.

Detailed description: Practical, scalable strategies are needed to help primary care practices better detect and manage cognitive impairment (CI), especially those caring for medically underserved, low socioeconomic status (SES) communities. Since 2017, our team has been a member of the Consortium for Detecting Cognitive Impairment, Including Dementia (DetectCID); a network dedicated to improving clinical paradigms for early detection of CI and Alzheimer's disease-related dementias (ADRD) and its subsequent management in everyday clinical settings. Having developed the NIH Toolbox for Assessment of Neurological and Behavioral Function and with expertise in health system re-design for patient-centered care, we validated our clinical paradigm, known as MyCog. This includes a brief, iPad-based, self-administered, electronic health record (EHR)-linked strategy to assess for CI during primary care visits when concerns are identified, and 'turnkey' recommendations to address them.

We will partner with a national primary care provider (Oak Street Health) and conduct a 2-arm, clinic-randomized, 'real world' pragmatic trial comparing MyCog to usual care. We will focus on populations experiencing CI/ADRD disparities: Black, H/L, and low SES older adults.

Our specific aims and hypotheses (H) are to:

Aim 1: Test the effectiveness of the MyCog paradigm to improve early detection of cognitive impairment and dementias among low SES, Black and Hispanic/Latino older adults.

Compared to usual care, primary care practices implementing MyCog will demonstrate:

H1: higher rates of detected and/or diagnosed cases of cognitive decline and impairment

Among detected and/or diagnosed cases of cognitive impairment, primary care practices implementing MyCog - compared to usual care - will have:

H2: a greater proportion of early stage (mild) cognitive impairments H3: more referrals for related medical and non-medical services H4: greater caregiver involvement in subsequent patient visits

Aim 2: Investigate the presence of disparities in early detection of cognitive impairment, its diagnosis, and rate of referrals by race and ethnicity.

H5: Disparities in early detection of CI, diagnosis, and referrals by race and ethnicity will be reduced among those primary care practices implementing MyCog compared to usual care.

Aim 3: Determine the fidelity and reliability of MyCog and identify any patient, caregiver, clinician, and/or health system barriers to its optimal, sustained implementation.

Aim 4: Assess the cost-effectiveness of the MyCog paradigm from a primary care perspective.

Eligibility criteria: Inclusion Criteria:

* been seen by an Oak Street healthcare provider affiliated with one of the 24 enrolled practices
* had at least one clinic visit (routine or Annual Wellness Visit) during the 3-year study period
* not been diagnosed previously with cognitive deficits, impairments or dementias.

Exclusion Criteria:

* Children, adolescence, and younger adults are excluded as cognitive impairment in these populations is often due to differences other than age-related changes.

Primary outcomes:
measure: Rate of detected impairment
timeFrame: 3 years
Secondary outcomes:
measure: Rate of detected cases with mild impairment
timeFrame: 3 years
measure: Rate of cognition-related referrals
timeFrame: 3 years
measure: Caregiver Involvement
timeFrame: 3 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Oak Street Health
state: Illinois
Study officials:
References: