A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use
- Conditions
- Agitation,Psychomotor
- Interventions
- Other: Multicomponent intervention program
- Registration Number
- NCT05783505
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
Despite deleterious effects, physical restraints are still commonly used in (expected to become) agitated patients in Dutch ICUs (20-25%). This study aims to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints in (expected to become) agitated adult ICU patients.
- Detailed Description
Applying physical restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated. Nonetheless, PR are still used in approximately 20-25% of all patients during their intensive care unit (ICU) stay in the Netherlands. The aim of this study is to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints on short- and long-term outcomes and healthcare costs in (expected to become) agitated adult ICU patients.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 480
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group Multicomponent intervention program Multicomponent intervention program
- Primary Outcome Measures
Name Time Method ICU-free days 28 days
- Secondary Outcome Measures
Name Time Method Mortality at 28 days, 3 months and 12 months Duration of mechanical ventilation in days up to 180 days Hospital length of stay in days up to 180 days Days with delirium 14 days Assessed using the Intensive Care Delirium Screening Checklist (ICDSC), Confusion Assessment Method for the ICU (CAM-ICU), or the Delirium Observation Screening scale for the ward (DOS)
Dexmedetomidine related adverse events (e.g., hypotension, bradycardia) that required intervention 14 days Days with propofol (and total administered dose) 14 days Number of delirium- and coma-free days 14 days Days with physical restraints 14 days Incidence rate of accidentally removed medical devices 14 days Days with coma 14 days Assessed using the Richmond Agitation and Sedation Scale (RASS)
Cognitive outcome at 3, 12 and 24 months E.g., cognitive impairment, assessed using a validated questionnaire
Quality of life at ICU admission, 3, 12 and 24 months Assessed using a validated QoL questionnaire
Incidence rate of (self-extubation induced) reintubations 14 days Days with dexmedetomidine (and total administered dose) 14 days Physical outcome at ICU admission, 3, 12 and 24 months E.g., fatigue, frailty, new or worsened physical problems, assessed using validated questionnaires
Mental outcome at ICU admission 3, 12 and 24 months E.g., post traumatic stress disorder (PTSD), anxiety, depression, assessed using validated questionnaires
Cost-effectiveness 12 months Measured by cost per Quality-Adjusted Life Year (QALY)
Trial Locations
- Locations (5)
Noordwest Ziekenhuisgroep
🇳🇱Alkmaar, Netherlands
Bravis Ziekenhuis
🇳🇱Bergen Op Zoom, Netherlands
VieCuri Medisch Centrum
🇳🇱Venlo, Netherlands
Elkerliek Ziekenhuis
🇳🇱Helmond, Netherlands
Amphia Ziekenhuis
🇳🇱Breda, Netherlands