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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06036264
Other study ID # IRBN132022/CHUSTE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2021

Study information

Verified date February 2023
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Collected of Datas
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 interview
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.

Locations

Country Name City State
France CH de Roanne Roanne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Year: 1
Secondary 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). Year: 1
Secondary 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. Year: 1
Secondary Identify the strengths and areas for improvement of this system. Analysis semi-structured interviews results. Year: 1
Secondary 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). Year: 1
Secondary 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. Year: 1
Secondary Isolate the obstacles and facilitators to the intervention of Advanced Practice Nurse (APN) in this care pathway Analysis semi-structured interviews results. Year: 1
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