A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use

Agitation,Psychomotor Clinical Trial

— PRAISE  

Official title:

PRevention of pAtient's agItation and Enhancement of Their SafEty (PRAISE): Improving Intensive Care Treatment Using a Multicomponent Pharmacological Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783505
• Other study ID #: 2022-16133
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: Radboud University Medical Center
• Contact: Rens Kooken, MSc
• Phone: +31 24 361 6735
• Email: rens.kooken[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated.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 information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Adult ICU patients (aged =18) with an expected ICU stay of >24 hours
• Patients who are (expected to become) agitated within the first 14 days of their ICU admission

Exclusion criteria:

• Contra indication for dexmedetomidine use (i.e., AV-block grade 2 or 3 unless a pacemaker is present, uncontrolled hypotension, acute cerebrovascular condition or known/suspected hypersensitivity);
• Neurological patients with an (expected risk of) increased intracranial pressure;
• An intoxication as a result of drug abuse (e.g., ethanol, ?-Hydroxybutyrate, opioids, benzodiazepines);
• Support with Extracorporeal Membrane Oxygenation (ECMO);
• Difficult airway (e.g., a Cormack and Lehane laryngoscopy grade 4 view or a tumor causing airway obstruction);
• A high risk of physical aggression towards healthcare professionals;
• No consent for long term follow up in the MONITOR-IC study;
• Not able to read or understand the Dutch language and no relatives able to assist;
• Enrolment in other sedation studies.

Related Conditions & MeSH terms

• Agitation,Psychomotor
• Psychomotor Agitation

Intervention

Other:
• Multicomponent intervention program
Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed

Locations

Country	Name	City	State
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	Bravis Ziekenhuis	Bergen Op Zoom
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Elkerliek Ziekenhuis	Helmond
Netherlands	VieCuri Medisch Centrum	Venlo

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence rate of falls out of bed		14 days
Primary	ICU-free days		28 days
Secondary	Incidence rate of accidentally removed medical devices		14 days
Secondary	Incidence rate of (self-extubation induced) reintubations		14 days
Secondary	Days with delirium	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)	14 days
Secondary	Days with coma	Assessed using the Richmond Agitation and Sedation Scale (RASS)	14 days
Secondary	Number of delirium- and coma-free days		14 days
Secondary	Days with physical restraints		14 days
Secondary	Days with dexmedetomidine (and total administered dose)		14 days
Secondary	Dexmedetomidine related adverse events (e.g., hypotension, bradycardia) that required intervention		14 days
Secondary	Days with propofol (and total administered dose)		14 days
Secondary	Duration of mechanical ventilation in days		up to 180 days
Secondary	Hospital length of stay in days		up to 180 days
Secondary	Mortality		at 28 days, 3 months and 12 months
Secondary	Physical outcome	E.g., fatigue, frailty, new or worsened physical problems, assessed using validated questionnaires	at ICU admission, 3, 12 and 24 months
Secondary	Mental outcome	E.g., post traumatic stress disorder (PTSD), anxiety, depression, assessed using validated questionnaires	at ICU admission 3, 12 and 24 months
Secondary	Cognitive outcome	E.g., cognitive impairment, assessed using a validated questionnaire	at 3, 12 and 24 months
Secondary	Quality of life	Assessed using a validated QoL questionnaire	at ICU admission, 3, 12 and 24 months
Secondary	Cost-effectiveness	Measured by cost per Quality-Adjusted Life Year (QALY)	12 months