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Antihypertensive Deprescribing in Long-term Care (OptimizeBP)

Primary Purpose

Hypertension, Frailty

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Antihypertensive medication
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Pragmatic trial, Long-term care, Nursing home, Hypertension, Antihypertensive agents, Deprescriptions, Routinely collected health data, Frail older adult

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Multiple long-term care facilities

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Deprescribing group

Usual care group

Arm Description

The facility pharmacist will actively deprescribe antihypertensive medication of residents in this group.

The facility pharmacist and the attending physician will provide usual care to residents in this group, and this includes quarterly medication reviews.

Outcomes

Primary Outcome Measures

All-cause mortality
As recorded in government health claim databases

Secondary Outcome Measures

All-cause hospitalization or emergency room visit
As recorded in government health claim databases
Average 30-day per-resident cost of all medication
As recorded in government health claim databases
Average monthly physician billing
As recorded in government health claim databases
Average monthly acute care costs
Calculated from all hospitalizations using the resource intensity weight (RIW) and length of stay (LOS) as recorded in government health claim databases
Non-vertebral fracture
As recorded in government health claim databases
Worsening of the Activities of Daily Living Score
As recorded in the Resident Assessment Instrument Minimum Data Set 2.0 (RAI-MDS 2.0) assessment during this time frame
Record of ≥1 fall in last 30-days for ambulatory residents
As recorded in RAI-MDS 2.0 assessment during this time frame
Worsening of the Cognitive Performance Score
As recorded in the RAI-MDS 2.0 assessment during this time frame
Number of residents with full thickness skin ulceration (stage 3 or 4)
As recorded in the RAI-MDS 2.0 assessment during this time frame

Full Information

First Posted
September 8, 2021
Last Updated
June 16, 2023
Sponsor
University of Alberta
Collaborators
Alberta Health services
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1. Study Identification

Unique Protocol Identification Number
NCT05047731
Brief Title
Antihypertensive Deprescribing in Long-term Care
Acronym
OptimizeBP
Official Title
Antihypertensive Deprescribing in Long-term Care: A Randomized Controlled Trial (OptimizeBP)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Alberta Health services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Frailty
Keywords
Pragmatic trial, Long-term care, Nursing home, Hypertension, Antihypertensive agents, Deprescriptions, Routinely collected health data, Frail older adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
383 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deprescribing group
Arm Type
Experimental
Arm Description
The facility pharmacist will actively deprescribe antihypertensive medication of residents in this group.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
The facility pharmacist and the attending physician will provide usual care to residents in this group, and this includes quarterly medication reviews.
Intervention Type
Drug
Intervention Name(s)
Antihypertensive medication
Intervention Description
Antihypertensive medication will be deprescribed to a blood pressure of 140 ±5 mmHg following the study algorithm.
Primary Outcome Measure Information:
Title
All-cause mortality
Description
As recorded in government health claim databases
Time Frame
through study completion (estimated to be 3 years, trial will continue until 247 events are reached)
Secondary Outcome Measure Information:
Title
All-cause hospitalization or emergency room visit
Description
As recorded in government health claim databases
Time Frame
through study completion (estimated to be 3 years, trial will continue until 247 events are reached)
Title
Average 30-day per-resident cost of all medication
Description
As recorded in government health claim databases
Time Frame
through study completion (estimated to be 3 years, trial will continue until 247 events are reached)
Title
Average monthly physician billing
Description
As recorded in government health claim databases
Time Frame
through study completion (estimated to be 3 years, trial will continue until 247 events are reached)
Title
Average monthly acute care costs
Description
Calculated from all hospitalizations using the resource intensity weight (RIW) and length of stay (LOS) as recorded in government health claim databases
Time Frame
through study completion (estimated to be 3 years, trial will continue until 247 events are reached)
Title
Non-vertebral fracture
Description
As recorded in government health claim databases
Time Frame
through study completion (estimated to be 3 years, trial will continue until 247 events are reached)
Title
Worsening of the Activities of Daily Living Score
Description
As recorded in the Resident Assessment Instrument Minimum Data Set 2.0 (RAI-MDS 2.0) assessment during this time frame
Time Frame
3-to-6-months post-randomization
Title
Record of ≥1 fall in last 30-days for ambulatory residents
Description
As recorded in RAI-MDS 2.0 assessment during this time frame
Time Frame
3-to-6-months post-randomization
Title
Worsening of the Cognitive Performance Score
Description
As recorded in the RAI-MDS 2.0 assessment during this time frame
Time Frame
3-to-6-months post-randomization
Title
Number of residents with full thickness skin ulceration (stage 3 or 4)
Description
As recorded in the RAI-MDS 2.0 assessment during this time frame
Time Frame
3-to-6-months post-randomization
Other Pre-specified Outcome Measures:
Title
Number of baseline antihypertensive medications with ≥50% reduction in dosage dispensed (in mg)
Description
As recorded in government health claim databases
Time Frame
3-and-6-months post-randomization
Title
Number of participants with ≥1 baseline antihypertensive medication with ≥50% reduction in dosage dispensed (in mg)
Description
As recorded in government health claim databases
Time Frame
3-to-6-months post-randomization
Title
Number of different medications used in the last 7 days
Description
As recorded in the RAI-MDS 2.0 assessment during this time frame
Time Frame
3-to-6-months post-randomization
Title
Average systolic blood pressure and average diastolic blood pressure
Description
As recorded by the long-term care facility
Time Frame
through study completion (estimated to be 3 years, trial will continue until 247 events are reached)
Title
Composite of emergency, hospital, and physician call-backs to the facility with a diagnosis of stroke, heart attack, congestive heart failure or atrial fibrillation
Description
As recorded in government health claim databases
Time Frame
through study completion (estimated to be 3 years, trial will continue until 247 events are reached)
Title
Worsening of the Depression rating scale
Description
As recorded in RAI-MDS 2.0 assessment during this time frame
Time Frame
3-to-6-months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roni Kraut
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Multiple long-term care facilities
City
Multiple Locations
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data will be available at the time of publications and is intended to be available long-term.
IPD Sharing Access Criteria
Freely accessible

Learn more about this trial

Antihypertensive Deprescribing in Long-term Care

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