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

Intensive Care Unit Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05155150
• Other study ID #: 112002
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2021
• Est. completion date: May 2024

Study information

• Verified date: April 2023
• Source: Radboud University Medical Center
• Contact: Marieke Zegers, PhD
• Phone: 0031243619269
• Email: Marieke.Zegers[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Intensive Care Unit Syndrome
• Patient Engagement

Intervention

Behavioral:
• Providing patient-reported outcome
Patients receive personalized information on expected quality of life one year after ICU during ICU admission (during a family meeting)

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Ziekenhuis	's-Hertogenbosch	Noord-Brabant
Netherlands	Radboud university medical centre	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Jeroen Bosch Ziekenhuis

Country where clinical trial is conducted

Netherlands, 

Outcome

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