Implementing Improved Blood Pressure Measurement in General Practice: A Multisite Implementation Trial Using Automated Office Blood Pressure (AOBP)

ConditionsHypertension Cardiovascular Diseases (CVD)Vascular Diseases

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMenzies Institute for Medical Research

About this trial

The goal of this clinical trial is to evaluate whether implementation of guideline-recommended Automated Office Blood Pressure (AOBP) measurement in Australian general practice clinics improves hypertension control among adults aged 18 years and older who are eligible for blood pressure assessment as part of routine clinical care. The study will also evaluate the implementation, sustainability, and health economic impact of AOBP in real-world primary care settings.

The main questions it aims to answer are:

* Does implementation of AOBP increase the proportion of patients with treated and controlled hypertension compared with the pre-implementation period? * Can AOBP be successfully adopted, implemented, integrated into routine general practice workflows, and maintained over time?

Researchers will compare outcomes following implementation of AOBP with routinely collected clinical data from the period before implementation.

Participants will:

* Provide informed consent and have their AOBP measurements performed during routine general practice visits. * Consent to the collection of AOBP measurement and relevant clinical information from their medical records for study evaluation. * Continue to receive usual clinical care from their general practitioner.

General practice staff will receive AOBP training, perform AOBP measurements, and participate in implementation evaluation activities.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged 45 to 79 years without known CVD

Adults aged 35 to 79 years with diabetes and without known CVD

First Nations peoples aged 30 to 79 years without known CVD

First Nations peoples aged 18 to 29 years

Disqualifiers

Patients who are unable to provide informed consent.

Patients whose participation is deemed clinically inappropriate by the treating general practitioner.

Trial design

Design model

Single group

Treatments tested in this trial

Automated Office Blood Pressure (AOBP) Standardized Measurement Protocol
Device
Implementation of a standardized AOBP measurement protocol using a validated automated sphygmomanometer. AOBP measurements will be conducted by trained general practice staff. Patients will be seated in a quiet area with back supported, feet flat on the floor, arm supported at heart level, and an appropriately sized cuff applied. Following a 5-minute automated rest period, the device automatically records three seated blood pressure measurements at 30-second intervals and a fourth brief measurement to detect arrhythmia/atrial fibrillation. The device automatically calculates and records the average of the three seated measurements, heart rate, and arrhythmia status. Where clinically indicated, a standing protocol will be performed following the seated protocol and consists of two standing blood pressure measurements recorded at 30-second intervals after 1 minute of standing, followed by an arrhythmia assessment. Results are provided to the treating general practitioner.

Treatment groups

6,000 Participants

are divided into 1 treatment group

Group A: AOBP Implementation InterventionOther 1 intervention

Trial outcomes

Primary outcomes

The proportion of patients with treated and controlled hypertension, with the primary estimand being the absolute difference in this proportion between the pre-implementation period and 12-month AOBP implementation period.

Hypertension control will be defined according to Australian guideline recommendations using AOBP thresholds (average systolic BP \<135 mmHg and diastolic BP \<85 mmHg). "Treated" refers to patients receiving antihypertensive therapy.

Time frame