Primary care detection of cognitive impairment leveraging health and consumer technologies in underserved US communities: protocol for a pragmatic randomised controlled trial of the MyCog paradigm
Introduction Early identification of cognitive impairment (CI), including Alzheimer’s disease and related dementias (ADRD), is a top public health priority. Yet, CI/ADRD is often undetected and underdiagnosed within primary care settings, and in health disparate populations. The MyCog paradigm is an...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/10/e080101.full |
| _version_ | 1797634618802831360 |
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| author | Michael Wolf Richard Gershon Michael Bass Minjee Kim Morgan Bonham Julia Yoshino Benavente Rebecca Lovett Zahra Hosseinian Greg J Byrne Maria Varela Diaz Lihua Yao Andrei Adin-Cristian Stephanie Batio Amanda Sluis Margaret Moran David R Buchanan Justin Hunt Stephanie R Young Cindy Nowinski |
| author_facet | Michael Wolf Richard Gershon Michael Bass Minjee Kim Morgan Bonham Julia Yoshino Benavente Rebecca Lovett Zahra Hosseinian Greg J Byrne Maria Varela Diaz Lihua Yao Andrei Adin-Cristian Stephanie Batio Amanda Sluis Margaret Moran David R Buchanan Justin Hunt Stephanie R Young Cindy Nowinski |
| author_sort | Michael Wolf |
| collection | DOAJ |
| description | Introduction Early identification of cognitive impairment (CI), including Alzheimer’s disease and related dementias (ADRD), is a top public health priority. Yet, CI/ADRD is often undetected and underdiagnosed within primary care settings, and in health disparate populations. The MyCog paradigm is an iPad-based, self-administered, validated cognitive assessment based on the National Institutes of Health (NIH) Toolbox Cognition Battery and coupled with clinician decision-support tools that is specifically tailored for CI/ADRD detection within diverse, primary care settings.Methods and analysis We will conduct a two-arm, primary care practice-randomised (N=24 practices; 45 257 active patients at the proposed practices), pragmatic trial among geographically diverse Oak Street Health sites to test the effectiveness of the MyCog paradigm to improve early detection CI/ADRD among low socioeconomic, black and Hispanic older adults compared with usual care. Participating practices randomised to the intervention arm will impart the MyCog paradigm as a new standard of care over a 3-year implementation period; as the cognitive component for Annual Wellness Visits and for any patient/informant-reported or healthcare provider-suspected cognitive concern. Rates of detected (cognitive test suggesting impairment) and/or diagnosed (relevant International Classification of Diseases-9/10 [ICD-9/10] code) cognitive deficits, impairments or dementias including ADRD will be our primary outcome of study compared between arms. Secondary outcomes will include ADRD severity (ie, mild or later stage), rates of cognitive-related referrals and rates of family member or caregiver involvement in ADRD care planning. We will use generalised linear mixed models to account for clustered study design. Secondary models will adjust for subject, clinic or visit-specific characteristics. We will use mixed-methods approaches to examine fidelity and cost-effectiveness of the MyCog paradigm.Ethics and dissemination The Institutional Review Board at Advarra has approved the study protocol (Pro00064339). Results will be published in peer-reviewed journals and summaries will be provided to the funders of the study.Trial registration number NCT05607732. |
| first_indexed | 2024-03-11T12:11:04Z |
| format | Article |
| id | doaj.art-c66e9165418c44808ef9ce93e21d7af5 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-11T12:11:04Z |
| publishDate | 2023-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-c66e9165418c44808ef9ce93e21d7af52023-11-07T14:10:08ZengBMJ Publishing GroupBMJ Open2044-60552023-10-01131010.1136/bmjopen-2023-080101Primary care detection of cognitive impairment leveraging health and consumer technologies in underserved US communities: protocol for a pragmatic randomised controlled trial of the MyCog paradigmMichael Wolf0Richard Gershon1Michael Bass2Minjee Kim3Morgan Bonham4Julia Yoshino Benavente5Rebecca Lovett6Zahra Hosseinian7Greg J Byrne8Maria Varela Diaz9Lihua Yao10Andrei Adin-Cristian11Stephanie Batio12Amanda Sluis13Margaret Moran14David R Buchanan15Justin Hunt16Stephanie R Young17Cindy Nowinski18General Internal Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA14Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USADepartment of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USANeurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USADivision of General Internal Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USACenter for Applied Research on