A Multidisciplinary Delirium Prevention Strategy Involving Psychiatry in the ICU

Delirium Clinical Trial

— ICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03550495
• Other study ID #: HS-17-00617
• Status: Completed
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: March 2020
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 1, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria are:

1. Patients who are =18 years of age

2. Patients admitted to the surgical ICU for >48 hours OR

3. Patients admitted to the ICU <24 hours who have been in the hospital >48 hours

OR

4. Patients who return to the ICU after being discharged from the ICU to the floor due a complication or need for higher acuity care.

5. 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:

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. Patients who don't speak or understand English

3. Current alcohol or substance abuse

4. 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.]

Related Conditions & MeSH terms

• Delirium

Intervention

Behavioral:
• psychiatry involvement
See arm description.

Locations

Country	Name	City	State
United States	Keck School of Medicine of the University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (31)

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Beach SR, Chen DT, Huffman JC. Educational impact of a psychiatric liaison in the medical intensive care unit: effects on attitudes and beliefs of trainees and nurses regarding delirium. Prim Care Companion CNS Disord. 2013;15(3). pii: PCC.12m01499. doi: — View Citation

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Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitiv — View Citation

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van den Boogaard M, Schoonhoven L, Evers AW, van der Hoeven JG, van Achterberg T, Pickkers P. Delirium in critically ill patients: impact on long-term health-related quality of life and cognitive functioning. Crit Care Med. 2012 Jan;40(1):112-8. doi: 10.1 — View Citation

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	in years	Average of one year.
Other	Gender	male or female	Average of one year.
Other	Body mass index (BMI)	weight and height will be used to calculate BMI in kg/m^2	Average of one year.
Other	History of alcohol or substance abuse	any remote history; patients must be sober 6 months prior to study enrollment	Average of one year.
Other	Admitting diagnosis	Verbal admitting diagnosis (not using ICD codes)	Average of one year.
Other	Dementia	yes or no	Average of one year.
Other	Comorbid conditions	verbal list of other medical conditions	Average of one year.
Other	admitting Sequential Organ Failure Assessment (SOFA) score	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)	Average of one year.
Other	Use of deliriogenic medications	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.	Average of one year.
Other	Treatment of delirium	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.	Average of one year.
Other	Number of days from hospital admission to study enrollment	In days	Average of one year.
Other	height	measured in meters-used for BMI calculation	Average of one year.
Other	weight	Measured in kilograms (kg)-used for BMI calculation.	Average of one year.
Primary	Incidence of ICU delirium.	primary outcome measure is the incidence of ICU delirium.	Average of one year.
Secondary	Duration of delirium.	Total days of delirium (even if they are non-consecutive).	Average of one year.
Secondary	Hospital length of stay	Total days of hospital length of stay.	Average of one year.
Secondary	Total days of mechanical ventilation.	In days.	Average of one year.
Secondary	In-hospital mortality	In-hospital mortality	Average of one year.
Secondary	ICU length of stay	Total days of ICU length of stay.	Average of one year.

External Links

•   Guastelli LR et al. Integral patient care: mental health in a critical patient service