Improving Shared-Decision Making in the Intensive Care Unit Using Patient-reported Outcome Information
NCT ID: NCT05155150
Last Updated: 2023-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2021-11-09
2024-05-31
Brief Summary
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Detailed Description
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To improve the ICU decision-making process and to make it more substantiated, the use of patient-reported outcome measures (PROMs) is of utmost importance. Therefore, the Radboudumc, in collaboration with six regional hospitals, including Jeroen Bosch Ziekenhuis (JBZ), set up a large-scale prospective cohort study, MONITOR-IC (www.monitor-ic.nl), to study long-term outcomes of ICU survivors', their QoL and their needs.
This research sets out to evaluate the effect of incorporation of outcome information in the ICU decision-making process on patient and family reported outcomes and experiences of patients, relatives and ICU clinicians in a randomized clinical trial design in the Jeroen Bosch Ziekenhuis and Radboudumc in the Netherlands.
Methods A prediction model for long-term QoL was previously developed using physiological, pathological, drug and treatment data from patients' electronic health record combined with PROMs from one centre of the MONITOR-IC. It was externally validated with the data of six other centres and an E-health tool was developed, incorporating this prediction model. For this research, the E-health tool will be incorporated in family meetings.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention group
Providing patient-reported outcome: patients receive personalized information on expected quality of life one year after ICU during ICU admission (during a family meeting)
Providing patient-reported outcome
Patients receive personalized information on expected quality of life one year after ICU during ICU admission (during a family meeting)
Control group
Family meetings take place as usual.
No interventions assigned to this group
Interventions
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Providing patient-reported outcome
Patients receive personalized information on expected quality of life one year after ICU during ICU admission (during a family meeting)
Eligibility Criteria
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Inclusion Criteria
* Patients (or their legal representative) provide written informed consent
Exclusion Criteria
* Moribund patients
16 Years
ALL
No
Sponsors
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Jeroen Bosch Ziekenhuis
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Marieke Zegers
PhD and Principal Investigator
Principal Investigators
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Marieke Zegers, PhD
Role: PRINCIPAL_INVESTIGATOR
Intensive Care, Radboud university medical center
Koen Simons, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Intensive Care, Jeroen Bosch Ziekenhuis
Mark Van den Boogaard, PhD
Role: PRINCIPAL_INVESTIGATOR
Intensive Care, Radboud university medical center
Locations
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Radboud university medical centre
Nijmegen, Gelderland, Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Porter LL, Simons KS, van der Hoeven JG, van den Boogaard M, Zegers M. Discussing expected long-term quality of life in the ICU: effect on experiences and outcomes of patients, family, and clinicians-a randomized clinical trial. Intensive Care Med. 2025 Mar;51(3):478-489. doi: 10.1007/s00134-025-07812-5. Epub 2025 Feb 24.
Other Identifiers
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112002
Identifier Type: -
Identifier Source: org_study_id
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