Respiratory Complaints Checklist Trial

Not Applicable

Completed

• Conditions: Cough; Dyspnea
• Interventions: Other: Checklist; Other: Conventional evaluation

• Registration Number: NCT02283892
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

This is a randomized clinical trial that evaluates the impact of using an internet-based checklist for systematic assessment of patients reporting respiratory complaints with the conventional assessment, without using the checklist.

Detailed Description

This is a randomized clinical trial that evaluates the impact of using an internet-based checklist for systematic assessment of patients reporting respiratory complaints with the conventional assessment, without using the checklist.

Study setting: emergency department related acute evaluation outpatient clinic

Inclusion criteria: 18 years of age or older; patients presenting to the ED reporting cough or dyspnea;

Exclusion criteria: acute respiratory failure; SpO2 \< 92%; any signs of hemodynamic or respiratory instability; possible concurrent diagnosis requiring immediate assessment (e.g..: acute coronary syndrome or stroke; )

Primary outcome: need of reassessment in the ED or hospitalization within 1 month of index evaluation (intervention).

Secondary outcomes: number of complete blood counts ordered in the index evaluation; number of other diagnostic tests ordered in the index evaluation;

Randomization: block 1:1; stratified by gender and age (\>50 years old).

Masking will be appllied to: patients; outcome assessors; data analysts;

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-05
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Checklist	Checklist	2 checklists available for consultation by the attending physician: (1) dyspnea evaluation checklist and (2) cough evaluation checklist. The checklists are available on computers and mobile devices (smartphone, PDA or tablet computer).
Conventional assessment	Conventional evaluation	Evaluation of patients reporting dyspnea or cough made by the attending physician, without the use of the checklists for dyspnea or cough evaluation.

Primary Outcome Measures

Name	Time	Method
Need to visit the emergency department or acute evaluation outpatient clinic	1 month
Complete blood count ordered in the index evaluation	1 month

Secondary Outcome Measures

Name	Time	Method
Number of diagnostic tests ordered in the index evaluation	1 month
Hospital admission	1 month
Antibiotics prescription	1 month	Frequency and type of antibiotic prescribed in each study arm
Major events	1 month	Composite endpoint: revisit to emergency department OR hospital admission OR death

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil