Renal DiseaseIPASIRCNCT06036264
Monocentric Retrospective Cohort Study of the Impact of Advanced Nursing Practice on the Follow-up of the End Stage Chronic Renal Disease Patient
An observational study of Renal Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
With regard to the fields of competence of advanced practice defined by the Order of October 22, 2021 amending the Order of July 18, 2018 on the system of studies for the State diploma of advanced practice nurse mentioning renal disease, dialysis and renal transplantation (MRDT) and the latest recommendations of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Disease
- What is being tested?
- Collected of Datas and semi-structured interview
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2016to 31 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient eligible for arteriovenous fistula (AVF) and/or renal transplantation who started dialysis sessions between January 1st 2016 and December 31st 2021 at the Roanne Hospital will be included.
Who may be able to join
- Patients starting dialysis sessions
- Patient eligible for arteriovenous fistula (AVF) and/or renal transplantation who started dialysis sessions between January 1st 2016 and December 31st 2021 at the Roanne Hospital.
Who cannot join
- Patient starting dialysis in emergency without prior nephrological followup.
- Patients who started dialysis in other dialysis centers (transfer: no knowledge of their previous nephrological follow-up)
- Patients starting dialysis at dates earlier or later than those determined in the study.
- Patients with missing data at the time of data collection.
- Patients under legal protection (guardianship, curatorship) or with cognitive impairment preventing informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocentric Retrospective Cohort Study of the Impact of Advanced Nursing Practice on the Follow-up of the End Stage Chronic Renal Disease Patient: Influence on the Implementation of an Arteriovenous Fistula Prior to Dialysis and on Access to Renal Transplantation
With regard to the fields of competence of advanced practice defined by the Order of October 22, 2021 amending the Order of July 18, 2018 on the system of studies for the State diploma of advanced practice nurse mentioning renal disease, dialysis and renal transplantation (MRDT) and the latest recommendations of the French National Authority for Health (HAS) of July 1 2021 on the monitoring of patients with Chronic Kidney Disease (CKD), the Advanced Practice Nurse (APN) has its place in improving practices and the care pathway of patients suffering from end-stage chronic renal failure (CKD).
In the literature, there are a number of studies arguing the benefits of advanced practice nurse follow-up with patients suffering from chronic renal failure (CKD) in terms of improving their psycho-social and self-care skills. However, few studies, particularly in France, demonstrate its role in the coordination of care. By virtue of their training, advanced practice nurse with an disease, dialysis and renal transplantation (MRDT) specialization acquire skills in managing pretransplant assessment files and in planning the creation of arteriovenous fistula (AVF), which enable them to be autonomous and relevant professionals in the coordination of these processes. This is why it seems appropriate to look at the added value that advanced nursing practice can bring to the follow-up of these patients.
Read the detailed description
To this end, a study of the practices and social representations of healthcare professionals involved in the management of Chronic Kidney Disease (CKD) patients can allow us to - To explore current practices under the focus of follow-up by a nephrologist and an advanced nurse on access to renal transplantation and on the implementation of arteriovenous fistula (AVF) versus follow-up by a nephrologist only.
- To perceive the "reading grids" that health professionals in transplant centers assign to the management of this type of patient by an Advanced Practice Nurse (APN).
- To question the identity issues associated with the actors by taking into account their status and roles in the institution and in interdisciplinaritý.
This study should produce initial results on the changes induced by advanced nursing practice on access to care and on the improvement of complex care pathways and more particularly for the Chronic Kidney Disease (CKD) patient.
- Conditions
- Renal Disease
- Being tested
- Collected of Datas, semi-structured interview
- Keywords
- advanced practice nurse, kidney transplantation, renal disease, arteriovenous fistula, Chronic Kidney Disease
- Medical subject headings
- Kidney Diseases, Arteriovenous Fistula, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collected of DatasOther
age, sex, mode of dialysis, emergency context, approach, date of creation of the arteriovenous fistula (if concerned), date of start of dialysis, transplant status, date of registration on the renal transplant waiting list (if concerned), nephrologist, date of first consultation with the pre-nurse in advanced practice (APN) (if concerned)
semi-structured interviewOther
Semi-structured interviews will be realized. The goal is to establish a qualitative analysis of the relevance and organization of pre-transplant assessments, of the reactivity in the adjustment of requests and assessments, and to identify the strong points or areas for improvement.
| Study group | Role | What they receive |
|---|---|---|
| Exposed subject group | Patients, starting dialysis, eligible for arteriovenous fistula (AVF) creation and/or renal transplantation who received pre-Advanced Practice Nurse (APN) intervention in their care pathway will be included Datas will be collected of medical record. Receives: Other: Collected of Datas | |
| Comparable unexposed subject group | All patients starting dialysis sessions eligible for arteriovenous fistula (AVF) creation and/or renal transplantation will be included.
