Intensive Care Unit SyndromeNCT05155150
Improving Shared-Decision Making in the Intensive Care Unit Using Patient-reported Outcome Information
A study testing Providing patient-reported outcome in people with Intensive Care Unit Syndrome and Patient Engagement, run by Radboud University Medical Center at 2 sites in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Intensive Care Unit Syndrome, Patient Engagement
- What is being tested?
- Providing patient-reported outcome
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesNetherlands
- Study dates
- 9 Nov 2021to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients admitted to the ICU for 12 hours or more
- Patients (or their legal representative) provide written informed consent
Who cannot join
- Patients admitted to the ICU due to a COVID-19 infection
- Moribund patients
Trial locations and contacts
2 sites in 1 country.
Mark van den Boogaard, PhD contact
Netherlands2 sites, 2 recruiting
- Recruiting
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, 5223GZ
Koen Simons, MD, PhD, k.simons@jbz.nl
- Recruiting
Radboud university medical centre
Nijmegen, Gelderland, 6525GA
Marieke Zegers, PhD, 0031243619269, Marieke.Zegers@radboudumc.nl
Mark van den Boogaard, PhD, Mark.vandenBoogaard@radboudumc.nl
About this study
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.
Read the 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.
- Conditions
- Intensive Care Unit Syndrome, Patient Engagement
- Being tested
- Providing patient-reported outcome
- Keywords
- Share decision making, Intensive Care Unit, Quality of life
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Providing patient-reported outcomeBehavioural
Patients receive personalized information on expected quality of life one year after ICU during ICU admission (during a family meeting)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Providing patient-reported outcome |
| Control group | No intervention | Family meetings take place as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported experience measure (PREM)
Patient and/or relative's experience (measured using the CollaboRATE)
Measured: Within 3 months of family meeting
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: After 3 months and after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start9 Nov 2021
- Primary completionMay 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jeroen Bosch Ziekenhuis
- Responsible party
- Principal investigator, Marieke Zegers, Radboud University Medical Center
- Investigators
- Marieke Zegers, PhD, Principal investigator, Intensive Care, Radboud university medical centerKoen Simons, MD, PhD, Principal investigator, Intensive Care, Jeroen Bosch ZiekenhuisMark Van den Boogaard, PhD, Principal investigator, Intensive Care, Radboud university medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155150
- Sponsor's protocol ID
- 112002
- Status last verified
- Apr 2023
- First submitted
- 17 Nov 2021
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39992444
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Shared-Decision Making in the Intensive Care Unit Using Patient-reported Outcome Information
- ClinicalTrials.gov ID
- NCT05155150
- Acronym / sponsor ID
- 112002
- Conditions
- Intensive Care Unit Syndrome, Patient Engagement
- Keywords
- Share decision making, Intensive Care Unit, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Jeroen Bosch Ziekenhuis
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Providing patient-reported outcomeProviding patient-reported outcome: patients receive personalized information on expected quality of life one year after ICU during ICU admission (during a family meeting) |
| Control group | No intervention | –Family meetings take place as usual. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients admitted to the ICU for 12 hours or more
- Patients (or their legal representative) provide written informed consent
Key exclusion criteria (2 listed)
- Patients admitted to the ICU due to a COVID-19 infection
- Moribund patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Providing patient-reported outcomePatients receive personalized information on expected quality of life one year after ICU during ICU admission (during a family meeting) | Behavioural | Intervention group |
Primary outcome
Patient reported experience measure (PREM)
Time frame: Within 3 months of family meeting
Patient and/or relative's experience (measured using the CollaboRATE)
3 secondary outcomes
Patient reported outcome measure (PROM)
Time frame: After 3 months and after 1 year
ICU professionals' experiences
Time frame: Two months before inclusion first patient and two months after inclusion last patient
Patient reported outcome measure (PROM)
Time frame: After 3 months and after 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Derived from this study: PubMed 39992444Porter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark van den Boogaard, PhD contact
Marieke Zegers, PhD principal investigator
Intensive Care, Radboud university medical center
Koen Simons, MD, PhD principal investigator
Intensive Care, Jeroen Bosch Ziekenhuis
Mark Van den Boogaard, PhD principal investigator
Intensive Care, Radboud university medical center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Providing patient-reported outcome in people with Intensive Care Unit Syndrome and Patient Engagement, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marieke Zegers, PhD (0031243619269, Marieke.Zegers@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported experience measure (PREM) (time frame: Within 3 months of family meeting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05155150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.