Primary CareeGERISSEPNCT06484933
Risk Management in Primary Care
An observational study of Primary Care, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The proposed research is a prospective, non-comparative study based on a qualitative method, comprising a literature review followed by 2 successive series of Focus Groups with users and healthcare professionals of primary care in the French AURA region. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Primary Care
- What is being tested?
- Focus groups of health professionals and users of primary care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jul 2024to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care organizations in France
Who may be able to join
- Healthcare professional
- Healthcare professional over 18 years of age, registered with the professional association on which he/she depends and holding an RPPS identification number with care activity as part of a coordinated practice, within a legally formalised care team working on a territorial health project, or care activity within a care team that is not legally formalized but defined as an entity bringing together ≥ 4 different professionals to care for the same patient.
- Most care provided on an outpatient basis
- Care activity in the AURA region
- Agreement to participate in the focus group Users
- Any user of the healthcare system over the age of 18
- Consulting a healthcare professional from a team included in the research
- Agreement to participate in the focus group
Who cannot join
- Healthcare professional
- Primary care healthcare professional with a specific exclusive practice that does not form part of the overall management of a patient (e.g. homeopathy, mesotherapy, acupuncture, etc.) Users
- Persons deprived of their liberty by a judicial or administrative decision
- Adults under legal protection (guardianship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
Trial locations and contacts
1 site in 1 country.
France1 site
Cabinet Medical
Oullins, 69600
Julie HAESEBAERT, MD, 04 72 68 49 05 ext. +33, julie.haesebaert@chu-lyon.fr
Marc CHANELIERE, MD,PhD, 04 27 85 63 18 ext. +33, marc.chaneliere@univ-lyon1.fr
About this study
Official title: Assessing Risk Management in Primary Care Teams
The proposed research is a prospective, non-comparative study based on a qualitative method, comprising a literature review followed by 2 successive series of Focus Groups with users and healthcare professionals of primary care in the French AURA region. The 2 Focus Group phases will make it possible to :
- propose an operational definition of the notion of a professional team in primary care (validation by consensus between the participants of the first 4 Focus Groups based on the definitions in the literature)
- describe the ways in which risks are managed in primary care teams (qualitative analysis of the contributions made by the participants in the next 12 Focus Groups organized in 12 primary care teams)
- Conditions
- Primary Care
- Being tested
- Focus groups of health professionals and users of primary care
- Keywords
- Primary care, Risk management, Teamwork
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groups of health professionals and users of primary careBehavioural
2 phases of Focus Group will be organized :
- the participants of the first 4 Focus Groups will propose an operational definition of the notion of a professional team in primary care (validation by consensus based on the definitions in the literature)
- 12 subsequent Focus Groups will be organized in 12 primary care teams to describe the ways in which risks are managed in primary care
| Study group | Role | What they receive |
|---|---|---|
| Healthcare professionals and users of primary care | Health professionals and users of primary care will be asked during focus groups on the definition of the professional team in primary care and on the risk management procedures put in place in primary care organisations. Receives: Behavioral: Focus groups of health professionals and users of primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operational definition of the notion of a professional team in primary care in the France, by means of focus groups and validation by consensus.
This definition will be based on data from a literature review adapted to the context of French primary care and the practices/experience of professionals and users by means of focus groups including professionals and users from the primary care teams.
Measured: up to 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start5 Jul 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary CareStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484933
- Sponsor's protocol ID
- 69HCL24_0010
- Acronym
- eGERISSEP
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Risk Management in Primary Care Teams
- ClinicalTrials.gov ID
- NCT06484933
- Acronym / sponsor ID
- eGERISSEP / 69HCL24_0010
- Conditions
- Primary Care
- Keywords
- Primary care, Risk management, Teamwork
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 Jul 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Jul 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.
The proposed research is a prospective, non-comparative study based on a qualitative method, comprising a literature review followed by 2 successive series of Focus Groups with users and healthcare professionals of primary care in the French AURA region. The 2 Focus Group phases will make it possible to :
- propose an operational definition of the notion of a professional team in primary care (validation by consensus between the participants of the first 4 Focus Groups based on the definitions in the literature)
- describe the ways in which risks are managed in primary care teams (qualitative analysis of the contributions made by the participants in the next 12 Focus Groups organized in 12 primary care teams)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare professionals and users of primary care | – | Behavioral: Focus groups of health professionals and users of primary careHealth professionals and users of primary care will be asked during focus groups on the definition of the professional team in primary care and on the risk management procedures put in place in primary care organisations. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care organizations in France
Key inclusion criteria (8 listed)
- Healthcare professional
- Healthcare professional over 18 years of age, registered with the professional association on which he/she depends and holding an RPPS identification number with care activity as part of a coordinated practice, within a legally formalised care team working on a territorial health project, or care activity within a care team that is not legally formalized but defined as an entity bringing together ≥ 4 different professionals to care for the same patient.
- Most care provided on an outpatient basis
- Care activity in the AURA region
- Agreement to participate in the focus group Users
Key exclusion criteria (5 listed)
- Healthcare professional
- Primary care healthcare professional with a specific exclusive practice that does not form part of the overall management of a patient (e.g. homeopathy, mesotherapy, acupuncture, etc.) Users
- Persons deprived of their liberty by a judicial or administrative decision
- Adults under legal protection (guardianship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus groups of health professionals and users of primary care2 phases of Focus Group will be organized : * the participants of the first 4 Focus Groups will propose an operational definition of the notion of a professional team in primary care (validation by consensus based on the definitions in the literature) * 12 subsequent Focus Groups will be organized in 12 primary care teams to describe the ways in which risks are managed in primary care | Behavioural | Healthcare professionals and users of primary care |
Primary outcome
Operational definition of the notion of a professional team in primary care in the France, by means of focus groups and validation by consensus.
Time frame: up to 23 months
This definition will be based on data from a literature review adapted to the context of French primary care and the practices/experience of professionals and users by means of focus groups including professionals and users from the primary care teams.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
Related trials for Primary Care
RecruitingObservational study
Targeted Health Dialogues in Primary Care
Health Behaviors, Risk Factors
RecruitingPhase 2
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma
Recruiting
HIV/HBV/HCV Triple Screening in Primary Care
HIV, HBV (Hepatitis B Virus)
RecruitingObservational study
Physical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program
Frailty, Fall Risk, Fall Prevention
Recruiting
Smartwatch-based Intervention for Cardiovascular Health (SWITCH)
Overweight , Obesity, Prediabetes
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. This study is not recruiting at the moment.
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 Primary Care, run by Hospices Civils de Lyon 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HAESEBAERT Julie, PU-PH (+33 (0)4 72 11 51 65, julie.haesebaert01@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operational definition of the notion of a professional team in primary care in the France, by means of focus groups and validation by consensus. (time frame: up to 23 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 3 Jul 2024.