- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06036264
Monocentric Retrospective Cohort Study of the Impact of Advanced Nursing Practice on the Follow-up of the End Stage Chronic Renal Disease Patient (IPASIRC)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Roanne, France
- CH de ROANNE
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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)
|
|
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. |
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)
|
|
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Year: 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of patients on the transplant list.
Time Frame: Year: 1
|
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).
|
Year: 1
|
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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
|
Analysis semi-structured interviews results.
|
Year: 1
|
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Identify the strengths and areas for improvement of this system.
Time Frame: Year: 1
|
Analysis semi-structured interviews results.
|
Year: 1
|
|
Rate of patients on the transplant list
Time Frame: Year: 1
|
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).
|
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
|
Analysis semi-structured interviews results.
|
Year: 1
|
|
Isolate the obstacles and facilitators to the intervention of Advanced Practice Nurse (APN) in this care pathway
Time Frame: Year: 1
|
Analysis semi-structured interviews results.
|
Year: 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Françoise RAY, Nurse, Centre hospitalier de Roanne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Urologic Diseases
- Disease Attributes
- Congenital Abnormalities
- Renal Insufficiency
- Pathological Conditions, Anatomical
- Cardiovascular Abnormalities
- Vascular Malformations
- Arteriovenous Malformations
- Vascular Fistula
- Fistula
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Renal Insufficiency, Chronic
- Kidney Failure, Chronic
- Arteriovenous Fistula
Other Study ID Numbers
- IRBN132022/CHUSTE
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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