Clinical trial NCT02442934: Reducing Discomforts in Critically Ill Patients: the IPREA3 Study
Official title: A Multicomponent Intervention to Reduce Perceived Discomforts in Critically Ill Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: Critical Care
Critical Care Nursing
Discomfort
Sleep deprivation
Noise
Thirst
Pain
Lead sponsor: Centre Hospitalier of Chartres
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 5411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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) .

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.

Eligibility 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

Primary outcomes:
measure: Overall score of discomfort
timeFrame: 1 Day of discharge from the ICU
Secondary outcomes:
measure: Scores reported for each discomfort-item
timeFrame: 1 Day of discharge from the ICU
Other outcomes:
Locations:
city: Auxerre
country: France
facility: CH Auxerre
city: Brest
country: France
facility: Hôpital de la Cavale Blanche
city: Chartres
country: France
facility: CH Louis Pasteur
city: Clichy
country: France
facility: CHU Beaujon APHP
city: Dijon
country: France
facility: CHU Hôpital Bocage
city: Douai
country: France
facility: CH Douai
city: Garches
country: France
facility: CHU Raymond Poincaré APHP
city: La Rochelle
country: France
facility: CH La Rochelle
city: Le Puy en Velay
country: France
facility: CH Le Puy en Velay
city: Lens
country: France
facility: CH Lens
city: Lyon
country: France
facility: CHU Edouard Herriot
city: Marseille
country: France
facility: Hôpital Européen
city: Marseille
country: France
facility: CHU Hôpital Nord
city: Neuilly-sur-Seine
country: France
facility: Clinique Ambroise Paré
city: Nice
country: France
facility: CHU Hôpital Pasteur2
city: Paris
country: France
facility: CHU Saint Louis APHP
city: Paris
country: France
facility: CHU La Pitié Salpétrière APHP
city: Paris
country: France
facility: CHU Cochin APHP
city: Paris
country: France
facility: Hôpital Saint Joseph
city: Paris
country: France
facility: CHU Hôpital Européen Georges Pompidou APHP
city: Poitiers
country: France
facility: CHU La Milétrie
city: Roubaix
country: France
facility: CH Victor Provo
city: Strasbourg
country: France
facility: CHU NHC
city: Strasbourg
country: France
facility: CHU Hautepierre
city: Toulon
country: France
facility: Hôpital Saint Musse
city: Troyes
country: France
facility: CH Troyes
Study officials:
affiliation: CH CHARTRES
name: Pierre KALFON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kalfon P, Mimoz O, Auquier P, Loundou A, Gauzit R, Lepape A, Laurens J, Garrigues B, Pottecher T, Malledant Y. Development and validation of a questionnaire for quantitative assessment of perceived discomforts in critically ill patients. Intensive Care Med. 2010 Oct;36(10):1751-1758. doi: 10.1007/s00134-010-1902-9. Epub 2010 May 26.
citation: Kalfon P, Boucekine M, Estagnasie P, Geantot MA, Berric A, Simon G, Floccard B, Signouret T, Fromentin M, Nyunga M, Audibert J, Ben Salah A, Mauchien B, Sossou A, Venot M, Robert R, Follin A, Renault A, Garrouste-Orgeas M, Collange O, Levrat Q, Villard I, Thevenin D, Pottecher J, Patrigeon RG, Revel N, Vigne C, Azoulay E, Mimoz O, Auquier P, Baumstarck K; IPREA Study Group. Risk factors and events in the adult intensive care unit associated with pain as self-reported at the end of the intensive care unit stay. Crit Care. 2020 Dec 7;24(1):685. doi: 10.1186/s13054-020-03396-2.
citation: Baumstarck K, Boucekine M, Estagnasie P, Geantot MA, Berric A, Simon G, Floccard B, Signouret T, Fromentin M, Nyunga M, Sossou A, Venot M, Robert R, Follin A, Audibert J, Renault A, Garrouste-Orgeas M, Collange O, Levrat Q, Villard I, Thevenin D, Pottecher J, Patrigeon RG, Revel N, Vigne C, Azoulay E, Mimoz O, Auquier P, Kalfon P; IPREA Study group. Assessment of patients' self-perceived intensive care unit discomforts: Validation of the 18-item version of the IPREA. Health Qual Life Outcomes. 2019 Feb 7;17(1):29. doi: 10.1186/s12955-019-1101-5.
citation: Kalfon P, Baumstarck K, Estagnasie P, Geantot MA, Berric A, Simon G, Floccard B, Signouret T, Boucekine M, Fromentin M, Nyunga M, Sossou A, Venot M, Robert R, Follin A, Audibert J, Renault A, Garrouste-Orgeas M, Collange O, Levrat Q, Villard I, Thevenin D, Pottecher J, Patrigeon RG, Revel N, Vigne C, Azoulay E, Mimoz O, Auquier P; IPREA Study group. A tailored multicomponent program to reduce discomfort in critically ill patients: a cluster-randomized controlled trial. Intensive Care Med. 2017 Dec;43(12):1829-1840. doi: 10.1007/s00134-017-4991-x. Epub 2017 Nov 27.
citation: Kalfon P, Mimoz O, Loundou A, Geantot MA, Revel N, Villard I, Amour J, Azoulay E, Garrouste-Orgeas M, Martin C, Sharshar T, Baumstarck K, Auquier P. Reduction of self-perceived discomforts in critically ill patients in French intensive care units: study protocol for a cluster-randomized controlled trial. Trials. 2016 Feb 16;17:87. doi: 10.1186/s13063-016-1211-x.