Antihypertensive Deprescribing in Long-term Care (OptimizeBP)

• ClinicalTrials.gov Identifier: NCT05047731
• Recruitment Status: Enrolling by invitation
• First Posted: September 17, 2021
• Last Update Posted: October 17, 2022
• Sponsor: University of Alberta
• Collaborator: Alberta Health services
• Information provided by (Responsible Party): University of Alberta

Study Description

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 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.

Condition or disease	Intervention/treatment	Phase
Hypertension; Frailty	Drug: Antihypertensive medication	Not Applicable

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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 383 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Antihypertensive Deprescribing in Long-term Care: A Randomized Controlled Trial (OptimizeBP)
• Actual Study Start Date: September 20, 2021
• Estimated Primary Completion Date: June 30, 2024
• Estimated Study Completion Date: June 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. All-cause mortality [ Time Frame: through study completion (estimated to be 3 years, trial will continue until 247 events are reached) ]
   As recorded in government health claim databases

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Number of baseline antihypertensive medications with ≥50% reduction in dosage dispensed (in mg) [ Time Frame: 3-and-6-months post-randomization ]
   As recorded in government health claim databases
2. Number of participants with ≥1 baseline antihypertensive medication with ≥50% reduction in dosage dispensed (in mg) [ Time Frame: 3-to-6-months post-randomization ]
   As recorded in government health claim databases
3. Number of different medications used in the last 7 days [ Time Frame: 3-to-6-months post-randomization ]
   As recorded in the RAI-MDS 2.0 assessment during this time frame
4. Average systolic blood pressure and average diastolic blood pressure [ Time Frame: through study completion (estimated to be 3 years, trial will continue until 247 events are reached) ]
   As recorded by the long-term care facility
5. Composite of emergency, hospital, and physician call-backs to the facility with a diagnosis of stroke, heart attack, congestive heart failure or atrial fibrillation [ Time Frame: through study completion (estimated to be 3 years, trial will continue until 247 events are reached) ]
   As recorded in government health claim databases
6. Worsening of the Depression rating scale [ Time Frame: 3-to-6-months post-randomization ]
   As recorded in RAI-MDS 2.0 assessment during this time frame

Eligibility Criteria

• Ages Eligible for Study: 70 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Canada, Alberta

Multiple long-term care facilities

Multiple Locations, Alberta, Canada

Sponsors and Collaborators

University of Alberta

Alberta Health services

Investigators

• Principal Investigator: Roni Kraut; University of Alberta

More Information

• Responsible Party: University of Alberta
• ClinicalTrials.gov Identifier: NCT05047731
• Other Study ID Numbers: Pro00097312
• First Posted: September 17, 2021
• Last Update Posted: October 17, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: A fully anonymized data set will be available when the study is published and will be downloadable from an affiliated website or repository.
• Supporting Materials: Study Protocol
• Time Frame: Data will be available at the time of publications and is intended to be available long-term.
• Access Criteria: Freely accessible

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Alberta:

Pragmatic trial; Long-term care; Nursing home; Hypertension; Antihypertensive agents; Deprescriptions; Routinely collected health data; Frail older adult

Additional relevant MeSH terms:

Hypertension; Frailty; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Antihypertensive Agents