Implementation of a Delirium Screening

NCT03360474 | Withdrawn

• 1 other identifier: 20170784
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this project is to improve patient outcomes in individuals affected by cancer, through the implementation of a delirium screening and treatment protocol in the ICU setting. The hypothesis is that patients who receive an accurate and early diagnosis of delirium coupled with a standardized intervention protocol will demonstrate improved patient outcomes as evidenced by fewer days spent in the ICU, fewer days spent in the hospital (overall length of stay) and the need for less sedative medication throughout their ICU stay as compared to patient data prior to the implementation of a delirium protocol.

Conditions

Delirium; Cancer; Bone Marrow Ablation

Outcome Measures

Primary Outcomes (1)

• ICU Length of Stay (LOS)

  Patient's length of stay in the ICU

  60 days

Secondary Outcomes (2)

• Overall LOS in hospital

  60 days

• Sedation Medication

  60 days

Study Arms (1)

Intervention

EXPERIMENTAL

Patients will be placed on the delirium screening intervention protocol arm. They will be screened for delirium twice per day. If positive, they will follow the treatment algorithm and assessed at 4 hour intervals until they reach 4 negative screens. Once 4 negative screens have been reached, they will be assessed twice daily.

Behavioral: Delirium Screen

Interventions

Delirium Screen BEHAVIORAL

Patients who screen positive for delirium will be assessed for pain, electrolyte imbalances,infection, the use of deliriogenic medications and any issues will be resolved. Those with persistent delirium following all other intervention will be treated with antipsychotic medication.

Intervention

Eligibility Criteria

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

You may qualify if:

• Patients will be included into the study who:
• Are over 18 years old
• Speak and read English
• Are admitted to the Sylvester Comprehensive Cancer Center intensive care unit in the first 60 days following implementation of the delirium protocol; approximately 10 patients per month.
• Patient data via electronic medical record (EMR) for all patients who were admitted to the Sylvester Comprehensive Cancer Center intensive care unit up to 60 days prior to the implementation of the delirium protocol.

You may not qualify if:

• This study will exclude:
• Patients who are unable to speak and read English
• Patients who are unable to provide written consent to participate.
• Patient data via EMR for any patients who were admitted to the Sylvester Comprehensive Cancer Center intensive care unit prior to 60 days before to the implementation of the delirium protocol.

Sponsors & Collaborators

• University of Miami: lead

Related Publications (16)

• Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. 5th ED. Washington, DC: American Psychiatric Association; 2013.

  BACKGROUND

• Ouimet S, Kavanagh BP, Gottfried SB, Skrobik Y. Incidence, risk factors and consequences of ICU delirium. Intensive Care Med. 2007 Jan;33(1):66-73. doi: 10.1007/s00134-006-0399-8. Epub 2006 Nov 11.

  PMID: 17102966 BACKGROUND

• Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. doi: 10.1007/s00134-001-1132-2. Epub 2001 Nov 8.

  PMID: 11797025 BACKGROUND

• McNicoll L, Pisani MA, Zhang Y, Ely EW, Siegel MD, Inouye SK. Delirium in the intensive care unit: occurrence and clinical course in older patients. J Am Geriatr Soc. 2003 May;51(5):591-8. doi: 10.1034/j.1600-0579.2003.00201.x.

  PMID: 12752832 BACKGROUND

• Pandharipande P, Cotton BA, Shintani A, Thompson J, Pun BT, Morris JA Jr, Dittus R, Ely EW. Prevalence and risk factors for development of delirium in surgical and trauma intensive care unit patients. J Trauma. 2008 Jul;65(1):34-41. doi: 10.1097/TA.0b013e31814b2c4d.

  PMID: 18580517 BACKGROUND

• Breitbart W, Alici Y. Evidence-based treatment of delirium in patients with cancer. J Clin Oncol. 2012 Apr 10;30(11):1206-14. doi: 10.1200/JCO.2011.39.8784. Epub 2012 Mar 12.

  PMID: 22412123 BACKGROUND

• 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 BACKGROUND

• Brummel, N., Jackson, J., Torres, R. et al: Does duration of ICU delirium predict long-term functional impairment? Am J. Respir Crit Care Med 2011; 183: A2653

  BACKGROUND

• Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.

  PMID: 15082703 BACKGROUND

• Spronk PE, Riekerk B, Hofhuis J, Rommes JH. Occurrence of delirium is severely underestimated in the ICU during daily care. Intensive Care Med. 2009 Jul;35(7):1276-80. doi: 10.1007/s00134-009-1466-8. Epub 2009 Apr 7.

  PMID: 19350214 BACKGROUND

• Pandharipande P, Cotton BA, Shintani A, Thompson J, Costabile S, Truman Pun B, Dittus R, Ely EW. Motoric subtypes of delirium in mechanically ventilated surgical and trauma intensive care unit patients. Intensive Care Med. 2007 Oct;33(10):1726-31. doi: 10.1007/s00134-007-0687-y. Epub 2007 Jun 5.

  PMID: 17549455 BACKGROUND

• 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 BACKGROUND

• 0-10 Numeric Pain Rating Scale: From McCaffery M, Pasero C. Pain: Clinical Manual, St. Louis, 1999, P. 16.

  BACKGROUND

• Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

  PMID: 9220806 BACKGROUND

• Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.

  PMID: 12421743 BACKGROUND

• Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91. doi: 10.1001/jama.289.22.2983.

  PMID: 12799407 BACKGROUND

MeSH Terms

Conditions

Delirium; Neoplasms

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

• Maria Rueda-Lara, MD

  SCCC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Profesor of Clinical Psychiatry

Model Details: Descriptive analysis will be conducted on demographic (e.g., age, gender) variables to report characteristics of the sample. The data to be collected are reflected in the attached measures. Days spent in the ICU and total days spent in the hospital will be analyzed using standard t-tests to assess difference in length of stay in ICU and overall hospitalization for 60 days prior to initiation of the delirium protocol and 60 days following the initiation of the protocol.

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: December 4, 2017
• Study Start: June 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 31, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share