Administrative information
Title {1} | 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 |
Trial registration {2a and 2b}. | Trial Registration: This trial was registered on June 13, 2019, at clinicaltrials.gov (NCT03984396 – retrospectively registered), https://clinicaltrials.gov/ct2/show/NCT03984396 |
Protocol version {3, 25} | At the time of article submission, the intervention is being delivered to the initial intervention group under protocol Version 5, January 25, 2020. Any protocol modifications are communicated by the study investigators to the KPCO IRB, DSMB, and study team. |
Funding {4} | Funder: National Institute on Aging (R33-AG057289) |
Author details {5a} | Bayliss EA*1,2, Shetterly SM1, Drace ML1, Norton J3, Green AR3, Reeve E4, Weffald LA5, Wright L1, Maciejewski ML6,7, Sheehan OC3, Wolff JL8, Gleason KS1, Kraus C1, Maiyani M1, Du Vall M5, Boyd CM*3 1 Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO 2 Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO 3 Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore MD 4 Quality Use of Medicines and Pharmacy Research Centre, UniSA: Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia 5 Geriatric Medicine Research, Faculty of Medicine, and College of Pharmacy, Dalhousie University and Nova Scotia Health Authority, Halifax, NS, Canada 5 Department of Clinical Pharmacy, Kaiser Permanente Colorado, Aurora, CO 6 Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham, Veterans Affairs Medical Center, Durham, NC 7 Department of Population Health Sciences, Duke University Medical Center, Durham, NC 8 School of Public Health, Johns Hopkins School of Medicine, Baltimore, MD * Drs. Bayliss and Boyd are co-Principal Investigators of the OPTIMIZE trial |
Name and contact information for the trial sponsor {5b} | National Institute on Aging. National Institute on Aging Building 31, Room 5C27 31 Center Drive, MSC 2292 Bethesda, MD 20892 1-800-222-2225 |
Role of sponsor {5c} {21a} | The funder had no role in developing the study design, data collection, management, interpretation or analysis, writing of the manuscript, or decision to submit the manuscript for publication. The funder does not have authority over any of these activities. The funder did contract with members of a Data Safety Monitoring Board. |
Contribution to the literature
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Deprescribing interventions in populations with cognitive impairment have been largely limited to inpatient or skilled nursing settings or focused on specific medication classes. This protocol describes the development of a pragmatic intervention for this population that targets multiple medications with the aim of being integrated and sustained in routine clinical practice.
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This study will test the effectiveness of an intervention that combines patient and family education and activation with continuing clinician education and preparation on medication deprescribing—a combination that has not been previously investigated.
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An effective pragmatic intervention to improve medication management for individuals with cognitive impairment can be taken to scale in multiple delivery systems and settings.
Introduction
Background and rationale {6a}
Methods/Design
Study aims and objectives {7}
Stakeholder engagement for intervention development
Pilot evaluation
Pilot evaluation results and intervention refinement
Protocol for the OPTIMIZE trial
Overview of design {8}
Study setting and intervention period {9} {6b}
Study Population {10}
Recruitment {15}
The intervention {11a} {11d}
1 | Clinician guidance for deprescribing – an overview |
2 | Introduce deprescribing to patients |
3 | Deprescribing to improve troubling symptoms |
4 | Prescribing is a discussion opportunity |
5 | Recognize prescribing cascades |
6 | Reduce burden through deprescribing |
7 | Consider treatment deintensification |
8 | Discontinue risky medications to avoid adverse outcomes |
9 | Deprescribing as patients approach the end of life |
10 | Discuss deprescribing with family and friends |
11 | Don't forget about over the counter products |
12 | Summary document: deprescribing poster listing Tip Sheet topics |
Control group {6b}
Treatment assignment procedures {16} {17}
Total N = 3671 | Intervention N = 1814 (49.4%) | Delayed control N = 1857 (50.6%) | Intervention vs delayed control p valueb | |
---|---|---|---|---|
1+ Potentially inappropriate Medication N (%) | 1226 (33.4%) | 598 (33.0%) | 628 (33.8%) | 0.58 |
Age in years, mean (SD) | 79.6 (7.4) | 79.6 (7.5) | 79.6 (7.3) | 0.83 |
Female gender | 2047 (55.8%) | 1025 (56.5%) | 1022 (55.0%) | 0.37 |
Non-white racebN (%) | 444 (13.3%) | 247 (14.5%) | 197 (12.0%) | 0.03 |
Missing race N (%) | 325 (8.9%) | 110 (6.1%) | 215 (11.6%) | < 0.001 |
Hispanic ethnicity N (%) | 441 (12.2%) | 128 (7.2%) | 313 (17.1%) | < 0.001 |
Missing ethnicity N (%) | 48 (1.3%) | 25 (1.4%) | 23 (1.2%) | 0.71 |