Datas will be collected of medical record. Receives: Other: Collected of Datas | |
| professional working with the pre-Advanced Practice Nurse (APN) | professional working with the pre-Advanced Practice Nurse (APN) will be included.
Semi-structured interview will be performed. Receives: Other: semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact of the implementation of an Advanced Practice Nurse (APN) dedicated to the nephrology care pathway on the creation of arteriovenous fistula before dialysis sessions.
Rate of patients arriving with a functional arteriovenous fistula (AVF) at dialysis start. This rate will be compared between patients starting dialysis who received alternating nephrologist/pre-Advanced Practice Nurse (APN) follow-up and patients starting dialysis who received usual follow-up (control group).
Measured: Year: 1
Secondary outcomes (6)
Rate of patients on the transplant list.
This rate will be compared between patients starting dialysis who received alternating nephrologist/pre-IP follow-up and patients starting dialysis who received usual follow-up (control group).
Measured: Year: 1
To explore the beliefs and attitudes of healthcare professionals in transplant centers regarding the management of patients by an Advanced Practice Nurse (APN).
Analysis semi-structured interviews results.
Measured: Year: 1
Identify the strengths and areas for improvement of this system.
Analysis semi-structured interviews results.
Measured: Year: 1
Rate of patients on the transplant list
This rate will be compared between patients starting dialysis who received alternating nephrologist/pre-Advanced Practice Nurse (APN) follow-up and patients starting dialysis who received usual follow-up (control group).
Measured: Year: 1
To explore the "reading grids" that healthcare professionals in transplant centers assign to the intervention of the Advanced Practice Nurse (APN) in the management of chronic renal failure (CKD) patients.
Analysis semi-structured interviews results.
Measured: Year: 1
Isolate the obstacles and facilitators to the intervention of Advanced Practice Nurse (APN) in this care pathway
Analysis semi-structured interviews results.
Measured: Year: 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Jan 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Françoise RAY, Nurse, Principal investigator, Centre Hospitalier de Roanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036264
- Sponsor's protocol ID
- IRBN132022/CHUSTE
- Acronym
- IPASIRC
- Status last verified
- Feb 2023
- First submitted
- 21 Aug 2023
- Last updated
- 13 Sep 2023
- 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 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Retrospective Cohort Study of the Impact of Advanced Nursing Practice on the Follow-up of the End Stage Chronic Renal Disease Patient: Influence on the Implementation of an Arteriovenous Fistula Prior to Dialysis and on Access to Renal Transplantation
- ClinicalTrials.gov ID
- NCT06036264
- Acronym / sponsor ID
- IPASIRC / IRBN132022/CHUSTE
- Conditions
- Renal Disease
- Keywords
- advanced practice nurse, kidney transplantation, renal disease, arteriovenous fistula, Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Sep 2023 (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.
With regard to the fields of competence of advanced practice defined by the Order of October 22, 2021 amending the Order of July 18, 2018 on the system of studies for the State diploma of advanced practice nurse mentioning renal disease, dialysis and renal transplantation (MRDT) and the latest recommendations of the French National Authority for Health (HAS) of July 1 2021 on the monitoring of patients with Chronic Kidney Disease (CKD), the Advanced Practice Nurse (APN) has its place in improving practices and the care pathway of patients suffering from end-stage chronic renal failure (CKD).
In the literature, there are a number of studies arguing the benefits of advanced practice nurse follow-up with patients suffering from chronic renal failure (CKD) in terms of improving their psycho-social and self-care skills. However, few studies, particularly in France, demonstrate its role in the coordination of care. By virtue of their training, advanced practice nurse with an disease, dialysis and renal transplantation (MRDT) specialization acquire skills in managing pretransplant assessment files and in planning the creation of arteriovenous fistula (AVF), which enable them to be autonomous and relevant professionals in the coordination of these processes. This is why it seems appropriate to look at the added value that advanced nursing practice can bring to the follow-up of these patients.
Detailed description
To this end, a study of the practices and social representations of healthcare professionals involved in the management of Chronic Kidney Disease (CKD) patients can allow us to - To explore current practices under the focus of follow-up by a nephrologist and an advanced nurse on access to renal transplantation and on the implementation of arteriovenous fistula (AVF) versus follow-up by a nephrologist only.
