Evaluating the Safety of an Educational Deprescribing Intervention: Lessons from the Optimize Trial.

Autor: Boyd CM; Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. cyboyd@jhmi.edu.; Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Veterans Affairs Medical Center, Durham, NC, USA. cyboyd@jhmi.edu., Shetterly SM; Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA., Powers JD; Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA., Weffald LA; Department of Clinical Pharmacy, Kaiser Permanente Colorado, Aurora, CO, USA., Green AR; Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Sheehan OC; Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Royal College of Surgeons in Ireland, Dublin, Ireland., Reeve E; Faculty of Pharmacy and Pharmaceutical Sciences, Centre for Medicine Use and Safety, Monash University, Melbourne, VIC, Australia.; Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Medical Science, University of South Australia, Adelaide, SA, Australia., Drace ML; Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA., Norton JD; Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Maiyani M; Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA., Gleason KS; Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA., Sawyer JK; Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA., Maciejewski ML; Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Veterans Affairs Medical Center, Durham, NC, USA.; Department of Population Health Sciences, Duke University Medical Center, Durham, NC, USA., Wolff JL; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA., Kraus C; Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA., Bayliss EA; Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, USA.; Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, USA.
Jazyk: angličtina
Zdroj: Drugs & aging [Drugs Aging] 2024 Jan; Vol. 41 (1), pp. 45-54. Date of Electronic Publication: 2023 Nov 20.
DOI: 10.1007/s40266-023-01080-y
Abstrakt: Background: Patients, family members, and clinicians express concerns about potential adverse drug withdrawal events (ADWEs) following medication discontinuation or fears of upsetting a stable medical equilibrium as key barriers to deprescribing. Currently, there are limited methods to pragmatically assess the safety of deprescribing and ascertain ADWEs. We report the methods and results of safety monitoring for the OPTIMIZE trial of deprescribing education for patients, family members, and clinicians.
Methods: This was a pragmatic cluster randomized trial with multivariable Poisson regression comparing outcome rates between study arms. We conducted clinical record review and adjudication of sampled records to assess potential causal relationships between medication discontinuation and outcomes. This study included adults aged 65+ with dementia or mild cognitive impairment, one or more additional chronic conditions, and prescribed 5+ chronic medications. The intervention included an educational brochure on deprescribing that was mailed to patients prior to primary care visits, a clinician notification about individual brochure mailings, and an educational tip sheets was provided monthly to primary care clinicians. The outcomes of the safety monitoring were rates of hospitalizations and mortality during the 4 months following brochure mailings and results of record review and adjudication. The adjudication process was conducted throughout the trial and included classifications: likely, possibly, and unlikely.
Results: There was a total of 3012 (1433 intervention and 1579 control) participants. There were 420 total hospitalizations involving 269 (18.8%) people in the intervention versus 517 total hospitalizations involving 317 (20.1%) people in the control groups. Adjusted risk ratios comparing intervention to control groups were 0.92 [95% confidence interval (CI) 0.72, 1.16] for hospitalization and 1.19 (95% CI 0.67, 2.11) for mortality. Both groups had zero deaths "likely" attributed to a medication change prior to the event. A total of 3 out of 30 (10%) intervention group hospitalizations and 7 out of 35 (20%) control group hospitalizations were considered "likely" due to a medication change.
Conclusions: Population-based deprescribing education is safe in the older adult population with cognitive impairment in our study. Pragmatic methods for safety monitoring are needed to further inform deprescribing interventions.
Trial Registration: NCT03984396. Registered on 13 June 2019.
(© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)
Databáze: MEDLINE
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