DeliriumUNDERPIN-ICUNCT03002701
The Impact of Nursing Delirium Preventive Interventions in the Intensive Care Unit
A study testing UNDERPIN-ICU program in people with Delirium, run by Radboud University Medical Center at 11 sites in Netherlands.
Trial summary
Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with serious short- and long-term consequences. This study focuses on a program of standardized nursing and physical therapy interventions to prevent delirium in the ICU, and determines the effect of the program on the number of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- UNDERPIN-ICU program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,750 participants
- Where
- 11 sitesNetherlands
- Study dates
- 31 Dec 2016to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- aged ≥ 18 years
- surgical, medical or trauma patients
- admitted to one of the participating ICUs
- at high risk for delirium (>35% determined with the E-PRE-DELIRIC prediction tool)
Who cannot join
- delirious before ICU admission
- an ICU stay < one day
- reliable assessment for delirium is not possible due to: sustained coma; serious auditory or visual disorders; inability to understand Dutch; severely mentally disabled; serious receptive aphasia.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Netherlands11 sites
Hospital Gelderse Vallei
Ede
Medical Spectrum Twente
Enschede
Hospital St. Jansdal
Harderwijk
Medical Center Leeuwarden
Leeuwarden
Radboud University Medical Center
Nijmegen, Gelderland, 6500HB
Haaglanden Medical Center location Westeinde
The Hague
Hospital ETZ location Elisabeth
Tilburg
Hospital ETZ location Tweesteden
Tilburg
Bernhoven Hospital
Uden
Maxima Medical Center
Veldhoven
ISALA clinics
Zwolle
About this study
Official title: The Impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit (UNDERPIN-ICU): A Multi-centre, Stepped Wedge Randomized Controlled Trial
Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with serious short- and long-term consequences. This study focuses on a program of standardized nursing and physical therapy interventions to prevent delirium in the ICU, and determines the effect of the program on the number of delirium-coma-free days in 28 days and several secondary outcomes in a multicenter randomized controlled trial.
Read the detailed description
Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with serious short- and long-term consequences, including re-intubations, ICU readmissions, prolonged ICU and hospital stay, persistent cognitive problems, and higher mortality rates. Considering the high incidence of delirium and its consequences, prevention of delirium is imperative. This study focuses on a program of standardized nursing and physical therapy interventions to prevent delirium in the ICU, called UNDERPIN-ICU (nUrsiNg DEliRium Preventive INterventions in the ICU).
Objective: To determine the effect of the UNDERPIN-ICU program on the number of delirium-coma-free days in 28 days and several secondary outcomes, such as delirium incidence, the number of days of survival in 28 and 90 days and delirium-related outcomes.
Design and Setting: A multicenter stepped wedge cluster randomized controlled trial.
Methods: Eight to ten Dutch ICUs will implement the UNDERPIN-ICU program in a randomized order. Every two months the UNDERPIN-ICU program will be implemented in an additional ICU following a two months period of staff training. UNDERPIN-ICU consists of standardized protocols focusing on several modifiable risk factors for delirium, including cognitive impairment, sleep deprivation, immobility and visual and hearing impairment.
Participants: ICU patients aged ≥ 18 years (surgical, medical, or trauma) and at high risk for delirium, E-PRE-DELIRIC ≥35%, will be included, unless delirium was detected prior ICU admission, expected length of ICU stay is less then one day or when delirium assessment is not possible.
- Conditions
- Delirium
- Being tested
- UNDERPIN-ICU program
- Keywords
- Prevention, Critical care, Delirium, Nurse, RCT
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNDERPIN-ICU programBehavioural
UNDERPIN-ICU consists of standardized protocols focusing on several modifiable risk factors for delirium, including cognitive impairment, sleep deprivation, immobility and visual and hearing impairment.
| Study group | Role | What they receive |
|---|---|---|
| Control - standard care | No intervention | Prior to implementation of the intervention package the current standard of care will be maintained. |
| Intervention group | Active comparator | After implementation the intervention package will be implemented as standard care. Receives: Behavioral: UNDERPIN-ICU program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of delirium-coma-free days
The number of days a patient is not delirious and not in coma in 28 days starting from the day of inclusion in the study after ICU admission.
Measured: 28 days
Secondary outcomes (14)
Delirium incidence
One or more episodes of positive delirium screening after ICU admission.
Measured: 28 days
The number of days of survival
The number of days survived since ICU admission.
Measured: 28 days
The number of days of survival
The number of days survived since ICU admission.
Measured: 90 days
Duration of mechanical ventilation
The number of days a patient was mechanically ventilated.
