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Sviluppo del ruolo, implementazione e valutazione degli infermieri (NUPRA-DI)

16 settembre 2026 aggiornato da: University Hospital, Ghent

Sviluppo del ruolo, implementazione e valutazione degli infermieri in un ospedale universitario belga.

Hospitals face new challenges in providing sustainable high quality care as the prevalence of chronic conditions, multimorbidity and the complexity of care increases. The high burden on healthcare teams, the growing costs and the increasing scarcity in healthcare providers (HCPs) result in unmet needs of patients and their families and a high workload on HCPs. Worldwide there is growing recognition that new care models integrating nurse practitioners (NPs) in interdisciplinary teams could contribute to respond to these challenges.

ANP is defined as an "advanced practice nurse (APN) who integrates clinical skills associated with nursing and medicine in order to assess, diagnose and manage patients in primary healthcare settings and acute care populations as well as ongoing care for populations with chronic illness".

Despite the proven benefits of integrating NPs in interdisciplinary teams, the introduction of NPs in Belgium is at an early stage. Advanced practice nurses, including NPs, are formally recognized in Belgium since 2019, but there is still no legal framework in which additional rights or agreements compared to other nursing groups are defined. Given the early stage of introduction, little is known about the development, implementation and impact of NPs in the Belgian health care context. Insights in implementation processes and the effectiveness of NP roles at different levels can inform healthcare managers and policy makers for future (nation-wide) implementation in a hospital setting.

The overall objective of this longitudinal pre-post mixed methods study is to develop, implement and evaluate the integration of the role of NPs in four different departments in a Belgian university hospital.

Panoramica dello studio

Descrizione dettagliata

A mixed methods design is used to enrich the gathered data, resulting in an integrated approach for addressing the complexity of this study. This method creates the opportunity to triangulate and integrate quantitative and qualitative data resulting in a complete and nuanced understanding of complex phenomena . Several strategies are used to enhance the internal validity of the quantitative part. At first, all questionnaires that will be used will be validated and selected after thorough consideration of several researchers with experience in mixed methods implementation research. Secondly, using a wide range of outcome indicators, increases the ability to distinguish confounding from independent variables. Thirdly, if possible a matched controlled group will be used to compare outcomes. Internal validity of qualitative data will be ensured in the stage of data collection by involving researchers who did not participate in the PAR-process to conduct the interviews and focus group interviews. In the stage of data analysis, internal validity of the qualitative data will be enhanced by systematically organizing and coding data and triangulation (data and researcher). Analysis and comparison of the four different settings will reinforce the external validity and transferability of the findings.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

1000

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Ghent, Belgio, 9000
        • University Hospital Ghent
    • East Flanders
      • Ghent, East Flanders, Belgio, 9000
        • Ghent University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

Patients

- Patients (or their parents in the paediatric department)

HCPs

  • Representatives of all relevant stakeholders (from each department) will be invited to participate (eg. head(s) of the medical department(s), physicians, physicians in training, (head) nurses, care managers, the chief medical officer, specialised nurses, social worker, pharmacist).
  • All HCPs who are currently involved in the care process of the targeted patient population.

Descrizione

Patients/parents

Inclusion Criteria:

  • Admitted on the participating ward (digestive surgery) or diagnosed stable liver cirrhosis or pediatric epilepsy
  • Be conscious
  • Speak Dutch

Exclusion Criteria:

- Dementia or other severe cognitive/mental disorders

Health care providers

Inclusion Criteria:

  • Have at least three months of clinical experience on the ward
  • Key stakeholders in the process of development, implementation and/or evaluation

Exclusion Criteria:

  • No contact with the nurse practitioner
  • Internship

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Patient - cohort 1

Patients (and their parents) recruited before introduction of the NP

Introduction of a Nurse Practitioner in the interdisciplinary care team

Patient - cohort 2

Patients (and their parents) recruited after introduction of the NP

Introduction of a Nurse Practitioner in the interdisciplinary care team

Healthcare providers

Healthcare providers involved in the process of development, implementation and evaluation as well as all healthcare providers who come into close contact with the Nurse Practitioner

Introduction of a Nurse Practitioner in the interdisciplinary care team

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in quality of care NPSS - ambulatory
Lasso di tempo: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Satisfaction with NP/doctor consultation. The data will be collected by use of a questionnaire for patients (and their parents). Validated tools, the Nurse Practitioner Satisfaction Survey (NPSS) and the Quality of care through the patients eyes will be used.

The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in quality of care though the patients eyes - ambulatory liver cirrhosis
Lasso di tempo: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Satisfaction with NP/doctor consultation. The data will be collected by use of a questionnaire for patients (and their parents). A validated tool, the Quality of care through the patients eyes will be used.

The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in Quality of care (GS-PEQ) - hospitalization
Lasso di tempo: The data will be collected at three points during the study: T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Patient perception and experiences of quality of care provided during hospitalisation. The data will be collected by use of a questionnaire for patients. A validated tool the Generic Short Patient Experiences Questionnaire will be used.

