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

NCT07687251 | Completed

• 2 other identifiers: 106/19CE 106/19
• Study Type: interventional
• Target: 1,708
• Locations: 1 country
• Sites: 5

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. 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. 2.What is the impact of the PN on nurse-related outcomes, including burnout, missed nursing care, job satisfaction, and intention to leave?

Conditions

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

Keywords

Primary Nursing; Nursing care model; nursing-sensitive outcomes

Outcome Measures

Primary Outcomes (1)

• healthcare-associated infection (HAI)

  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.

  From hospital admission to discharge (approximately 10 days)

Secondary Outcomes (10)

• New pressure injury

  From hospital admission to hospital discharge (approximately 10 days)

• Patient fall

  From hospital admission to hospital discharge (approximately 10 days)

• Discharge outcome

  At hospital discharge (approximately 10 days)

• Length of hospital stay

  From hospital admission to hospital discharge (approximately 10 days)

• Functional status (Barthel Index)

  At hospital admission and at discharge (approximately 10 days)

Study Arms (1)

PN implementation

EXPERIMENTAL

All participating wards implemented the PN care pattern, replacing their existing nursing care models (functional or team nursing).

Other: Primary Nursing

Interventions

Primary Nursing OTHER

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.

PN implementation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \- Nursing staff employed in the study ward for at least 6 months

You may not qualify if:

• Nursing staff joining the ward after the implementation phase of the PN model

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: collaborator
• Ospedale San Luigi Gonzaga, Orbassano: collaborator
• Azienda Sanitaria Locale CN1 Cuneo: collaborator
• Humanitas Gradenigo - Torino: collaborator
• Azienda Unità Sanitaria Locale Ferrara: collaborator
• Università degli Studi del Piemonte Orientale Amedeo Avogadro: lead

Study Sites (5)

ASL CN1

Cuneo, Italy

Location

AUSL Ferrara

Ferrara, Italy

Location

AOU Maggiore della Carità

Novara, Italy

Location

Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Orbassano, Italy

Location

Humanitas Gradenigo

Torino, Italy

Location

Related Publications (5)

• Ventura-Silva, J. M., Martins, M. M., Trindade, L. L., Faria, A. C., Barros, S. C., Castro, S. F., Rocha, C. G., Mendes, M., Ribeiro, O. M., Implementation of the Primary Nursing Care Model in a Hospital Service: A Quasi-Experimental Study, Nursing Forum, 2024, 5549115, 8 pages, 2024. https://doi.org/10.1155/2024/5549115

  BACKGROUND

• Moura ECC, Lima MB, Peres AM, Lopez V, Batista MEM, Braga FDCSAG. Relationship between the implementation of primary nursing model and the reduction of missed nursing care. J Nurs Manag. 2020 Nov;28(8):2103-2112. doi: 10.1111/jonm.12846. Epub 2019 Oct 17.

  PMID: 31433878 BACKGROUND

• Dal Molin A, Gatta C, Boggio Gilot C, Ferrua R, Cena T, Manthey M, Croso A. The impact of primary nursing care pattern: Results from a before-after study. J Clin Nurs. 2018 Mar;27(5-6):1094-1102. doi: 10.1111/jocn.14135. Epub 2018 Jan 17.

  PMID: 29076592 BACKGROUND

• Goncalves I, Mendes DA, Caldeira S, Jesus E, Nunes E. The Primary Nursing Care Model and Inpatients' Nursing-Sensitive Outcomes: A Systematic Review and Narrative Synthesis of Quantitative Studies. Int J Environ Res Public Health. 2023 Jan 29;20(3):2391. doi: 10.3390/ijerph20032391.

  PMID: 36767759 BACKGROUND

• Geltmeyer K, Duprez V, Blondeel M, Serraes B, Eeckloo K, Malfait S. The effect of different care delivery models in a hospital setting on patient- and nurse-related outcomes: A systematic review with narrative synthesis. J Adv Nurs. 2025 Jan;81(1):140-155. doi: 10.1111/jan.16271. Epub 2024 Jun 18.

  PMID: 38888260 BACKGROUND

MeSH Terms

Conditions

Cross Infection

Interventions

Primary Nursing

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nursing Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Cristina Torgano, RN, MSN

  AOU Maggiore della Carità, Novara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 7, 2026
• Study Start: November 22, 2019
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 7, 2026

Record last verified: 2026-07

Locations

IT (5)