Clinical trial NCT04247607: Specialized Treatment, Rehabilitation and Outcome in Patients With Prolonged Critical Illness
Official title: A Prospective Observational Study of Patients Suffering From Prolonged Critical Illness Treated by Patient Centered Multidisciplinary Teams at a Specialized Unit: Patient Characteristics, Treatment and Follow-up Results
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Keywords: persistent critical illness
chronic critical illness
prolonged intensive care
weaning from mechanical ventilation
decannulation
multidisciplinary team
intensive care rehabilitation
Lead sponsor: Remeo AB
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2020-01-30
Enrollment: 250
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with prolonged critical illness treated at the specialized unit (Remeo, Stockholm, Sweden)

Brief summary: This prospective observational study aims to describe the outcome for patients with persistent or chronic critical illness treated at Remeo, a clinic specialized for patients in need of prolonged intensive care and intensive care rehabilitation in Sweden. Patients' disease characteristics and the treatment in multidisciplinary patient centered teams for intensive care, weaning from mechanical ventilation and simultaneous rehabilitation will be described. Patients will be followed one year after discharge to document health related quality of life, physical function, frailty, mental illness and used health care resources.


Eligibility criteria: Inclusion Criteria:

Admission to unit (Remeo, Stockholm, Sweden) Treated for prolonged critical illness

Exclusion Criteria:

Treated less than 48 hours at unit (Remeo, Stockholm, Sweden)

Primary outcomes:
measure: Change in mechanical ventilation status
timeFrame: Assessed at admittance and immediately after discharge from unit
measure: Change in tracheostomy status
timeFrame: Assessed at admittance and immediately after discharge from unit
measure: In-patient mortality and mortality
timeFrame: Assessed immediately after discharge from unit
measure: Mortality during 12 months follow-up after discharge
timeFrame: Assessed 12 months after discharge
measure: Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36)
timeFrame: 3 months after discharge from unit
measure: Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36)
timeFrame: 6 months after discharge from unit
measure: Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36)
timeFrame: 12 months after discharge from unit
measure: Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L)
timeFrame: 3 months after discharge from unit
measure: Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L)
timeFrame: 6 months after discharge from unit
measure: Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L)
timeFrame: 12 months after discharge from unit
measure: Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)
timeFrame: At admission to unit
measure: Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)
timeFrame: Immediately before decannulation
measure: Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)
timeFrame: Immediately before discharge from unit
measure: Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)
timeFrame: 6 months after discharge from unit
measure: Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)
timeFrame: 12 months after discharge from unit
Secondary outcomes:
measure: Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 3 months after discharge from unit
measure: Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 6 months after discharge from unit
measure: Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12 months after discharge from unit
measure: Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire
timeFrame: 3 months after discharge from unit
measure: Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire
timeFrame: 6 months after discharge
measure: Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire
timeFrame: 12 months after discharge from unit
measure: Frailty as assessed by the Clinical frailty scale (CFS)
timeFrame: At admission to unit
measure: Frailty as assessed by the Clinical frailty scale (CFS)
timeFrame: Immediately before discharge from unit
measure: Frailty as assessed by the Clinical frailty scale (CFS)
timeFrame: At 6 months after discharge from unit
measure: Frailty as assessed by the Clinical frailty scale (CFS)
timeFrame: At 12 months after discharge from unit
measure: Physical status as assessed by the 6 minutes walk test
timeFrame: At admission to unit
measure: Physical status as assessed by the 6 minutes walk test
timeFrame: Immediately before decannulation
measure: Physical status as assessed by the 6 minutes walk test
timeFrame: Immediately before discharge from unit
measure: Physical status as assessed by the 6 minutes walk test
timeFrame: 6 months after discharge from unit
measure: Physical status as assessed by the 6 minutes walk test
timeFrame: 12 months after discharge from unit
measure: Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test
timeFrame: At admission to unit
measure: Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test
timeFrame: Immediately before decannulation
measure: Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test
timeFrame: Immediately before discharge from unit
measure: Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).
timeFrame: At admission to unit
measure: Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).
timeFrame: Immediately after decannulation
measure: Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).
timeFrame: Immediately before discharge from unit
measure: Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).
timeFrame: 6 months after discharge from unit
measure: Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).
timeFrame: 12 months after discharge from unit
measure: Swallowing function and possibility of oral intake
timeFrame: At admission to unit
measure: Swallowing function and possibility of oral intake
timeFrame: Immediately before decannulation
measure: Swallowing function and possibility of oral intake
timeFrame: Immediately before discharge from unit
measure: Swallowing function and possibility of oral intake
timeFrame: At at 6 months after discharge from unit
measure: Swallowing function and possibility of oral intake
timeFrame: At at 12 months after discharge from unit
measure: Inflammatory status relative to outcome
timeFrame: Through study completion, an average of 14 months
Other outcomes:
measure: Antibiotic use
timeFrame: From admittance until discharge
measure: Antibiotic use 12 months after discharge
timeFrame: From discharge until12 month thereafter
measure: Discharge destination
timeFrame: Immediately after discharge from unit
measure: Need of support after discharge for patients discharged home
timeFrame: Immediately after discharge from unit
measure: Number and type of Health care Contacts after discharge
timeFrame: Assessed 12 months after discharge from unit
Locations:
city: Sköndal
country: Sweden
facility: Remeo
state: Stockholm
Study officials:
affiliation: Remeo and Karolinska Institutet
name: Eva Sundman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: