Frailty, Hypertension
Conditions
Keywords
Pragmatic trial, Long-term care, Nursing home, Hypertension, Antihypertensive agents, Deprescriptions, Routinely collected health data, Frail older adult
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.
Interventions
Antihypertensive medication will be continually reduced provided an upper systolic threshold of 145 mmHg is not exceeded
Sponsors
Alberta Health services
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Composite of all-cause death and unplanned hospital admission or emergency room visit - as recorded in government health claim databases |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Deteriorated Cognition as Compared to Status 90 Days Prior | 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 |
| All-Cause Unplanned Hospitalization | 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 |
| Non-Vertebral Fracture | 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 |
| Number of Participants with Record of ≥1 Fall in Last 30-days | 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 |
| Number of Participants with Partial or Full Thickness Skin Ulceration (stage 2 to 4) | 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 |
| Number of Participants with Renal Insufficiency | ≥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 |
| Unplanned All-Cause Hospitalization with a Diagnosis of Stroke, Heart Attack, Congestive Heart Failure or Atrial Fibrillation | 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 |
| Number of Participants with Deteriorated Activities of Daily Living (ADL) as Compared to Status 90 Days Prior | 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 |
| 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 | 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 |
| Acute Care Costs | 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 |
| Total Costs of Care | 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. |
| Number of Antihypertensive Medications with ≥25%, ≥50%, and 100% Reduction from Baseline in Dosage Dispensed | 3- and 6-months post-randomization | As recorded in government health claim databases |
| Number of Participants with ≥1 Baseline Antihypertensive Medication with ≥25%, ≥50%, and 100% Reduction in Dosage Dispensed | 3- and 6-months post-randomization | As recorded in government health claim databases |
| Number of Participants with the Addition of ≥1 New Antihypertensive Medication or Increase in Dosage from Baseline. | 3- and 6-months post-randomization | As recorded in government health claim databases |
| Number of Discrete Antihypertensive Medications Used in the Last 15 days (baseline, 3- and 6-months post-randomisation) | 3- and 6-months post-randomization | As recorded in government health claim databases |
| Number of Discrete Medications Used in the Last 15 Days (baseline, 3- and 6-months post-randomisation) | 3- to 6-months post-randomization | As recorded in government health claim databases |
| Average Systolic Blood Pressure and Average Diastolic Blood Pressure | 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 |
| Number of Participants with Deteriorated Mood as Compared to Status 90 Days Prior | 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 |
Countries
Canada
Outcome results
None listed