Keck School of Medicine of the University of Southern California
Los Angeles, California, 90033, United States
NCT Number: NCT03550495
Delirium affects up to 80% of intensive care unit (ICU) patients and is associated with longer hospital stays, increased morbidity and mortality, and increased costs. There is no FDA-approved treatment for delirium; the most effective strategy is prevention by nonpharmacological methods. The investigators propose to study a comprehensive delirium prevention bundle that has been effective against delirium in preliminary studies in elderly in-hospital patients and elderly ICU patients. This delirium prevention bundle includes the novel addition of psychiatrists to daily ICU rounds, as these professionals are specially trained to screen for latent mental illness and provide treatment for these illnesses. The effects of daily psychiatric evaluation of ICU patients has never been systematically studied, as ICU professionals are well-equipped to manage ICU delirium. Psychiatric consultation is reserved for severe and/or refractory cases of delirium. The investigators hypothesize that a multidisciplinary rounding approach including psychiatry within the ICU team will help diagnose psychiatric components that may contribute to delirium at an earlier time point, and thus can reduce the incidence and duration of delirium. The investigators also hypothesize that the proposed multidisciplinary approach will shorten hospital and ICU lengths of stay, duration of mechanical ventilation, and decrease in-hospital mortality.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Los Angeles, California, 90033, United States
This is a prospective, single institution, controlled pilot study of adult patients admitted to the surgical ICU. A sample size of 104 (52 per group) is targeted. Patients in the control group will undergo usual care which includes ABCDEF bundle (Appendix 1) use, including daily delirium screening using the CAM-ICU score (Appendix 2), but will not have routine psychiatric involvement. Patients in the intervention group will also have ABCDEF bundle performed, and additionally have psychiatry routinely participating in ICU rounds. A member of the psychiatry team (attending, resident, or fellow) will round with the surgical ICU team in the surgical ICU daily. On a daily basis, the ICU attending will review the list of the ICU patients with the psychiatry team to determine if there are any changes to the patient's management required.
Inclusion criteria
are: 1. any patient >18 years of age admitted to the surgical ICU for >48 hours; 2. Patients admitted to the ICU <24 hours who have been in the hospital >48 hours; 3. Patients who return to the ICU after being discharged from the ICU to the floor due a complication or need for higher acuity care. Exclusion criteria are: 1. Patients in whom CAM-ICU cannot be performed (severe dementia, stroke or other neurological condition, encephalopathy, mental retardation, severe psychiatric disorder, vegetative state, severe traumatic brain injury, deaf/blind, etc.); 2. Vulnerable patient populations (i.e. transplant recipients); 3. Patients who don't speak or understand English; 4. Current alcohol or substance abuse. Patients will be screened for eligibility on rounds daily. Study personnel will obtain informed written consent from patients or their families.
A psychiatry attending, psychiatry resident, or psychiatry nurse practitioner will round with the surgical ICU team on 7W daily until the target subject enrollment # of 52 is achieved. On a daily basis, the ICU attending will review the list of the ICU patients with the psychiatry team to determine if there are any changes to the patient's management required. The ABCDEF bundle will be implemented on daily rounds, which includes daily screening for delirium using the CAM-ICU scale.
Data which will be collected includes: age, gender, body mass index, history or alcohol or substance abuse, admitting diagnosis, dementia, comorbid conditions, admitting SOFA score, deliriogenic medications used during study enrollment, the interventions/medications used to treat delirium as designated by psychiatry (in intervention group) and the ICU team (control group), and the number of days from admission to study enrollment. Data on the incidence of ICU delirium, duration of delirium/mechanical ventilation, in-house mortality, ICU and total hospital length of stay will also be collected.
Descriptive statistics, including Student's t-test or Mann-Whitney U-test, for continuous variables and χ2 or Fisher's exact test, for categorical variables, will be used to summarize the data and compare characteristics between the 2 groups. The incidence of delirium will be compared using χ2 test and multivariable logistic regression. Differences in the duration of delirium and MV between the intervention and control groups will be analyzed by analysis of variance (ANOVA). The length of stay will be compared by truncated negative binomial regression, while mortality rates will be compared via logistic regression. A sensitivity analysis will be performed in order to assess the possible confounding effect of the non-randomized nature of our study design. A propensity score model for receipt of standard care vs. psychiatric involvement will be performed in order to approximate a balanced covariate distribution between the 2 groups as that would be expected by randomization. The investigators will then use the propensity score for each subject to perform an inverse probability weighted comparison of the groups on our trial outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
are:
OR
Exclusion criteria
are:
See arm description.
Time frame: Average of one year.
primary outcome measure is the incidence of ICU delirium.
Time frame: Average of one year.
Total days of delirium (even if they are non-consecutive).
Time frame: Average of one year.
Total days of hospital length of stay.
Time frame: Average of one year.
In days.
Time frame: Average of one year.
In-hospital mortality
Time frame: Average of one year.
Total days of ICU length of stay.
Time frame: Average of one year.
in years
Time frame: Average of one year.
male or female
Time frame: Average of one year.
weight and height will be used to calculate BMI in kg/m^2
Time frame: Average of one year.
any remote history; patients must be sober 6 months prior to study enrollment
Time frame: Average of one year.
Verbal admitting diagnosis (not using ICD codes)
Time frame: Average of one year.
yes or no
Time frame: Average of one year.
verbal list of other medical conditions
Time frame: Average of one year.
Use MDCalc to calculate score using: admitting PaO2 (mmHg), FiO2 (%), platelets (x10^3/mcL), glasgow coma scale (points 3-15), bilirubin (mg/dL), level of hypotension (0-4 point scale based on mean arterial pressure value in mmHg, and the number and doses of vasopressors the patient is on), Creatinine (point assigned from 0-4 based on creatinine values ranging from Cr<1.2 mg/dL to Cr>5mg/dL)
Time frame: Average of one year.
List of medications which are known to be deliriogenic as described in literature and the 2018 American Geriatric Society Beers criteria which are administered to the participant.
Time frame: Average of one year.
Description of intervention used to treat delirium (i.e. non pharmacological measures like family involvement) or medications (i.e. haloperidol). It will also be specified if the treatment was initiated by the ICU or psychiatry team.
Time frame: Average of one year.
In days
Time frame: Average of one year.
measured in meters-used for BMI calculation
Time frame: Average of one year.
Measured in kilograms (kg)-used for BMI calculation.
University of Southern California
Other
A Multidisciplinary Delirium Prevention Strategy Involving Psychiatry in the Intensive Care Unit (ICU): Effects on Delirium Incidence and Outcomes
Acronym: ICU
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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