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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.
Trials. 2020 Jun 18; 21(1):542.T

Abstract

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.

Authors+Show Affiliations

Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA. Elizabeth.Bayliss@kp.org. Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, USA. Elizabeth.Bayliss@kp.org.Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.Quality Use of Medicines and Pharmacy Research Centre, UniSA: Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia. Geriatric Medicine Research, Faculty of Medicine, and College of Pharmacy, Dalhousie University and Nova Scotia Health Authority, Halifax, NS, Canada.Department of Clinical Pharmacy, Kaiser Permanente Colorado, Aurora, CO, USA.Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham, Veterans Affairs Medical Center, Durham, NC, USA. Department of Population Health Sciences, Duke University Medical Center, Durham, NC, USA.Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.School of Public Health, Johns Hopkins School of Medicine, Baltimore, MD, USA.Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.Department of Clinical Pharmacy, Kaiser Permanente Colorado, Aurora, CO, USA.Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32552857

Citation

Bayliss, E A., et al. "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." Trials, vol. 21, no. 1, 2020, p. 542.
Bayliss EA, Shetterly SM, Drace ML, et al. 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. Trials. 2020;21(1):542.
Bayliss, E. A., Shetterly, S. M., Drace, M. L., Norton, J., Green, A. R., Reeve, E., Weffald, L. A., Wright, L., Maciejewski, M. L., Sheehan, O. C., Wolff, J. L., Gleason, K. S., Kraus, C., Maiyani, M., Du Vall, M., & Boyd, C. M. (2020). 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. Trials, 21(1), 542. https://doi.org/10.1186/s13063-020-04482-0
Bayliss EA, et al. 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. Trials. 2020 Jun 18;21(1):542. PubMed PMID: 32552857.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Bayliss,E A, AU - Shetterly,S M, AU - Drace,M L, AU - Norton,J, AU - Green,A R, AU - Reeve,E, AU - Weffald,L A, AU - Wright,L, AU - Maciejewski,M L, AU - Sheehan,O C, AU - Wolff,J L, AU - Gleason,K S, AU - Kraus,C, AU - Maiyani,M, AU - Du Vall,M, AU - Boyd,C M, Y1 - 2020/06/18/ PY - 2020/02/24/received PY - 2020/06/06/accepted PY - 2020/6/20/entrez PY - 2020/6/20/pubmed PY - 2020/6/20/medline KW - Dementia KW - Deprescribing KW - Multimorbidity KW - Polypharmacy SP - 542 EP - 542 JF - Trials JO - Trials VL - 21 IS - 1 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/32552857/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 L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04482-0 DB - PRIME DP - Unbound Medicine ER -
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