Clinical trial NCT05302505: Simulation-based Training for Nurses and Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients
Official title: Impact of Simulation-based Training in Addition to Theoretical Training Versus Theoretical Training Alone for Nurses on the Occurring of Adverse Events Related to Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nursing Caries
Arteriovenous Fistula
Simulation-based Training
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 9600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Currently, the technique of arteriovenous fistula puncture is transmitted by companionship within hemodialysis units. Although the main principles of the technique are well known and common to all hemodialysis units, strong rationales are still lacking to standardize fine practices such as the relative position of the needles, the angle of attack of the needle at puncture, the position of the bevel at the time of puncture and once the needle is in the vascular lumen.

The training of professionals using a simulation-based training program on the approach to arteriovenous fistula puncture, in a process of optimizing practices and continuous improvement of care, while respecting the principles of andragogy, seems to be a suitable tool. This program is built in a multi-professional team from nephrology, nursing and health simulation.

Detailed description: Currently, the technique of arteriovenous fistula puncture is transmitted by companionship within hemodialysis units. Although the main principles of the technique are well known and common to all hemodialysis units, strong rationales are still lacking to standardize fine practices such as the relative position of the needles, the angle of attack of the needle at puncture, the position of the bevel at the time of puncture and once the needle is in the vascular lumen.

The training of professionals using a simulation-based training program on the approach to arteriovenous fistula puncture, in a process of optimizing practices and continuous improvement of care, while respecting the principles of andragogy, seems to be a suitable tool. This program is built in a multi-professional team from nephrology, nursing and health simulation.

The aim of this study is to evaluate whether a simulation-based training program for nurses, concerning arteriovenous fistula puncture puncture, would allow to decrease the adverse events related to punctures.

The investigators propose a prospective, comparative, randomized, multicenter study involving 8 hemodialysis centers. The primary objective is to compare the number of arteriovenous fistula puncture-related adverse events between:

* A group receiving theoretical training + simulation-based training (4 centers)
* A group receiving theoretical training only (4 centers)

Will be included all adult patients who are to receive an arteriovenous fistula puncture puncture by a hemodialysis-trained IDE, during a scheduled chronic dialysis session.

This study is innovative for several reasons:

* simulation-based training in continuing education, among professionals is not widely used
* simulation-based training in continuing education allows the conceptualization of the team approach to VF by its modeling in simulation
* the evaluation of the direct benefit of the training on the patient, a Kirkpatrick level 4, is very little described in the literature.

Thus, this study is of major interest to patients managed in nephrology with the simulation-based training tool.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Arteriovenous fistula puncture in the hemodialysis unit of the nephrology, dialysis, transplantation department
* Nurses trained in hemodialysis

Exclusion Criteria:

* arteriovenous fistula puncture in the emergency area/foldout of the unit
* Refuse of data collection
* Not speak French
* Minor
* Under guardianship or unable to give informed consent
* Not enrolled in a social security plan
* Pregnant or breastfeeding women

Primary outcomes:
measure: Number of adverse events occurring during arteriovenous fistula puncture (comparison of the percentages of event occurrence)
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Alençon
country: France
facility: Center hospital of Alençon
city: Caen
country: France
facility: University hospital center of Caen
city: Caen
country: France
facility: Private Hospital St Martin
city: Dieppe
country: France
facility: Center Hospital of Dieppe
city: Flers
country: France
facility: Center Hospital of Flers
city: Hérouville-Saint-Clair
country: France
facility: ANIDER
city: Lisieux
country: France
facility: Center Hospital of Lisieux
city: Saint-Germain-du-Corbéis
country: France
facility: Anider Alencon
city: Saint-Lô
country: France
facility: Center Hospital of Memorial United States of St Lo
Study officials:
affiliation: University Hospital, Caen
name: Erwan Guillouët
role: PRINCIPAL_INVESTIGATOR
References: