Clinical trial NCT05520203: Role Development, Implementation and Evaluation of Nurse Practitioners
Official title: Role Development, Implementation and Evaluation of Nurse Practitioners in a Belgian University Hospital.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Nurse Practitioners
Implementation Research
Quality of Care
Keywords: advanced practice nursing
interdisciplinary health team
participatory action research
longitudinal mixed methods study
nursing
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2022-08-29
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in quality of care NPSS - ambulatory
timeFrame: 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)
measure: Change in quality of care though the patients eyes - ambulatory liver cirrhosis
timeFrame: 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)
measure: Change in Quality of care (GS-PEQ) - hospitalization
timeFrame: 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)
measure: Change in Quality of care (Picker) - hospitalization
timeFrame: 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 outcomes:
measure: Change in hospital admissions - ambulatory
timeFrame: 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)
measure: Length of stay hospital admissions - ambulatory
timeFrame: Length of stay of all admissions 12 months before and 12 months after introduction of the Nurse practitioner will be registered.
measure: Change in readmission - hospitalization
timeFrame: 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)
measure: Change in mortality rates
timeFrame: 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)
measure: Change in pain Scores
timeFrame: 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)
measure: Change in completeness of recording profile
timeFrame: 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)
measure: Change in timely resignation letters
timeFrame: 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)
measure: Change in protocol adherence
timeFrame: 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)
measure: Change in psychosocial conditions in workplaces
timeFrame: 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)
measure: Change in team collaboration
timeFrame: 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)
measure: Change in effectiveness of mentoring
timeFrame: The data will be collected at three points during the study: T1 (6 months after introduction) and T2 (1 year after introduction)
measure: Number of medication prescriptions
timeFrame: 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)
measure: Change in selfmanagement liver cirrhosis (HEIQ)
timeFrame: 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)
measure: Change in selfmanagement epilepsy medication (PEMSQ)
timeFrame: 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)
measure: Change in bed occupancy rates
timeFrame: 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)
Other outcomes:
measure: Change in Quality of life (QOL)
timeFrame: 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)
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: East Flanders
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: Ghent University/Ghent University Hospital
name: Frank Vermassen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: