Multiple long-term care facilities
Multiple Locations, Alberta, Canada
NCT Number: NCT05047731
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.
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Notify Me70 year and older
All sexes
Interventional
Not applicable
Multiple Locations, Alberta, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Antihypertensive medication will be continually reduced provided an upper systolic threshold of 145 mmHg is not exceeded
Time frame: 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
Time frame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Composite of all-cause death and unplanned hospital admission or emergency room visit - as recorded in government health claim databases
Time frame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
All cause hospitalization or emergency room visit excluding elective surgeries or booked procedures/planned follow-up care - as recorded in governmental health claims databases
Time frame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Any physician billing (hospital or community) for a fracture other than a vertebral fracture (which might indicate a vertebral compression fracture secondary to osteoporosis, and not trauma) - as recorded in government health claim databases
Time frame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
As recorded in the first quarterly Resident Assessment Instruction Minimum Data Set 2.0 (RAI-MDS 2.0) at the LTC facility in the 3- to 6-month window following randomization
Time frame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
As recorded in the first quarterly RAI-MDS 2.0 assessment at the LTC facility in the 3- to 6-month window following randomization
Time frame: ≥6-weeks post-randomisation through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Any eGFR <30 ml/min/1.73m2 ≥6-weeks post-randomisation as recorded in governmental health claim databases
Time frame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Unplanned hospital admission or emergency room visit for stroke, acute coronary syndrome/myocardial infarction, heart failure, or atrial fibrillation - as recorded in governmental health claims databases
Time frame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
As recorded in the first quarterly RAI-MDS 2.0 at the LTC facility in the 3- to 6-month window following randomization
Time frame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
As recorded in the first quarterly RAI-MDS 2.0 assessment at the LTC facility in the 3- to 6-month window following randomization
Time frame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
As recorded in the first quarterly RAI-MDS 2.0 assessment at the LTC facility in the 3- to 6-month window following randomization
Time frame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
As recorded in the first quarterly RAI-MDS 2.0 assessment at the LTC facility in the 3- to 6-month window following randomization
Time frame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Calculated from each hospital/emergency admission's resource intensity weight as recorded in government health claim databases
Time frame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Acute care costs + medication costs + physician billings + nursing/facility costs as recorded in governmental health claims data. Nursing/facility costs will be estimated from level of care and duration of stay.
Time frame: 3- and 6-months post-randomization
As recorded in government health claim databases
Time frame: 3- and 6-months post-randomization
As recorded in government health claim databases
Time frame: 3- and 6-months post-randomization
As recorded in government health claim databases
Time frame: 3- and 6-months post-randomization
As recorded in government health claim databases
Time frame: 3- to 6-months post-randomization
As recorded in government health claim databases
Time frame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
As recorded by the long-term care facility
University of Alberta
Other
Antihypertensive Deprescribing in Long-term Care: A Randomized Controlled Trial (OptimizeBP)
Acronym: OptimizeBP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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