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Respiratory Complaints Checklist Trial (RCC)

Primary Purpose

Dyspnea, Cough

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Checklist
Conventional evaluation
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspnea focused on measuring respiratory complaints, dyspnea, cough, checklist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; )

Sites / Locations

  • Hospital de Clinicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Checklist

Conventional assessment

Arm Description

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).

Evaluation of patients reporting dyspnea or cough made by the attending physician, without the use of the checklists for dyspnea or cough evaluation.

Outcomes

Primary Outcome Measures

Need to visit the emergency department or acute evaluation outpatient clinic
Complete blood count ordered in the index evaluation

Secondary Outcome Measures

Number of diagnostic tests ordered in the index evaluation
Hospital admission
Antibiotics prescription
Frequency and type of antibiotic prescribed in each study arm
Major events
Composite endpoint: revisit to emergency department OR hospital admission OR death

Full Information

First Posted
November 3, 2014
Last Updated
February 22, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02283892
Brief Title
Respiratory Complaints Checklist Trial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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;

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea, Cough
Keywords
respiratory complaints, dyspnea, cough, checklist

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Checklist
Arm Type
Experimental
Arm Description
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).
Arm Title
Conventional assessment
Arm Type
Active Comparator
Arm Description
Evaluation of patients reporting dyspnea or cough made by the attending physician, without the use of the checklists for dyspnea or cough evaluation.
Intervention Type
Other
Intervention Name(s)
Checklist
Other Intervention Name(s)
Clinical protocol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional evaluation
Other Intervention Name(s)
Unaided physician evaluation
Intervention Description
Physician evaluation without the use of checklists
Primary Outcome Measure Information:
Title
Need to visit the emergency department or acute evaluation outpatient clinic
Time Frame
1 month
Title
Complete blood count ordered in the index evaluation
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Number of diagnostic tests ordered in the index evaluation
Time Frame
1 month
Title
Hospital admission
Time Frame
1 month
Title
Antibiotics prescription
Description
Frequency and type of antibiotic prescribed in each study arm
Time Frame
1 month
Title
Major events
Description
Composite endpoint: revisit to emergency department OR hospital admission OR death
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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; )
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil

12. IPD Sharing Statement

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Respiratory Complaints Checklist Trial

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