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| ID | Type | Description | Link |
|---|---|---|---|
| CE 106/19 | Other Identifier | Local Ethics Committee |
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| Name | Class |
|---|---|
| Azienda Ospedaliero Universitaria Maggiore della Carita | OTHER |
| Humanitas Gradenigo - Torino | UNKNOWN |
| Ospedale San Luigi Gonzaga, Orbassano | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PN implementation | Experimental | All participating wards implemented the PN care pattern, replacing their existing nursing care models (functional or team nursing). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| New pressure injury | 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. |
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Inclusion Criteria (patients):
Inclusion Criteria (nurses):
- Nursing staff employed in the study ward for at least 6 months
Exclusion Criteria (nurses):
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| Name | Affiliation | Role |
|---|---|---|
| Cristina Torgano, RN, MSN | AOU Maggiore della Carità, Novara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASL CN1 | Cuneo | Italy | ||||
| AUSL Ferrara |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 31433878 | 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. | |
| 29076592 |
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| Azienda Sanitaria Locale CN1 Cuneo |
| OTHER_GOV |
| Azienda Unità Sanitaria Locale Ferrara | UNKNOWN |
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|
| From hospital admission to hospital discharge (approximately 10 days) |
| Patient fall | 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. | From hospital admission to hospital discharge (approximately 10 days) |
| Discharge outcome | 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. | At hospital discharge (approximately 10 days) |
| Length of hospital stay | 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. | From hospital admission to hospital discharge (approximately 10 days) |
| Functional status (Barthel Index) | 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. | At hospital admission and at discharge (approximately 10 days) |
| Patient satisfaction (Caring Behaviours Inventory, CBI) | 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. | At hospital discharge (approximately 10 days) |
| Nurse's burnout | 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. | baseline (pre-PN) and post-PN (approximately 21 months) |
| Intention to leave | Assessed using a single dichotomous item (Yes/No). The item was administered to the same nurses before and after PN implementation.. | baseline (pre-PN) and post-PN (approximately 21 months) |
| Missed nursing care | 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. | baseline (pre-PN) and post-PN (approximately 21 months) |
| Job satisfaction | 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. | baseline (pre-PN) and post-PN (approximately 21 months) |
| Ferrara |
| Italy |
| AOU Maggiore della Carità | Novara | Italy |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga | Orbassano | Italy |
| Humanitas Gradenigo | Torino | Italy |
| 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. |
| 36767759 | 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. |
| 38888260 | 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. |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011321 | Primary Nursing |
| ID | Term |
|---|---|
| D009732 | Nursing Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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