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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05155150
Enrollment
160
Registered
2021-12-13
Start date
2021-11-09
Completion date
2024-05-31
Last updated
2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit Syndrome, Patient Engagement

Keywords

Share decision making, Intensive Care Unit, Quality of life

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.

Interventions

BEHAVIORALProviding patient-reported outcome

Patients receive personalized information on expected quality of life one year after ICU during ICU admission (during a family meeting)

Sponsors

Jeroen Bosch Ziekenhuis
CollaboratorOTHER
Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Randomized trial

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient reported experience measure (PREM)Within 3 months of family meetingPatient and/or relative's experience (measured using the CollaboRATE)

Secondary

MeasureTime frameDescription
Patient reported outcome measure (PROM)After 3 months and after 1 yearQuality 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.
ICU professionals' experiencesTwo months before inclusion first patient and two months after inclusion last patientMeasured 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.

Countries

Netherlands

Contacts

Primary ContactMarieke Zegers, PhD
Marieke.Zegers@radboudumc.nl0031243619269
Backup ContactMark van den Boogaard, PhD
Mark.vandenBoogaard@radboudumc.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026