- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06355505
Process of Emergence and Implementation of Advanced Practice Nursing in France (PEIPA)
Study Overview
Status
Conditions
Detailed Description
For 40 years, France has faced an increase in demand for care. At the same time, it faces problems of scarcity and unequal geographical distribution of human resources in health. Recent projections by the Ministry of Health predict a decline in French medical density over the next few years, which would more particularly concern the provision of care in private general practice. According to the Organisation for Economic Co-operation and Development (OECD), this development raises fears that the already significant spatial inequalities in staffing will be exacerbated. Another key player are nurses (state registered nurses), who remain insufficiently numerous and unevenly distributed, although their density is increasing in France as in most OECD countries. The WHO (World Health Organization) recommends strengthening the attractiveness of their profession and rethinking professional boundaries in order to foster cooperation with the medical professions.
In France, the framework of practice of some state registered nurses has evolved within the framework of programs aimed at developing the delegation of tasks (cooperation protocols, e.g. Asalé device) and coordinated practice (health homes, health centers). In addition, in 2018, the regulatory framework for advanced practice nursing was created with a dual objective: to improve access to care and the quality of patient pathways. A specific 2-year master's degree course is currently provided by 24 universities. To date, there are 2400 APNs and 700 graduate each year.
Amendment 9 relating to the APN exercise (2023) sets the financial valuation of the advanced practice nursing activity (PAI packages). A pilot study conducted by Julie Devictor et al from 2019 to 2021 showed that among the APNs of the two 1st cohorts, 20% work in primary care (mixed activity APN/state registered nurses majority), 50% in health facilities and 30% do not practice as APNs. Obstacles and levers to the implementation of advanced practice are identified in the international literature. The study hypothesize that there are also some in France, which it is necessary to identify in the context of the health system.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Julie Devictor, PhD
- Phone Number: 06 64 71 26 75
- Email: julie.devictor@aphp.fr
Study Contact Backup
- Name: Anne Leclercq, PhD
- Phone Number: 033 7 62 70 58 05
- Email: anne.leclercq2@aphp.fr
Study Locations
-
-
France
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Clichy, France, France, 92110
- Recruiting
- Beaujon Hospital
-
Contact:
- Julie Devictor, PhD
- Phone Number: 06 64 71 26 75
- Email: julie.devictor@aphp.fr
-
Contact:
- Anne Leclercq, PhD
- Phone Number: 0033 7 62 70 58 05
- Email: anne.leclercq2@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria :
For the questionnaires :
- be enrolled in the 2nd year (semester 3 or 4) in one of the 24 universities offering the State Diploma of Advanced Practice Nursing, regardless of the mention between 2024 and 2026
- be the holder of the state APN diploma at the beginning of the study (year 2024)
For case studies:
- hold the state diploma of Advanced Practice Nurse and have been practicing for more than 6 months as an APN in a hospital structure, in a health facility in primary care or via a liberal activity in primary care
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Graduate APNs
700 participants who hold the state diploma of advanced practice nurse and have been practising for more than 6 months as an APN in a hospital structure, in a health establishment in primary care or via a liberal activity in primary care
|
|
3 consecutive classes of advanced practice students
900 participants recruited during the 2nd year of training from 3 consecutive classes of students
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Factors influencing the effective implementation of advanced practice nursing in France in primary care and health facilities
Time Frame: 48 months
|
The explanatory variables to be studied will be selected from data from the literature related to the implementation of advanced practice and the obstacles and levers identified internationally.
|
48 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mapping of APNs in France with socio-demographic data
Time Frame: 48 months
|
Socio-demographic data includes : seniority, professional background, training path, motivations and expectations, access to training, financing studies, diplomas, mode and place of practice, position held, mention, quantification of activity in advanced practice (patients, number of physicians who have signed the organizational protocols, remuneration) and scope of practice / missions carried out (clinical, education, research, leadership, professional development, consultation).
|
48 months
|
|
Definition by the APN of its role and missions
Time Frame: 48 months
|
48 months
|
|
|
Implementation and dissemination of the APN practice in the territory according to the context of practice (community care, hospital)
Time Frame: 48 months
|
Assessement of the APN scope of practice with an approach internationally validated and used
|
48 months
|
|
Identification of potential impact dimensions of Advanced Practice Nursing
Time Frame: 48 months
|
Formulation of hypotheses on the extent of these impacts in the following main directions: quality of care and services provided for patients (screening, prevention, follow-up), efficiency of care pathways (medical, specialized and hospital recourse), productivity according to modes and structures of practice.
|
48 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Julie Devictor, PhD, Assistance Publique Hopitaux de Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
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
- APHP220836
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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