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Implementation of a Delirium Screening

Primary Purpose

Delirium, Cancer, Bone Marrow Ablation

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Delirium Screen
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Delirium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    ICU Length of Stay (LOS)
    Patient's length of stay in the ICU

    Secondary Outcome Measures

    Overall LOS in hospital
    Patient's length of stay in hospital
    Sedation Medication
    Total amount of sedating medication given to patient during their hospitalization.

    Full Information

    First Posted
    November 17, 2017
    Last Updated
    May 29, 2018
    Sponsor
    University of Miami
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03360474
    Brief Title
    Implementation of a Delirium Screening
    Official Title
    The Implementation of a Delirium Screening and Intervention Protocol for Critically Ill Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Changed to a QI project
    Study Start Date
    June 2018 (Anticipated)
    Primary Completion Date
    August 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Miami

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Delirium, Cancer, Bone Marrow Ablation

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Delirium Screen
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    ICU Length of Stay (LOS)
    Description
    Patient's length of stay in the ICU
    Time Frame
    60 days
    Secondary Outcome Measure Information:
    Title
    Overall LOS in hospital
    Description
    Patient's length of stay in hospital
    Time Frame
    60 days
    Title
    Sedation Medication
    Description
    Total amount of sedating medication given to patient during their hospitalization.
    Time Frame
    60 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria Rueda-Lara, MD
    Organizational Affiliation
    SCCC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. 5th ED. Washington, DC: American Psychiatric Association; 2013.
    Results Reference
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    PubMed Identifier
    17102966
    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.
    Results Reference
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    11797025
    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.
    Results Reference
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    PubMed Identifier
    12752832
    Citation
    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.
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    Citation
    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.
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    Citation
    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.
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    Citation
    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
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    Implementation of a Delirium Screening

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