Measured: 28 days
Incidence of re-intubation
Patients who need to be intubated within 28 days after ICU admission, following a previous extubation, irrespectively the reason for re-intubation, will be counted as incident case for re-intubation.
Measured: 28 days
Incidence of ICU re-admission
Patients who need to be readmitted to the ICU within 28 days, irrespectively the reason for readmission, will be counted as incident cases for ICU readmission.
Measured: 28 days
Incidence of unplanned removal of tubes/catheters
Incidents in which patients remove their tube or catheter themselves will be counted as incident cases for unplanned removal. The period in which this is measured is during patients' ICU stay or during the period when the patient is delirious (in case a patient is discharged to the ward) with a maximum of 28 days.
Measured: 28 days
Incidence of physical restraints
Patients who need physical restraints (fixation of their limbs to prevent them from removing tubes or lines) within 28 days, will be counted as incident cases for physical restraints.
Measured: 28 days
ICU length of stay
This is defined as the number of days a patient is admitted to the ICU. Hospital length of stay is defined as number of days a patient is admitted to the hospital.
Measured: 365 days
Hospital length of stay
This is defined as the number of days a patient is admitted to the ICU. Hospital length of stay is defined as number of days a patient is admitted to the hospital.
Measured: 365 days
Health related quality of Life (HRQoL)
Measured: 90 days after ICU admission
Health related quality of Life (HRQoL)
Measured: 365 days after ICU admission
Post-hoc analysis
Measured: During admission
Cost-effectiveness
Measured: During ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study start31 Dec 2016
- Primary completion31 May 2019
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,750 participants (actual)
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
- Mark van den Boogaard, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002701
- Sponsor's protocol ID
- UNDERPIN-ICU
- Acronym
- UNDERPIN-ICU
- Status last verified
- Oct 2020
- First submitted
- 25 Nov 2016
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Wassenaar A, Rood P, Schoonhoven L, Teerenstra S, Zegers M, Pickkers P, van den Boogaard M. The impact of nUrsiNg DEliRium Preventive INnterventions in the Intensive Care Unit (UNDERPIN-ICU): A study protocol for a multi-centre, stepped wedge randomized controlled trial. Int J Nurs Stud. 2017 Mar;68:1-8. doi: 10.1016/j.ijnurstu.2016.11.018. Epub 2016 Dec 8.
PubMed 28013104Tilburgs B, Rood PJT, Zegers M, van den Boogaard M; UNDERPIN-ICU study group. The implementation of nUrsiNg DEliRium preventive INterventions in the Intensive Care Unit (UNDERPIN-ICU): A qualitative evaluation. Int J Nurs Stud. 2023 Jan;137:104386. doi: 10.1016/j.ijnurstu.2022.104386. Epub 2022 Nov 8.
PubMed 36427481Rood PJT, Zegers M, Ramnarain D, Koopmans M, Klarenbeek T, Ewalds E, van der Steen MS, Oldenbeuving AW, Kuiper MA, Teerenstra S, Adang E, van Loon LM, Wassenaar A, Vermeulen H, Pickkers P, van den Boogaard M; UNDERPIN-ICU Study Investigators. The Impact of Nursing Delirium Preventive Interventions in the ICU: A Multicenter Cluster-randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2021 Sep 15;204(6):682-691. doi: 10.1164/rccm.202101-0082OC.
PubMed 34170798
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit (UNDERPIN-ICU): A Multi-centre, Stepped Wedge Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03002701
- Acronym / sponsor ID
- UNDERPIN-ICU / UNDERPIN-ICU
- Conditions
- Delirium
- Keywords
- Prevention, Critical care, Delirium, Nurse, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,750 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 31 Dec 2016 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 26 Dec 2016 (estimated)
- 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.
Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with serious short- and long-term consequences. This study focuses on a program of standardized nursing and physical therapy interventions to prevent delirium in the ICU, and determines the effect of the program on the number of delirium-coma-free days in 28 days and several secondary outcomes in a multicenter randomized controlled trial.
Detailed description
Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with serious short- and long-term consequences, including re-intubations, ICU readmissions, prolonged ICU and hospital stay, persistent cognitive problems, and higher mortality rates. Considering the high incidence of delirium and its consequences, prevention of delirium is imperative. This study focuses on a program of standardized nursing and physical therapy interventions to prevent delirium in the ICU, called UNDERPIN-ICU (nUrsiNg DEliRium Preventive INterventions in the ICU).
Objective: To determine the effect of the UNDERPIN-ICU program on the number of delirium-coma-free days in 28 days and several secondary outcomes, such as delirium incidence, the number of days of survival in 28 and 90 days and delirium-related outcomes.
