Agitation,PsychomotorPRAISENCT05783505
A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use
A study testing Multicomponent intervention program in people with Agitation,Psychomotor, run by Radboud University Medical Center at 5 sites in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Agitation,Psychomotor
- What is being tested?
- Multicomponent intervention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 5 sitesNetherlands
- Study dates
- 1 Jun 2023to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Netherlands5 sites, 5 recruiting
- Recruiting
Noordwest Ziekenhuisgroep
Alkmaar
Wouter de Ruijter, MD, PhD
- Recruiting
Bravis Ziekenhuis
Bergen op Zoom
Bram Simons, MD
- Recruiting
Amphia Ziekenhuis
Breda
Thijs Rettig, MD, PhD
- Recruiting
Elkerliek Ziekenhuis
Helmond
Rens van de Weyer, MD
- Recruiting
VieCuri Medisch Centrum
Venlo
Quirine Habes, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Agitation,Psychomotor
- Being tested
- Multicomponent intervention program
- Keywords
- ICU, Agitation, Physical Restraints, Non-pharmacologic interventions, Dexmedetomidine
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent intervention programOther
Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Multicomponent intervention program Receives: Other: Multicomponent intervention program |
| Control group | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU-free days
Measured: 28 days
Secondary outcomes (17)
Incidence rate of accidentally removed medical devices
Measured: 14 days
Incidence rate of (self-extubation induced) reintubations
Measured: 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)
Measured: 14 days
Days with coma
Assessed using the Richmond Agitation and Sedation Scale (RASS)
Measured: 14 days
Number of delirium- and coma-free days
Measured: 14 days
Days with physical restraints
Measured: 14 days
Days with dexmedetomidine (and total administered dose)
Measured: 14 days
Dexmedetomidine related adverse events (e.g., hypotension, bradycardia) that required intervention
Measured: 14 days
Days with propofol (and total administered dose)
Measured: 14 days
Duration of mechanical ventilation in days
Measured: up to 180 days
Hospital length of stay in days
Measured: up to 180 days
Mortality
Measured: at 28 days, 3 months and 12 months
Physical outcome
E.g., fatigue, frailty, new or worsened physical problems, assessed using validated questionnaires
Measured: at ICU admission, 3, 12 and 24 months
Mental outcome
E.g., post traumatic stress disorder (PTSD), anxiety, depression, assessed using validated questionnaires
Measured: at ICU admission 3, 12 and 24 months
Cognitive outcome
E.g., cognitive impairment, assessed using a validated questionnaire
Measured: at 3, 12 and 24 months
Quality of life
Assessed using a validated QoL questionnaire
Measured: at ICU admission, 3, 12 and 24 months
Cost-effectiveness
Measured by cost per Quality-Adjusted Life Year (QALY)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Jun 2023
- Primary completion1 Oct 2025
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Agitation,PsychomotorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter stepped wedge cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Bram Tilburgs, PhD, Principal investigator, Radboud University Medical CenterMark van den Boogaard, PhD, Study director, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783505
- Sponsor's protocol ID
- 2022-16133
- Acronym
- PRAISE
- Status last verified
- Aug 2026
- First submitted
- 8 Jan 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon reasonable request
Publications
Kooken RWJ, Tilburgs B, Ter Heine R, Ramakers B, van den Boogaard M; PRAISE study group. A multicomponent intervention program to Prevent and Reduce AgItation and phySical rEstraint use in the ICU (PRAISE): study protocol for a multicenter, stepped-wedge, cluster randomized controlled trial. Trials. 2023 Dec 11;24(1):800. doi: 10.1186/s13063-023-07807-x.
PubMed 38082351
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRevention of pAtient's agItation and Enhancement of Their SafEty (PRAISE): Improving Intensive Care Treatment Using a Multicomponent Pharmacological Intervention
- ClinicalTrials.gov ID
- NCT05783505
- Acronym / sponsor ID
- PRAISE / 2022-16133
- Conditions
- Agitation,Psychomotor
- Keywords
- ICU, Agitation, Physical Restraints, Non-pharmacologic interventions, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter stepped wedge cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Multicomponent intervention programMulticomponent intervention program |
| Control group | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent intervention programNon-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed | Other | Treatment group |
Primary outcome
ICU-free days
Time frame: 28 days
17 secondary outcomes
Incidence rate of accidentally removed medical devices
Time frame: 14 days
Incidence rate of (self-extubation induced) reintubations
Time frame: 14 days
Days with delirium
Time frame: 14 days
Days with coma
Time frame: 14 days
Number of delirium- and coma-free days
Time frame: 14 days
Days with physical restraints
Time frame: 14 days
Days with dexmedetomidine (and total administered dose)
Time frame: 14 days
Dexmedetomidine related adverse events (e.g., hypotension, bradycardia) that required intervention
Time frame: 14 days
Days with propofol (and total administered dose)
Time frame: 14 days
Duration of mechanical ventilation in days
Time frame: up to 180 days
Hospital length of stay in days
Time frame: up to 180 days
Mortality
Time frame: at 28 days, 3 months and 12 months
Physical outcome
Time frame: at ICU admission, 3, 12 and 24 months
Mental outcome
Time frame: at ICU admission 3, 12 and 24 months
Cognitive outcome
Time frame: at 3, 12 and 24 months
Quality of life
Time frame: at ICU admission, 3, 12 and 24 months
Cost-effectiveness
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 38082351Kooken RWJ, Tilburgs B, Ter Heine R, Ramakers B, van den Boogaard M; PRAISE study group. A multicomponent intervention program to Prevent and Reduce AgItation and phySical rEstraint use in the ICU (PRAISE): study protocol for a multicenter, stepped-wedge, cluster randomized controlled trial. Trials. 2023 Dec 11;24(1):800. doi: 10.1186/s13063-023-07807-x.
- Individual participant dataSharing planned: Yes. upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bram Tilburgs, PhD principal investigator
Radboud University Medical Center
Mark van den Boogaard, PhD study director
Radboud University Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent intervention program in people with Agitation,Psychomotor, run by Radboud University Medical Center at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rens Kooken, MSc (+31 24 361 6735, rens.kooken@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU-free days (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05783505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.