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

Sponsor

Radboud University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05783505

Collaborator

ZonMw: The Netherlands Organisation for Health Research and Development (Other)

480

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Agitation,Psychomotor	Other: Multicomponent intervention program	N/A

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restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated.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

Study Type:

Interventional

Anticipated Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Multicenter stepped wedge cluster randomized controlled trialMulticenter stepped wedge cluster randomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Treatment group

Multicomponent intervention program

Other: Multicomponent intervention program

Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed

No Intervention: Control group

Standard care

Outcome Measures

Primary Outcome Measures

ICU-free days [28 days]

Secondary Outcome Measures

Incidence rate of accidentally removed medical devices [14 days]
Incidence rate of (self-extubation induced) reintubations [14 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)
Days with coma [14 days]
Assessed using the Richmond Agitation and Sedation Scale (RASS)
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 [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
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
Cost-effectiveness [12 months]
Measured by cost per Quality-Adjusted Life Year (QALY)

Other Outcome Measures

Incidence rate of falls out of bed [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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);
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.

Contacts and Locations

Locations

	Site	City	Country
1	Noordwest Ziekenhuisgroep	Alkmaar	Netherlands
2	Bravis Ziekenhuis	Bergen Op Zoom	Netherlands
3	Amphia Ziekenhuis	Breda	Netherlands
4	Zuyderland Ziekenhuis	Heerlen	Netherlands
5	Elkerliek Ziekenhuis	Helmond	Netherlands