CritillPro: Specialized Treatment, Rehabilitation and Outcome in Patients With Prolonged Critical Illness

Sponsor

Remeo AB (Other)

Overall Status

Recruiting

CT.gov ID

NCT04247607

Collaborator

Karolinska Institutet (Other)

250

Enrollment

Location

47.6

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

250 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Actual Study Start Date :

Dec 13, 2019

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

Change in mechanical ventilation status [Assessed at admittance and immediately after discharge from unit]
Time (Days) from admittance to unit until weaned from mechanical ventilation
Change in tracheostomy status [Assessed at admittance and immediately after discharge from unit]
Time (Days) from admittance to unit until decannulation
In-patient mortality and mortality [Assessed immediately after discharge from unit]
Mortality during care at unit
Mortality during 12 months follow-up after discharge [Assessed 12 months after discharge]
Mortality during 12 months follow-up after discharge
Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36) [3 months after discharge from unit]
RAND36 (scale 0-100, higher value better) questionnaire
Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36) [6 months after discharge from unit]
RAND36 (scale 0-100, higher value better) questionnaire
Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36) [12 months after discharge from unit]
RAND36 (scale 0-100, higher value better) questionnaire
Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L) [3 months after discharge from unit]
EQ-5D-5L questionnaire
Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L) [6 months after discharge from unit]
EQ-5D-5L questionnaire
Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L) [12 months after discharge from unit]
EQ-5D-5L questionnaire
Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL) [At admission to unit]
Katz ADL (scale 0-6, higher value better)
Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL) [Immediately before decannulation]
Katz ADL (scale 0-6, higher value better)
Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL) [Immediately before discharge from unit]
Katz ADL (scale 0-6, higher value better)
Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL) [6 months after discharge from unit]
Katz ADL (scale 0-6, higher value better)
Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL) [12 months after discharge from unit]
Katz ADL (scale 0-6, higher value better)

Secondary Outcome Measures

Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) [3 months after discharge from unit]
PHQ-9, a patient related outcome questionnaire, scale 0-27, higher value indicating more severe symptoms
Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) [6 months after discharge from unit]
PHQ-9, a patient related outcome questionnaire, scale 0-27, higher value indicating more severe symptoms
Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) [12 months after discharge from unit]
PHQ-9, a patient related outcome questionnaire, scale 0-27, higher value indicating more severe symptoms
Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire [3 months after discharge from unit]
GAD-7, a patient related outcome questionnaire, scale 0-21, higher value indicating more severe symptoms
Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire [6 months after discharge]
GAD-7, a patient related outcome questionnaire, scale 0-21, higher value indicating more severe symptoms
Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire [12 months after discharge from unit]
GAD-7, a patient related outcome questionnaire, scale 0-21, higher value indicating more severe symptoms
Frailty as assessed by the Clinical frailty scale (CFS) [At admission to unit]
The Clinical frailty scale has 9 levels from very fit to terminally ill (1-9, lower value indicate better outcome)
Frailty as assessed by the Clinical frailty scale (CFS) [Immediately before discharge from unit]
The Clinical frailty scale has 9 levels from very fit to terminally ill (1-9, lower value indicate better outcome)
Frailty as assessed by the Clinical frailty scale (CFS) [At 6 months after discharge from unit]
The Clinical frailty scale has 9 levels from very fit to terminally ill (1-9, lower value indicate better outcome)
Frailty as assessed by the Clinical frailty scale (CFS) [At 12 months after discharge from unit]
The Clinical frailty scale has 9 levels from very fit to terminally ill (1-9, lower value indicate better outcome)
Physical status as assessed by the 6 minutes walk test [At admission to unit]
The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)
Physical status as assessed by the 6 minutes walk test [Immediately before decannulation]
The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)
Physical status as assessed by the 6 minutes walk test [Immediately before discharge from unit]
The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)
Physical status as assessed by the 6 minutes walk test [6 months after discharge from unit]
The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)
Physical status as assessed by the 6 minutes walk test [12 months after discharge from unit]
The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)
Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test [At admission to unit]
Performed by an occupational therapist. The MoCa test score scale is 0-30 Points, higher value indicate better outcome
Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test [Immediately before decannulation]
Performed by an occupational therapist. The MoCa test score scale is 0-30 Points, higher value indicate better outcome
Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test [Immediately before discharge from unit]
Performed by an occupational therapist. The MoCa test score scale is 0-30 Points, higher value indicate better outcome
Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx). [At admission to unit]
CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome)
Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx). [Immediately after decannulation]
CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome)
Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx). [Immediately before discharge from unit]
CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome)
Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx). [6 months after discharge from unit]
CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome)
Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx). [12 months after discharge from unit]
CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome)
Swallowing function and possibility of oral intake [At admission to unit]
Using the Functional oral intake scale (FOIS)
Swallowing function and possibility of oral intake [Immediately before decannulation]
Using the Functional oral intake scale (FOIS)
Swallowing function and possibility of oral intake [Immediately before discharge from unit]
Using the Functional oral intake scale (FOIS), seven different levels 1-7, higher level indicate better function
Swallowing function and possibility of oral intake [At at 6 months after discharge from unit]
Using the Functional oral intake scale (FOIS), seven different levels 1-7, higher level indicate better function
Swallowing function and possibility of oral intake [At at 12 months after discharge from unit]
Using the Functional oral intake scale (FOIS), seven different levels 1-7, higher level indicate better function
Inflammatory status relative to outcome [Through study completion, an average of 14 months]
HMGB1 and routine inflammation markers' effect on outcome measures

Other Outcome Measures

Antibiotic use [From admittance until discharge]
Days with antibiotic treatment during stay at unit.
Antibiotic use 12 months after discharge [From discharge until12 month thereafter]
Number of infections treated with antibiotics after discharge
Discharge destination [Immediately after discharge from unit]
The location the patient was discharged to; home, rehabilitation unit, acute care hospital, nursing home, palliative care unit
Need of support after discharge for patients discharged home [Immediately after discharge from unit]
For patients discharged home, the type of homecare needed (if any)
Number and type of Health care Contacts after discharge [Assessed 12 months after discharge from unit]
Number of Contacts with primary care, emergency room and hospital admissions after discharge