Prevention of Critical Incidents Related to the Nursing With Patients in Intensive Care Units (PREVENIR)

Prevention of Critical Incidents Related to the Nursing With Patients in Intensive Care Units PREVENIR Study.

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.

Study Overview

• Status: Unknown
• Conditions: Acute Conditions in Intensive Care
• Intervention / Treatment: Behavioral: Best practices

Detailed Description

To develop the best practices nursing protocol in intensive care units, three steps were necessary:

1. An incidence study of occurrence of critical incidents linked to nursing was conducted during a month in nine intensive care units to identify high risk clinical situations
2. A qualitative study (individual interviews and focus groups) with nurses was led to elicit nurse's risk anticipatory strategies during nursing
3. Based on the results of the two previous step, a working group proposed a best nursing practices protocol to limit critical incidents

Methodology to assess the effectiveness of the protocol of best nursing practices:

The statistical unit is the nursing act for one patient meeting the inclusion criteria (a patient is nursed two times or more per day) Nine intensive care units are included in the study Intensive care units includes 127 beds, their average occupancy rate is approximately 80 % which means about 330 nursing a day and about 9900 nursing a month.

An occurrence of critical incidents (primary outcome measure) of 25% is expected (approximately 2475 critical incidents per month). To show a reduction of 50% of critical incidents in the interventional group, 6 month inclusion will be necessary, whatever the value of the inflation coefficient.

The patient will be under observation during 60 min if a critical incident occurs. And only during nursing if no critical incident occurs.

Data will be collected at bedside.

Patients will be included for the entire duration of the hospitalization in intensive care unit, if inclusion criteria are still met.

Data collection:

• Characteristics of the intensive care unit
• Characteristics of the patient
• Characteristics of the nurse
• Characteristics of the medical equipment of the patient
• Physiological parameters before, during and after nursing (see primary outcome measures)

The best nursing practices protocol will be consider as efficient if a reduction of 50% of critical incident can be established.

Statistical analysis will be in the intent-to-treat.

Hospitals as part of qualitative policy request a declaration of each critical incident. This circus of declaration will not be changed.

• Study Type: Observational
• Enrollment (Anticipated): 59400

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • Recruiting
    • CHRU Nancy
    • Contact: Martine LESNY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in intensive care units

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Best practices; Assessment of critical incidents linked to nursing with a best practices protocol	Behavioral: Best practices; Nurses in intensive care units will be trained to the best practices protocol for a period of two-month preceding the trial
Common practices; Assessment of critical incidents linked to nursing in common practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Martine LESNY, CHRU Nancy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 6, 2019
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: August 24, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (ESTIMATE): August 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 10, 2019
• Last Update Submitted That Met QC Criteria: June 7, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Nursing Care; Intensive care units; Critical incidents; Best practices
• Other Study ID Numbers: PHRIP 2013/PREVENIR-LESNY/NK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No