Advanced practice nurse intervention versus usual care for hypertension control: study protocol for an open-label randomized controlled trial

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.