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Advanced practice nurse intervention versus usual care for hypertension control: study protocol for an open-label
Juliette Vay-Demouy1, Alexandre Cinaud1, Nathan Malka1
1Diagnosis and Therapeutic Center, Hôtel-Dieu University Hospital, Assistance Publique-Hôpitaux de Paris, Paris Cité University, Paris, 75004, France.
Insights
Advanced practice nurses (APNs) may improve hypertension control in France. This study assesses APN intervention versus usual care to enhance blood pressure management and treatment adherence in hypertensive patients.
Area of Science:
- Cardiology
- Public Health
- Nursing Science
Background:
- Hypertension is a prevalent global chronic condition and a major modifiable cardiovascular risk factor.
- In France, a significant proportion of treated hypertensive patients have uncontrolled blood pressure, often due to poor adherence to antihypertensive medications.
- The introduction of advanced practice nurses (APNs) in the French healthcare system since 2018 offers a new approach to patient management.
Purpose of the Study:
- To evaluate the impact of an advanced practice nurse (APN) intervention on hypertension control.
- To compare the effectiveness of APN-led care versus usual care in managing hypertension.
- To assess the role of APNs in improving treatment adherence and blood pressure control.
Main Methods:
- A prospective, randomized, controlled, monocentric superiority trial conducted at Hôtel-Dieu University Hospital, Paris.
- Participants recruited during day hospitalization for hypertension management will be randomized into two groups: usual care and APN intervention.
- The intervention group will receive APN support between hospitalization and medical doctor consultations, with outcomes monitored for 12 months.
Main Results:
- The primary outcome is the rate of controlled blood pressure (BP < 140/90 mmHg) in both groups.
- The study hypothesizes that APN intervention will lead to improved hypertension control compared to usual care.
- Blood pressure measurements and treatment adherence will be key indicators assessed.
Conclusions:
- This study represents the first evaluation of APNs in hypertension management in France.
- Findings will provide objective insights into the efficacy of APNs in improving hypertension control and patient adherence.
- The results will inform the integration and role of APNs within the broader context of hypertension management.
Background:
Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension. Since 2018, a new profession has entered the French healthcare system: advanced practice nurses (APN). They have many broad-based skills, at the interface of nursing and medical exercises. The purpose of this study is to assess the impact of an APN intervention versus usual care on hypertension control.
Methods:
The study will take place at the Hôtel-Dieu University Hospital, Paris, France, as prospective, open-label, controlled, randomized 1-to-1, monocentric, and superiority trial. The participants will be recruited during day hospitalization for cardiovascular assessment in the context of their hypertension management. Patients will be divided into two groups: a "usual care" group which will continue traditional follow-up (day hospitalization followed by consultation with a medical doctor (MD) within approximately 2-12 months) and an "intervention" group which will meet an APN between the day hospitalization and the MD consultation. Participants will be monitored until 12 months after the day hospitalization, depending on their last follow-up study appointment (MD consultation). The primary outcome is the rate of controlled BP (BP < 140/90 mmHg in office BP measurement) in each group. The hypothesis formulated is that an individual APN intervention, included in usual hypertension management, improves hypertension control.
Discussion:
This innovative study will be the first in France where APNs are beginning to be established in the healthcare system. It will provide an objective look at this new profession and the impact it can have in the framework of global management of hypertension.
Trial Registration:
ClinicalTrials.gov NCT0448249. Registered on June 24, 2020.
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