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

Primary Nursing: Uno Studio Pre e Post - Studio PRIMARY

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07687251
Acronym
PRIMARY
Enrollment
1708
Registered
2026-07-07
Start date
2019-11-22
Completion date
2025-06-30
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Falls, Acute Care Unit, Cross Infection (Hospital-Acquired Infections)

Keywords

Primary Nursing, Nursing care model, nursing-sensitive outcomes

Brief 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.

Interventions

Primary Nursing is a care delivery model in which each patient is assigned to a single reference nurse who assumes responsibility 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. The model emphasises the nurse-patient therapeutic relationship, individual accountability, and active patient participation in care planning.

Sponsors

Università degli Studi del Piemonte Orientale Amedeo Avogadro
Lead SponsorOTHER
Azienda Ospedaliero Universitaria Maggiore della Carita
CollaboratorOTHER
Humanitas Gradenigo - Torino
CollaboratorUNKNOWN
Ospedale San Luigi Gonzaga, Orbassano
CollaboratorUNKNOWN
Azienda Sanitaria Locale CN1 Cuneo
CollaboratorOTHER_GOV
Azienda Unità Sanitaria Locale Ferrara
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
healthcare-associated infection (HAI)From hospital admission to discharge (approximately 10 days)An infection acquired during hospitalisation, with onset on Day 3 or later, or earlier following an invasive device/procedure on Day 1-2. Patients were monitored for HAIs throughout their stay in the study ward, and the occurrence of HAIs was recorded by the nurse at patient discharge in both the pre- and post-PN implementation phases.

Secondary

MeasureTime frameDescription
New pressure injuryFrom hospital admission to hospital discharge (approximately 10 days)Localised damage to the skin and underlying tissue, typically over a bony prominence, resulting from pressure or pressure combined with shear forces. Patients were monitored for pressure injuries throughout their stay in the study ward, and the occurrence of new pressure injuries was recorded by the nurse at patient discharge in both the pre- and post-PN implementation phases.
Patient fallFrom hospital admission to hospital discharge (approximately 10 days)Falls were defined as unexpected events in which the patient comes to rest on the ground, floor, or a lower level, excluding intentional changes in position. Patients were monitored for falls throughout their stay in the study ward, and the occurrence of falls was recorded by the nurse at patient discharge in both the pre- and post-PN implementation phases.
Discharge outcomeAt hospital discharge (approximately 10 days)Categorised as discharged home, transferred to another facility, or in-hospital death. Discharge disposition was recorded by the nurse at patient discharge in both the pre- and post-PN implementation phases.
Length of hospital stayFrom hospital admission to hospital discharge (approximately 10 days)Total number of days between admission to and discharge from the study ward for each patient in both the pre- and post-PN implementation phases.
Functional status (Barthel Index)At hospital admission and at discharge (approximately 10 days)Barthel index: 10-item instrument measuring performance in basic activities of daily living; total scores range from 0 to 100, with higher scores indicating greater independence. The Barthel Index was administered to each patient at admission and at discharge from the study ward in both the pre- and post-PN implementation phases.
Patient satisfaction (Caring Behaviours Inventory, CBI)At hospital discharge (approximately 10 days)Patient satisfaction was assessed using the validated Italian version of the Caring Behaviours Inventory (CBI), a 24-item instrument measuring patients' perceptions of nurses' caring behaviours across four dimensions: Assurance, Knowledge and Skill, Respectfulness, and Connectedness. Items are rated on a six-point Likert scale ranging from 1 (never) to 6 (always), with total scores ranging from 24 to 144; higher scores indicate a greater perception of caring behaviours. The CBI was administered to each patient at hospital discharge in both the pre- and post-PN implementation phases.
Nurse's burnoutbaseline (pre-PN) and post-PN (approximately 21 months)Nurses' job-related stress was assessed using the Maslach Burnout Inventory - General Survey (MBI-GS), a 22-item instrument measuring three independent dimensions of burnout syndrome, each rated on a seven-point frequency scale ranging from 0 (never) to 6 (every day): Emotional Exhaustion (9 items): low risk ≤17, intermediate risk 18-29, high risk ≥30 Depersonalization (5 items): low risk ≤5, intermediate risk 6-11, high risk ≥12 Personal Accomplishment (8 items): low risk ≥40, intermediate risk 34-39, high risk ≤33 The MBI-GS was administered to the same nurses before and after PN implementation.
Intention to leavebaseline (pre-PN) and post-PN (approximately 21 months)Assessed using a single dichotomous item (Yes/No). The item was administered to the same nurses before and after PN implementation..
Missed nursing carebaseline (pre-PN) and post-PN (approximately 21 months)Missed nursing care was assessed using the Italian version of the MISSCARE Survey, a self-report questionnaire for nurses. Section A includes 24 nursing care interventions, rated on a 5-point Likert scale indicating how often each element was missed during the nurse's last shift, from 1 (always missed) to 5 (never missed). Section B includes 17 possible reasons for missed care, rated on a 4-point Likert scale from 1 (significant reason) to 4 (not a significant reason). The survey was administered to the same nurses before and after PN implementation.
Job satisfactionbaseline (pre-PN) and post-PN (approximately 21 months)Assessed using a 5-item Likert scale ranging from "totally dissatisfied" to "totally satisfied". The outcome was measured in the same nurses before and after PN implementation.

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORCristina Torgano, RN, MSN

AOU Maggiore della Carità, Novara

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026