- To perceive the "reading grids" that health professionals in transplant centers assign to the management of this type of patient by an Advanced Practice Nurse (APN).
- To question the identity issues associated with the actors by taking into account their status and roles in the institution and in interdisciplinaritý.
This study should produce initial results on the changes induced by advanced nursing practice on access to care and on the improvement of complex care pathways and more particularly for the Chronic Kidney Disease (CKD) patient.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exposed subject group | – | Other: Collected of DatasPatients, starting dialysis, eligible for arteriovenous fistula (AVF) creation and/or renal transplantation who received pre-Advanced Practice Nurse (APN) intervention in their care pathway will be included Datas will be collected of medical record. |
| Comparable unexposed subject group | – | Other: Collected of DatasAll patients starting dialysis sessions eligible for arteriovenous fistula (AVF) creation and/or renal transplantation will be included. Datas will be collected of medical record. |
| professional working with the pre-Advanced Practice Nurse (APN) | – | Other: semi-structured interviewprofessional working with the pre-Advanced Practice Nurse (APN) will be included. Semi-structured interview will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient eligible for arteriovenous fistula (AVF) and/or renal transplantation who started dialysis sessions between January 1st 2016 and December 31st 2021 at the Roanne Hospital will be included.
Key inclusion criteria (2 listed)
- Patients starting dialysis sessions
- Patient eligible for arteriovenous fistula (AVF) and/or renal transplantation who started dialysis sessions between January 1st 2016 and December 31st 2021 at the Roanne Hospital.
Key exclusion criteria (5 listed)
- Patient starting dialysis in emergency without prior nephrological followup.
- Patients who started dialysis in other dialysis centers (transfer: no knowledge of their previous nephrological follow-up)
- Patients starting dialysis at dates earlier or later than those determined in the study.
- Patients with missing data at the time of data collection.
- Patients under legal protection (guardianship, curatorship) or with cognitive impairment preventing informed consent.
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 |
|---|---|---|
| Collected of Datasage, sex, mode of dialysis, emergency context, approach, date of creation of the arteriovenous fistula (if concerned), date of start of dialysis, transplant status, date of registration on the renal transplant waiting list (if concerned), nephrologist, date of first consultation with the pre-nurse in advanced practice (APN) (if concerned) | Other | Comparable unexposed subject group, Exposed subject group |
| semi-structured interviewSemi-structured interviews will be realized. The goal is to establish a qualitative analysis of the relevance and organization of pre-transplant assessments, of the reactivity in the adjustment of requests and assessments, and to identify the strong points or areas for improvement. | Other | professional working with the pre-Advanced Practice Nurse (APN) |
Primary outcome
To evaluate the impact of the implementation of an Advanced Practice Nurse (APN) dedicated to the nephrology care pathway on the creation of arteriovenous fistula before dialysis sessions.
Time frame: Year: 1
Rate of patients arriving with a functional arteriovenous fistula (AVF) at dialysis start. This rate will be compared between patients starting dialysis who received alternating nephrologist/pre-Advanced Practice Nurse (APN) follow-up and patients starting dialysis who received usual follow-up (control group).
6 secondary outcomes
Rate of patients on the transplant list.
Time frame: Year: 1
To explore the beliefs and attitudes of healthcare professionals in transplant centers regarding the management of patients by an Advanced Practice Nurse (APN).
Time frame: Year: 1
Identify the strengths and areas for improvement of this system.
Time frame: Year: 1
Rate of patients on the transplant list
Time frame: Year: 1
To explore the "reading grids" that healthcare professionals in transplant centers assign to the intervention of the Advanced Practice Nurse (APN) in the management of chronic renal failure (CKD) patients.
Time frame: Year: 1
Isolate the obstacles and facilitators to the intervention of Advanced Practice Nurse (APN) in this care pathway
Time frame: Year: 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- 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. This study is not recruiting at the moment.
Françoise RAY, Nurse principal investigator
Centre Hospitalier de Roanne
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 Renal Disease, run by Centre Hospitalier Universitaire de Saint Etienne 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 2 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: finished, as of the sponsor's last update on 13 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the impact of the implementation of an Advanced Practice Nurse (APN) dedicated to the nephrology care pathway on the creation of arteriovenous fistula before dialysis sessions. (time frame: Year: 1). 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 13 Sep 2023.