NCT05066984Active, not recruitingNot Applicable
Evaluation of Structured, Multidisciplinary and Personalized Post-ICU Care on Physical and Psychological Functioning, and Quality of Life of Former ICU Patients
Radboud University Medical Center2 sites in 1 country2,250 target enrollmentStarted: February 1, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 2,250
- Locations
- 2
- Primary Endpoint
- Individual's perception of their position in life assessed by the EuroQol-5 dimension (EQ5D) .
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
structured, multidisciplinary and personalized post-ICU care
Experimental
structured, multidisciplinary and personalized post-ICU care
Intervention: structured, multidisciplinary and personalized post-ICU care (Other)
Ususal care
No Intervention
Usual care
Outcomes
Primary Outcomes
Individual's perception of their position in life assessed by the EuroQol-5 dimension (EQ5D) .
Time Frame: 1 year post-ICU
Quality of life (QoL) assessed by the EQ5D at 1-year post-ICU.
Mental impairments assessed by the Hospital Anxiety and Depression Scale (HADS)
Time Frame: 1 year post-ICU
Anxiety and depression (assessed by the HADS) at 1-year post-ICU.
Secondary Outcomes
- Physical functioning measured by fatigue assessed by the Checklist Individual Strength (CIS).(1- and 2-year post-ICU)
- Physical functioning measured by new physical complaints assessed by the number of new physical complaints.(1- and 2-year post-ICU)
- Post traumatic stress disorder 1- and 2-year post-ICU assessed by the Impact of Event Scale-Revised (IES-R).(1- and 2-year post-ICU)
- Cost effectiveness measured by cost per Quality-Adjusted Life Years (QALY)(1- and 2-year post-ICU)
- Physical functioning measured by frailty assessed by the Clinical Frailty Scale (CFS).(1- and 2-year post-ICU)
- Cognitive functioning 1- and 2-year post-ICU assessed by the 14-item Cognitive Failure Questionnaire (CFQ14).(1- and 2-year post-ICU)
- Social economic consequences measured by the novel question set designed by Griffiths et al.(1- and 2-year post-ICU)
Investigators
Study Sites (2)
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