Overview
- 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.
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