Antihypertensive Deprescribing in Long-term Care

Study Overview
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Brief Summary
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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 will reduce blood pressure medication until the blood pressure reaches the target systolic blood pressure of 140 ±5 mmHg. The control group will receive usual care. The primary outcome is all-cause mortality but the study will also be tracking all-cause hospitalization or emergency room visits, hip fractures, cost of medication, and quality of life. The hypothesis is that avoiding unnecessarily low systolic blood pressure is beneficial in a frail, end-of-life population.

Detailed Description
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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 to achieve a systolic blood pressure of 140 ±5 mmHg, compared to no change in prescribing, will delay all-cause mortality (our primary outcome). The investigators will secondarily examine other outcomes including adverse events, quality of life, and cost of care. 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 Research Data 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 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 Wright, hypertension specialist and Coordinating Editor of the Cochrane Hypertension Working 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.

Official Title
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Antihypertensive Deprescribing in Long-term Care: A Randomized Controlled Trial (OptimizeBP)

Conditions
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Frailty, Hypertension

Intervention / Treatment
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* Drug: Antihypertensive medication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥2 diagnoses (dx) of hypertension from either a community practitioner or/and from a hospital admission; on ≥1 oral antihypertensive medication; and average recorded systolic BP of <135 mmHg. Exclusion Criteria: ≥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; ≥2 community dx of tachycardia/atrial fibrillation or ≥1 dx of in hospital tachycardia/atrial fibrillation and the only antihypertensive prescribed in the last 15 days is a beta blocker and/or a calcium channel blocker; ≥2 community dx of coronary artery disease or ≥1 dx of in hospital coronary artery disease and the only antihypertensive prescribed in the last 15 days is a beta blocker and/or a calcium channel blocker; the resident's only antihypertensive prescribed in the last 15 days is a beta blocker; the resident's only antihypertensive prescribed in the last 15 days is an alpha blocker; the resident's physician declines to participate in the study; or the resident or legal guardian declines to participate in the study.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deprescribing group<br>The facility pharmacist will actively deprescribe antihypertensive medication of residents in this group. | Drug: Antihypertensive medication<br>* Antihypertensive medication will be deprescribed to a blood pressure of 140 ±5 mmHg following the study algorithm.<br>|
| No Intervention: Usual care group<br>The facility pharmacist and the attending physician will provide usual care to residents in this group, and this includes quarterly medication reviews. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | As recorded in government health claim databases | through study completion (estimated to be 3 years, trial will continue until 247 events are reached) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause hospitalization or emergency room visit | As recorded in government health claim databases | through study completion (estimated to be 3 years, trial will continue until 247 events are reached) | 
| Average 30-day per-resident cost of all medication | As recorded in government health claim databases | through study completion (estimated to be 3 years, trial will continue until 247 events are reached) | 
| Average monthly physician billing | As recorded in government health claim databases | through study completion (estimated to be 3 years, trial will continue until 247 events are reached) | 
| Average monthly acute care costs | Calculated from all hospitalizations using the resource intensity weight (RIW) and length of stay (LOS) as recorded in government health claim databases | through study completion (estimated to be 3 years, trial will continue until 247 events are reached) | 
| Non-vertebral fracture | As recorded in government health claim databases | through study completion (estimated to be 3 years, trial will continue until 247 events are reached) | 
| Worsening of the Activities of Daily Living Score | As recorded in the Resident Assessment Instrument Minimum Data Set 2.0 (RAI-MDS 2.0) assessment during this time frame | 3-to-6-months post-randomization | 
| Record of ≥1 fall in last 30-days for ambulatory residents | As recorded in RAI-MDS 2.0 assessment during this time frame | 3-to-6-months post-randomization | 
| Worsening of the Cognitive Performance Score | As recorded in the RAI-MDS 2.0 assessment during this time frame | 3-to-6-months post-randomization | 
| Number of residents with full thickness skin ulceration (stage 3 or 4) | As recorded in the RAI-MDS 2.0 assessment during this time frame | 3-to-6-months post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Routinely collected health data, Frail older adult, Pragmatic trial, Long-term care, Nursing home, Hypertension, Antihypertensive agents, Deprescriptions