Reducing Discomforts in Critically Ill Patients: the IPREA3 Study

Critical Illness Clinical Trial

— IPREA3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02442934
• Other study ID #: 2012-AO1696-37
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2015
• Last updated: May 12, 2015
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: May 2015
• Source: Centre Hospitalier of Chartres
• Contact: Pierre KALFON, MD, PhD
• Phone: 0033237303073
• Email: pkalfon[@]ch-chartres.fr
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5440
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Critical Illness

Intervention

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
• 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
• 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.

Locations

Country	Name	City	State
France	CH Auxerre	Auxerre
France	Hôpital de la Cavale Blanche	Brest
France	CH Louis Pasteur	Chartres
France	CHU Beaujon APHP	Clichy
France	CHU Hôpital Bocage	Dijon
France	CHU Hôpital Bocage	Dijon
France	CH Douai	Douai
France	CHU Raymond Poincaré APHP	Garches
France	CH La Rochelle	La Rochelle
France	CH Le Puy en Velay	Le Puy en Velay
France	CH Lens	Lens
France	CHU Edouard Herriot	Lyon
France	CHU La Timone	Marseille
France	CHU La Timone	Marseille
France	Hôpital Européen	Marseille
France	Clinique Ambroise Paré	Neuilly-sur-Seine
France	CHU Saint Roch	Nice
France	CHU Cochin APHP	Paris
France	Chu Hegp Aphp	Paris
France	CHU La Pitié Salpétrière APHP	Paris
France	CHU Saint Louis APHP	Paris
France	Hôpital Saint Joseph	Paris
France	CHU La Milétrie	Poitiers
France	CHU La Milétrie	Poitiers
France	CH Victor Provo	Roubaix
France	CHU Hautepierre	Strasbourg
France	CHU NHC	Strasbourg
France	Hôpital Saint Musse	Toulon
France	CH Troyes	Troyes

Sponsors (1)

Lead Sponsor	Collaborator
Dr Pierre KALFON

Country where clinical trial is conducted

France, 

References & Publications (1)

Kalfon P, Mimoz O, Auquier P, Loundou A, Gauzit R, Lepape A, Laurens J, Garrigues B, Pottecher T, Mallédant Y. Development and validation of a questionnaire for quantitative assessment of perceived discomforts in critically ill patients. Intensive Care Med. 2010 Oct;36(10):1751-8. doi: 10.1007/s00134-010-1902-9. Epub 2010 May 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No