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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Agitation,Psychomotor
• Intervention / Treatment: Other: Multicomponent intervention program

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restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated.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

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rens Kooken, MSc; Phone Number: +31 24 361 6735; Email: rens.kooken@radboudumc.nl
• Study Contact Backup: Name: Bram Tilburgs, PhD; Phone Number: +31 24 361 4996; Email: bram.tilburgs@radboudumc.nl

Study Locations

• Netherlands
  • Alkmaar, Netherlands
    • Recruiting
    • Noordwest Ziekenhuisgroep
    • Contact: Wouter de Ruijter, MD, PhD
  • Bergen Op Zoom, Netherlands
    • Recruiting
    • Bravis Ziekenhuis
    • Contact: Bram Simons, MD
  • Breda, Netherlands
    • Recruiting
    • Amphia ziekenhuis
    • Contact: Thijs Rettig, MD, PhD
  • Helmond, Netherlands
    • Recruiting
    • Elkerliek Ziekenhuis
    • Contact: Rens van de Weyer, MD
  • Venlo, Netherlands
    • Recruiting
    • VieCuri Medisch Centrum
    • Contact: Quirine Habes, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
Incidence rate of falls out of bed	14 days

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Study Director: Mark van den Boogaard, PhD, Radboud University Medical Center; Principal Investigator: Bram Tilburgs, PhD, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 8, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: ICU; Dexmedetomidine; Agitation; Physical Restraints; Non-pharmacologic interventions
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation
• Other Study ID Numbers: 2022-16133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No