NCT02442934

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) .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,411

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 21, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

May 11, 2015

Last Update Submit

March 18, 2016

Conditions

Critical Illness

Keywords

Critical CareCritical Care NursingDiscomfortSleep deprivationNoiseThirstPain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Scores reported for each discomfort-item

    1 Day of discharge from the ICU

Study Arms (2)

Multicomponent program

EXPERIMENTAL

Multicomponent intervention to reduce perceived discomforts in critically ill patients : the IPREA3 program

Other: Administration of the IPREA3 questionnaireOther: Immediate feedback through electronic reminder messagesOther: Targeted interventions in each ICU to reduce discomforts

Standard Care

ACTIVE COMPARATOR

Standard care

Other: Administration of the IPREA3 questionnaire

Interventions

Administration of the IPREA3 questionnaireOTHER

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

Multicomponent programStandard Care
Immediate feedback through electronic reminder messagesOTHER

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

Multicomponent program
Targeted interventions in each ICU to reduce discomfortsOTHER

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.

Multicomponent program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

CH Auxerre

Auxerre, 89000, France

Location

Hôpital de la Cavale Blanche

Brest, 29609, France

Location

CH Louis Pasteur

Chartres, 28018, France

Location

CHU Beaujon APHP

Clichy, 92110, France

Location

CHU Hôpital Bocage

Dijon, 21079, France

Location

CH Douai

Douai, 59507, France

Location

CHU Raymond Poincaré APHP

Garches, 92380, France

Location

CH La Rochelle

La Rochelle, 17022, France

Location

CH Le Puy en Velay

Le Puy-en-Velay, 43000, France

Location

CH Lens

Lens, 62300, France

Location

CHU Edouard Herriot

Lyon, 69003, France

Location

Hôpital Européen

Marseille, 13003, France

Location

CHU Hôpital Nord

Marseille, 13005, France

Location

Clinique Ambroise Paré

Neuilly-sur-Seine, 92200, France

Location

CHU Hôpital Pasteur2

Nice, 06000, France

Location

CHU Saint Louis APHP

Paris, 75010, France

Location

CHU La Pitié Salpétrière APHP

Paris, 75013, France

Location

CHU Cochin APHP

Paris, 75014, France

Location

Hôpital Saint Joseph

Paris, 75014, France

Location

CHU Hôpital Européen Georges Pompidou APHP

Paris, 75015, France

Location

CHU La Milétrie

Poitiers, 86000, France

Location

CH Victor Provo

Roubaix, 59100, France

Location

CHU NHC

Strasbourg, 67000, France

Location

CHU Hautepierre

Strasbourg, 67100, France

Location

Hôpital Saint Musse

Toulon, 83100, France

Location

CH Troyes

Troyes, 10000, France

Location

Related Publications (5)

  • 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.

    PMID: 20502874BACKGROUND

  • 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.

    PMID: 33287910DERIVED

  • 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.

    PMID: 30732654DERIVED

  • 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.

    PMID: 29181557DERIVED

  • 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.

    PMID: 26880373DERIVED

MeSH Terms

Conditions

Critical IllnessSleep DeprivationPain

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsMental Disorders

Study Officials

  • Pierre KALFON, MD, PhD

    CH CHARTRES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 13, 2015

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

March 21, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

Locations

FR(26)