Pharmacists Intervention to Improve Hypertension Management in Primary Care

Study Overview
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Brief Summary
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Arterial hypertension is the single largest contributor to mortality world-wide, and only 30-50% of diagnosed and treated patients achieve their blood pressure goal. The APOTHECARE trial is designed to identify treated patients with uncontrolled hypertension in community pharmacies in order to improve blood pressure control through intensification of antihypertensive therapy.

Detailed Description
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Patients with medically treated arterial hypertension, who attend a pharmacy in order to obtain their antihypertensive medication are invited to participate in the trial. The main inclusion criteria is uncontrolled hypertension, as determined by an automated office blood pressure measurement at a threshold of 135/85 mmHg. Main exclusion criteria include a first-ever prescription of an antihypertensive agent, resistant hypertension, systolic blood pressure ≥ 180 mmHg and dialysis. Randomization occurs on the level of pharmacies (cluster randomization). Patients in the interventional arm are immediately referred to their treating physician for up-titration of antihypertensive therapy. Re-examination of automated automated office blood-pressure occurs in the respective pharmacy, and patients are referred to their treating physician again if required. These measures are accompanied by a structured and educational blood pressure record card. Patients in the observational arm undergo periodic automated office blood pressure measurements and are referred to their treating physician at the end of the trial in case of persistently uncontrolled blood pressure.

Official Title
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Pharmacists Intervention to Improve Hypertension Management in Primary Care (APOTHECARE): A Cluster-randomized Trial

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Referral of hypertensive patients to the attending physician


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Age > 18 years Medically pre-treated arterial hypertension Automated office blood pressure ≥ 135 mmHg systolic or ≥ 85 mmHg diastolic Exclusion Criteria: First ever prescription of antihypertensive medication First prescription of a new antihypertensive substance or dose adjustment Prior therapy with 4 or more different antihypertensive substances Systolic blood pressure ≥ 180 mmHg Dialysis Adherence to the study protocol not to be anticipated Inclusion into the study at another study site

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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No

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
Interventional Model Description: Prospective, cluster randomized, controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Arm<br>Immediate referral of hypertensive patients to the attending physician based on automated office blood pressure measurements | Behavioral: Referral of hypertensive patients to the attending physician<br>* Immediate referral to the treating physician in case of elevated automated office blood pressure measurements<br>|
| No Intervention: Observational Arm<br>Repeated automated office blood pressure measurements and referral of hypertensive patients to the attending physician after completion of the trial | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg at 10 weeks of follow-up (automated office blood pressure measurement) | Primary endpoint | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average systolic blood pressure (automated office blood pressure measurement) | Secondary endpoint | 10 weeks | 
| Change in average systolic blood pressure (automated office blood pressure measurement) | Secondary endpoint | 20 weeks | 
| Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg (automated office blood pressure measurement) | Secondary endpoint | 20 weeks | 
| Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg (home blood pressure, mean of available readings) | Secondary endpoint, patients with available home blood pressure measurements | 20 weeks |