ICU Triage Practices in a Cancer Hospital

February 27, 2018 updated by: M.D. Anderson Cancer Center

Intensive Care Unit (ICU) Triage Practices in a Cancer Hospital

The primary objective of this study is aimed at analyzing the ICU triage practices of clinicians at a cancer hospital with and without the use of an algorithm-based triage tool, and to assess whether or not the triage tool improves the consensus amongst practioners on the prioritization of patients for ICU admission. Secondary objectives include assessment of whether or not triage practices based on guidelines correlate with what is done in actual practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective study designed to evaluate the ICU triage practices of clinicians at MD Anderson Cancer Center using the standard Society of Critical Care Medicine Prioritization Model (SCCMP) versus a uniquely designed flowchart-based triage tool created specifically for the oncologic setting.

Study participants will initially receive either an email explaining the study and asking if they would agree to participate in the survey, or a hard copy of an identical letter. Their participation will remain anonymous, and will strictly be on a volunteer basis. If the participant wishes to participate, they will be given either a link to the survey using an institutionally improved electronic survey tool, or alternatively a hard copy of the survey with identical instructions.

The survey consists of 15 fictional patient case scenarios, and participants will be asked to use the modified SCCMP to prioritize each patient scenario into one of the 5-point likert-scale categories for admission. The participants will be randomized with 1:1 ratio to use either a) the standard SCCMP or b) the SCCMP in addition to a newly designed flowchart-based triage guide to prioritize each patient case scenario into one of the 5-point likert-scale categories.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
257

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ecuador
    • Manabí Province
      • Manta, Manabí Province, Ecuador
        • 5th International Oncology Course Conference
  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Latino-American Critical Care Trial Network (LACTIN)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

1) Study participant must be a health care provider who frequently refers or accepts oncologic patients to the ICU

Exclusion Criteria:

1) none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Standard SCCMP
Health care provider completes triage survey of 15 fictional patient case scenarios using the standard SCCMP to prioritize each for admission.
Behavioral: Survey
Survey of 15 fictional patient case scenarios to be assessed by participant using the standard prioritization or modified SCCMP to prioritize each patient scenario into one of a 5-point likert-scale categories for ICU admission. SCCMP scale categorized as 1-Critically ill to 4-Less likely to require ICU.
Other Names:
  • Society of Critical Care Medicine Prioritization Model
EXPERIMENTAL: SCCMP + Algorithm-based Triage Tool
Health care provider completes triage survey of 15 fictional patient case scenarios using SCCMP in addition to a newly designed flowchart-based triage guide to prioritize each for admission.
Behavioral: Survey
Survey of 15 fictional patient case scenarios to be assessed by participant using the standard prioritization or modified SCCMP to prioritize each patient scenario into one of a 5-point likert-scale categories for ICU admission. SCCMP scale categorized as 1-Critically ill to 4-Less likely to require ICU.
Other Names:
  • Society of Critical Care Medicine Prioritization Model
Behavioral: Algorithm-based Triage Tool
Newly designed flowchart-based triage guide to prioritize each patient case scenario into one of the 5-point likert-scale categories, used in conjunction with SCCMP for ICU admission.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Agreement among clinicians for each of triage tools: SCCMP Standard versus SCCMP + Algorithm-based Triage Tool
Time Frame: 20 minutes for participant survey completion

Survey responses used to evaluate the ICU triage practices of clinicians using the standard SCCMP versus a uniquely designed flowchart-based triage tool created specifically for the oncologic setting. Participants are randomized to use either a) the standard SCCMP or b) the SCCMP in addition to a newly designed flowchart-based triage guide to prioritize 15 fictional patient case scenarios into one of the 5-point likert-scale categories for admission.

SCCMP system defines those that will benefit most from the ICU (Priority 1) to those that will not benefit at all (Priority 4) from ICU admission. Reported proportion of clinicians choosing category i in the 5-point likert-scale, i=1, 2, 3, 4a or 4b, for a particular patient case. The range of the entropy is between 0 (perfect agreement among the clinicians) and 1.61 (total disagreement among the clinicians).
20 minutes for participant survey completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nisha Rathi, MD, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2009-0450

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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