Demonstration of an Electronic Clinical Decision Support Module for Dengue in Burkina Faso
Primary Purpose
Dengue
Status
Unknown status
Phase
Not Applicable
Locations
Burkina Faso
Study Type
Interventional
Intervention
Dengue module and rapid diagnostic tests
Sponsored by
About this trial
This is an interventional diagnostic trial for Dengue focused on measuring Non-malarial fevers, Clinical decision support tools, Rapid diagnostic test
Eligibility Criteria
Inclusion Criteria:
- Older than 6 month
- Presentation with fever (axillary temperature ≥ 37,5⁰C) or history of fever for 2-7 days without localizing signs of another pathology such as malaria diagnosed by RDT
- Malaria diagnosis: negative malaria RDT performed at the the study site by a nurse as part of the routine consultation, or a positive malaria RDT with antimalarial treatment failure
Exclusion Criteria:
- Neonates (0-2 months) and children ≤ 6 month for operational reasons such as difficulties with blood draw
- Patients with severe disease requiring urgent care
Sites / Locations
- Centre de Santé et de Promotion Sociale (Sandogo)Recruiting
- Centre de Santé et de Promotion Sociale (Secteur 16)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dengue module and rapid diagnostic tests
Arm Description
Outcomes
Primary Outcome Measures
Point estimates of the percentage of dengue consultations performed using the dengue module, with 95% confidence intervals
This outcome will be evaluated by reporting the ratio of dengue consultations performed using the dengue module over the total number of consultations, together with a 95% confidence interval based on Wilson's score method.
Evaluation of the adherence to the different steps of the module
This outcome will be evaluated by the percentage ratio of dengue module steps adhered by patients over the total number of patients at each step.
Secondary Outcome Measures
Estimate of the operational characteristic, Efficacy, of the dengue module: percentage of forms emitted from the module received in the surveillance system
Estimate of the operational characteristic, Timeliness, of the dengue module: percentage of forms that are received by the surveillance system on time, as defined by the national surveillance system.
Estimate of operational characteristic, Completeness, of the dengue module: percentage of fields that are completed.
Positive predictive value of dengue rapid diagnostic test
Polymerase chain reaction results will be used as the reference test.
Full Information
NCT ID
NCT04582474
First Posted
September 8, 2020
Last Updated
October 5, 2020
Sponsor
Foundation for Innovative New Diagnostics, Switzerland
Collaborators
Ministry of Health, Burkina Faso, Terre des hommes, Burkina Faso & Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT04582474
Brief Title
Demonstration of an Electronic Clinical Decision Support Module for Dengue in Burkina Faso
Official Title
Demonstration of an Electronic Clinical Decision Support Module for Dengue Case Management and Reporting in Burkina Faso
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2020 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation for Innovative New Diagnostics, Switzerland
Collaborators
Ministry of Health, Burkina Faso, Terre des hommes, Burkina Faso & Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Integrated Management of Childhood Illness (IMCI) guideline has been implemented in Burkina Faso and is used across primary health facilities to assess children under the age of 5 years. A part from a rapid diagnostic test (RDT) for malaria, no other point of care in vitro diagnostic tests are widely used to improve disease diagnosis and inform treatment decisions. Dengue fever has been reported in Burkina Faso since 1925 and the recent epidemics in 2016 and 2017 have prompted the government to validate and deploy a clinical management algorithm for Dengue and a case reporting process to support surveillance for a targeted response.
The organisation Terre des hommes has digitalised IMCI and implemented the module through its Integrated electronic Diagnosis Approach (IeDA) programme across primary health care centers (PHCs) in the country with proven impact on clinical care and proven reduction in antibiotic prescriptions. Many recognize the need to update the IMCI guideline with current evidence. However this is challenging and may require large clinical trials. The advantage of electronic clinical decision support systems is plural: they improve quality of care through increased adherence and feedback information to the system; they strengthen surveillance systems by connecting relevant patient related data and provide geo-tagged coordinates for targeted responses; and they can become evidence-adaptive.
An electronic module of the Burkina Faso Dengue clinical management guideline accompanied with dengue rapid diagnostic tests has the potential to improve the diagnosis of non-malaria fevers in particular during "dengue seasons" and improve the efficiency of surveillance for this disease.
In this study, the investigators aim to assess the usability and the performance of the dengue module for patient management in primary health care facilities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue
Keywords
Non-malarial fevers, Clinical decision support tools, Rapid diagnostic test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
335 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dengue module and rapid diagnostic tests
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Dengue module and rapid diagnostic tests
Intervention Description
Digital platform providing clinical decision support for Dengue, Dengue rapid diagnostic tests and training will be deployed at study sites for Dengue screening, diagnosis, case management as well as reporting to surveillance system following local guidelines
Primary Outcome Measure Information:
Title
Point estimates of the percentage of dengue consultations performed using the dengue module, with 95% confidence intervals
Description
This outcome will be evaluated by reporting the ratio of dengue consultations performed using the dengue module over the total number of consultations, together with a 95% confidence interval based on Wilson's score method.
Time Frame
4 months
Title
Evaluation of the adherence to the different steps of the module
Description
This outcome will be evaluated by the percentage ratio of dengue module steps adhered by patients over the total number of patients at each step.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Estimate of the operational characteristic, Efficacy, of the dengue module: percentage of forms emitted from the module received in the surveillance system
Time Frame
4 months
Title
Estimate of the operational characteristic, Timeliness, of the dengue module: percentage of forms that are received by the surveillance system on time, as defined by the national surveillance system.
Time Frame
4 months
Title
Estimate of operational characteristic, Completeness, of the dengue module: percentage of fields that are completed.
Time Frame
4 months
Title
Positive predictive value of dengue rapid diagnostic test
Description
Polymerase chain reaction results will be used as the reference test.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Older than 6 month
Presentation with fever (axillary temperature ≥ 37,5⁰C) or history of fever for 2-7 days without localizing signs of another pathology such as malaria diagnosed by RDT
Malaria diagnosis: negative malaria RDT performed at the the study site by a nurse as part of the routine consultation, or a positive malaria RDT with antimalarial treatment failure
Exclusion Criteria:
Neonates (0-2 months) and children ≤ 6 month for operational reasons such as difficulties with blood draw
Patients with severe disease requiring urgent care
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brice W Bicaba, MD
Phone
+22670264393
Email
bicaba_brico@yahoo.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Maimouna Sow, MD
Phone
+22670264393
Email
beldoso@yahoo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brice W Bicaba, MD
Organizational Affiliation
Ministry of Health, Burkina Faso
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Santé et de Promotion Sociale (Sandogo)
City
Ouagadougou
State/Province
District Boulmiougou
Country
Burkina Faso
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brice W Bicaba, MD
Facility Name
Centre de Santé et de Promotion Sociale (Secteur 16)
City
Ouagadougou
State/Province
District Boulmiougou
Country
Burkina Faso
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brice W Bicaba, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Demonstration of an Electronic Clinical Decision Support Module for Dengue in Burkina Faso
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