Intensive Care Unit Syndrome Clinical Trial
Official title:
Improving Shared-Decision Making in the Intensive Care Unit Using Patient-reported Outcome Information
NCT number | NCT05155150 |
Other study ID # | 112002 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 9, 2021 |
Est. completion date | May 2024 |
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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | May 2024 |
Est. primary completion date | May 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - Patients admitted to the ICU for 12 hours or more - Patients (or their legal representative) provide written informed consent Exclusion Criteria: - Patients admitted to the ICU due to a COVID-19 infection - Moribund patients |
Country | Name | City | State |
---|---|---|---|
Netherlands | Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | Noord-Brabant |
Netherlands | Radboud university medical centre | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center | Jeroen Bosch Ziekenhuis |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient reported experience measure (PREM) | Patient and/or relative's experience (measured using the CollaboRATE) | Within 3 months of family meeting | |
Secondary | 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 | |
Secondary | ICU professionals' experiences | 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 | |
Secondary | 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 |
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