Improving Shared-Decision Making in the Intensive Care Unit Using Patient-reported Outcome Information

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Shared-Decision Making in the Intensive Care Unit Using Patient-reported Outcome Information

Conditions
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Intensive Care Unit Syndrome, Patient Engagement

Intervention / Treatment
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* Behavioral: Providing patient-reported outcome


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Providing patient-reported outcome: patients receive personalized information on expected quality of life one year after ICU during ICU admission (during a family meeting) | Behavioral: Providing patient-reported outcome<br>* Patients receive personalized information on expected quality of life one year after ICU during ICU admission (during a family meeting)<br>|
| No Intervention: Control group<br>Family meetings take place as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Share decision making, Intensive Care Unit, Quality of life