- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05520203
Role Development, Implementation and Evaluation of Nurse Practitioners (NUPRA)
Role Development, Implementation and Evaluation of Nurse Practitioners in a Belgian University Hospital.
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Laurence Dehennin, MSc
- Phone Number: 003293328948
- Email: Laurence.dehennin@uzgent.be
Study Locations
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Ghent, Belgium, 9000
- University Hospital Ghent
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East Flanders
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Ghent, East Flanders, Belgium, 9000
- Ghent University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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.
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patient - cohort 1
Patients (and their parents) recruited before introduction of the NP
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Introduction of a Nurse Practitioner in the interdisciplinary care team
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Patient - cohort 2
Patients (and their parents) recruited after introduction of the NP
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Introduction of a Nurse Practitioner in the interdisciplinary care team
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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
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Introduction of a Nurse Practitioner in the interdisciplinary care team
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of care NPSS - ambulatory
Time Frame: 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)
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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.
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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)
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Change in quality of care though the patients eyes - ambulatory liver cirrhosis
Time Frame: 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)
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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.
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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)
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Change in Quality of care (GS-PEQ) - hospitalization
Time Frame: 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)
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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.
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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)
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Change in Quality of care (Picker) - hospitalization
Time Frame: 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)
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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.
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in hospital admissions - ambulatory
Time Frame: 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)
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Number of hospital admissions for patients in ambulatory care.
The data will be collected from the patients medical file.
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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)
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Length of stay hospital admissions - ambulatory
Time Frame: Length of stay of all admissions 12 months before and 12 months after introduction of the Nurse practitioner will be registered.
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Length of stay in hospital for patients in ambulatory care.
The data will be collected from the patients medical file.
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Length of stay of all admissions 12 months before and 12 months after introduction of the Nurse practitioner will be registered.
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Change in readmission - hospitalization
Time Frame: 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)
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Readmission within seven days after discharge.
The data will be collected from the patients medical file.
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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)
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Change in mortality rates
Time Frame: 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)
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Mortality rates of patients included in the study.
The data will be collected from the patients medical file.
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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)
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Change in pain Scores
Time Frame: 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)
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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.
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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)
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Change in completeness of recording profile
Time Frame: 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)
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Completeness of recording profile within 24h after admission will be registered.
The data will be collected from the patients medical file.
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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)
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Change in timely resignation letters
Time Frame: 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)
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Availability of the resignation letter within 24h after admission will be registered.
The data will be collected from the patients medical file.
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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)
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Change in protocol adherence
Time Frame: 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)
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Care provided after surgery will be compared to the ERAS-protocol.
The data will be collected from the patients medical file.
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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)
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Change in psychosocial conditions in workplaces
Time Frame: 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)
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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.
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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)
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Change in team collaboration
Time Frame: 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)
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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.
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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)
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Change in effectiveness of mentoring
Time Frame: The data will be collected at three points during the study: T1 (6 months after introduction) and T2 (1 year after introduction)
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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.
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The data will be collected at three points during the study: T1 (6 months after introduction) and T2 (1 year after introduction)
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Number of medication prescriptions
Time Frame: 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)
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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.
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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)
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Change in selfmanagement liver cirrhosis (HEIQ)
Time Frame: 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)
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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.
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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)
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Change in selfmanagement epilepsy medication (PEMSQ)
Time Frame: 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)
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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.
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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)
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Change in bed occupancy rates
Time Frame: 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)
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Bed occupancy rates at the ward before and after introduction of the nurse practitioner.
The data will be collected from the administrative files.
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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)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Quality of life (QOL)
Time Frame: 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)
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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.
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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)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Frank Vermassen, MD, PhD, Ghent University/Ghent University Hospital
Publications and helpful links
General Publications
- Hajat C, Stein E. The global burden of multiple chronic conditions: A narrative review. Prev Med Rep. 2018 Oct 19;12:284-293. doi: 10.1016/j.pmedr.2018.10.008. eCollection 2018 Dec.
- WHO. (2018). European health report 2018: More than numbers-evidence for all: World Health Organization. Regional Office for Europe.
- Schober M. Global emergence of nurse practitioner/advanced practice nursing roles. J Am Assoc Nurse Pract. 2018 Apr;30(4):182-184. doi: 10.1097/JXX.0000000000000029. No abstract available.
- ICN, I. C. o. N. (2020). Guidelines on advanced practice nursing. In: International Council of Nurses Geneva.
- Jarrett LA, Emmett M. Utilizing trauma nurse practitioners to decrease length of stay. J Trauma Nurs. 2009 Apr-Jun;16(2):68-72. doi: 10.1097/JTN.0b013e3181ac91c1.
- Jennings N, Clifford S, Fox AR, O'Connell J, Gardner G. The impact of nurse practitioner services on cost, quality of care, satisfaction and waiting times in the emergency department: a systematic review. Int J Nurs Stud. 2015 Jan;52(1):421-35. doi: 10.1016/j.ijnurstu.2014.07.006. Epub 2014 Jul 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KW2196/DVE/001/001
- B6702021000685 (Other Identifier: Ethics Committee UZ Gent)
- B6702021000300 (Other Identifier: Ethics Committee UZ Gent)
- B6702021000479 (Other Identifier: Ethics Committee UZ Gent)
- B6702021000046 (Other Identifier: Ethics Committee UZ Gent)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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