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| Name | Class |
|---|---|
| Jeroen Bosch Ziekenhuis | OTHER |
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The aim of this study is to evaluate the effect of incorporation of outcome information in the Intensive Care Unit (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.
Background Due to advances in critical care medicine, more patients survive their critical illness. However, many Intensive Care Unit (ICU) survivors suffer from physical, cognitive and/or mental problems impacting patients' quality of life (QoL). Because of a lack of long-term outcome information, ICU physicians make decisions regarding ICU treatment based on their clinical experience and intuition. Moreover, patients and relatives are often not involved in the decision-making process.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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 | No Intervention | Family meetings take place as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Providing patient-reported outcome | Behavioral | Patients receive personalized information on expected quality of life one year after ICU during ICU admission (during a family meeting) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported experience measure (PREM) | Patient and/or relative's experience (measured using the CollaboRATE) | Within 3 months of family meeting |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported outcome measure (PROM) | Quality of life, measured using the EuroQol five-dimensional questionnaire (EQ-5D-5L). The Dutch EQ-5D-5L index ranges from -0.446 to 1, with a higher score indicating a better health related quality of life. | After 3 months and after 1 year |
| ICU professionals' experiences |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marieke Zegers, PhD | Contact | 0031243619269 | Marieke.Zegers@radboudumc.nl | |
| Mark van den Boogaard, PhD | Contact | Mark.vandenBoogaard@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Marieke Zegers, PhD | Intensive Care, Radboud university medical center | Principal Investigator |
| Koen Simons, MD, PhD | Intensive Care, Jeroen Bosch Ziekenhuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud university medical centre | Recruiting | Nijmegen | Gelderland | 6525GA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39992444 | Derived | 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. |
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| ID | Term |
|---|---|
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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Randomized trial
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Measured using the Ethical Decision-Making Climate Questionnaire (EDMCQ). The EDMCQ consists of three parts: interdisciplinary collaboration and communication (5-point Likert Scale ranging from strongly disagree to strongly agree), leadership by physicians (5-point Likert Scale ranging from never to always) and ethical environment (4-point Likert Scale ranging from strongly disagree to strongly agree). These three parts cover a total of seven factors. Factor scores range from 1-5 or 1-4, with higher scores reflecting more positive views. |
| Two months before inclusion first patient and two months after inclusion last patient |
| Patient reported outcome measure (PROM) | Anxiety and depression, measured using the Hospital Anxiety and Depression Scale (HADS). The HADS consists of two components (anxiety and depression), with each score ranging from 0-21. A higher score indicates more severe symptoms. | After 3 months and after 1 year |
| Mark Van den Boogaard, PhD |
| Intensive Care, Radboud university medical center |
| Principal Investigator |
| Jeroen Bosch Ziekenhuis | Recruiting | 's-Hertogenbosch | North Brabant | 5223GZ | Netherlands |
|