Deprescribing anticholinergics to preserve brain health: reducing the risk of dementia through deprescribing (R2D2): study protocol for a randomized clinical trial
Abstract Background Older adults commonly experience chronic medical conditions and are at risk of cognitive impairment as a result of age, chronic comorbidity, and medications prescribed to manage multiple chronic conditions. Anticholinergic medications are common treatments for chronic conditions...
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BMC
2024-11-01
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| Online Access: | https://doi.org/10.1186/s13063-024-08618-4 |
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| author | Noll L. Campbell Richard J. Holden Sujuan Gao Frederick W. Unverzagt Kathleen A. Lane Allie Carter Addison B. Harrington Sneha Manoharan Neha Manoharan Danielle L. Rosenthal Christopher Pitts Kathryn Pelkey Emily Papineau David M. Lauck Noha Keshk Khalid Alamer Hussein Khalil Malaz A. Boustani |
| author_facet | Noll L. Campbell Richard J. Holden Sujuan Gao Frederick W. Unverzagt Kathleen A. Lane Allie Carter Addison B. Harrington Sneha Manoharan Neha Manoharan Danielle L. Rosenthal Christopher Pitts Kathryn Pelkey Emily Papineau David M. Lauck Noha Keshk Khalid Alamer Hussein Khalil Malaz A. Boustani |
| author_sort | Noll L. Campbell |
| collection | DOAJ |
| description | Abstract Background Older adults commonly experience chronic medical conditions and are at risk of cognitive impairment as a result of age, chronic comorbidity, and medications prescribed to manage multiple chronic conditions. Anticholinergic medications are common treatments for chronic conditions and have been repeatedly associated with poor cognitive outcomes, including delirium and dementia, in epidemiologic studies. However, no study has definitively evaluated the causal relationship between anticholinergics and cognition in a randomized controlled trial design. Utilizing our prior experience in deprescribing anticholinergic medications in various clinical environments, we designed an outpatient deprescribing intervention to prospectively test the potential causal relationship between anticholinergics and cognition in primary care older adults. Methods This cluster randomized clinical trial will be conducted to evaluate the impact of an anticholinergic deprescribing intervention compared to usual care on outcomes of cognition and safety in primary care older adults. Participants will include those aged 65 years and over, receiving primary care in the greater Indianapolis area, using a strong anticholinergic within the last 2 weeks or with evidence of high-risk exposure in the past year. Those excluded will have a diagnosis of Alzheimer’s disease or related dementia, or serious mental illness. The trial plans to enroll 344 participants who will be cluster-randomized at the level of primary care physician to avoid contamination. Participants will complete outcome assessments every 6 months up to 2 years by blinded outcome assessors. The primary outcome of the study is a composite measure of cognition that includes domains assessing executive cognitive function, language, and memory. Secondary outcomes include patient-reported measures of pain intensity, depression, anxiety, sleep disturbance, and health-related quality of life. Discussion The R2D2 trial will be the largest and longest prospective randomized trial testing the impact of an anticholinergic-specific deprescribing intervention on cognition in primary care older adults. Results could influence deprescribing methodology and provide new insight on the relationship between anticholinergics and cognition. Trial registration ClinicalTrials.gov NCT04270474. Registered on February 17, 2020. |
| format | Article |
| id | doaj-art-c16700f65c8c4401884510c6f3487021 |
| institution | Kabale University |
| issn | 1745-6215 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-c16700f65c8c4401884510c6f34870212024-11-24T12:42:12ZengBMCTrials1745-62152024-11-0125111210.1186/s13063-024-08618-4Deprescribing anticholinergics to preserve brain health: reducing the risk of dementia through deprescribing (R2D2): study protocol for a randomized clinical trialNoll L. Campbell0Richard J. Holden1Sujuan Gao2Frederick W. Unverzagt3Kathleen A. Lane4Allie Carter5Addison B. Harrington6Sneha Manoharan7Neha Manoharan8Danielle L. Rosenthal9Christopher Pitts10Kathryn Pelkey11Emily Papineau12David M. Lauck13Noha Keshk14Khalid Alamer15Hussein Khalil16Malaz A. Boustani17Department of Pharmacy Practice, Purdue University College of PharmacyCenter for Health Innovation and Implementation Science, Indiana UniversityDepartment of Biostatistics and Health Data Science, Indiana University School of MedicineDepartment of Psychiatry, Indiana University School of MedicineDepartment of Biostatistics and Health Data Science, Indiana University School of MedicineDepartment of Biostatistics and Health Data Science, Indiana University School of MedicineIndiana University