Demonstration of an Electronic Clinical Decision Support Module for Dengue in Burkina Faso

Dengue Clinical Trial

Official title:

Demonstration of an Electronic Clinical Decision Support Module for Dengue Case Management and Reporting in Burkina Faso

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04582474
• Other study ID #: FE008
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: December 2020

Study information

• Verified date: September 2020
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: Brice W Bicaba, MD
• Phone: +22670264393
• Email: bicaba_brico[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 335
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

• Older than 6 month

• Presentation with fever (axillary temperature = 37,5°C) 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

Related Conditions & MeSH terms

• Dengue

Intervention

Other:
• Dengue module and rapid diagnostic tests
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

Locations

Country	Name	City	State
Burkina Faso	Centre de Santé et de Promotion Sociale (Sandogo)	Ouagadougou	District Boulmiougou
Burkina Faso	Centre de Santé et de Promotion Sociale (Secteur 16)	Ouagadougou	District Boulmiougou

Sponsors (3)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland	Ministry of Health, Burkina Faso, Terre des hommes, Burkina Faso & Switzerland

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months
Primary	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.	4 months
Secondary	Estimate of the operational characteristic, Efficacy, of the dengue module: percentage of forms emitted from the module received in the surveillance system		4 months
Secondary	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.		4 months
Secondary	Estimate of operational characteristic, Completeness, of the dengue module: percentage of fields that are completed.		4 months
Secondary	Positive predictive value of dengue rapid diagnostic test	Polymerase chain reaction results will be used as the reference test.	4 months