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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05066984
Other study ID # 2021-13125
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date July 1, 2026

Study information

Verified date December 2023
Source Radboud University Medical Center
Contact Dries van Sleeuwen, MSc
Phone +31 24 3617273
Email dries.vansleeuwen@radboudumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2250
Est. completion date July 1, 2026
Est. primary completion date July 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
structured, multidisciplinary and personalized post-ICU care
Structured, personalized and multidisciplinary post-ICU care tailored to patients' health problems initiated by ICU clinicians and coordinated by GPs.

Locations

Country Name City State
Netherlands Canisius Wilhelmina Ziekenhuis Nijmegen Gelderland
Netherlands Radboudumc Nijmegen Gelderland

Sponsors (3)

Lead Sponsor Collaborator
Radboud University Medical Center Dutch National Health Care Institute, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary 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
Secondary Physical functioning measured by frailty assessed by the Clinical Frailty Scale (CFS). Frailty (CFS) Patients' level of frailty and vulnerability will be assed using the Clinical Frailty Score (CFS). 1- and 2-year post-ICU
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
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Recruiting NCT06182995 - Anticipating Decline and Providing Therapy N/A
Completed NCT04887220 - Persistent Pain and Its Impact on Quality of Life COVID-19 Patients That Required Critical Care