Clinical trial NCT03360474: Implementation of a Delirium Screening
Official title: The Implementation of a Delirium Screening and Intervention Protocol for Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Delirium
Cancer
Bone Marrow Ablation
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: ICU Length of Stay (LOS)
timeFrame: 60 days
Secondary outcomes:
measure: Overall LOS in hospital
timeFrame: 60 days
measure: Sedation Medication
timeFrame: 60 days
Other outcomes:
Locations:
Study officials:
affiliation: SCCC
name: Maria Rueda-Lara, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. 5th ED. Washington, DC: American Psychiatric Association; 2013.
citation: 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.
citation: 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.
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citation: 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.
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