MONITOR-IC Post ICU Care Study (MiCare)

Radboud University Medical Center

Status

Active, not recruiting

Conditions

Post ICU Syndrome

Treatments

Other: structured, multidisciplinary and personalized post-ICU care

Study type

Interventional

Funder types

Other

Identifiers

NCT05066984

2021-13125

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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