Intensive Care UnitsNCT03401411
ICU Triage Practices in a Cancer Hospital
A study testing Survey and Algorithm-based Triage Tool in people with Intensive Care Units and Triage, run by M.D. Anderson Cancer Center at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intensive Care Units, Triage
- What is being tested?
- Survey and Algorithm-based Triage Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 17 Nov 2014to 20 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1) Study participant must be a health care provider who frequently refers or accepts oncologic patients to the ICU
Who cannot join
- 1) none
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Latino-American Critical Care Trial Network (LACTIN)
Houston, Texas, 77030
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Ecuador1 site
5th International Oncology Course Conference
Manta, Manabí Province
About this study
Official title: 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.
Read the 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.
- Conditions
- Intensive Care Units, Triage
- Being tested
- Survey, Algorithm-based Triage Tool
- Keywords
- ICU, ICU Triage Practices, Cancer Patients, Oncology ICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
Also called Society of Critical Care Medicine Prioritization Model
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.
Algorithm-based Triage ToolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard SCCMP | Experimental | Health care provider completes triage survey of 15 fictional patient case scenarios using the standard SCCMP to prioritize each for admission. Receives: Behavioral: Survey |
| SCCMP + Algorithm-based Triage Tool | Experimental | 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. Receives: Behavioral: Survey; Behavioral: Algorithm-based Triage Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement among clinicians for each of triage tools: SCCMP Standard versus SCCMP + Algorithm-based Triage Tool
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).
Measured: 20 minutes for participant survey completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start17 Nov 2014
- Primary completion20 Feb 2018
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nisha Rathi, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401411
- Sponsor's protocol ID
- 2009-0450
- Status last verified
- Feb 2018
- First submitted
- 9 Jan 2018
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Care Unit (ICU) Triage Practices in a Cancer Hospital
- ClinicalTrials.gov ID
- NCT03401411
- Acronym / sponsor ID
- 2009-0450
- Conditions
- Intensive Care Units, Triage
- Keywords
- ICU, ICU Triage Practices, Cancer Patients, Oncology ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 17 Nov 2014 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard SCCMP | Experimental | Behavioral: SurveyHealth care provider completes triage survey of 15 fictional patient case scenarios using the standard SCCMP to prioritize each for admission. |
| SCCMP + Algorithm-based Triage Tool | Experimental | Behavioral: Survey, Behavioral: Algorithm-based Triage ToolHealth 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Study participant must be a health care provider who frequently refers or accepts oncologic patients to the ICU
Key exclusion criteria (1 listed)
- 1) none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyAlso: Society of Critical Care Medicine Prioritization ModelSurvey 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. | Behavioural | SCCMP + Algorithm-based Triage Tool, Standard SCCMP |
| Algorithm-based Triage ToolNewly 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. | Behavioural | SCCMP + Algorithm-based Triage Tool |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- The University of Texas (UT) MD Anderson Cancer Center Official WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nisha Rathi, MD principal investigator
UT MD Anderson Cancer Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey and Algorithm-based Triage Tool in people with Intensive Care Units and Triage, run by M.D. Anderson Cancer Center at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement among clinicians for each of triage tools: SCCMP Standard versus SCCMP + Algorithm-based Triage Tool (time frame: 20 minutes for participant survey completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.