A Multidisciplinary Delirium Prevention Strategy Involving Psychiatry in the ICU

NCT03550495 | Completed DMC

• 1 other identifier: HS-17-00617
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delirium

Keywords

ICU delirium; prevention; psychiatry

Outcome Measures

Primary Outcomes (1)

• Incidence of ICU delirium.

  primary outcome measure is the incidence of ICU delirium.

  Average of one year.

Secondary Outcomes (5)

• Duration of delirium.

  Average of one year.

• Hospital length of stay

  Average of one year.

• Total days of mechanical ventilation.

  Average of one year.

• In-hospital mortality

  Average of one year.

• ICU length of stay

  Average of one year.

Other Outcomes (13)

• Age

  Average of one year.

• Gender

  Average of one year.

• Body mass index (BMI)

  Average of one year.

Study Arms (2)

Control

NO INTERVENTION

Patients will undergo standard of care including the use of the ABCDEF bundle; psychiatry team will not be involved on daily ICU rounds.

Intervention

EXPERIMENTAL

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

Interventions

psychiatry involvement BEHAVIORAL

See arm description.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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 \[Defined as a positive CAM-ICU test, or based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition ( DSM-V) diagnostic criteria:
• Disturbance in attention (ie, reduced ability to direct, focus, sustain, and shift attention) and awareness.
• Change in cognition (eg, memory deficit, disorientation, language disturbance, perceptual disturbance) that is not better accounted for by a preexisting, established, or evolving dementia.
• The disturbance develops over a short period (usually hours to days) and tends to fluctuate during the course of the day.
• There is evidence from the history, physical examination, or laboratory findings that the disturbance is caused by a direct physiologic consequence of a general medical condition, an intoxicating substance, medication use, or more than one cause.\]

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck School of Medicine of the University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (31)

• Jackson P, Khan A. Delirium in critically ill patients. Crit Care Clin. 2015 Jul;31(3):589-603. doi: 10.1016/j.ccc.2015.03.011. Epub 2015 May 4.

  PMID: 26118922 RESULT

• Fong TG, Tulebaev SR, Inouye SK. Delirium in elderly adults: diagnosis, prevention and treatment. Nat Rev Neurol. 2009 Apr;5(4):210-20. doi: 10.1038/nrneurol.2009.24.

  PMID: 19347026 RESULT

• Brummel NE, Girard TD. Preventing delirium in the intensive care unit. Crit Care Clin. 2013 Jan;29(1):51-65. doi: 10.1016/j.ccc.2012.10.007.

  PMID: 23182527 RESULT

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  PMID: 15082703 RESULT

• van Eijk MM, van Marum RJ, Klijn IA, de Wit N, Kesecioglu J, Slooter AJ. Comparison of delirium assessment tools in a mixed intensive care unit. Crit Care Med. 2009 Jun;37(6):1881-5. doi: 10.1097/CCM.0b013e3181a00118.

  PMID: 19384206 RESULT

• Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.

  PMID: 23269131 RESULT

• Hayhurst CJ, Pandharipande PP, Hughes CG. Intensive Care Unit Delirium: A Review of Diagnosis, Prevention, and Treatment. Anesthesiology. 2016 Dec;125(6):1229-1241. doi: 10.1097/ALN.0000000000001378.

  PMID: 27748656 RESULT

• Salluh JI, Latronico N. Making advances in delirium research: coupling delirium outcomes research and data sharing. Intensive Care Med. 2015 Jul;41(7):1327-9. doi: 10.1007/s00134-015-3864-4. Epub 2015 Jun 3. No abstract available.

  PMID: 26077062 RESULT

• Zhang H, Lu Y, Liu M, Zou Z, Wang L, Xu FY, Shi XY. Strategies for prevention of postoperative delirium: a systematic review and meta-analysis of randomized trials. Crit Care. 2013 Mar 18;17(2):R47. doi: 10.1186/cc12566.

  PMID: 23506796 RESULT

• Ringdal GI, Ringdal K, Juliebo V, Wyller TB, Hjermstad MJ, Loge JH. Using the Mini-Mental State Examination to screen for delirium in elderly patients with hip fracture. Dement Geriatr Cogn Disord. 2011;32(6):394-400. doi: 10.1159/000335743. Epub 2012 Feb 1.

