Clinical trial NCT05155150: Improving Shared-Decision Making in the Intensive Care Unit Using Patient-reported Outcome Information
Official title: Improving Shared-Decision Making in the Intensive Care Unit Using Patient-reported Outcome Information
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intensive Care Unit Syndrome
Patient Engagement
Keywords: Share decision making
Intensive Care Unit
Quality of life
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Jeroen Bosch Ziekenhuis
First posted: 2021-12-13
Enrollment: 160
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient reported experience measure (PREM)
timeFrame: Within 3 months of family meeting
Secondary outcomes:
measure: Patient reported outcome measure (PROM)
timeFrame: After 3 months and after 1 year
measure: ICU professionals' experiences
timeFrame: Two months before inclusion first patient and two months after inclusion last patient
measure: Patient reported outcome measure (PROM)
timeFrame: After 3 months and after 1 year
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical centre
state: Gelderland
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
state: Noord-Brabant
Study officials:
affiliation: Intensive Care, Radboud university medical center
name: Marieke Zegers, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Intensive Care, Jeroen Bosch Ziekenhuis
name: Koen Simons, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Intensive Care, Radboud university medical center
name: Mark Van den Boogaard, PhD
role: PRINCIPAL_INVESTIGATOR
References: