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

January 7, 2016 updated by: João Gabriel Rosa Ramos, University of Sao Paulo General Hospital

Vignette-based Randomized Controlled Trial of the Decision Making Process of Bed Allocation in the Intensive Care Unit: Impact of Bed Availability and Cognitive Load.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

178

Phase

  • Not Applicable

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

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Intensive care unit doctors participating in specialty email lists

Exclusion Criteria:

  • Consent not provided

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Subjected to increased cognitive load
Behavioral: Increased cognitive load
simulated conditions to increase cognitive load: encourage first impression, time-limit, distractions
No Intervention: Control
Not subjected to increased cognitive load

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
simulated ICU admission rates
Time Frame: 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)
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to complete the questionnaire
Time Frame: 60 minutes
difference on time to complete the questionnaire between the two groups
60 minutes

Collaborators and Investigators

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

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Joao G Ramos, MD, Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo

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

April 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

April 14, 2015

First Submitted That Met QC Criteria

April 26, 2015

First Posted (Estimate)

April 30, 2015

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 43084815.0.0000.0068

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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