Study in Intensive Care Follow-up Programme in Improving Long-term Outcomes of ICU Survivors

NCT ID: NCT01796509

Last Updated: 2022-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 545 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2020-03-11

Brief Summary

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.

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.

Conditions

Quality of Life; Post ICU Discharge

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

multidisciplinary follow-up

Group Type: EXPERIMENTAL

Medical, psychological, social

Intervention Type: OTHER

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 follow-up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tarek Sharshar, MD, PHD

Role: STUDY_DIRECTOR

ICU, Hôpital Raymond Poincaré

Diane Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

ICU, Hôpital Raymond Poincaré

Locations

Hôpital Raymond Poincaré

Garches, Île-de-France Region, France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 35532996 (View on PubMed)

Other Identifiers

P100147

Identifier Type: -

Identifier Source: org_study_id