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

NCT07822022 | Not Yet Recruiting

• 2 other identifiers: H40663Grant ID 2053493
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Vascular Diseases; Cardiovascular Diseases (CVD)

Keywords

Hypertension; Automated Office Blood Pressure; AOBP; General Practice; Implementation Science; Evaluation Research; Blood Pressure Monitoring

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.

Secondary Outcomes (24)

• Average systolic and diastolic BP measured using AOBP

  Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.

• Heart rate recording during AOBP measurement

  Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.

• Frequency of repeat AOBP measures during the study period

  Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.

• Changes in systolic and diastolic blood pressure values over time, measured using AOBP

  Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.

• Clinician-measured BP values recorded in the electronic medical record, where available

  Assessed during the 12-month AOBP implementation period. Patients included in longitudinal treatment-response analyses must have ≥6 weeks of follow-up after the index AOBP measurement.

Other Outcomes (4)

• Cardiovascular disease risk factors ascertained via data linkage

  Exploratory outcome assessed 12-months following AOBP implementation period.

• Death

  Exploratory outcome assessed 12-months following AOBP implementation period.

• Hospitalization ascertained via data linkage

  Exploratory outcome assessed 12-months following AOBP implementation period.

Study Arms (1)

AOBP Implementation Intervention

OTHER

Device: Automated Office Blood Pressure (AOBP) Standardized Measurement Protocol

Interventions

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.

AOBP Implementation Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be eligible to participate if they meet Australian guideline-recommended criteria for BP measurement, either for absolute CVD risk assessment or for BP assessment as an individual risk factor, and are attending a participating general practice clinic during the study period.
• Eligible participants include:
• Adults attending participating general practice clinics who are eligible for BP measurement for absolute CVD risk assessment, including:
• 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
• Adults eligible for BP assessment as an individual risk factor, including:
• First Nations peoples aged 18 to 29 years
• Adults aged 18 years and over where BP measurement is clinically indicated based on individual risk factors or clinical judgement (e.g. suspected hypertension from BP measurements outside the clinic, obesity, abnormal cholesterol levels, secondary causes of hypertension, or time elapsed since last BP measurement)

You may not qualify if:

• Patients who are unable to provide informed consent.
• Patients whose participation is deemed clinically inappropriate by the treating general practitioner.

Sponsors & Collaborators

• Menzies Institute for Medical Research: lead
• National Health and Medical Research Council, Australia: collaborator
• Hypertension Australia: collaborator
• Australian Cardiovascular Alliance: collaborator
• Pharmaceutical Society of Australia: collaborator
• Ochre Health: collaborator
• Uscom Limited: collaborator
• JA Davey: collaborator
• A&D Australasia: collaborator
• Servier Laboratories (Australia) Pty Ltd: collaborator
• National Heart Foundation, Australia: collaborator

Study Sites (1)

Menzies Institute for Medical Research, University of Tasmania

Hobart, Tasmania, 7000, Australia

Location

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

James E Sharman, PhD

CONTACT

+61 3 6226 4709; james.sharman@utas.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Research

Model Details: Participating general practice clinics will implement a standardized Automated Office Blood Pressure (AOBP) measurement protocol with patients as part of routine clinical practice following site onboarding and staff training. All consented patients will receive the intervention. This study is a pragmatic, multisite, hybrid type 2 implementation-effectiveness trial using a non-randomised pre-post design with participating practices serving as their own controls. Outcomes following implementation of AOBP will be compared with routinely collected baseline clinical data collected prior to implementation.

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 16, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: September 16, 2026

Record last verified: 2026-09

Locations

AU (1)