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

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ClinicalTrials.gov Identifier: NCT02442934
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : March 21, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Pierre KALFON, Centre Hospitalier of Chartres

Brief Summary:
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) .

Condition or disease Intervention/treatment Phase
Critical Illness Other: Administration of the IPREA3 questionnaire Other: Immediate feedback through electronic reminder messages Other: Targeted interventions in each ICU to reduce discomforts Not Applicable

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  (Clinical Trial)
Actual Enrollment : 5411 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Multicomponent Intervention to Reduce Perceived Discomforts in Critically Ill Patients: a Randomized Controlled Trial
Study Start Date : October 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: Multicomponent program
Multicomponent intervention to reduce perceived discomforts in critically ill patients : the IPREA3 program
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

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.


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442934


Locations
France
CH Auxerre
Auxerre, France, 89000
Hôpital de la Cavale Blanche
Brest, France, 29609
CH Louis Pasteur
Chartres, France, 28018
CHU Beaujon APHP
Clichy, France, 92110
CHU Hôpital Bocage
Dijon, France, 21079
CH Douai
Douai, France, 59507
CHU Raymond Poincaré APHP
Garches, France, 92380
CH La Rochelle
La Rochelle, France, 17022
CH Le Puy en Velay
Le Puy en Velay, France, 43000
CH Lens
Lens, France, 62300
CHU Edouard Herriot
Lyon, France, 69003
Hôpital Européen
Marseille, France, 13003
CHU Hôpital Nord
Marseille, France, 13005
Clinique Ambroise Paré
Neuilly-sur-Seine, France, 92200
CHU Hôpital Pasteur2
Nice, France, 06000
CHU Saint Louis APHP
Paris, France, 75010
CHU La Pitié Salpétrière APHP
Paris, France, 75013
CHU Cochin APHP
Paris, France, 75014
Hôpital Saint Joseph
Paris, France, 75014
CHU Hôpital Européen Georges Pompidou APHP
Paris, France, 75015
CHU La Milétrie
Poitiers, France, 86000
CH Victor Provo
Roubaix, France, 59100
CHU NHC
Strasbourg, France, 67000
CHU Hautepierre
Strasbourg, France, 67100
Hôpital Saint Musse
Toulon, France, 83100
CH Troyes
Troyes, France, 10000
Sponsors and Collaborators
Dr Pierre KALFON
Investigators
Principal Investigator: Pierre KALFON, MD, PhD CH CHARTRES

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Pierre KALFON, MD, PhD, Centre Hospitalier of Chartres
ClinicalTrials.gov Identifier: NCT02442934     History of Changes
Other Study ID Numbers: 2012-AO1696-37
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: March 21, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Dr Pierre KALFON, Centre Hospitalier of Chartres:
Critical Care
Critical Care Nursing
Discomfort
Sleep deprivation
Noise
Thirst
Pain

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes