NCT02881645

Brief Summary

The purpose of this study is to assess the effectiveness of a best practices nursing protocol in intensive care units on the occurrence of critical incidents compared to the common practices.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
59,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
2.7 years until next milestone

Study Start

First participant enrolled

May 6, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 10, 2019

Status Verified

June 1, 2019

Enrollment Period

7 months

First QC Date

August 24, 2016

Last Update Submit

June 7, 2019

Conditions

Keywords

Intensive care unitsNursing CareCritical incidentsBest practices

Outcome Measures

Primary Outcomes (1)

  • Proportion of critical incidents linked to nursing

    The need to call a doctor Or the presence of three failures (desaturation, desadaptation, hypotension, hypertension, bradycardia, tachycardia, cardiac rhythm disorder, Pain) Or one failure persisting more than 60 min Or accidental remove of invasive equipment during nursing Or death

    6 month

Study Arms (2)

Best practices

Assessment of critical incidents linked to nursing with a best practices protocol

Behavioral: Best practices

Common practices

Assessment of critical incidents linked to nursing in common practices

Interventions

Best practicesBEHAVIORAL

Nurses in intensive care units will be trained to the best practices protocol for a period of two-month preceding the trial

Best practices

Eligibility Criteria

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

Patients in intensive care units

You may qualify if:

  • Patient in intensive care units
  • Patient who has received complete information on the organization of the research and who has not objected to his participation and the exploitation of his data

You may not qualify if:

  • Moribund patients
  • Nursing made in the chair or in the shower stretcher
  • Patient able to wash and dress alone (or just with the assistance of a nurse)
  • Person under legal protection
  • Person deprived of liberty by a judicial or administrative decision
  • Person being the object of psychiatric care by virtue of articles L. 3212-1 and L. 3213-1 of the french Code of Public Health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chru Nancy

Nancy, 54000, France

RECRUITING

Related Publications (1)

  • Lesny M, Conrad M, Latarche C, Sylvestre A, Gaujard E, Dubois V, Quignard C, Citro V, Thomas JC, Bridey C, Weber AM, Simon C, Klein S, Gibot S, Bollaert PE. Adverse events during nursing care procedure in intensive care unit: The PREVENIR study. Intensive Crit Care Nurs. 2020 Oct;60:102881. doi: 10.1016/j.iccn.2020.102881. Epub 2020 Jun 1.

MeSH Terms

Interventions

Practice Guidelines as Topic

Intervention Hierarchy (Ancestors)

Guidelines as TopicQuality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Martine LESNY

    CHRU NANCY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2016

First Posted

August 29, 2016

Study Start

May 6, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

June 10, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

Locations