Respiratory Complaints Checklist Trial

Study Overview
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Brief Summary
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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
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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;

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

Conditions
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Dyspnea, Cough

Intervention / Treatment
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* Other: Checklist
* Other: Conventional evaluation


Participation Criteria
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Eligibility Criteria
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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; )

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Checklist<br>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). | Other: Checklist<br>* 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.<br>* Other names: Clinical protocol;|
| Active Comparator: Conventional assessment<br>Evaluation of patients reporting dyspnea or cough made by the attending physician, without the use of the checklists for dyspnea or cough evaluation. | Other: Conventional evaluation<br>* Physician evaluation without the use of checklists<br>* Other names: Unaided physician evaluation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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respiratory complaints, dyspnea, cough, checklist