Aging, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USAPsychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USAMedical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USAMedical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USAMedical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USAMedical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USAPreventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USAGeneral Internal Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USAOak Street Health LLC, Chicago, Illinois, USAOak Street Health LLC, Chicago, Illinois, USAOak Street Health LLC, Chicago, Illinois, USAOak Street Health LLC, Chicago, Illinois, USAMedical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USAMedical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USAIntroduction Early identification of cognitive impairment (CI), including Alzheimer’s disease and related dementias (ADRD), is a top public health priority. Yet, CI/ADRD is often undetected and underdiagnosed within primary care settings, and in health disparate populations. The MyCog paradigm is an iPad-based, self-administered, validated cognitive assessment based on the National Institutes of Health (NIH) Toolbox Cognition Battery and coupled with clinician decision-support tools that is specifically tailored for CI/ADRD detection within diverse, primary care settings.Methods and analysis We will conduct a two-arm, primary care practice-randomised (N=24 practices; 45 257 active patients at the proposed practices), pragmatic trial among geographically diverse Oak Street Health sites to test the effectiveness of the MyCog paradigm to improve early detection CI/ADRD among low socioeconomic, black and Hispanic older adults compared with usual care. Participating practices randomised to the intervention arm will impart the MyCog paradigm as a new standard of care over a 3-year implementation period; as the cognitive component for Annual Wellness Visits and for any patient/informant-reported or healthcare provider-suspected cognitive concern. Rates of detected (cognitive test suggesting impairment) and/or diagnosed (relevant International Classification of Diseases-9/10 [ICD-9/10] code) cognitive deficits, impairments or dementias including ADRD will be our primary outcome of study compared between arms. Secondary outcomes will include ADRD severity (ie, mild or later stage), rates of cognitive-related referrals and rates of family member or caregiver involvement in ADRD care planning. We will use generalised linear mixed models to account for clustered study design. Secondary models will adjust for subject, clinic or visit-specific characteristics. We will use mixed-methods approaches to examine fidelity and cost-effectiveness of the MyCog paradigm.Ethics and dissemination The Institutional Review Board at Advarra has approved the study protocol (Pro00064339). Results will be published in peer-reviewed journals and summaries will be provided to the funders of the study.Trial registration number NCT05607732.https://bmjopen.bmj.com/content/13/10/e080101.full |
| spellingShingle | Michael Wolf Richard Gershon Michael Bass Minjee Kim Morgan Bonham Julia Yoshino Benavente Rebecca Lovett Zahra Hosseinian Greg J Byrne Maria Varela Diaz Lihua Yao Andrei Adin-Cristian Stephanie Batio Amanda Sluis Margaret Moran David R Buchanan Justin Hunt Stephanie R Young Cindy Nowinski Primary care detection of cognitive impairment leveraging health and consumer technologies in underserved US communities: protocol for a pragmatic randomised controlled trial of the MyCog paradigm BMJ Open |
| title | Primary care detection of cognitive impairment leveraging health and consumer technologies in underserved US communities: protocol for a pragmatic randomised controlled trial of the MyCog paradigm |
| title_full | Primary care detection of cognitive impairment leveraging health and consumer technologies in underserved US communities: protocol for a pragmatic randomised controlled trial of the MyCog paradigm |
| title_fullStr | Primary care detection of cognitive impairment leveraging health and consumer technologies in underserved US communities: protocol for a pragmatic randomised controlled trial of the MyCog paradigm |
| title_full_unstemmed | Primary care detection of cognitive impairment leveraging health and consumer technologies in underserved US communities: protocol for a pragmatic randomised controlled trial of the MyCog paradigm |
| title_short | Primary care detection of cognitive impairment leveraging health and consumer technologies in underserved US communities: protocol for a pragmatic randomised controlled trial of the MyCog paradigm |
| title_sort | primary care detection of cognitive impairment leveraging health and consumer technologies in underserved us communities protocol for a pragmatic randomised controlled trial of the mycog paradigm |
| url | https://bmjopen.bmj.com/content/13/10/e080101.full |
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