DyspneaRCCNCT02283892
Respiratory Complaints Checklist Trial
A study testing Checklist and Conventional evaluation in people with Dyspnea and Cough, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Checklist and Conventional evaluation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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; )
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
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
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.
Read the 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;
- Being tested
- Checklist, Conventional evaluation
- Keywords
- respiratory complaints, dyspnea, cough, checklist
- Medical subject headings
- Dyspnea, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChecklistOther
Also called Clinical protocol
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 evaluationOther
Also called Unaided physician evaluation
Physician evaluation without the use of checklists
| Study group | Role | What they receive |
|---|---|---|
| Checklist | Experimental | 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). Receives: Other: Checklist |
| Conventional assessment | Active comparator | Evaluation of patients reporting dyspnea or cough made by the attending physician, without the use of the checklists for dyspnea or cough evaluation. Receives: Other: Conventional evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need to visit the emergency department or acute evaluation outpatient clinic
Measured: 1 month
Complete blood count ordered in the index evaluation
Measured: 1 month
Secondary outcomes (4)
Number of diagnostic tests ordered in the index evaluation
Measured: 1 month
Hospital admission
Measured: 1 month
Antibiotics prescription
Frequency and type of antibiotic prescribed in each study arm
Measured: 1 month
Major events
Composite endpoint: revisit to emergency department OR hospital admission OR death
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Luis Ferreira Azeredo-Da-Silva, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283892
- Sponsor's protocol ID
- 14-0198
- Acronym
- RCC
- Status last verified
- Feb 2016
- First submitted
- 3 Nov 2014
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02283892
- Acronym / sponsor ID
- RCC / 14-0198
- Keywords
- respiratory complaints, dyspnea, cough, checklist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Checklist | Experimental | Other: Checklist2 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). |
| Conventional assessment | Active comparator | Other: Conventional evaluationEvaluation of patients reporting dyspnea or cough made by the attending physician, without the use of the checklists for dyspnea or cough evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChecklistAlso: Clinical protocol3 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 | Checklist |
| Conventional evaluationAlso: Unaided physician evaluationPhysician evaluation without the use of checklists | Other | Conventional assessment |
Primary outcome
Need to visit the emergency department or acute evaluation outpatient clinic
Time frame: 1 month
Complete blood count ordered in the index evaluation
Time frame: 1 month
4 secondary outcomes
Number of diagnostic tests ordered in the index evaluation
Time frame: 1 month
Hospital admission
Time frame: 1 month
Antibiotics prescription
Time frame: 1 month
Major events
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Checklist and Conventional evaluation in people with Dyspnea and Cough, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need to visit the emergency department or acute evaluation outpatient clinic (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.