Clinical Trial

Impact of Primary Nursing on Nursing-sensitive Outcomes in Inpatients Units: a Multicentre Pre-Post Study

Study acronym: PRIMARY
Completed
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Summary
The aim of this quasi-experimental before-after study is to evaluate whether the implementation of the Primary Nursing (PN) pattern of care improves nursing-sensitive outcomes in adult inpatients and nurse-related outcomes across hospital wards in Northern Italy. The main questions it aims to answer are: 1. What is the impact of the PN on inpatients' nursing-sensitive outcomes, including healthcare-associated infections, falls, pressure injuries, functional status, and patient satisfaction? 2. What is the impact of the PN on nurse-related outcomes, including burnout, missed nursing care, job satisfaction, and intention to leave? This study follows a multicentre, uncontrolled before-after design: in the pre-intervention phase, wards operated according to their existing nursing care models (functional or team nursing); this was followed by the implementation of the PN across all participating wards. The PN assigns each patient to a single reference nurse who is responsible for planning, delivering, and evaluating nursing care throughout the entire hospital stay. In the primary nurse's absence, an associate nurse ensures continuity by following the individualised care plan.
Trial Details
NCT Number NCT07687251
Lead Sponsor Università degli Studi del Piemonte Orientale Amedeo Avogadro
Collaborators: Azienda Ospedaliero Universitaria Maggiore della Carita, Humanitas Gradenigo - Torino, Ospedale San Luigi Gonzaga, Orbassano, Azienda Sanitaria Locale CN1 Cuneo, Azienda Unità Sanitaria Locale Ferrara
Conditions Accidental Falls, Cross Infection (Hospital-Acquired Infections), Acute Care Unit
Enrollment 1,708 participants
Start Date 2019-11-22
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-07