Clinical trial NCT05066984: MONITOR-IC Post ICU Care Study
Official title: Evaluation of Structured, Multidisciplinary and Personalized Post-ICU Care on Physical and Psychological Functioning, and Quality of Life of Former ICU Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post ICU Syndrome
Keywords: post-ICU care
cost-effectiveness
QoL
PROMs
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Dutch National Health Care Institute
First posted: 2021-10-04
Enrollment: 2250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter stepped-wedge cluster randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Individual's perception of their position in life assessed by the EuroQol-5 dimension (EQ5D) .
timeFrame: 1 year post-ICU
measure: Mental impairments assessed by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 year post-ICU
Secondary outcomes:
measure: Physical functioning measured by fatigue assessed by the Checklist Individual Strength (CIS).
timeFrame: 1- and 2-year post-ICU
measure: Physical functioning measured by frailty assessed by the Clinical Frailty Scale (CFS).
timeFrame: 1- and 2-year post-ICU
measure: Physical functioning measured by new physical complaints assessed by the number of new physical complaints.
timeFrame: 1- and 2-year post-ICU
measure: Post traumatic stress disorder 1- and 2-year post-ICU assessed by the Impact of Event Scale-Revised (IES-R).
timeFrame: 1- and 2-year post-ICU
measure: Cognitive functioning 1- and 2-year post-ICU assessed by the 14-item Cognitive Failure Questionnaire (CFQ14).
timeFrame: 1- and 2-year post-ICU
measure: Social economic consequences measured by the novel question set designed by Griffiths et al.
timeFrame: 1- and 2-year post-ICU
measure: Cost effectiveness measured by cost per Quality-Adjusted Life Years (QALY)
timeFrame: 1- and 2-year post-ICU
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Mark van den Boogaard, PhD
role: STUDY_DIRECTOR
affiliation: Radboud University Medical Center
name: Marieke Zegers, PhD
role: STUDY_DIRECTOR
References:
citation: van Sleeuwen D, van de Laar FA, Simons K, van Bommel D, Burgers-Bonthuis D, Koeter J, Bisschops LLA, Vloet L, Brackel M, Teerenstra S, Adang E, van der Hoeven JG, Zegers M, van den Boogaard M. MiCare study, an evaluation of structured, multidisciplinary and personalised post-ICU care on physical and psychological functioning, and quality of life of former ICU patients: a study protocol of a stepped-wedge cluster randomised controlled trial. BMJ Open. 2022 Sep 15;12(9):e059634. doi: 10.1136/bmjopen-2021-059634.