Antihypertensive Deprescribing in Long-term Care — OptimizeBP  

Hypertension Clinical Trial

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

Status Enrolling by invitation

Clinical Trial Summary

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 primary outcome is all-cause mortality but the study will also be tracking all-cause hospitalization or emergency room visits, hip fractures, falls, skin ulceration, renal insufficiency, cognitive and behavioural outcomes and costs of care.

The hypothesis is that avoiding unnecessarily low systolic blood pressure is beneficial in a frail, end-of-life population.

Clinical Trial Description

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 investigators will secondarily examine other outcomes including adverse events, cognition and behaviour, 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) 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. ;

Related Conditions & MeSH terms

• Frailty
• Hypertension

• NCT number: NCT05047731
• Study type: Interventional
• Source: University of Alberta
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 20, 2021
• Completion date: June 30, 2025