Reducing Discomforts in Critically Ill Patients: the IPREA3 Study (IPREA3)

March 18, 2016 updated by: Dr Pierre KALFON

A Multicomponent Intervention to Reduce Perceived Discomforts in Critically Ill Patients: a Randomized Controlled Trial

Since critically ill patients are exposed to stressful conditions, the investigators evaluated the effectiveness of a multicomponent program to reduce perceived discomforts in the Intensive Care Unit (ICU) .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators conducted a cluster-randomized trial randomizing 34 ICUs. The program targeted staff members with 3 components : web-based systematic measurement of discomforts on the day of ICU discharge by institutional caregivers (nurses and assistant nurses of the participating ICU), immediate feedback through electronic reminder messages intended to caregivers, and targeted interventions in each ICU based on comparative discomfort scores monthly reported to local champions who were also responsible for staff education.

The measurement of discomforts perceived by critically ill patients at the end of the ICU stay, related to the whole stay in the ICU, was performed by the bedside nurse using a specific questionnaire, the IPREA questionnaire whose construct validity, external validity, reliability, reproducibility and acceptability have been already demonstrated (Development and validation of a questionnaire for quantitative assessment of perceived discomforts in critically ill patients. Kalfon P et al, Intensive care Med 2010, 36:1751-58). The version of the IPREA questionnaire used in the study was a 18-item questionnaire : noise ; excessive light ; discomfort related to sleeping in a different bed from home ; sleep deprivation ; thirst ; hunger ; feeling of cold ; feeling of heat ; pain ; being tied down by perfusion lines, tubes or as a result of connections due to monitoring devices ; no respect for intimacy ; anxiety ; isolation ; limited visiting hours ; absence of phone ; lack of information ; shortness of breath ; and depression.

The duration of the program is 6 months in each arm. Potential participants in the study were consecutive patients admitted in all the participating ICU that are divided in two groups of 17 ICUs.

During October 2014, the IPREA questionnaire is administered to all potentially eligible patients hospitalized in the 34 participating ICUs without applying the program (period P1). The 17 ICUs of the group 1 do not apply the multicomponent program during 5 months (until March 2015), while the 17 ICUs of the group 2 apply the program (period P2). During April 2015, the questionnaire IPREA is administered again in both groups (period P3). From May 2015 until September 2015, the multicomponent program is only applied in the group 1 and no longer in the group 2 (period P4) in order to achieve the crossover of the intervention. During October 2015, the questionnaire IPREA is administered again in both groups (period P5).

The overall score of discomfort and the scores for each item will be compared in the control arm and in the interventional arm.

The control arm consists in the patients included in the group 2 during October 2014 and the patients included in the group 1 during April 2015, i.e. patients included during the month preceding the implementation of the multicomponent program.

The interventional arm consists in the patients included in the group 2 during April 2015 and the patients included in the group 1 during October 2015, i.e. patients included during the last month of the period of application of the multicomponent program.

Study Type

Interventional

Enrollment (Actual)

5411

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Auxerre, France, 89000
        • Ch Auxerre
      • Brest, France, 29609
        • Hopital De La Cavale Blanche
      • Chartres, France, 28018
        • CH Louis Pasteur
      • Clichy, France, 92110
        • CHU Beaujon APHP
      • Dijon, France, 21079
        • CHU Hôpital Bocage
      • Douai, France, 59507
        • CH DOUAI
      • Garches, France, 92380
        • CHU Raymond Poincaré APHP
      • La Rochelle, France, 17022
        • CH La Rochelle
      • Le Puy en Velay, France, 43000
        • CH Le Puy en Velay
      • Lens, France, 62300
        • CH LENS
      • Lyon, France, 69003
        • Chu Edouard Herriot
      • Marseille, France, 13003
        • Hôpital Européen
      • Marseille, France, 13005
        • CHU Hôpital Nord
      • Neuilly-sur-Seine, France, 92200
        • Clinique Ambroise Pare
      • Nice, France, 06000
        • CHU Hôpital Pasteur2
      • Paris, France, 75014
        • Hopital Saint Joseph
      • Paris, France, 75010
        • CHU Saint Louis APHP
      • Paris, France, 75014
        • CHU Cochin APHP
      • Paris, France, 75013
        • CHU La Pitié Salpétrière APHP
      • Paris, France, 75015
        • CHU Hôpital Européen Georges Pompidou APHP
      • Poitiers, France, 86000
        • CHU La Milétrie
      • Roubaix, France, 59100
        • CH Victor PROVO
      • Strasbourg, France, 67000
        • CHU NHC
      • Strasbourg, France, 67100
        • CHU HautePierre
      • Toulon, France, 83100
        • Hôpital Saint Musse
      • Troyes, France, 10000
        • CH Troyes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult critically ill patients
  • ICU stay of three calendar days or more

Exclusion Criteria:

  • deceased patient in the ICU
  • ICU stay of two calendar days or less
  • patient younger than 18
  • patient under trusteeship
  • patient refusing to participate to the study
  • patient with diminished mental capacity
  • patient not understanding French sufficiently to be questioned (language barrier)
  • transfer to another ICU while mechanically ventilated
  • emergency discharge

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multicomponent program
Multicomponent intervention to reduce perceived discomforts in critically ill patients : the IPREA3 program
Other: Immediate feedback through electronic reminder messages
After the nurse had administered the questionnaire, warning messages are displayed on the screen corresponding to the key points to prevent the three discomforts reported with the highest scores
Other: Targeted interventions in each ICU to reduce discomforts

These targeted interventions are implemented through the coordination of two local champions.

The central coordination IPREA3 team sends each month to the local champions monthly and cumulative discomfort scores of their unit (overall score of discomfort and scores for each item) and their ranking relative to other units assigned to the interventional arm i.e applying the IPREA3 program.

The local champions organize monthly meetings with the unit staff to present the results in terms of perceived discomforts measured by the IPREA questionnaire, identify main discomfort sources and actions to be conducted to reduce the discomforts reported with the highest scores in the unit and those that are most easily preventable, and assess the efficacy of already applied measures.

Other: Administration of the IPREA3 questionnaire
On the day of the ICU discharge, the bedside nurse administers to the patient the 18-item IPREA questionnaire i.e the nurse asks the patient to rate the severity of each discomfort source contained in the IPREA3 questionnaire experienced during the entire stay in the ICU
Active Comparator: Standard Care
Standard care
Other: Administration of the IPREA3 questionnaire
On the day of the ICU discharge, the bedside nurse administers to the patient the 18-item IPREA questionnaire i.e the nurse asks the patient to rate the severity of each discomfort source contained in the IPREA3 questionnaire experienced during the entire stay in the ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall score of discomfort
Time Frame: 1 Day of discharge from the ICU
Each discomfort-item is scored 0-10 (example 0 = no pain ; 10 = pain as bad as can be). For each individual, the overall score of discomfort is computed as the mean of the 18 scores reported for each discomfort-item multiplied by 10, yielding an overall score between 0 and 100.
1 Day of discharge from the ICU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scores reported for each discomfort-item
Time Frame: 1 Day of discharge from the ICU
Each of the 18 discomfort-items is scored 0-10 (example 0 = no thirst ; 10 = thirst as bad as can be).
1 Day of discharge from the ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Pierre KALFON

Investigators

  • Principal Investigator: Pierre KALFON, MD, PhD, CH Chartres

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Estimate)

March 21, 2016

Last Update Submitted That Met QC Criteria

March 18, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-AO1696-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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