Design and Setting: A multicenter stepped wedge cluster randomized controlled trial.
Methods: Eight to ten Dutch ICUs will implement the UNDERPIN-ICU program in a randomized order. Every two months the UNDERPIN-ICU program will be implemented in an additional ICU following a two months period of staff training. UNDERPIN-ICU consists of standardized protocols focusing on several modifiable risk factors for delirium, including cognitive impairment, sleep deprivation, immobility and visual and hearing impairment.
Participants: ICU patients aged ≥ 18 years (surgical, medical, or trauma) and at high risk for delirium, E-PRE-DELIRIC ≥35%, will be included, unless delirium was detected prior ICU admission, expected length of ICU stay is less then one day or when delirium assessment is not possible.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - standard care | No intervention | –Prior to implementation of the intervention package the current standard of care will be maintained. |
| Intervention group | Active comparator | Behavioral: UNDERPIN-ICU programAfter implementation the intervention package will be implemented as standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged ≥ 18 years
- surgical, medical or trauma patients
- admitted to one of the participating ICUs
- at high risk for delirium (>35% determined with the E-PRE-DELIRIC prediction tool)
Key exclusion criteria (3 listed)
- delirious before ICU admission
- an ICU stay < one day
- reliable assessment for delirium is not possible due to: sustained coma; serious auditory or visual disorders; inability to understand Dutch; severely mentally disabled; serious receptive aphasia.
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 |
|---|---|---|
| UNDERPIN-ICU programUNDERPIN-ICU consists of standardized protocols focusing on several modifiable risk factors for delirium, including cognitive impairment, sleep deprivation, immobility and visual and hearing impairment. | Behavioural | Intervention group |
Primary outcome
The number of delirium-coma-free days
Time frame: 28 days
The number of days a patient is not delirious and not in coma in 28 days starting from the day of inclusion in the study after ICU admission.
14 secondary outcomes
Delirium incidence
Time frame: 28 days
The number of days of survival
Time frame: 28 days
The number of days of survival
Time frame: 90 days
Duration of mechanical ventilation
Time frame: 28 days
Incidence of re-intubation
Time frame: 28 days
Incidence of ICU re-admission
Time frame: 28 days
Incidence of unplanned removal of tubes/catheters
Time frame: 28 days
Incidence of physical restraints
Time frame: 28 days
ICU length of stay
Time frame: 365 days
Hospital length of stay
Time frame: 365 days
Health related quality of Life (HRQoL)
Time frame: 90 days after ICU admission
Health related quality of Life (HRQoL)
Time frame: 365 days after ICU admission
Post-hoc analysis
Time frame: During admission
Cost-effectiveness
Time frame: During ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Results publication: PubMed 28013104Wassenaar A, Rood P, Schoonhoven L, Teerenstra S, Zegers M, Pickkers P, van den Boogaard M. The impact of nUrsiNg DEliRium Preventive INnterventions in the Intensive Care Unit (UNDERPIN-ICU): A study protocol for a multi-centre, stepped wedge randomized controlled trial. Int J Nurs Stud. 2017 Mar;68:1-8. doi: 10.1016/j.ijnurstu.2016.11.018. Epub 2016 Dec 8.
- Derived from this study: PubMed 36427481Tilburgs B, Rood PJT, Zegers M, van den Boogaard M; UNDERPIN-ICU study group. The implementation of nUrsiNg DEliRium preventive INterventions in the Intensive Care Unit (UNDERPIN-ICU): A qualitative evaluation. Int J Nurs Stud. 2023 Jan;137:104386. doi: 10.1016/j.ijnurstu.2022.104386. Epub 2022 Nov 8.
- Derived from this study: PubMed 34170798Rood PJT, Zegers M, Ramnarain D, Koopmans M, Klarenbeek T, Ewalds E, van der Steen MS, Oldenbeuving AW, Kuiper MA, Teerenstra S, Adang E, van Loon LM, Wassenaar A, Vermeulen H, Pickkers P, van den Boogaard M; UNDERPIN-ICU Study Investigators. The Impact of Nursing Delirium Preventive Interventions in the ICU: A Multicenter Cluster-randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2021 Sep 15;204(6):682-691. doi: 10.1164/rccm.202101-0082OC.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Mark van den Boogaard, PhD principal investigator
Radboud University Medical Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UNDERPIN-ICU program in people with Delirium, run by Radboud University Medical Center at 11 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of delirium-coma-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 NCT03002701, which also lists 3 linked publications.
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 9 Oct 2020.