The OPTIMIZE patient- and family-centered, primary care-based deprescribing intervention for older adults with dementia or mild cognitive impairment and multiple chronic conditions: study protocol for a pragmatic cluster randomized controlled trial
| Autor: | Jonathan Norton, Courtney R. Kraus, Kathy Gleason, Linda A. Weffald, M. L. Drace, Matthew L. Maciejewski, Orla C. Sheehan, Jennifer L. Wolff, M. Du Vall, Elizabeth A. Bayliss, Leslie Wright, S. M. Shetterly, M. Maiyani, Cynthia M. Boyd, Emily Reeve, Ariel R. Green |
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| Přispěvatelé: | Bayliss, EA, Shetterly, SM, Drace, ML, Norton, J, Green, AR, Reeve, E, Weffald, LA, Wright, L, Maciejewski, ML, Sheehan, OC, Wolff, JL, Gleason, K. S., Kraus, C, Maiyani, M, Du Vall, M, Boyd, CM |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Activities of daily living
Medicine (miscellaneous) 01 natural sciences law.invention Study Protocol Deprescriptions 0302 clinical medicine Randomized controlled trial deprescribing law Patient-Centered Care Pharmacology (medical) Multiple Chronic Conditions 030212 general & internal medicine Letter to the Editor Potentially Inappropriate Medication List lcsh:R5-920 Communication Hospitalization Deprescribing lcsh:Medicine (General) medicine.medical_specialty Colorado Drug-Related Side Effects and Adverse Reactions multimorbidity Disease cluster 03 medical and health sciences Patient Education as Topic Intervention (counseling) Pragmatic Clinical Trials as Topic medicine Humans Dementia Cognitive Dysfunction Family 0101 mathematics polypharmacy Aged Polypharmacy Primary Health Care business.industry 010102 general mathematics Multimorbidity Emergency department medicine.disease Emergency medicine business dementia |
| Zdroj: | Trials, Vol 21, Iss 1, Pp 1-13 (2020) J Gen Intern Med Trials |
| Popis: | Background Most individuals with dementia or mild cognitive impairment (MCI) have multiple chronic conditions (MCC). The combination leads to multiple medications and complex medication regimens and is associated with increased risk for significant treatment burden, adverse drug events, cognitive changes, hospitalization, and mortality. Optimizing medications through deprescribing (the process of reducing or stopping the use of inappropriate medications or medications unlikely to be beneficial) may improve outcomes for MCC patients with dementia or MCI. Methods With input from patients, family members, and clinicians, we developed and piloted a patient-centered, pragmatic intervention (OPTIMIZE) to educate and activate patients, family members, and primary care clinicians about deprescribing as part of optimal medication management for older adults with dementia or MCI and MCC. The clinic-based intervention targets patients on 5 or more medications, their family members, and their primary care clinicians using a pragmatic, cluster-randomized design at Kaiser Permanente Colorado. The intervention has two components: a patient/ family component focused on education and activation about the potential value of deprescribing, and a clinician component focused on increasing clinician awareness about options and processes for deprescribing. Primary outcomes are total number of chronic medications and total number of potentially inappropriate medications (PIMs). We estimate that approximately 2400 patients across 9 clinics will receive the intervention. A comparable number of patients from 9 other clinics will serve as wait-list controls. We have > 80% power to detect an average decrease of − 0.70 (< 1 medication). Secondary outcomes include the number of PIM starts, dose reductions for selected PIMs (benzodiazepines, opiates, and antipsychotics), rates of adverse drug events (falls, hemorrhagic events, and hypoglycemic events), ability to perform activities of daily living, and skilled nursing facility, hospital, and emergency department admissions. Discussion The OPTIMIZE trial will examine whether a primary care-based, patient- and family-centered intervention educating patients, family members, and clinicians about deprescribing reduces numbers of chronic medications and PIMs for older adults with dementia or MCI and MCC. Trial registration NCT03984396. Registered on 13 June 2019 |
| Databáze: | OpenAIRE |
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