Back to resultsA Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use (PRAISE)
Primary Purpose
Agitation,Psychomotor
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Multicomponent intervention program
Sponsored by
About this trial
This is an interventional treatment trial for Agitation,Psychomotor focused on measuring ICU, Agitation, Physical Restraints, Non-pharmacologic interventions, Dexmedetomidine
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.
Sites / Locations
- Noordwest ZiekenhuisgroepRecruiting
- Bravis ZiekenhuisRecruiting
- Amphia ZiekenhuisRecruiting
- Elkerliek ZiekenhuisRecruiting
- VieCuri Medisch CentrumRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment group
Control group
Arm Description
Multicomponent intervention program
Standard care
Outcomes
Primary Outcome Measures
ICU-free days
Secondary Outcome Measures
Incidence rate of accidentally removed medical devices
Incidence rate of (self-extubation induced) reintubations
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)
Days with coma
Assessed using the Richmond Agitation and Sedation Scale (RASS)
Number of delirium- and coma-free days
Days with physical restraints
Days with dexmedetomidine (and total administered dose)
Dexmedetomidine related adverse events (e.g., hypotension, bradycardia) that required intervention
Days with propofol (and total administered dose)
Duration of mechanical ventilation in days
Hospital length of stay in days
Mortality
Physical outcome
E.g., fatigue, frailty, new or worsened physical problems, assessed using validated questionnaires
Mental outcome
E.g., post traumatic stress disorder (PTSD), anxiety, depression, assessed using validated questionnaires
Cognitive outcome
E.g., cognitive impairment, assessed using a validated questionnaire
Quality of life
Assessed using a validated QoL questionnaire
Cost-effectiveness
Measured by cost per Quality-Adjusted Life Year (QALY)
Full Information
NCT ID
NCT05783505
First Posted
January 8, 2023
Last Updated
August 11, 2023
Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT05783505
Brief Title
A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use
Acronym
PRAISE
Official Title
PRevention of pAtient's agItation and Enhancement of Their SafEty (PRAISE): Improving Intensive Care Treatment Using a Multicomponent Pharmacological Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
4. Oversight
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
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation,Psychomotor
Keywords
ICU, Agitation, Physical Restraints, Non-pharmacologic interventions, Dexmedetomidine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter stepped wedge cluster randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Multicomponent intervention program
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Other
Intervention Name(s)
Multicomponent intervention program
Intervention Description
Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed
Primary Outcome Measure Information:
Title
ICU-free days
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Incidence rate of accidentally removed medical devices
Time Frame
14 days
Title
Incidence rate of (self-extubation induced) reintubations
Time Frame
14 days
Title
Days with delirium
Description
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
Title
Days with coma
Description
Assessed using the Richmond Agitation and Sedation Scale (RASS)
Time Frame
14 days
Title
Number of delirium- and coma-free days
Time Frame
14 days
Title
Days with physical restraints
Time Frame
14 days
Title
Days with dexmedetomidine (and total administered dose)
Time Frame
14 days
Title
Dexmedetomidine related adverse events (e.g., hypotension, bradycardia) that required intervention
Time Frame
14 days
Title
Days with propofol (and total administered dose)
Time Frame
14 days
Title
Duration of mechanical ventilation in days
Time Frame
up to 180 days
Title
Hospital length of stay in days
Time Frame
up to 180 days
Title
Mortality
Time Frame
at 28 days, 3 months and 12 months
Title
Physical outcome
Description
E.g., fatigue, frailty, new or worsened physical problems, assessed using validated questionnaires
Time Frame
at ICU admission, 3, 12 and 24 months
Title
Mental outcome
Description
E.g., post traumatic stress disorder (PTSD), anxiety, depression, assessed using validated questionnaires
Time Frame
at ICU admission 3, 12 and 24 months
Title
Cognitive outcome
Description
E.g., cognitive impairment, assessed using a validated questionnaire
Time Frame
at 3, 12 and 24 months
Title
Quality of life
Description
Assessed using a validated QoL questionnaire
Time Frame
at ICU admission, 3, 12 and 24 months
Title
Cost-effectiveness
Description
Measured by cost per Quality-Adjusted Life Year (QALY)
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Incidence rate of falls out of bed
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rens Kooken, MSc
Phone
+31 24 361 6735
Email
rens.kooken@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Bram Tilburgs, PhD
Phone
+31 24 361 4996
Email
bram.tilburgs@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bram Tilburgs, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark van den Boogaard, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Noordwest Ziekenhuisgroep
City
Alkmaar
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wouter de Ruijter, MD, PhD
Facility Name
Bravis Ziekenhuis
City
Bergen Op Zoom
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bram Simons, MD
Facility Name
Amphia Ziekenhuis
City
Breda
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thijs Rettig, MD, PhD
Facility Name
Elkerliek Ziekenhuis
City
Helmond
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rens van de Weyer, MD
Facility Name
VieCuri Medisch Centrum
City
Venlo
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quirine Habes, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
upon reasonable request
Learn more about this trial
A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use
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