  PMID: 22301509 RESULT

• Roberts DJ, Goralski KB, Renton KW, Julien LC, Webber AM, Sleno L, Volmer DA, Hall RI. Effect of acute inflammatory brain injury on accumulation of morphine and morphine 3- and 6-glucuronide in the human brain. Crit Care Med. 2009 Oct;37(10):2767-74. doi: 10.1097/CCM.0b013e3181b755d5.

  PMID: 19865006 RESULT

• Collinsworth AW, Priest EL, Campbell CR, Vasilevskis EE, Masica AL. A Review of Multifaceted Care Approaches for the Prevention and Mitigation of Delirium in Intensive Care Units. J Intensive Care Med. 2016 Feb;31(2):127-41. doi: 10.1177/0885066614553925. Epub 2014 Oct 27.

  PMID: 25348864 RESULT

• Kalabalik J, Brunetti L, El-Srougy R. Intensive care unit delirium: a review of the literature. J Pharm Pract. 2014 Apr;27(2):195-207. doi: 10.1177/0897190013513804. Epub 2013 Dec 10.

  PMID: 24326408 RESULT

• Slooter AJ, Van De Leur RR, Zaal IJ. Delirium in critically ill patients. Handb Clin Neurol. 2017;141:449-466. doi: 10.1016/B978-0-444-63599-0.00025-9.

  PMID: 28190430 RESULT

• Abelha FJ, Luis C, Veiga D, Parente D, Fernandes V, Santos P, Botelho M, Santos A, Santos C. Outcome and quality of life in patients with postoperative delirium during an ICU stay following major surgery. Crit Care. 2013 Oct 29;17(5):R257. doi: 10.1186/cc13084.

  PMID: 24168808 RESULT

• Van Rompaey B, Schuurmans MJ, Shortridge-Baggett LM, Truijen S, Elseviers M, Bossaert L. Long term outcome after delirium in the intensive care unit. J Clin Nurs. 2009 Dec;18(23):3349-57. doi: 10.1111/j.1365-2702.2009.02933.x. Epub 2009 Sep 4.

  PMID: 19735334 RESULT

• Pisani MA, Kong SY, Kasl SV, Murphy TE, Araujo KL, Van Ness PH. Days of delirium are associated with 1-year mortality in an older intensive care unit population. Am J Respir Crit Care Med. 2009 Dec 1;180(11):1092-7. doi: 10.1164/rccm.200904-0537OC. Epub 2009 Sep 10.

  PMID: 19745202 RESULT

• Turnbull AE, Neufeld KJ, Needham DM. Contradictory findings on one-year mortality following ICU delirium. Crit Care. 2015 Jan 30;19(1):29. doi: 10.1186/s13054-015-0747-6. No abstract available.

  PMID: 25887540 RESULT

• Leslie DL, Inouye SK. The importance of delirium: economic and societal costs. J Am Geriatr Soc. 2011 Nov;59 Suppl 2(Suppl 2):S241-3. doi: 10.1111/j.1532-5415.2011.03671.x.

  PMID: 22091567 RESULT

• 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: 10.1097/CCM.0b013e31822e9fc9.

  PMID: 21926597 RESULT

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  PMID: 19687169 RESULT

• 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 cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.

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• Peris A, Bonizzoli M, Iozzelli D, Migliaccio ML, Zagli G, Bacchereti A, Debolini M, Vannini E, Solaro M, Balzi I, Bendoni E, Bacchi I, Trevisan M, Giovannini V, Belloni L. Early intra-intensive care unit psychological intervention promotes recovery from post traumatic stress disorders, anxiety and depression symptoms in critically ill patients. Crit Care. 2011;15(1):R41. doi: 10.1186/cc10003. Epub 2011 Jan 27.

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Related Links

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

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Catherine M Kuza, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: June 8, 2018
• Study Start: April 16, 2018
• Primary Completion: April 30, 2019
• Study Completion: June 1, 2019
• Last Updated: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)