- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05520203
Rozvoj rolí, implementace a hodnocení sester (NUPRA-DI)
Rozvoj rolí, implementace a hodnocení sester v belgické fakultní nemocnici.
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
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Ghent, Belgie, 9000
- University Hospital Ghent
-
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East Flanders
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Ghent, East Flanders, Belgie, 9000
- Ghent University Hospital
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in quality of care NPSS - ambulatory
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in hospital admissions - ambulatory
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Quality of life (QOL)
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Frank Vermassen, MD, PhD, Ghent University/Ghent University Hospital
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- BC-09817
- B6702021000685 (Jiný identifikátor: Ethics Committee UZ Gent)
- B6702021000300 (Jiný identifikátor: Ethics Committee UZ Gent)
- B6702021000479 (Jiný identifikátor: Ethics Committee UZ Gent)
- B6702021000046 (Jiný identifikátor: Ethics Committee UZ Gent)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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