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Completed

NCT Number: NCT02283892

Respiratory Complaints Checklist Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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;

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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; )

Treatment and study plan

Checklist

Other

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.

Other names: Clinical protocol

Conventional evaluation

Other

Physician evaluation without the use of checklists

Other names: Unaided physician evaluation

Primary outcomes

  1. Need to visit the emergency department or acute evaluation outpatient clinic

    Time frame: 1 month

  2. Complete blood count ordered in the index evaluation

    Time frame: 1 month

Secondary outcomes

  1. Number of diagnostic tests ordered in the index evaluation

    Time frame: 1 month

  2. Hospital admission

    Time frame: 1 month

  3. Antibiotics prescription

    Time frame: 1 month

    Frequency and type of antibiotic prescribed in each study arm

  4. Major events

    Time frame: 1 month

    Composite endpoint: revisit to emergency department OR hospital admission OR death

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study 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

Acronym: RCC

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 5, 2014
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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