MONITOR-IC Post ICU Care Study

Post ICU Syndrome Clinical Trial

— MiCare  

Official title:

Evaluation of Structured, Multidisciplinary and Personalized Post-ICU Care on Physical and Psychological Functioning, and Quality of Life of Former ICU Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05066984
• Other study ID #: 2021-13125
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: July 1, 2026

Study information

• Verified date: December 2023
• Source: Radboud University Medical Center
• Contact: Dries van Sleeuwen, MSc
• Phone: +31 24 3617273
• Email: dries.vansleeuwen[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• OBJECTIVE To evaluate the clinical effectiveness and cost effectiveness of structured, multidisciplinary and personalized post-ICU care versus usual care on physical and psychological functioning, and quality of life (QoL) of ICU survivors one and two years post-ICU.

• RESEARCH QUESTION What is the clinical- and cost effectiveness of structured, personalized post-ICU care versus usual care on physical and psychological functioning, and QoL of ICU survivors?

• HYPOTHESIS Structured, multidisciplinary, and personalized post-ICU care results in improved QoL of ICU survivors and is more cost effective compared to usual care.

Description:

• OBJECTIVE To evaluate the clinical effectiveness and cost effectiveness of structured, multidisciplinary and personalized post-ICU care versus usual care on physical and psychological functioning, and quality of life (QoL) of ICU survivors one and two years post-ICU.

• RESEARCH QUESTION What is the clinical- and cost effectiveness of structured, personalized post-ICU care versus usual care on physical and psychological functioning, and QoL of ICU survivors?

• HYPOTHESIS Structured, multidisciplinary, and personalized post-ICU care results in improved QoL of ICU survivors and is more cost effective compared to usual care.

• STUDY POPULATION Adult patients at high risk of critical illness-associated morbidity post-ICU.

• INTERVENTION Structured, personalized and multidisciplinary post-ICU care tailored to patients' health problems initiated by ICU clinicians and coordinated by GPs.

• USUAL CARE / COMPARISON No or unstructured post-ICU care.

• OUTCOMES Primary: QoL and mental functioning 1-year post-ICU. Secondary: physical and cognitive functioning 1- and 2-year post-ICU, cost effectiveness and cost utility.

• FOLLOW-UP TIME One and two years post-ICU.

• STUDY DESIGN Stepped wedge cluster RCT in 5 hospitals.

• SAMPLE SIZE & DATA ANALYSIS 5 ICUs (11 patients/ICU/month, in total 770 intervention patients, and 1480 (active and historical) controls gives power of 87% to detect effect of 0.074 in EQ-5D (ICC 0.035; SD 0.26). Data will be analysed according to intention to treat principles, also per-protocol analyses will be performed.

• COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS Comparison of 'cost per QALY' gained between patients in the intervention and control group. Decision analytical modelling will be used to calculate the average savings per patient; extrapolated to population level using a budget-holders perspective.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2250
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ICU patients at high risk of critical illness-associated morbidity post-ICU

• 18 years or older

• Patient or legal representative understands the Dutch language

Exclusion Criteria:

• Patients discharged from ICU/hospital direct to a nursing home

• Patients discharged from ICU/hospital direct to a medical or geriatric rehabilitation clinic

• Patients discharged for palliative care

Related Conditions & MeSH terms

• Post ICU Syndrome

Intervention

Other:
• structured, multidisciplinary and personalized post-ICU care
Structured, personalized and multidisciplinary post-ICU care tailored to patients' health problems initiated by ICU clinicians and coordinated by GPs.

Locations

Country	Name	City	State
Netherlands	Canisius Wilhelmina Ziekenhuis	Nijmegen	Gelderland
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Radboud University Medical Center	Dutch National Health Care Institute, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual's perception of their position in life assessed by the EuroQol-5 dimension (EQ5D) .	Quality of life (QoL) assessed by the EQ5D at 1-year post-ICU.	1 year post-ICU
Primary	Mental impairments assessed by the Hospital Anxiety and Depression Scale (HADS)	Anxiety and depression (assessed by the HADS) at 1-year post-ICU.	1 year post-ICU
Secondary	Physical functioning measured by fatigue assessed by the Checklist Individual Strength (CIS).	Fatigue (CIS) Patients' level of frailty and vulnerability will be assed using the Clinical Frailty Score (CFS).	1- and 2-year post-ICU
Secondary	Physical functioning measured by frailty assessed by the Clinical Frailty Scale (CFS).	Frailty (CFS) Patients' level of frailty and vulnerability will be assed using the Clinical Frailty Score (CFS).	1- and 2-year post-ICU
Secondary	Physical functioning measured by new physical complaints assessed by the number of new physical complaints.	New physical complaints Patients' level of frailty and vulnerability will be assed using the Clinical Frailty Score (CFS).	1- and 2-year post-ICU
Secondary	Post traumatic stress disorder 1- and 2-year post-ICU assessed by the Impact of Event Scale-Revised (IES-R).	Post traumatic stress disorder (IES-R)	1- and 2-year post-ICU
Secondary	Cognitive functioning 1- and 2-year post-ICU assessed by the 14-item Cognitive Failure Questionnaire (CFQ14).	Cognitive functioning (CFQ14)	1- and 2-year post-ICU
Secondary	Social economic consequences measured by the novel question set designed by Griffiths et al.	Social consequences and return to work will be measured using the novel question set designed by Griffiths et al to determine changes in family circumstances, socioeconomic stability and care requirements.; (Griffiths J, Hatch RA, Bishop J, et al. An exploration of social and economic outcome and associated health-related quality of life after critical illness in general intensive care unit survivors: a 12-month follow-up study. Critical care. 2013;17(3):R100.)	1- and 2-year post-ICU
Secondary	Cost effectiveness measured by cost per Quality-Adjusted Life Years (QALY)	A cost-effectiveness analysis will be carried out to evaluate whether the costs of structured, multidisciplinary and personalized post-ICU care weigh up to the benefits compared to usual care.	1- and 2-year post-ICU