Respiratory Complaints Checklist Trial

Not Applicable

Completed

• Conditions: Cough; Dyspnea

• 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

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