Implementing Improved Blood Pressure Measurement in General Practice: A Multisite Implementation Trial Using Automated Office Blood Pressure (AOBP)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
Hypertension is the most common condition managed in general practice and remains one of the leading modifiable risk factors for cardiovascular disease (CVD). Accurate blood pressure (BP) measurement is fundamental to hypertension diagnosis and management; however, guideline-recommended clinic BP measurement procedures are often difficult to implement in routine practice because of time, staffing, and workflow constraints. General practitioners have reported that guideline-recommended BP measurement approaches are frequently impractical in routine clinical care, which may contribute to reduced confidence in clinic BP readings and therapeutic inertia.
Automated Office Blood Pressure (AOBP) measurement is a standardized approach to clinic BP assessment designed to reduce observer and procedural bias. The method incorporates an automated rest period followed by repeated automated measurements obtained while the patient remains seated, quiet, and undisturbed. AOBP values correlate closely with out-of-office BP measurement methods and, in 2025, AOBP was endorsed by Hypertension Australia and the National Hypertension Taskforce as the recommended standard for clinic BP measurement in Australia.
AOBP is typically performed by a trained staff member before the patient sees the general practitioner, in a quiet area outside the consultation room. This approach is intended to provide a more standardized BP assessment, reduce demands on consultation time, and support clinical decision-making through more reliable BP information while maintaining existing clinical care pathways and clinician responsibility for diagnosis, treatment, follow-up, and referral decisions.
Despite guideline endorsement and supporting evidence, AOBP has not been routinely implemented in Australian general practice. Barriers to implementation are predominantly structural rather than clinical and include limited access to validated equipment, staff training requirements, workflow integration challenges, and the absence of coordinated implementation support.
The study was informed by extensive co-design work involving general practitioners, practice staff, partner organisations, and community members. Previous pilot implementation work demonstrated that AOBP could be integrated into general practice workflows and was considered feasible, acceptable, and adaptable across diverse practice settings when supported by appropriate training, workflow integration, and governance arrangements. GPs participating in pilot implementation work reported increased trust in BP readings and greater confidence in hypertension management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Patients who are unable to provide informed consent.
- •Patients whose participation is deemed clinically inappropriate by the treating general practitioner.
研究组 & 干预措施
AOBP Implementation Intervention
干预措施: Automated Office Blood Pressure (AOBP) Standardized Measurement Protocol (Device)
结局指标
主要结局
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.
时间窗: 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.
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.
次要结局
- 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.)
- Initiation of 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.)
- Intensification of 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.)
- Changes in antihypertensive medication prescribing patterns(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 cardiovascular medication prescribing patterns(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.)
- Proportion of participants receiving treatment for hypertension(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.)
- Documented referral for further assessment related to elevated BP (detected by AOBP device)(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.)
- Documented follow-up investigations related to elevated BP (detected by AOBP device [e.g. electrocardiogram monitoring, standard clinic blood pressure measurement, home BP monitoring, 24-hour ambulatory BP monitoring])(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.)
- Dates of clinic visits related to elevated BP (detected by AOBP device), 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.)
- Proportion of participants with possible arrhythmia (including AF) indicated by the AOBP device(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.)
- Documented referral for further assessment of possible arrhythmia (including AF) indicated by the AOBP device(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.)
- Dates of clinic visits related to possible arrhythmia (including AF) indicated by AOBP device, 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.)
- Completion of an absolute CVD risk calculation(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.)
- Documentation of patient characteristics relevant to cardiovascular risk (e.g. age, sex, smoking status, relevant CVD risk factors and pathology [i.e. cholesterol, glucose] and clinical conditions such as diabetes)(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.)
- Implementation outcomes will be evaluated within the overarching RE-AIM framework and will include measures of Reach, Adoption, Implementation and Maintenance.(Assessed throughout the 12-month AOBP implementation period, with Maintenance assessed at 18 months following the 6-month maintenance phase.)
- PRISM (Practical, Robust Implementation and Sustainability Model) will guide the implementation component by identifying anticipated and experienced barriers and enablers, and contextual factors influencing implementation and sustainability.(Assessed throughout the 12-month AOBP implementation period, with Maintenance assessed at 18 months following the 6-month maintenance phase.)
- Costs associated with implementation of AOBP at the practice level, including equipment, staff training, workflow integration, and ongoing quality assurance(Outcome assessed 12-months following AOBP implementation period.)
- Costs per patient correctly diagnosed and managed for hypertension using AOBP compared with usual care BP measurement(Outcome assessed 12-months following AOBP implementation period.)
- Practice level and system level costs related to changes in clinical management, including antihypertensive prescribing and follow up(Outcome assessed 12-months following AOBP implementation period.)
- Downstream health service utilisation and cost implications associated with CVD events, hospitalisations, and mortality (where data permit)(Outcome assessed 12-months following AOBP implementation period.)
研究者
James E Sharman
Professor of Medical Research
Menzies Institute for Medical Research