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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Dutch National Health Care Institute | OTHER |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| structured, multidisciplinary and personalized post-ICU care | Experimental | structured, multidisciplinary and personalized post-ICU care |
|
| Ususal care | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| structured, multidisciplinary and personalized post-ICU care | Other | Structured, personalized and multidisciplinary post-ICU care tailored to patients' health problems initiated by ICU clinicians and coordinated by GPs. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Physical functioning measured by frailty assessed by the Clinical Frailty Scale (CFS). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark van den Boogaard, PhD | Radboud University Medical Center | Study Director |
| Marieke Zegers, PhD | Radboud University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | Gelderland | 6525GA | Netherlands | ||
| Canisius Wilhelmina Ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36109035 | Derived | 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. |
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Data will be shared on reasonable request to the researchers.
After finalizing the final analysis in 2026 for a period of 5 years.
Data will be shared on reasonable request to the researchers.
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Multicenter stepped-wedge cluster randomized controlled trial
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Frailty (CFS) Patients' level of frailty and vulnerability will be assed using the Clinical Frailty Score (CFS). |
| 1- and 2-year post-ICU |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Nijmegen |
| Gelderland |
| 6532SZ |
| Netherlands |