Improving Early Dementia Detection Among Diverse Older Adults With Cognitive Concerns With the 5-Cog Paradigm: Protocol for a Hybrid Effectiveness-Implementation Clinical Trial
BackgroundThe 5-Cog paradigm is a 5-minute brief cognitive assessment coupled with a clinical decision support tool designed to improve clinicians’ early detection of cognitive impairment, including dementia, in their diverse older primary care patients. The 5-Cog battery use...
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JMIR Publications
2025-04-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2025/1/e60471 |
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| author | Rachel Beth Rosansky Chalmer Emmeline Ayers Erica F Weiss Nicole R Fowler Andrew Telzak Diana Summanwar Jessica Zwerling Cuiling Wang Huiping Xu Richard J Holden Kevin Fiori Dustin D French Celeste Nsubayi Asif Ansari Paul Dexter Anna Higbie Pratibha Yadav James M Walker Harrshavasan Congivaram Dristi Adhikari Mairim Melecio-Vazquez Malaz Boustani Joe Verghese |
| author_facet | Rachel Beth Rosansky Chalmer Emmeline Ayers Erica F Weiss Nicole R Fowler Andrew Telzak Diana Summanwar Jessica Zwerling Cuiling Wang Huiping Xu Richard J Holden Kevin Fiori Dustin D French Celeste Nsubayi Asif Ansari Paul Dexter Anna Higbie Pratibha Yadav James M Walker Harrshavasan Congivaram Dristi Adhikari Mairim Melecio-Vazquez Malaz Boustani Joe Verghese |
| author_sort | Rachel Beth Rosansky Chalmer |
| collection | DOAJ |
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BackgroundThe 5-Cog paradigm is a 5-minute brief cognitive assessment coupled with a clinical decision support tool designed to improve clinicians’ early detection of cognitive impairment, including dementia, in their diverse older primary care patients. The 5-Cog battery uses picture- and symbol-based assessments and a questionnaire. It is low cost, simple, minimizes literacy bias, and is culturally fair. The decision support component of the paradigm helps nudge appropriate care provider response to an abnormal 5-Cog battery.
ObjectiveThe objective of our study is to evaluate the effectiveness, implementation, and cost of the 5-Cog paradigm.
MethodsWe will enroll 6600 older patients with cognitive concerns from 22 primary care clinics in the Bronx, New York, and in multiple locations in Indiana for this hybrid type 1 effectiveness-implementation trial. We will analyze the effectiveness of the 5-Cog paradigm to increase the rate of new diagnoses of mild cognitive impairment syndrome or dementia using a pragmatic, cluster randomized clinical trial design. The secondary outcome is the ordering of new tests, treatments, and referrals for cognitive indications within 90 days after the study visit. The 5-Cog’s decision support component will be deployed as an electronic medical record feature. We will analyze the 5-Cog’s implementation process, context, and outcomes through the Consolidated Framework for Implementation Research using a mixed methods design (surveys and interviews). The study will also examine cost-effectiveness from societal and payer (Medicare) perspectives by estimating the cost per additional dementia diagnosis.
ResultsThe study is funded by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health (2U01NS105565). The protocol was approved by the Albert Einstein College of Medicine Institutional Review Board in September 2022. A validation study was completed to select cut scores for the 5-Cog battery. Among the 76 patients enrolled, the resulting clinical diagnoses were as follows: dementia in 32 (42%); mild cognitive impairment in 28 (37%); subjective cognitive concerns without objective cognitive impairment in 12 (16%); no cognitive diagnosis assigned in 2 (3%). The mean scores were Picture-Based Memory Impairment Screen 5.8 (SD 2.7), Symbol Match 27.2 (SD 18.2), and Subjective Motoric Cognitive Risk 2.4 (SD 1.7). The cut scores for an abnormal or positive result on the 5-Cog components were as follows: Picture-Based Memory Impairment Screen ≤6 (range 0-8), Symbol Match ≤25 (range 0-65), and Subjective Motoric Cognitive Risk >5 (range 0-7). As of December 2024, a total of 12 clinics had completed the onboarding processes, and 2369 patients had been enrolled.
