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

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

UNKNOWN

Total Enrollment

59400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-06

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Conditions in Intensive Care

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Best practices

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

Best practices

Intervention Type BEHAVIORAL

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

No interventions assigned to this group

Interventions

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Best practices

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No