NCT06036264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
Last Updated

September 13, 2023

Status Verified

February 1, 2023

Enrollment Period

6 years

First QC Date

August 21, 2023

Last Update Submit

September 12, 2023

Conditions

Keywords

advanced practice nursekidney transplantationrenal diseasearteriovenous fistulaChronic Kidney Disease

Outcome Measures

Primary Outcomes (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.

    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 Outcomes (6)

  • Rate of patients on the transplant list.

    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).

    Year: 1

  • Identify the strengths and areas for improvement of this system.

    Year: 1

  • Rate of patients on the transplant list

    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.

    Year: 1

  • +1 more secondary outcomes

Study Arms (3)

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

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

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

Interventions

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 groupExposed subject group

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.

professional working with the pre-Advanced Practice Nurse (APN)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH de Roanne

Roanne, France

Location

MeSH Terms

Conditions

Kidney DiseasesArteriovenous FistulaRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsRenal InsufficiencyChronic DiseaseDisease AttributesPathologic Processes

Study Officials

  • Françoise RAY, Nurse

    Centre Hospitalier de Roanne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

September 13, 2023

Study Start

January 1, 2016

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

September 13, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations