Clinical trial NCT04582474: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Dengue
Keywords: Non-malarial fevers
Clinical decision support tools
Rapid diagnostic test
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Burkina Faso
name: Terre des hommes, Burkina Faso & Switzerland
First posted: 2020-10-09
Enrollment: 335
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Point estimates of the percentage of dengue consultations performed using the dengue module, with 95% confidence intervals
timeFrame: 4 months
measure: Evaluation of the adherence to the different steps of the module
timeFrame: 4 months
Secondary outcomes:
measure: Estimate of the operational characteristic, Efficacy, of the dengue module: percentage of forms emitted from the module received in the surveillance system
timeFrame: 4 months
measure: 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.
timeFrame: 4 months
measure: Estimate of operational characteristic, Completeness, of the dengue module: percentage of fields that are completed.
timeFrame: 4 months
measure: Positive predictive value of dengue rapid diagnostic test
timeFrame: 4 months
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Centre de Santé et de Promotion Sociale (Sandogo)
state: District Boulmiougou
city: Ouagadougou
country: Burkina Faso
facility: Centre de Santé et de Promotion Sociale (Secteur 16)
state: District Boulmiougou
Study officials:
affiliation: Ministry of Health, Burkina Faso
name: Brice W Bicaba, MD
role: PRINCIPAL_INVESTIGATOR
References: