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

Not Applicable

Recruiting

• Conditions: Patient Engagement; Intensive Care Unit Syndrome
• Interventions: Behavioral: Providing patient-reported outcome

• Registration Number: NCT05155150
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-11-09
• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2021-11-29
• Study First Posted: 2021-12-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-10
• Primary Completion: 2023-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Providing patient-reported outcome	Providing patient-reported outcome: patients receive personalized information on expected quality of life one year after ICU during ICU admission (during a family meeting)

Primary Outcome Measures

Name	Time	Method
Patient reported experience measure (PREM)	Within 3 months of family meeting	Patient and/or relative's experience (measured using the CollaboRATE)

Secondary Outcome Measures

Name	Time	Method
Patient reported outcome measure (PROM)	After 3 months and after 1 year	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.
ICU professionals' experiences	Two months before inclusion first patient and two months after inclusion last patient	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.

Trial Locations

Locations (2)

Jeroen Bosch Ziekenhuis; 🇳🇱 's-Hertogenbosch, Noord-Brabant, Netherlands

Radboud university medical centre; 🇳🇱 Nijmegen, Gelderland, Netherlands