Process of Emergence and Implementation of Advanced Practice Nursing in France (PEIPA)

Longitudinal, observational research with a mixed quantitative (by questionnaires) and qualitative (by interviews and observations) approach, multidisciplinary, among Advanced Practice Nurses (APNs) already graduated and 3 consecutive classes of advanced practice students who will be followed annually during their implementation as APN until the last year of the study. The questionnaires will focus on APN scope of practice evolution, economical analysis and geographical distribution of APN. The ethnographical approach will assess APN settlements and relation with healthcare colleagues and patients.

Study Overview

Status

Recruiting

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

Observational

Enrollment (Estimated)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • France
      • Clichy, France, France, 92110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

700 participants recruited among graduate APNs 900 participants recruited during the 2nd year of training from 3 consecutive student classes i.e. 1600 participants in total

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Julie Devictor, PhD, Assistance Publique Hopitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • APHP220836

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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