ConclusionsThe findings of this study will facilitate the rapid adaptation and dissemination of this effective and practical clinical tool across diverse primary care clinical settings.
Trial RegistrationClinicalTrials.gov NCT05515224; https://www.clinicaltrials.gov/study/NCT05515224
International Registered Report Identifier (IRRID)DERR1-10.2196/60471 |
| format | Article |
| id | doaj-art-133704abfcdd49f289489e68185d9c77 |
| institution | DOAJ |
| issn | 1929-0748 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj-art-133704abfcdd49f289489e68185d9c772025-08-20T03:06:43ZengJMIR PublicationsJMIR Research Protocols1929-07482025-04-0114e6047110.2196/60471Improving Early Dementia Detection Among Diverse Older Adults With Cognitive Concerns With the 5-Cog Paradigm: Protocol for a Hybrid Effectiveness-Implementation Clinical TrialRachel Beth Rosansky Chalmerhttps://orcid.org/0000-0001-6394-6539Emmeline Ayershttps://orcid.org/0000-0002-5061-3708Erica F Weisshttps://orcid.org/0000-0002-0726-7547Nicole R Fowlerhttps://orcid.org/0000-0002-6465-0008Andrew Telzakhttps://orcid.org/0000-0003-1695-9809Diana Summanwarhttps://orcid.org/0000-0002-7529-3632Jessica Zwerlinghttps://orcid.org/0000-0003-3286-3225Cuiling Wanghttps://orcid.org/0000-0002-1399-1048Huiping Xuhttps://orcid.org/0000-0002-4025-6401Richard J Holdenhttps://orcid.org/0000-0002-3603-6158Kevin Fiorihttps://orcid.org/0000-0003-1370-7366Dustin D Frenchhttps://orcid.org/0000-0003-4064-3206Celeste Nsubayihttps://orcid.org/0009-0008-4929-6670Asif Ansarihttps://orcid.org/0009-0002-6176-615XPaul Dexterhttps://orcid.org/0000-0002-0399-0156Anna Higbiehttps://orcid.org/0009-0008-6066-0402Pratibha Yadavhttps://orcid.org/0000-0001-9769-0033James M Walkerhttps://orcid.org/0000-0002-9661-6322Harrshavasan Congivaramhttps://orcid.org/0009-0003-5897-0560Dristi Adhikarihttps://orcid.org/0000-0002-4289-1329Mairim Melecio-Vazquezhttps://orcid.org/0009-0007-1060-3760Malaz Boustanihttps://orcid.org/0000-0003-0330-677XJoe Verghesehttps://orcid.org/0000-0003-4252-2547 BackgroundThe 5-Cog paradigm is a 5-minute brief cognitive assessment coupled with a clinical decision support tool designed to improve clinicians’ early detection of cognitive impairment, including dementia, in their diverse older primary care patients. The 5-Cog battery uses picture- and symbol-based assessments and a questionnaire. It is low cost, simple, minimizes literacy bias, and is culturally fair. The decision support component of the paradigm helps nudge appropriate care provider response to an abnormal 5-Cog battery. ObjectiveThe objective of our study is to evaluate the effectiveness, implementation, and cost of the 5-Cog paradigm. MethodsWe will enroll 6600 older patients with cognitive concerns from 22 primary care clinics in the Bronx, New York, and in multiple locations in Indiana for this hybrid type 1 effectiveness-implementation trial. We will analyze the effectiveness of the 5-Cog paradigm to increase the rate of new diagnoses of mild cognitive impairment syndrome or dementia using a pragmatic, cluster randomized clinical trial design. The secondary outcome is the ordering of new tests, treatments, and referrals for cognitive indications within 90 days after the study visit. The 5-Cog’s decision support component will be deployed as an electronic medical record feature. We will analyze the 5-Cog’s implementation process, context, and outcomes through the Consolidated Framework for Implementation Research using a mixed methods design (surveys