Impact of Bed Availability and Cognitive Load on Intensive Care Unit Bed Allocation: a Vignette-based Clinical Trial

Not Applicable

• Conditions: There Are no Specific Conditions Under Study; This Study Evaluates the Clinical Decision-Making Associated With Intensive Care Units Rationing
• Interventions: Behavioral: Increased cognitive load

• Registration Number: NCT02430454
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

Decisions about ICU beds allocations are made everyday, specially in countries with scarcity of ICU beds, such as Brazil. ICU triage, most of the time, is not structured, which may lead to faulty decision making, possibly leading to bad clinical outcomes. It has been shown that external factors may influence the decision making process. The investigators intend to evaluate the impact of bed availability and cognitive load on the ICU bed allocation process by submitting groups of individuals to a vignette based randomized controlled trial simulating conditions with or without increased cognitive load and conditions with or without scarcity of ICU beds.

Detailed Description

Vignettes will be constructed based on consecutive patients for whom ICU bed was solicited. Vignettes will be validated through the evaluation of 8 experts in situations with or without bed scarcity. Vignettes with more than 80% concordance on ICU disposition (admission or refusion) will be used in the trial.

Intensive care doctors in Brazil will be asked to answer an online questionnaire with demographic characteristics and randomized to one of two groups. The experimental group will be submitted to increased cognitive load conditions, meaning that they will be encouraged to give their first impression on the vignettes, will have a time limit to answer the questions and will have popups with sound and videos, with the purpose to distract the respondents. The control group will be encouraged to think thoroughly and will have no time limit or distractions.

Vignettes will be presented, randomly, in conditions with or without scarcity of ICU beds to both groups. So, respondents with and without increased cognitive load will evaluate vignettes in conditions with and without scarcity of ICU beds.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-04-26
• Study First Posted: 2015-04-30
• Primary Completion: 2015-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-01-08
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

• Intensive care unit doctors participating in specialty email lists

Exclusion Criteria

• Consent not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Increased cognitive load	Subjected to increased cognitive load

Primary Outcome Measures

Name	Time	Method
simulated ICU admission rates	24 hours	difference on simulated ICU admission rates between the experimental and control groups, comparing to the expected allocation (designated by the experts that validated the vignettes and Society of Critical Care Medicine priority rank)

Secondary Outcome Measures

Name	Time	Method
Time to complete the questionnaire	60 minutes	difference on time to complete the questionnaire between the two groups