Center for Aging Research, Regenstrief Institute, IncIndiana University Center for Aging Research, Regenstrief Institute, IncIndiana University Center for Aging Research, Regenstrief Institute, IncIndiana University Center for Aging Research, Regenstrief Institute, IncDepartment of Pharmacy, Indiana University HealthDepartment of Pharmacy, Community Health NetworkDepartment of Pharmacy, Community Health NetworkDepartment of Medicine, Community Health NetworkDepartment of Pharmacy Practice, Purdue University College of PharmacyPharmacy Practice Department, College of Clinical Pharmacy, Imam Abdulrahman Bin Faisal UniversityDepartment of Pharmacy Practice, Purdue University College of PharmacyIndiana University Center for Aging Research, Regenstrief Institute, IncAbstract Background Older adults commonly experience chronic medical conditions and are at risk of cognitive impairment as a result of age, chronic comorbidity, and medications prescribed to manage multiple chronic conditions. Anticholinergic medications are common treatments for chronic conditions and have been repeatedly associated with poor cognitive outcomes, including delirium and dementia, in epidemiologic studies. However, no study has definitively evaluated the causal relationship between anticholinergics and cognition in a randomized controlled trial design. Utilizing our prior experience in deprescribing anticholinergic medications in various clinical environments, we designed an outpatient deprescribing intervention to prospectively test the potential causal relationship between anticholinergics and cognition in primary care older adults. Methods This cluster randomized clinical trial will be conducted to evaluate the impact of an anticholinergic deprescribing intervention compared to usual care on outcomes of cognition and safety in primary care older adults. Participants will include those aged 65 years and over, receiving primary care in the greater Indianapolis area, using a strong anticholinergic within the last 2 weeks or with evidence of high-risk exposure in the past year. Those excluded will have a diagnosis of Alzheimer’s disease or related dementia, or serious mental illness. The trial plans to enroll 344 participants who will be cluster-randomized at the level of primary care physician to avoid contamination. Participants will complete outcome assessments every 6 months up to 2 years by blinded outcome assessors. The primary outcome of the study is a composite measure of cognition that includes domains assessing executive cognitive function, language, and memory. Secondary outcomes include patient-reported measures of pain intensity, depression, anxiety, sleep disturbance, and health-related quality of life. Discussion The R2D2 trial will be the largest and longest prospective randomized trial testing the impact of an anticholinergic-specific deprescribing intervention on cognition in primary care older adults. Results could influence deprescribing methodology and provide new insight on the relationship between anticholinergics and cognition. Trial registration ClinicalTrials.gov NCT04270474. Registered on February 17, 2020.https://doi.org/10.1186/s13063-024-08618-4AnticholinergicsDeprescribingCognitionDementia |
| spellingShingle | Noll L. Campbell Richard J. Holden Sujuan Gao Frederick W. Unverzagt Kathleen A. Lane Allie Carter Addison B. Harrington Sneha Manoharan Neha Manoharan Danielle L. Rosenthal Christopher Pitts Kathryn Pelkey Emily Papineau David M. Lauck Noha Keshk Khalid Alamer Hussein Khalil Malaz A. Boustani Deprescribing anticholinergics to preserve brain health: reducing the risk of dementia through deprescribing (R2D2): study protocol for a randomized clinical trial Trials Anticholinergics Deprescribing Cognition Dementia |
| title | Deprescribing anticholinergics to preserve brain health: reducing the risk of dementia through deprescribing (R2D2): study protocol for a randomized clinical trial |
| title_full | Deprescribing anticholinergics to preserve brain health: reducing the risk of dementia through deprescribing (R2D2): study protocol for a randomized clinical trial |
| title_fullStr | Deprescribing anticholinergics to preserve brain health: reducing the risk of dementia through deprescribing (R2D2): study protocol for a randomized clinical trial |
| title_full_unstemmed | Deprescribing anticholinergics to preserve brain health: reducing the risk of dementia through deprescribing (R2D2): study protocol for a randomized clinical trial |
| title_short | Deprescribing anticholinergics to preserve brain health: reducing the risk of dementia through deprescribing (R2D2): study protocol for a randomized clinical trial |
| title_sort | deprescribing anticholinergics to preserve brain health reducing the risk of dementia through deprescribing r2d2 study protocol for a randomized clinical trial |
| topic | Anticholinergics Deprescribing Cognition Dementia |
| url | https://doi.org/10.1186/s13063-024-08618-4 |
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