Impact of Primary Nursing on Nursing-sensitive Outcomes in Inpatients Units: a Multicentre Pre-Po… (NCT07687251) | Clinical Trial Compass
CompletedNot Applicable
Impact of Primary Nursing on Nursing-sensitive Outcomes in Inpatients Units: a Multicentre Pre-Post Study
Italy1,708 participantsStarted 2019-11-22
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (patients):
* Hospital stay of at least 48 hours in the study ward
* Capacity to provide written informed consent
* Clinical conditions permitting completion of self-reported outcome measures
Inclusion Criteria (nurses):
\- Nursing staff employed in the study ward for at least 6 months
Exclusion Criteria (nurses):
* Nursing staff joining the ward after the implementation phase of the PN model
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study looked at whether having a dedicated primary nurse assigned to each patient reduced hospital-acquired infections — did the hospital where I'm being treated use a primary nursing model, and how might that affect my own risk of getting an infection during my stay?
2Since this was a pre-post study comparing outcomes before and after a care model change rather than a randomized trial, how confident is my care team in the strength of the evidence it produced about reducing infections and falls?
3The trial also tracked accidental falls as a nursing-sensitive outcome — what specific fall-prevention practices does my care team have in place for me during my inpatient stay, and are those based on approaches like the ones studied here?
4Because this trial is completed, are the results published or available yet, and would my doctor be willing to review the findings with me to understand whether primary nursing made a meaningful difference in patient safety outcomes?
5If primary nursing was found to improve outcomes in this study, is that model currently being used in the unit where I would be admitted, or is there a way to request that level of consistent nursing assignment for my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
healthcare-associated infection (HAI)
Timeframe: From hospital admission to discharge (approximately 10 days)
Trial details
NCT IDNCT07687251
SponsorUniversità degli Studi del Piemonte Orientale Amedeo Avogadro