NCT05520203

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.1 years

First QC Date

April 15, 2022

Last Update Submit

September 5, 2024

Conditions

Keywords

advanced practice nursinginterdisciplinary health teamparticipatory action researchlongitudinal mixed methods studynursing

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (15)

  • Change in hospital admissions - ambulatory

    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

    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

    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

    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

    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)

  • +10 more secondary outcomes

Other Outcomes (1)

  • Change in Quality of life (QOL)

    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)

Study Arms (3)

Patient - cohort 1

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

Other: Care provided by the Nurse Practitioner

Patient - cohort 2

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

Other: Care provided by the Nurse Practitioner

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

Other: Care provided by the Nurse Practitioner

Interventions

Introduction of a Nurse Practitioner in the interdisciplinary care team

Healthcare providersPatient - cohort 1Patient - cohort 2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • \- Dementia or other severe cognitive/mental disorders
  • Health care providers
  • Have at least three months of clinical experience on the ward
  • Key stakeholders in the process of development, implementation and/or evaluation
  • No contact with the nurse practitioner
  • Internship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ghent University Hospital

Ghent, East Flanders, 9000, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Publications (1)

  • Dehennin L, Kinnaer LM, Vermassen F, Van Hecke A. Role development, implementation and evaluation of nurse practitioners in a Belgian university hospital: a mixed methods study protocol. BMJ Open. 2023 May 3;13(5):e068101. doi: 10.1136/bmjopen-2022-068101.

Study Officials

  • Frank Vermassen, MD, PhD

    Ghent University/Ghent University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2022

First Posted

August 29, 2022

Study Start

November 1, 2021

Primary Completion

November 23, 2023

Study Completion

December 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations