Respiratory Complaints Checklist Trial

Dyspnea Clinical Trial

— RCC  

Official title:

Randomized Clinical Trial of the Impact of a Respiratory Complaints Assessment Checklist on Resources Utilization and Clinical Outcomes in an Acute Evaluation Outpatient Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02283892
• Other study ID #: 14-0198
• 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

• Cough
• Dyspnea

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