Critical IllnessIPREA3NCT02442934
Reducing Discomforts in Critically Ill Patients: the IPREA3 Study
A study testing Administration of the IPREA3 questionnaire, Immediate feedback through electronic reminder messages and Targeted interventions in each ICU to reduce discomforts in people with Critical Illness, run by Dr Pierre KALFON at 26 sites in France.
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) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Administration of the IPREA3 questionnaire, Immediate feedback through electronic reminder messages and Targeted interventions in each ICU to reduce discomforts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,411 participants
- Where
- 26 sitesFrance
- Study dates
- Oct 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult critically ill patients
- ICU stay of three calendar days or more
Who cannot join
- 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
Show all 9Show fewer
- patient not understanding French sufficiently to be questioned (language barrier)
- transfer to another ICU while mechanically ventilated
- emergency discharge
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
CH Auxerre
Auxerre, 89000
Hôpital de la Cavale Blanche
Brest, 29609
CH Louis Pasteur
Chartres, 28018
CHU Beaujon APHP
Clichy, 92110
CHU Hôpital Bocage
Dijon, 21079
CH Douai
Douai, 59507
CHU Raymond Poincaré APHP
Garches, 92380
CH La Rochelle
La Rochelle, 17022
CH Le Puy en Velay
Le Puy-en-Velay, 43000
CH Lens
Lens, 62300
CHU Edouard Herriot
Lyon, 69003
Hôpital Européen
Marseille, 13003
CHU Hôpital Nord
Marseille, 13005
Clinique Ambroise Paré
Neuilly-sur-Seine, 92200
CHU Hôpital Pasteur2
Nice, 06000
CHU Saint Louis APHP
Paris, 75010
CHU La Pitié Salpétrière APHP
Paris, 75013
CHU Cochin APHP
Paris, 75014
Hôpital Saint Joseph
Paris, 75014
CHU Hôpital Européen Georges Pompidou APHP
Paris, 75015
CHU La Milétrie
Poitiers, 86000
CH Victor Provo
Roubaix, 59100
CHU NHC
Strasbourg, 67000
CHU Hautepierre
Strasbourg, 67100
Hôpital Saint Musse
Toulon, 83100
CH Troyes
Troyes, 10000
About this study
Official title: A Multicomponent Intervention to Reduce Perceived Discomforts in Critically Ill Patients: a Randomized Controlled Trial
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) .
Read the 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.
- Conditions
- Critical Illness
- Being tested
- Administration of the IPREA3 questionnaire, Immediate feedback through electronic reminder messages, Targeted interventions in each ICU to reduce discomforts
- Keywords
- Critical Care, Critical Care Nursing, Discomfort, Sleep deprivation, Noise, Thirst, Pain
- Medical subject headings
- Critical Illness, Sleep Deprivation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
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.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent program | Experimental | Multicomponent intervention to reduce perceived discomforts in critically ill patients : the IPREA3 program Receives: Other: Administration of the IPREA3 questionnaire; Other: Immediate feedback through electronic reminder messages; Other: Targeted interventions in each ICU to reduce discomforts |
| Standard Care | Active comparator | Standard care Receives: Other: Administration of the IPREA3 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Day of discharge from the ICU
Secondary outcomes (1)
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).
Measured: 1 Day of discharge from the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5,411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Pierre KALFON
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Pierre KALFON, Centre Hospitalier of Chartres
- Investigators
- Pierre KALFON, MD, PhD, Principal investigator, CH CHARTRES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442934
- Sponsor's protocol ID
- 2012-AO1696-37
- Acronym
- IPREA3
- Status last verified
- Mar 2016
- First submitted
- 11 May 2015
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 20502874Kalfon 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.
PubMed 33287910Baumstarck 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.
PubMed 30732654Kalfon 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.
PubMed 29181557Kalfon 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.
PubMed 26880373
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicomponent Intervention to Reduce Perceived Discomforts in Critically Ill Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02442934
- Acronym / sponsor ID
- IPREA3 / 2012-AO1696-37
- Conditions
- Critical Illness
- Keywords
- Critical Care, Critical Care Nursing, Discomfort, Sleep deprivation, Noise, Thirst, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,411 participants (actual)
- Lead sponsor
- Dr Pierre KALFONUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent program | Experimental | Other: Administration of the IPREA3 questionnaire, Other: Immediate feedback through electronic reminder messages, Other: Targeted interventions in each ICU to reduce discomfortsMulticomponent intervention to reduce perceived discomforts in critically ill patients : the IPREA3 program |
| Standard Care | Active comparator | Other: Administration of the IPREA3 questionnaireStandard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult critically ill patients
- ICU stay of three calendar days or more
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of the IPREA3 questionnaireOn 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 | Multicomponent program, Standard Care |
| Immediate feedback through electronic reminder messagesAfter 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 | Multicomponent program |
| Targeted interventions in each ICU to reduce discomfortsThese 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. | Other | Multicomponent program |
Primary outcome
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.
1 secondary outcome
Scores reported for each discomfort-item
Time frame: 1 Day of discharge from the ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
- Background: PubMed 20502874Kalfon 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.
- Derived from this study: PubMed 33287910Kalfon 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.
- Derived from this study: PubMed 30732654Baumstarck 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.
- Derived from this study: PubMed 29181557Kalfon 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.
- Derived from this study: PubMed 26880373Kalfon 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre KALFON, MD, PhD principal investigator
CH CHARTRES
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of the IPREA3 questionnaire, Immediate feedback through electronic reminder messages and Targeted interventions in each ICU to reduce discomforts in people with Critical Illness, run by Dr Pierre KALFON at 26 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall score of discomfort (time frame: 1 Day of discharge from the ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02442934, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2016.