Simulation-based Training for Nurses and Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients

NCT ID: NCT05302505

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

9600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-05

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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Nursing Caries Arteriovenous Fistula Simulation-based Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Simulation

Theoretical training in e-learning for nurses on :

* arteriovenous fistula puncture
* use of ultrasound with echoreferencing and ultrasound guidance
* therapeutic communication

And simulation-based training (procedural) on :

* arteriovenous fistula puncture
* use of ultrasound with echoreferencing and ultrasound guidance
* therapeutic communication

Group Type EXPERIMENTAL

simulation-based training

Intervention Type OTHER

Based-simulation training for nurses in a simulation center : puncture of arteriovenous fistula and utilization of echograph and conversational hypnosis

Control

Theoretical training for nurses in e-learning on :

* arteriovenous fistula puncture
* use of ultrasound with echoreferencing and ultrasound guidance
* therapeutic communication

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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simulation-based training

Based-simulation training for nurses in a simulation center : puncture of arteriovenous fistula and utilization of echograph and conversational hypnosis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erwan Guillouët

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

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Center hospital of Alençon

Alençon, , France

Site Status NOT_YET_RECRUITING

University hospital center of Caen

Caen, , France

Site Status RECRUITING

Private Hospital St Martin

Caen, , France

Site Status NOT_YET_RECRUITING

Center Hospital of Dieppe

Dieppe, , France

Site Status NOT_YET_RECRUITING

Center Hospital of Flers

Flers, , France

Site Status NOT_YET_RECRUITING

ANIDER

Hérouville-Saint-Clair, , France

Site Status RECRUITING

Center Hospital of Lisieux

Lisieux, , France

Site Status NOT_YET_RECRUITING

Anider Alencon

Saint-Germain-du-Corbéis, , France

Site Status RECRUITING

Center Hospital of Memorial United States of St Lo

Saint-Lô, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Erwan Guillouët

Role: CONTACT

+33231063403

Clémence Tomadesso

Role: CONTACT

+33231063106

Facility Contacts

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Erick Cardineau, MD

Role: primary

02 33 32 30 30

Erwan Guillouët

Role: primary

Anaïs BENABED, MD

Role: primary

0 826 46 14 00

EMMANUELLE HECQUET, MD

Role: primary

0232147248

Victor GUEUTIN, MD

Role: primary

02 31 06 31 06

PATRICK HENRI, MD

Role: primary

02 31 46 97 97

Loay Al Moussalla, MD

Role: primary

02 31 61 31 55

Jean Pierre DIONE, MD

Role: primary

0233323097

Elie ZAGDOUN, MD

Role: primary

02 33 06 33 33

References

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Guillouet E, Tomadesso C, Flores BA, Henri P, Lanot A, Morello R, Guillouet S. Impact of simulation-based training in addition to theoretical training versus theoretical training of nurses alone in the occurrence of adverse events related to arteriovenous fistula puncture in chronic hemodialysis patients: study for a cluster randomized controlled trial (SIMFAV2). Trials. 2023 Aug 7;24(1):500. doi: 10.1186/s13063-023-07513-8.

Reference Type DERIVED
PMID: 37550740 (View on PubMed)

Other Identifiers

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2021-A01813-38

Identifier Type: -

Identifier Source: org_study_id

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