Study in Intensive Care Follow-up Programme in Improving Long-term Outcomes of ICU Survivors (SUIVI-REA)

Multicenter Randomised, Controlled Trial of a Intensive Care Follow -up Programme in Improving Long-term Outcomes of ICU Survivors

Study Hypothesis:

Critical illness is associated with long-term medical and psychological sequelae that can impact the professional and private life. The purpose of the present multicenter randomized controlled trial is to assess whether or not a medical, psychological and social follow-up improves quality of life of critically ill patients at one year after their discharge from intensive care unit (ICU).

Primary Purpose:

Death or severe alteration of quality of life assessed with help of EQ5D questionnaire at one year after ICU discharge.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Post ICU Discharge
• Intervention / Treatment: Other: Medical, psychological, social

Detailed Description

Critically ill patients who had required at least 3 days of mechanical ventilation and who consented to participate will be randomized at time of ICU discharge in either follow-up or not follow-up arm. The medical, psychological and social follow-up consists of multidisciplinary consultation at time of ICU discharge (i.e. inclusion), at three, six and 12 months afterward. Patients of the "non follow-up group" will be seen only at one year. Medical consultation will be focused on evaluation of pre-existing co-morbidities, detection of new ones and of physical disorders related to critical illness (i.e. ICU-acquired paresis, pain, functional disability, cognitive dysfunction…). Psychological assessment will be focused on detection of anxiety, depression and post-traumatic stress syndrome. Social follow-up will assess the social need of the patient in the professional and private domains. Each assessment will be standardized by using validated or appropriate scores. At the end of each multidisciplinary consultation, a report will be sent to the patient and his general practitioner. When necessary, a consultation with a specialist will be organized. At one year, an observer blinded from randomization will call all the patients to assess their quality of life with help of EQ5D questionnaire. Economical cost of multidisciplinary follow-up will be assessed.

To our knowledge, there is no follow-up studies that have combined a medical, psychological and social cares. For instance, the PracTical study has not evidenced an improvement of quality of life in patients who had beneficiated from nurse consultations at 3 and 9 months.

• Study Type: Interventional
• Enrollment (Actual): 545
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Garches, Ile De France, France, 92380
      • Hopital Raymond Poincare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women older than 18
• Living in an area near the hospital
• Hospitalized in the ICU medical surgical hospitals in this study.
• Who required mechanical ventilation more than 3 days
• Having a life expectancy greater than one year (Mc Cabe score >2, absence of metastatic cancer)
• Having a general practitioner identified
• Is affiliated to a social health care
• And who have given their written informed consent

Exclusion Criteria:

• Patients hospitalized in ICU in the previous year
• Patients followed for a preexisting myopathy
• The burn patients, patients with brain injury (Glasgow initial <8) or trauma
• Patients hospitalized for suicide or self-induced poisoning
• Patients with psychiatric disorders
• Patients with ore dementia
• Pregnant women
• Patients who do not speak fluently French
• Patients with guardianship
• Homeless patients
• No having a general practitioner identified

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multidisciplinary follow-up	Other: Medical, psychological, social; After having given his consent, the patient filled auto questionnaire, and then randomized either in follow up arm (i.e. intervention group) or in no follow up arm (i.e. control group). In the follow up arm, medical, psychological and social consultation will be planned within the first seven days after inclusion, and then 3, 6, 12 months. During medical consultation a general examination will be performed, muscle strength, cognitive function, functional disabilities will be assessed with help of MRC, MMS. During psychological consultation, anxiety and depression will be assessed with the help of HAD, IES. The psychologist will also have a free interview. During social consultation personal and professional reinsertion will be assessed.
No Intervention: no follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death or severe alteration of quality of life assessed after ICU discharge	Death or severe alteration of quality of life assessed with help of EQ5D questionnaire at one year after ICU discharge.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of life quality in Medical domain	ICU-acquired paresis assessed with help of MRC sum score, Functional disabilities assessed with help of Barthel and IADL scales, Cognitive dysfunctions assessed with help of MMS score, Pain, Comorbidities (Hypertension, etc…).	1 year
Assessment in psychological domain	Anxiety assessed with help of HAD scale, Depression assessed with help of HAD scale Post-traumatic stress syndrome assessed with help of IES scale.	1 year
Assessment in social domain	Social reinsertion with help of RNLI scale.	1 year
Assessment in economical cost	Number of hospitalization,number of outpatient consultation and prescription of new treatment will be assessed within 1 year.	1 year

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Tarek Sharshar, MD, PHD, ICU, Hôpital Raymond Poincaré; Principal Investigator: Diane Friedman, MD, ICU, Hôpital Raymond Poincaré

Publications and helpful links

General Publications

• Friedman D, Grimaldi L, Cariou A, Aegerter P, Gaudry S, Ben Salah A, Oueslati H, Megarbane B, Meunier-Beillard N, Quenot JP, Schwebel C, Jacob L, Robin Lagandre S, Kalfon P, Sonneville R, Siami S, Mazeraud A, Sharshar T. Impact of a Postintensive Care Unit Multidisciplinary Follow-up on the Quality of Life (SUIVI-REA): Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2022 May 9;11(5):e30496. doi: 10.2196/30496.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): March 11, 2020

Study Registration Dates

• First Submitted: February 13, 2013
• First Submitted That Met QC Criteria: February 19, 2013
• First Posted (Estimate): February 21, 2013

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Quality of life,; Sequela disorders,; Socio-professional impact,; Anxiety, depression,; Post traumatic stress disorder,; ICU acquired paresis.
• Other Study ID Numbers: P100147