Nurse's RolePEIPANCT06355505
Process of Emergence and Implementation of Advanced Practice Nursing in France
An observational study of Nurse's Role, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role
- How many people
- 1,600 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2024to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Beaujon hospital
Clichy, France, 92110
Julie Devictor, PhD, 06 64 71 26 75, julie.devictor@aphp.fr
Anne Leclercq, PhD, 0033 7 62 70 58 05, anne.leclercq2@aphp.fr
About this study
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.
Read the 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.
- Conditions
- Nurse's Role
- Keywords
- advanced practice nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Factors influencing the effective implementation of advanced practice nursing in France in primary care and health facilities
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.
Measured: 48 months
Secondary outcomes (4)
Mapping of APNs in France with socio-demographic data
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).
Measured: 48 months
Definition by the APN of its role and missions
Measured: 48 months
Implementation and dissemination of the APN practice in the territory according to the context of practice (community care, hospital)
Assessement of the APN scope of practice with an approach internationally validated and used
Measured: 48 months
Identification of potential impact dimensions of Advanced Practice Nursing
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.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Mar 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Devictor, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355505
- Sponsor's protocol ID
- APHP220836
- Acronym
- PEIPA
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Process of Emergence and Implementation of Advanced Practice Nursing in France
- ClinicalTrials.gov ID
- NCT06355505
- Acronym / sponsor ID
- PEIPA / APHP220836
- Conditions
- Nurse's Role
- Keywords
- advanced practice nursing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Mapping of APNs in France with socio-demographic data
Time frame: 48 months
Definition by the APN of its role and missions
Time frame: 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
Identification of potential impact dimensions of Advanced Practice Nursing
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie Devictor, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nurse's Role, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Devictor, PhD (06 64 71 26 75, julie.devictor@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors influencing the effective implementation of advanced practice nursing in France in primary care and health facilities (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.