Antihypertensive Deprescribing in Long-term Care: A Randomized Controlled Trial (OptimizeBP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 522
- 试验地点
- 1
- 主要终点
- All-Cause Mortality
研究概览
简要总结
Frail older adults are commonly prescribed blood pressure medication, yet it is unclear if blood pressure medication is actually beneficial for them. Observational studies in this population suggest blood pressure medication has limited benefit and may even be harmful, including an increased risk for falls and cognitive impairment. Randomized controlled trials are needed to confirm this.
This study is a randomized controlled trial of blood pressure medication deprescribing, amongst long-term care residents with systolic blood pressure lower than 135 mmHg. In the intervention group, with physician consent, the facility pharmacist or nurse practitioner will continually reduce antihypertensives provided an upper systolic threshold of 145 mmHg is not exceeded. The control group will receive usual care. The hypothesis is that avoiding unnecessarily low systolic blood pressure is beneficial in a frail, end-of-life population.
详细描述
Observational evidence suggests antihypertensive medications have limited benefit and may even be harmful in the frail older adult population. Although more modest blood pressure targets are already recommended, the impact of deprescribing antihypertensive medication on mortality and morbidity in the frail older adult population has yet to be confirmed by randomized controlled trials.
The objective of this study is to determine, in hypertensive long-term care residents with a systolic blood pressure below 135 mmHg, whether "deprescribing" antihypertensive medications (provided an upper systolic threshold of 145 mmHg is not exceeded), compared to no change in prescribing, will delay all-cause mortality (our primary outcome).
The study is an event-driven 2-parallel group randomized controlled trial, to be conducted in participating Alberta long-term care (LTC) facilities. The trial operates under a waiver of consent, as the intervention is recommended care, with residents, physicians, and family having the ability to opt individual residents out of the study before eligibility is determined. Eligibility will be determined using linked administrative claims databases holding physician diagnoses and medication dispensed, and by using usual care systolic blood pressure collected by the LTC facility. The provincial data steward (Alberta Health Services) will access this data, determine eligibility, individually randomize eligible residents who have not opted out, and advise the facility pharmacist which patients are in the intervention group.
Facility pharmacists or nurse practitioners will then stop or reduce doses of antihypertensive medication in the intervention group according to a pre-defined deprescribing algorithm. The data steward will track outcomes using administrative claims data, and the study will end once 247 primary outcome events have been observed. This is anticipated to occur 3-years post the start of randomization. An interim data safety monitoring board, chaired by Dr. James M.Wright, hypertension specialist and Co-ordinating Editor of the Cochrane Hypertension Review Group, will convene upon observing 124 primary outcomes. This group will recommend whether or not the study should stop early based on observed efficacy, or safety concerns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥2 diagnoses (dx) of hypertension from either a community practitioner or/and from a hospital admission.
- •On ≥1 oral antihypertensive medication (requires a dispensation in the preceeding 15 days).
- •Average recorded systolic BP of <135 mmHg.
排除标准
- •≥2 community dx of congestive heart failure, ≥1 dx of in hospital congestive heart failure, ≥1 dx of emergency visit of congestive heart failure, dx of congestive heart failure in RAI-MDS 2.0, or prescription of furosemide in the last 15 days.
- •The resident's only antihypertensive prescribed is a beta blocker.
- •The resident's only antihypertensive prescribed is a calcium channel blocker and the resident has ≥1 health system encounters with a diagnosis of angina.
- •The resident's only antihypertensive prescribed is an alpha blocker.
- •Admitted to the hospital at the time of randomization; or opted out of the trial by the resident, their family, their physician, or the facility.
研究组 & 干预措施
Deprescribing group
The facility pharmacist will actively deprescribe antihypertensive medication of residents in this group.
干预措施: Antihypertensive medication (Drug)
结局指标
主要结局
All-Cause Mortality
时间窗: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
All-cause death - as recorded in government health claim databases
次要结局
- Composite of All-Cause Mortality or All-Cause Unplanned Hospitalization(through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event))