A Multidisciplinary Delirium Prevention Strategy Involving Psychiatry in the ICU

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multidisciplinary Delirium Prevention Strategy Involving Psychiatry in the Intensive Care Unit (ICU): Effects on Delirium Incidence and Outcomes

Conditions
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Delirium

Intervention / Treatment
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* Behavioral: psychiatry involvement


Participation Criteria
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Eligibility Criteria
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Inclusion criteria are: Patients who are ≥18 years of age Patients admitted to the surgical ICU for >48 hours OR Patients admitted to the ICU <24 hours who have been in the hospital >48 hours OR Patients who return to the ICU after being discharged from the ICU to the floor due a complication or need for higher acuity care. Patients admitted to any surgical service who are receiving care in the 7 West surgical ICU, who are either medically or conservatively managed (non-surgical) or surgically managed as part of their care Exclusion criteria are: 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.) Patients who don't speak or understand English Current alcohol or substance abuse Patients who already have delirium within 24-48 hours of their ICU admission [Defined as a positive CAM-ICU test, or based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition ( DSM-V) diagnostic criteria: Disturbance in attention (ie, reduced ability to direct, focus, sustain, and shift attention) and awareness. Change in cognition (eg, memory deficit, disorientation, language disturbance, perceptual disturbance) that is not better accounted for by a preexisting, established, or evolving dementia. The disturbance develops over a short period (usually hours to days) and tends to fluctuate during the course of the day. There is evidence from the history, physical examination, or laboratory findings that the disturbance is caused by a direct physiologic consequence of a general medical condition, an intoxicating substance, medication use, or more than one cause.]

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective, single institution, controlled, pilot study of patients admitted to the 7W ICU which will compare the incidence and delirium rates among patients undergoing routine care before intervention (no routine psychiatric involvement) (control group) and patients after the intervention (psychiatry team rounding with the ICU team daily) (intervention group) . Randomization is not possible for this study; although block randomization was considered, it will result in sub-optimal data subject to bias.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients will undergo standard of care including the use of the ABCDEF bundle; psychiatry team will not be involved on daily ICU rounds. | |
| Experimental: Intervention<br>Patients will receive standard ICU care, including the use of the ABCDEF bundle, but will also receive the intervention of psychiatry involvement; the psychiatry team will participate in daily ICU rounds with the ICU team to help identify, prevent, and treat ICU delirium and identify other psychiatric disorders which may be otherwise undetected by the ICU team. | Behavioral: psychiatry involvement<br>* See arm description.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ICU delirium. | primary outcome measure is the incidence of ICU delirium. | Average of one year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of delirium. | Total days of delirium (even if they are non-consecutive). | Average of one year. | 
| Hospital length of stay | Total days of hospital length of stay. | Average of one year. | 
| Total days of mechanical ventilation. | In days. | Average of one year. | 
| In-hospital mortality | In-hospital mortality | Average of one year. | 
| ICU length of stay | Total days of ICU length of stay. | Average of one year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU delirium, prevention, psychiatry