Alberta Clinical Trial in Optimizing Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of enhanced pharmacist care (patient identification, assessment, education, prescribing/titration of antihypertensive medications and close follow-up) on systolic blood pressure (BP) reduction in patients with poorly controlled hypertension in the community setting.

Detailed Description
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The study is a randomized, controlled trial of enhanced pharmacist care, with the unit of randomization as the patient. Participants will be randomized to enhanced pharmacist care (patient identification, assessment, education, close follow-up and prescribing/titration of antihypertensive medications or usual care. Participants will be patients in Alberta with undiagnosed or uncontrolled BP as defined by the Canadian Hypertension Education Program. The primary intervention will be enhanced pharmacist care. Pharmacists will assess patients with regards to cardiovascular risk reduction including reviewing BP control, treatment goals and determining lifestyle modifications for the patient to undertake to help manage their BP. The primary outcome will be a comparison of difference in change in systolic BP between enhanced care and usual care at 24 weeks follow-up. Secondary outcomes include the number of patients at their BP target at 24 weeks, number of new antihypertensive medication starts, number of antihypertensive dosage changes, number of antihypertensive medication changes and number of new prescriptions for ASA and cholesterol medications.

Official Title
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Alberta Clinical Trial in Optimizing Hypertension: The RxAction Study

Conditions
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Hypertension

Intervention / Treatment
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* Other: Enhanced pharmacist care
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overall average (after 2 visits) systolic ≥180 OR diastolic ≥110 mmHg in undiagnosed patients without macrovascular target organ damage, diabetes or chronic kidney disease Overall average (after 2 visits) systolic ≥140 OR diastolic ≥90 for patients with undiagnosed hypertension with macrovascular target organ damage (coronary artery disease, cerebrovascular disease, DM) In patients with diagnosed hypertension, systolic ≥140 (≥ 130 with DM or CKD) OR diastolic ≥90, (≥ 80 with DM or CKD) Overall average (after 5 visits, for those without macrovascular target organ damage, DM, or CKD and without an existing hypertension diagnosis) systolic ≥140 OR diastolic ≥90 mmHg Overall average (after 7 days of twice-daily home blood pressure monitoring , for those without macrovascular target organ damage, DM, or CKD and without an existing hypertension diagnosis) systolic ≥135 OR diastolic ≥85 Exclusion Criteria: Patients with hypertensive urgency or emergency: Urgency: SBP ≥ 180 mm Hg or DBP ≥ 120 mm Hg with no acute signs of end-organ damage Unwilling to participate/sign consent form Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br> | Other: Usual Care<br>* Patients randomized to usual care will receive a wallet card for BP readings, pamphlet on BP and usual pharmacist and physician care. Patients will be seen at 12 weeks for interim BP measurement only. Both groups of patients will be seen at 24 weeks for BP measurement.<br>* Other names: Control;|
| Experimental: Enhanced pharmacist care<br> | Other: Enhanced pharmacist care<br>* The primary intervention will be enhanced pharmacist care. Pharmacists will assess patients with regards to cardiovascular risk reduction including reviewing BP control, treatment goals and determining lifestyle modifications for the patient to undertake to help manage their BP. The pharmacist will also review the patient's current hypertensive therapy regimen and decide on the options for improvement of BP control (lifestyle modification, increase dose, additional BP medications), and implementation of these strategies.<br>* Other names: Treatment group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of difference in change in systolic BP between enhanced care and usual care |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients at their BP target |  | 24 weeks | 
| number of new antihypertensive medication starts |  | 24 weeks | 
| number of antihypertensive dosage changes |  | 24 weeks | 
| EQ-5D |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, pharmacists, rural health, prescribing