The data will be collected at three points during the study: T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in Quality of care (Picker) - hospitalization
Lasso di tempo: The data will be collected at three points during the study: T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Patient perception and experiences of quality of care provided during hospitalisation. The data will be collected by use of a questionnaire for patients. A validated tool the Picker Patient Experience Questionnaire will be used.

The data will be collected at three points during the study: T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in hospital admissions - ambulatory
Lasso di tempo: All admissions one year before and after introduction will be registered. The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Number of hospital admissions for patients in ambulatory care. The data will be collected from the patients medical file.

All admissions one year before and after introduction will be registered. The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Length of stay hospital admissions - ambulatory
Lasso di tempo: Length of stay of all admissions 12 months before and 12 months after introduction of the Nurse practitioner will be registered.

Length of stay in hospital for patients in ambulatory care. The data will be collected from the patients medical file.

Length of stay of all admissions 12 months before and 12 months after introduction of the Nurse practitioner will be registered.
Change in readmission - hospitalization
Lasso di tempo: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Readmission within seven days after discharge. The data will be collected from the patients medical file.

The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in mortality rates
Lasso di tempo: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Mortality rates of patients included in the study. The data will be collected from the patients medical file.

The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in pain Scores
Lasso di tempo: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Pain scores during hospitalization of surgical patients. The data will be collected from the patiënts medical file. Data will be registered from admission until dismissal.

The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in completeness of recording profile
Lasso di tempo: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Completeness of recording profile within 24h after admission will be registered. The data will be collected from the patients medical file.

The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in timely resignation letters
Lasso di tempo: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Availability of the resignation letter within 24h after admission will be registered. The data will be collected from the patients medical file.

The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in protocol adherence
Lasso di tempo: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Care provided after surgery will be compared to the ERAS-protocol. The data will be collected from the patients medical file.

The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in psychosocial conditions in workplaces
Lasso di tempo: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Psychosocial conditions in workplaces of healthcare providers. The data will be collected by use of a questionnaire for healthcare providers. A validated tool, the Copenhagen Psychosocial Questionnaire (COPSOQ III) will be used.

The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in team collaboration
Lasso di tempo: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Team effectiveness experienced by healthcare providers. The data will be collected by use of a questionnaire for healtcare providers. A validated tool, the Perceptions of Team Effectiveness (PTE) will be used.

The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in effectiveness of mentoring
Lasso di tempo: The data will be collected at three points during the study: T1 (6 months after introduction) and T2 (1 year after introduction)

Effectiveness of mentoring experienced by the Nurse practitioner and mentor of the Nurse practitioner. The data will be collected by use of individual interviews (mentor and trainee). Additionally data will be collected by use of a questionnaire for trainees. A validated tool, the mentorship effectiveness scale will be used.

The data will be collected at three points during the study: T1 (6 months after introduction) and T2 (1 year after introduction)
Number of medication prescriptions
Lasso di tempo: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Medication prescriptions before and after introduction of the nurse practitioner. The data will be collected from the patients medical file. Data will be registered from admission until dismissal.

The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in selfmanagement liver cirrhosis (HEIQ)
Lasso di tempo: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Knowledge, skills and confidence in selfmanagement. The data will be collected by use of a questionnaire for patients. Avalidated tools, Health Education Impact Questionnaire (HEIQ) for liver cirrhosis will be used.

The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in selfmanagement epilepsy medication (PEMSQ)
Lasso di tempo: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Knowledge, skills and confidence in selfmanagement. The data will be collected by use of a questionnaire for parents of patients. A validated tool, the Pediatric Epilepsy Medication Self-Management Questionnaire (PEMSQ), will be used.

The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)
Change in bed occupancy rates
Lasso di tempo: he data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Bed occupancy rates at the ward before and after introduction of the nurse practitioner. The data will be collected from the administrative files.

he data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Quality of life (QOL)
Lasso di tempo: The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Quality of life in children with epilepsy and patients with liver cirrhosis. The data will be collected by use of a questionnaire for parents of children with epilepsy. Validated tools: the Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-16) Liver disease symptom index and EQ-5D, will be used.

The data will be collected at three points during the study: baseline T0 (before introduction), T1 (6 months after introduction) and T2 (1 year after introduction)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Collaboratori

Investigatori

  • Investigatore principale: Frank Vermassen, MD, PhD, Ghent University/Ghent University Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

17 maggio 2021

Completamento primario (Effettivo)

1 marzo 2024

Completamento dello studio (Effettivo)

1 marzo 2024

Date di iscrizione allo studio

Primo inviato

15 aprile 2022

Primo inviato che soddisfa i criteri di controllo qualità

26 agosto 2022

Primo Inserito (Effettivo)

29 agosto 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • BC-09817
  • B6702021000685 (Altro identificatore: Ethics Committee UZ Gent)
  • B6702021000300 (Altro identificatore: Ethics Committee UZ Gent)
  • B6702021000479 (Altro identificatore: Ethics Committee UZ Gent)
  • B6702021000046 (Altro identificatore: Ethics Committee UZ Gent)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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