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

Study Overview
=================
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restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated.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.

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

Conditions
-----------------
Agitation,Psychomotor

Intervention / Treatment
-----------------
* Other: Multicomponent intervention program


Participation Criteria
=================
Eligibility Criteria
-----------------
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, γ-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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter stepped wedge cluster randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Multicomponent intervention program | Other: Multicomponent intervention program<br>* Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed<br>|
| No Intervention: Control group<br>Standard care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU-free days |  | 28 days | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU, Agitation, Physical Restraints, Non-pharmacologic interventions, Dexmedetomidine