The Impact of Nursing Delirium Preventive Interventions in the Intensive Care Unit (UNDERPIN-ICU)
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| ClinicalTrials.gov Identifier: NCT03002701 |
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Recruitment Status :
Completed
First Posted : December 26, 2016
Last Update Posted : October 9, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Delirium | Behavioral: UNDERPIN-ICU program | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1750 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | The Impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit (UNDERPIN-ICU): A Multi-centre, Stepped Wedge Randomized Controlled Trial |
| Actual Study Start Date : | December 31, 2016 |
| Actual Primary Completion Date : | May 31, 2019 |
| Actual Study Completion Date : | May 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Control - standard care
Prior to implementation of the intervention package the current standard of care will be maintained.
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Active Comparator: Intervention group
After implementation the intervention package will be implemented as standard care.
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Behavioral: UNDERPIN-ICU program
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. |
- 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.
- Delirium incidence [ Time Frame: 28 days ]One or more episodes of positive delirium screening after ICU admission.
- The number of days of survival [ Time Frame: 28 days ]The number of days survived since ICU admission.
- The number of days of survival [ Time Frame: 90 days ]The number of days survived since ICU admission.
- Duration of mechanical ventilation [ Time Frame: 28 days ]The number of days a patient was mechanically ventilated.
- Incidence of re-intubation [ Time Frame: 28 days ]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.
- Incidence of ICU re-admission [ Time Frame: 28 days ]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.
- Incidence of unplanned removal of tubes/catheters [ Time Frame: 28 days ]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.
- Incidence of physical restraints [ Time Frame: 28 days ]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.
- ICU length of stay [ Time Frame: 365 days ]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.
- Hospital length of stay [ Time Frame: 365 days ]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.
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002701
| Netherlands | |
| Radboud University Medical Center | |
| Nijmegen, Gelderland, Netherlands, 6500HB | |
| Haaglanden Medical Center location Westeinde | |
| Den Haag, Netherlands | |
| Hospital Gelderse Vallei | |
| Ede, Netherlands | |
| Medical Spectrum Twente | |
| Enschede, Netherlands | |
| Hospital St. Jansdal | |
| Harderwijk, Netherlands | |
| Medical Center Leeuwarden | |
| Leeuwarden, Netherlands | |
| Hospital ETZ location Elisabeth | |
| Tilburg, Netherlands | |
| Hospital ETZ location Tweesteden | |
| Tilburg, Netherlands | |
| Bernhoven Hospital | |
| Uden, Netherlands | |
| Maxima Medical Center | |
| Veldhoven, Netherlands | |
| ISALA clinics | |
| Zwolle, Netherlands | |
| Principal Investigator: | Mark van den Boogaard, PhD | Radboud University Medical Center |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Radboud University Medical Center |
| ClinicalTrials.gov Identifier: | NCT03002701 |
| Other Study ID Numbers: |
UNDERPIN-ICU |
| First Posted: | December 26, 2016 Key Record Dates |
| Last Update Posted: | October 9, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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Prevention Critical care Delirium Nurse RCT |
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Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Neurocognitive Disorders Mental Disorders |