Oak Street Health
Chicago, Illinois, 60617, United States
NCT Number: NCT05607732
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.
This study is active but is not currently recruiting participants.
45 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60617, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MyCog uses well-validated, self-administered, iPad-based measures from the NIH Toolbox for the Assessment of Neurological Behavior and Function Cognition Battery to provide an efficient and sensitive cognitive screen that can be easily implemented in primary care. Preliminary data shows these tests can discriminate between cognitively normal older adults and those with CI (specifically mild cognitive impairment); enabling physicians to assess CI in ways currently not available.
Time frame: 3 years
This will be operationalized as either results of an administered cognitive test suggesting impairment ('detected') or having any relevant International Classification of Diseases (ICD) 10 code recorded in a patient's record after the trial launch date and throughout follow-up observation period ('diagnosis').
Time frame: 3 years
Mild vs. other impairment rates will be compared across trial arms, operationalized by ICD code groupings.
Time frame: 3 years
Extraction from the electronic data warehouse for whether or not a cognitive-related referral was made (medical or non-medical) following a "detected" cognitive screen
Time frame: 3 years
Text search of clinic note from any follow-up visit post AWV, wellness visit mention of accompanying family member/caregiver; extraction from Enterprise Data Warehouse to determine if proxy access to patient's MyChart portal has been shared.
Northwestern University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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