Reducing Discomforts in Critically Ill Patients: the IPREA3 Study

Study Overview
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Brief Summary
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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) .

Detailed Description
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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.

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

Conditions
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Critical Illness

Intervention / Treatment
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* Other: Administration of the IPREA3 questionnaire
* Other: Immediate feedback through electronic reminder messages
* Other: Targeted interventions in each ICU to reduce discomforts


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multicomponent program<br>Multicomponent intervention to reduce perceived discomforts in critically ill patients : the IPREA3 program | Other: Administration of the IPREA3 questionnaire<br>* 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<br>Other: Immediate feedback through electronic reminder messages<br>* 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<br>Other: Targeted interventions in each ICU to reduce discomforts<br>* 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.<br>|
| Active Comparator: Standard Care<br>Standard care | Other: Administration of the IPREA3 questionnaire<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall score of discomfort | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical Care, Critical Care Nursing, Discomfort, Sleep deprivation, Noise, Thirst, Pain