Clinical trial NCT05047731: Antihypertensive Deprescribing in Long-term Care
Official title: Antihypertensive Deprescribing in Long-term Care: A Randomized Controlled Trial (OptimizeBP)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Frailty
Keywords: Pragmatic trial
Long-term care
Nursing home
Hypertension
Antihypertensive agents
Deprescriptions
Routinely collected health data
Frail older adult
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Health services
First posted: 2021-09-17
Enrollment: 450
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* ≥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.

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.
* 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.

Primary outcomes:
measure: All-Cause Mortality
timeFrame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Secondary outcomes:
measure: Composite of All-Cause Mortality or All-Cause Unplanned Hospitalization
timeFrame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Other outcomes:
measure: All-Cause Unplanned Hospitalization
timeFrame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
measure: Non-Vertebral Fracture
timeFrame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
measure: Number of Participants with Record of ≥1 Fall in Last 30-days
timeFrame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
measure: Number of Participants with Partial or Full Thickness Skin Ulceration (stage 2 to 4)
timeFrame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
measure: Number of Participants with Renal Insufficiency
timeFrame: ≥6-weeks post-randomisation through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
measure: Unplanned All-Cause Hospitalization with a Diagnosis of Stroke, Heart Attack, Congestive Heart Failure or Atrial Fibrillation
timeFrame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
measure: Number of Participants with "Deteriorated Cognition as Compared to Status 90 Days Prior"
timeFrame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
measure: Number of Participants with "Deteriorated Mood as Compared to Status 90 Days Prior"
timeFrame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
measure: Number of Participants with "Deteriorated Activities of Daily Living (ADL) as Compared to Status 90 Days Prior"
timeFrame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
measure: Number of Participants with "Behavioural Symptoms that are Present a Minimum of 4 Days per Week and Not Easily Altered" Including a) Wandering, b) Verbal Abuse, c) Physical Abuse, d) Socially Inappropriate or Disruptive Behaviour, or e) Resisting Care
timeFrame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
measure: Acute Care Costs
timeFrame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
measure: Total Costs of Care
timeFrame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
measure: Number of Antihypertensive Medications with ≥25%, ≥50%, and 100% Reduction from Baseline in Dosage Dispensed
timeFrame: 3- and 6-months post-randomization
measure: Number of Participants with ≥1 Baseline Antihypertensive Medication with ≥25%, ≥50%, and 100% Reduction in Dosage Dispensed
timeFrame: 3- and 6-months post-randomization
measure: Number of Participants with the Addition of ≥1 New Antihypertensive Medication or Increase in Dosage from Baseline.
timeFrame: 3- and 6-months post-randomization
measure: Number of Discrete Antihypertensive Medications Used in the Last 15 days (baseline, 3- and 6-months post-randomisation)
timeFrame: 3- and 6-months post-randomization
measure: Number of Discrete Medications Used in the Last 15 Days (baseline, 3- and 6-months post-randomisation)
timeFrame: 3- to 6-months post-randomization
measure: Average Systolic Blood Pressure and Average Diastolic Blood Pressure
timeFrame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Locations:
city: Multiple Locations
country: Canada
facility: Multiple long-term care facilities
state: Alberta
Study officials:
affiliation: University of Alberta
name: Roni Kraut
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kraut RY, Youngson E, Sadowski CA, Bakal JA, Faulder D, Korownyk CS, Vucenovic A, Eurich DT, Manca DP, Lundby C, Kivi P, Manville M, Garrison SR. Antihypertensive deprescribing in frail long-term care residents (OptimizeBP): protocol for a prospective, randomised, open-label pragmatic trial. BMJ Open. 2024 Aug 29;14(8):e084619. doi: 10.1136/bmjopen-2024-084619.