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

Not Applicable

Completed

• Conditions: Quality of Life; Post ICU Discharge
• Interventions: Other: Medical, psychological, social

• Registration Number: NCT01796509
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-19
• Study First Posted: 2013-02-21
• Primary Completion: 2018-09
• Study Completion: 2020-03-11
• Status Verified: 2021-02
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 545

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
multidisciplinary follow-up	Medical, psychological, social	-

Primary Outcome Measures

Name	Time	Method
Death or severe alteration of quality of life assessed after ICU discharge	1 year	Death or severe alteration of quality of life assessed with help of EQ5D questionnaire at one year after ICU discharge.

Secondary Outcome Measures

Name	Time	Method
Assessment in social domain	1 year	Social reinsertion with help of RNLI scale.
Assessment in psychological domain	1 year	Anxiety assessed with help of HAD scale, Depression assessed with help of HAD scale Post-traumatic stress syndrome assessed with help of IES scale.
Assessment in economical cost	1 year	Number of hospitalization,number of outpatient consultation and prescription of new treatment will be assessed within 1 year.
Assessment of life quality in Medical domain	1 year	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...).

Trial Locations

Locations (1)

Hôpital Raymond Poincaré; 🇫🇷 Garches, Ile De France, France