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Completed

NCT Number: NCT07687251

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASL CN1, Cuneo, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. healthcare-associated infection (HAI)

    Time frame: 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 outcomes

  1. New pressure injury

    Time frame: From 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.

  2. Patient fall

    Time frame: From 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.

  3. Discharge outcome

    Time frame: At 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.

  4. Length of hospital stay

    Time frame: From 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.

  5. Functional status (Barthel Index)

    Time frame: 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.

  6. Patient satisfaction (Caring Behaviours Inventory, CBI)

    Time frame: 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.

  7. Nurse's burnout

    Time frame: baseline (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.

  8. Intention to leave

    Time frame: baseline (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..

  9. Missed nursing care

    Time frame: baseline (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.

  10. Job satisfaction

    Time frame: baseline (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.

Sponsors and collaborators

Lead sponsor

Università degli Studi del Piemonte Orientale Amedeo Avogadro

Other

Collaborators

  • Azienda Ospedaliero Universitaria Maggiore della Carita
  • Azienda Sanitaria Locale CN1 Cuneo
  • Azienda Unità Sanitaria Locale Ferrara
  • Humanitas Gradenigo - Torino
  • Ospedale San Luigi Gonzaga, Orbassano

Registry information

Official study title

Primary Nursing: Uno Studio Pre e Post - Studio PRIMARY

Acronym: PRIMARY

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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