Multicomponent intervention program
OtherNon-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed
NCT Number: NCT05783505
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Noordwest Ziekenhuisgroep, Alkmaar, Netherlands
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restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated.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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed
Time frame: 28 days
Time frame: 14 days
Time frame: 14 days
Time frame: 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)
Time frame: 14 days
Assessed using the Richmond Agitation and Sedation Scale (RASS)
Time frame: 14 days
Time frame: 14 days
Time frame: 14 days
Time frame: 14 days
Time frame: 14 days
Time frame: up to 180 days
Time frame: up to 180 days
Time frame: at 28 days, 3 months and 12 months
Time frame: at ICU admission, 3, 12 and 24 months
E.g., fatigue, frailty, new or worsened physical problems, assessed using validated questionnaires
Time frame: at ICU admission 3, 12 and 24 months
E.g., post traumatic stress disorder (PTSD), anxiety, depression, assessed using validated questionnaires
Time frame: at 3, 12 and 24 months
E.g., cognitive impairment, assessed using a validated questionnaire
Time frame: at ICU admission, 3, 12 and 24 months
Assessed using a validated QoL questionnaire
Time frame: 12 months
Measured by cost per Quality-Adjusted Life Year (QALY)
Time frame: 14 days
Time frame: To be conducted within one year after study completion
A secondary Bayesian analysis of the trial including heterogeneity of treatment effect
Contact information is provided by the study sponsor or research team.
Bram Tilburgs, PhD
CONTACT
Rens Kooken, MSc
CONTACT
Radboud University Medical Center
Other
PRevention of pAtient's agItation and Enhancement of Their SafEty (PRAISE): Improving Intensive Care Treatment Using a Multicomponent Pharmacological Intervention
Acronym: PRAISE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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