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

NCT ID: NCT02430454

Last Updated: 2016-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-06-30

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.

Conditions

There Are no Specific Conditions Under Study; This Study Evaluates the Clinical Decision-Making Associated With Intensive Care Units Rationing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Experimental

Subjected to increased cognitive load

Group Type: EXPERIMENTAL

Increased cognitive load

Intervention Type: BEHAVIORAL

simulated conditions to increase cognitive load: encourage first impression, time-limit, distractions

Control

Not subjected to increased cognitive load

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Increased cognitive load

simulated conditions to increase cognitive load: encourage first impression, time-limit, distractions

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Intensive care unit doctors participating in specialty email lists

Exclusion Criteria

• Consent not provided

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

João Gabriel Rosa Ramos

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joao G Ramos, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

Other Identifiers

43084815.0.0000.0068

Identifier Type: -

Identifier Source: org_study_id