and interviews). The study will also examine cost-effectiveness from societal and payer (Medicare) perspectives by estimating the cost per additional dementia diagnosis. ResultsThe study is funded by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health (2U01NS105565). The protocol was approved by the Albert Einstein College of Medicine Institutional Review Board in September 2022. A validation study was completed to select cut scores for the 5-Cog battery. Among the 76 patients enrolled, the resulting clinical diagnoses were as follows: dementia in 32 (42%); mild cognitive impairment in 28 (37%); subjective cognitive concerns without objective cognitive impairment in 12 (16%); no cognitive diagnosis assigned in 2 (3%). The mean scores were Picture-Based Memory Impairment Screen 5.8 (SD 2.7), Symbol Match 27.2 (SD 18.2), and Subjective Motoric Cognitive Risk 2.4 (SD 1.7). The cut scores for an abnormal or positive result on the 5-Cog components were as follows: Picture-Based Memory Impairment Screen ≤6 (range 0-8), Symbol Match ≤25 (range 0-65), and Subjective Motoric Cognitive Risk >5 (range 0-7). As of December 2024, a total of 12 clinics had completed the onboarding processes, and 2369 patients had been enrolled. ConclusionsThe findings of this study will facilitate the rapid adaptation and dissemination of this effective and practical clinical tool across diverse primary care clinical settings. Trial RegistrationClinicalTrials.gov NCT05515224; https://www.clinicaltrials.gov/study/NCT05515224 International Registered Report Identifier (IRRID)DERR1-10.2196/60471https://www.researchprotocols.org/2025/1/e60471 |
| spellingShingle | Rachel Beth Rosansky Chalmer Emmeline Ayers Erica F Weiss Nicole R Fowler Andrew Telzak Diana Summanwar Jessica Zwerling Cuiling Wang Huiping Xu Richard J Holden Kevin Fiori Dustin D French Celeste Nsubayi Asif Ansari Paul Dexter Anna Higbie Pratibha Yadav James M Walker Harrshavasan Congivaram Dristi Adhikari Mairim Melecio-Vazquez Malaz Boustani Joe Verghese Improving Early Dementia Detection Among Diverse Older Adults With Cognitive Concerns With the 5-Cog Paradigm: Protocol for a Hybrid Effectiveness-Implementation Clinical Trial JMIR Research Protocols |
| title | Improving Early Dementia Detection Among Diverse Older Adults With Cognitive Concerns With the 5-Cog Paradigm: Protocol for a Hybrid Effectiveness-Implementation Clinical Trial |
| title_full | Improving Early Dementia Detection Among Diverse Older Adults With Cognitive Concerns With the 5-Cog Paradigm: Protocol for a Hybrid Effectiveness-Implementation Clinical Trial |
| title_fullStr | Improving Early Dementia Detection Among Diverse Older Adults With Cognitive Concerns With the 5-Cog Paradigm: Protocol for a Hybrid Effectiveness-Implementation Clinical Trial |
| title_full_unstemmed | Improving Early Dementia Detection Among Diverse Older Adults With Cognitive Concerns With the 5-Cog Paradigm: Protocol for a Hybrid Effectiveness-Implementation Clinical Trial |
| title_short | Improving Early Dementia Detection Among Diverse Older Adults With Cognitive Concerns With the 5-Cog Paradigm: Protocol for a Hybrid Effectiveness-Implementation Clinical Trial |
| title_sort | improving early dementia detection among diverse older adults with cognitive concerns with the 5 cog paradigm protocol for a hybrid effectiveness implementation clinical trial |
| url | https://www.researchprotocols.org/2025/1/e60471 |
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