Pharmacists Intervention to Improve Hypertension Management in Primary Care (APOTHECARE)

Wilhelminenspital Vienna

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Referral of hypertensive patients to the attending physician

Study type: Interventional

Funder types: Other

Identifiers

NCT03274531

APOTHECARE

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 497 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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497 participants in 2 patient groups

Interventional Arm

Experimental group

Description:

Immediate referral of hypertensive patients to the attending physician based on automated office blood pressure measurements

Treatment:

Behavioral: Referral of hypertensive patients to the attending physician

Observational Arm

No Intervention group

Description:

Repeated automated office blood pressure measurements and referral of hypertensive patients to the attending physician after completion of the trial