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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Eva Sundman, MD, PhD; Phone Number: +46702086783; Email: eva.sundman@remeo.se
• Study Contact Backup: Name: Anna Cedborg, MD, PhD; Phone Number: +46709564216; Email: anna.cedborg@remeo.se

Study Locations

• Sweden
  • Stockholm
    • Sköndal, Stockholm, Sweden, 12864
      • Recruiting
      • Remeo
      • Contact: Eva Sundman, MD, PhD; Phone Number: +46702086783; Email: eva.sundman@remeo.se
      • Contact: Anna Cedborg, MD, PhD; Phone Number: +46709564216; Email: anna.cedborg@remeo.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with prolonged critical illness treated at the specialized unit (Remeo, Stockholm, Sweden)

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Remeo AB
• Collaborators: Karolinska Institutet
• Investigators: Principal Investigator: Eva Sundman, MD, PhD, Remeo and Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: multidisciplinary team; chronic critical illness; weaning from mechanical ventilation; decannulation; persistent critical illness; prolonged intensive care; intensive care rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2019120000; Dnr 2019-05294 (Other Identifier: Swedish Ethical Review Authority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No