NCT05155150

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 13, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

1.5 years

First QC Date

November 17, 2021

Last Update Submit

April 6, 2023

Conditions

Intensive Care Unit SyndromePatient Engagement

Keywords

Share decision makingIntensive Care UnitQuality of life

Outcome Measures

Primary Outcomes (1)

  • Patient reported experience measure (PREM)

    Patient and/or relative's experience (measured using the CollaboRATE)

    Within 3 months of family meeting

Secondary Outcomes (3)

  • Patient reported outcome measure (PROM)

    After 3 months and after 1 year

  • ICU professionals' experiences

    Two months before inclusion first patient and two months after inclusion last patient

  • Patient reported outcome measure (PROM)

    After 3 months and after 1 year

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Family meetings take place as usual.

Interventions

Providing patient-reported outcomeBEHAVIORAL

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

Intervention group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to the ICU for 12 hours or more
  • Patients (or their legal representative) provide written informed consent

You may not qualify if:

  • Patients admitted to the ICU due to a COVID-19 infection
  • Moribund patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radboud university medical centre

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, 5223GZ, Netherlands

RECRUITING

Related Publications (1)

  • Porter LL, Simons KS, van der Hoeven JG, van den Boogaard M, Zegers M. Discussing expected long-term quality of life in the ICU: effect on experiences and outcomes of patients, family, and clinicians-a randomized clinical trial. Intensive Care Med. 2025 Mar;51(3):478-489. doi: 10.1007/s00134-025-07812-5. Epub 2025 Feb 24.

    PMID: 39992444DERIVED

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Marieke Zegers, PhD

    Intensive Care, Radboud university medical center

    PRINCIPAL INVESTIGATOR

  • Koen Simons, MD, PhD

    Intensive Care, Jeroen Bosch Ziekenhuis

    PRINCIPAL INVESTIGATOR

  • Mark Van den Boogaard, PhD

    Intensive Care, Radboud university medical center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marieke Zegers, PhD

CONTACT

0031243619269Marieke.Zegers@radboudumc.nl

Mark van den Boogaard, PhD

CONTACT

Mark.vandenBoogaard@radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD and Principal Investigator

Study Record Dates

First Submitted

November 17, 2021

First Posted

December 13, 2021

Study Start

November 9, 2021

Primary Completion

May 1, 2023

Study Completion

May 1, 2024

Last Updated

April 10, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)