IPASIRC: Monocentric Retrospective Cohort Study of the Impact of Advanced Nursing Practice on the Follow-up of the End Stage Chronic Renal Disease Patient

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Completed
CT.gov ID
NCT06036264
Collaborator
(none)
100
1
72
1.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Collected of Datas
  • Other: semi-structured interview

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

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm 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.

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)

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.

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)

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. 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. [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).

Secondary Outcome Measures

  1. Rate of patients on the transplant list. [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).

  2. To explore the beliefs and attitudes of healthcare professionals in transplant centers regarding the management of patients by an Advanced Practice Nurse (APN). [Year: 1]

    Analysis semi-structured interviews results.

  3. Identify the strengths and areas for improvement of this system. [Year: 1]

    Analysis semi-structured interviews results.

  4. Rate of patients on the transplant list [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).

  5. 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. [Year: 1]

    Analysis semi-structured interviews results.

  6. Isolate the obstacles and facilitators to the intervention of Advanced Practice Nurse (APN) in this care pathway [Year: 1]

    Analysis semi-structured interviews results.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CH de Roanne Roanne France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Françoise RAY, Nurse, Centre Hospitalier de Roanne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT06036264
Other Study ID Numbers:
  • IRBN132022/CHUSTE
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2023