Accidental FallsPRIMARYNCT07687251
Impact of Primary Nursing on Nursing-sensitive Outcomes in Inpatients Units: a Multicentre Pre-Post Study
A study testing Primary Nursing in people with Accidental Falls and Cross Infection (Hospital-Acquired Infections), run by Università degli Studi del Piemonte Orientale Amedeo Avogadro at 5 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Accidental Falls, Cross Infection (Hospital-Acquired Infections), Acute Care Unit
- What is being tested?
- Primary Nursing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,708 participants
- Where
- 5 sitesItaly
- Study dates
- 22 Nov 2019to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Nursing staff joining the ward after the implementation phase of the PN model
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
ASL CN1
Cuneo
AUSL Ferrara
Ferrara
AOU Maggiore della Carità
Novara
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano
Humanitas Gradenigo
Torino
About this study
Official title: Primary Nursing: Uno Studio Pre e Post - Studio PRIMARY
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:
Read more
- What is the impact of the PN on inpatients' nursing-sensitive outcomes, including healthcare-associated infections, falls, pressure injuries, functional status, and patient satisfaction?
- 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.
- Being tested
- Primary Nursing
- Keywords
- Primary Nursing, Nursing care model, nursing-sensitive outcomes
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary NursingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PN implementation | Experimental | All participating wards implemented the PN care pattern, replacing their existing nursing care models (functional or team nursing). Receives: Other: Primary Nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From hospital admission to discharge (approximately 10 days)
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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..
Measured: 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.
Measured: 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.
Measured: baseline (pre-PN) and post-PN (approximately 21 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start22 Nov 2019
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,708 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria Maggiore della Carita, Humanitas Gradenigo - Torino, San Luigi Gonzaga Hospital, Azienda Sanitaria Locale CN1 Cuneo, Azienda Unità Sanitaria Locale Ferrara
- Responsible party
- Sponsor
- Investigators
- Cristina Torgano, RN, MSN, Principal investigator, AOU Maggiore della Carità, Novara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687251
- Sponsor's protocol ID
- 106/19
- Other IDs
- CE 106/19
- Acronym
- PRIMARY
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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
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.
PubMed 31433878Dal 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.
PubMed 29076592Goncalves 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.
PubMed 36767759Geltmeyer 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.
PubMed 38888260
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Nursing: Uno Studio Pre e Post - Studio PRIMARY
- ClinicalTrials.gov ID
- NCT07687251
- Acronym / sponsor ID
- PRIMARY / 106/19
- Keywords
- Primary Nursing, Nursing care model, nursing-sensitive outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,708 participants (actual)
- Lead sponsor
- Università degli Studi del Piemonte Orientale Amedeo AvogadroUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria Maggiore della Carita, Humanitas Gradenigo - Torino, San Luigi Gonzaga Hospital, Azienda Sanitaria Locale CN1 Cuneo, Azienda Unità Sanitaria Locale Ferrara
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the impact of the PN on inpatients' nursing-sensitive outcomes, including healthcare-associated infections, falls, pressure injuries, functional status, and patient satisfaction?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PN implementation | Experimental | Other: Primary NursingAll participating wards implemented the PN care pattern, replacing their existing nursing care models (functional or team nursing). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Nursing staff joining the ward after the implementation phase of the PN model
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary NursingPrimary 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. | Other | PN implementation |
Primary outcome
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.
10 secondary outcomes
New pressure injury
Time frame: From hospital admission to hospital discharge (approximately 10 days)
Patient fall
Time frame: From hospital admission to hospital discharge (approximately 10 days)
Discharge outcome
Time frame: At hospital discharge (approximately 10 days)
Length of hospital stay
Time frame: From hospital admission to hospital discharge (approximately 10 days)
Functional status (Barthel Index)
Time frame: At hospital admission and at discharge (approximately 10 days)
Patient satisfaction (Caring Behaviours Inventory, CBI)
Time frame: At hospital discharge (approximately 10 days)
Nurse's burnout
Time frame: baseline (pre-PN) and post-PN (approximately 21 months)
Intention to leave
Time frame: baseline (pre-PN) and post-PN (approximately 21 months)
Missed nursing care
Time frame: baseline (pre-PN) and post-PN (approximately 21 months)
Job satisfaction
Time frame: baseline (pre-PN) and post-PN (approximately 21 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- BackgroundVentura-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: PubMed 31433878Moura 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.
- Background: PubMed 29076592Dal 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.
- Background: PubMed 36767759Goncalves 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.
- Background: PubMed 38888260Geltmeyer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Torgano, RN, MSN principal investigator
AOU Maggiore della Carità, Novara
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Nursing in people with Accidental Falls and Cross Infection (Hospital-Acquired Infections), run by Università degli Studi del Piemonte Orientale Amedeo Avogadro at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healthcare-associated infection (HAI) (time frame: From hospital admission to discharge (approximately 10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07687251, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.