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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02283892
Other study ID # 14-0198
Secondary ID
Status Completed
Phase N/A
First received November 3, 2014
Last updated February 22, 2016
Start date January 2014
Est. completion date January 2016

Study information

Verified date February 2016
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


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;


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 18 years of age or older; patients presenting to the ED reporting cough or dyspnea; legally capable.

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; )

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Checklist
3 page checklist with suggestions of possible diagnosis according to clinical presentation of patients presenting with dyspnea or cough; also suggests diagnostic tests that are likely to be useful in each situation.
Conventional evaluation
Physician evaluation without the use of checklists

Locations

Country Name City State
Brazil Hospital de Clinicas de Porto Alegre Porto Alegre Rio Grande do Sul

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Need to visit the emergency department or acute evaluation outpatient clinic 1 month No
Primary Complete blood count ordered in the index evaluation 1 month No
Secondary Number of diagnostic tests ordered in the index evaluation 1 month No
Secondary Hospital admission 1 month No
Secondary Antibiotics prescription Frequency and type of antibiotic prescribed in each study arm 1 month No
Secondary Major events Composite endpoint: revisit to emergency department OR hospital admission OR death 1 month Yes
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