NCT02283892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

November 3, 2014

Last Update Submit

February 22, 2016

Conditions

Keywords

respiratory complaintsdyspneacoughchecklist

Outcome Measures

Primary Outcomes (2)

  • Need to visit the emergency department or acute evaluation outpatient clinic

    1 month

  • Complete blood count ordered in the index evaluation

    1 month

Secondary Outcomes (4)

  • Number of diagnostic tests ordered in the index evaluation

    1 month

  • Hospital admission

    1 month

  • Antibiotics prescription

    1 month

  • Major events

    1 month

Study Arms (2)

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).

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.

Other: Conventional evaluation

Interventions

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.

Also known as: Clinical protocol
Checklist

Physician evaluation without the use of checklists

Also known as: Unaided physician evaluation
Conventional assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas de Porto Alegre

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

Location

MeSH Terms

Conditions

DyspneaCough

Interventions

ChecklistClinical Protocols

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationTherapeuticsEpidemiologic Study Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal Medicine Department Physician

Study Record Dates

First Submitted

November 3, 2014

First Posted

November 5, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations