Role Development, Implementation and Evaluation of Nurse Practitioners

Quality of Care Clinical Trial

— NUPRA  

Official title:

Role Development, Implementation and Evaluation of Nurse Practitioners in a Belgian University Hospital.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05520203
• Other study ID #: KW2196/DVE/001/001
• Secondary ID: B6702021000685B6
• Status: Active, not recruiting
• Start date: November 1, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 1, 2024
• Est. primary completion date: November 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Implementation Research
• Quality of Care

Intervention

Other:
• Care provided by the Nurse Practitioner
Introduction of a Nurse Practitioner in the interdisciplinary care team

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent	East Flanders
Belgium	University Hospital Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

WHO. (2018). European health report 2018: More than numbers-evidence for all: World Health Organization. Regional Office for Europe.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Quality of life (QOL)	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)
Primary	Change in quality of care NPSS - ambulatory	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)
Primary	Change in quality of care though the patients eyes - ambulatory liver cirrhosis	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)
Primary	Change in Quality of care (GS-PEQ) - hospitalization	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)
Primary	Change in Quality of care (Picker) - hospitalization	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)
Secondary	Change in hospital admissions - ambulatory	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)
Secondary	Length of stay hospital admissions - ambulatory	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.
Secondary	Change in readmission - hospitalization	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)
Secondary	Change in mortality rates	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)
Secondary	Change in pain Scores	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)
Secondary	Change in completeness of recording profile	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)
Secondary	Change in timely resignation letters	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)
Secondary	Change in protocol adherence	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)
Secondary	Change in psychosocial conditions in workplaces	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)
Secondary	Change in team collaboration	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)
Secondary	Change in effectiveness of mentoring	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)
Secondary	Number of medication prescriptions	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)
Secondary	Change in selfmanagement liver cirrhosis (HEIQ)	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)
Secondary	Change in selfmanagement epilepsy medication (PEMSQ)	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)
Secondary	Change in bed occupancy rates	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)