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

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ClinicalTrials.gov Identifier: NCT04582474
Recruitment Status : Unknown
Verified September 2020 by Foundation for Innovative New Diagnostics, Switzerland.
Recruitment status was:  Recruiting
First Posted : October 9, 2020
Last Update Posted : October 9, 2020
Sponsor:
Collaborators:
Ministry of Health, Burkina Faso
Terre des hommes, Burkina Faso & Switzerland
Information provided by (Responsible Party):
Foundation for Innovative New Diagnostics, Switzerland

Study Description
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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.


Condition or disease Intervention/treatment Phase
Dengue Other: Dengue module and rapid diagnostic tests Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 335 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Demonstration of an Electronic Clinical Decision Support Module for Dengue Case Management and Reporting in Burkina Faso
Actual Study Start Date : September 10, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dengue module and rapid diagnostic tests 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


Outcome Measures
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Primary Outcome Measures :
  1. Point estimates of the percentage of dengue consultations performed using the dengue module, with 95% confidence intervals [ Time Frame: 4 months ]
    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.

  2. Evaluation of the adherence to the different steps of the module [ Time Frame: 4 months ]
    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 :
  1. 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 ]
  2. 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 ]
  3. Estimate of operational characteristic, Completeness, of the dengue module: percentage of fields that are completed. [ Time Frame: 4 months ]
  4. Positive predictive value of dengue rapid diagnostic test [ Time Frame: 4 months ]
    Polymerase chain reaction results will be used as the reference test.


Eligibility Criteria
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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582474


Contacts
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Contact: Brice W Bicaba, MD +22670264393 bicaba_brico@yahoo.fr
Contact: Maimouna Sow, MD +22670264393 beldoso@yahoo.fr

Locations
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Burkina Faso
Centre de Santé et de Promotion Sociale (Sandogo) Recruiting
Ouagadougou, District Boulmiougou, Burkina Faso
Contact: Brice W Bicaba, MD         
Centre de Santé et de Promotion Sociale (Secteur 16) Recruiting
Ouagadougou, District Boulmiougou, Burkina Faso
Contact: Brice W Bicaba, MD         
Sponsors and Collaborators
Foundation for Innovative New Diagnostics, Switzerland
Ministry of Health, Burkina Faso
Terre des hommes, Burkina Faso & Switzerland
Investigators
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Principal Investigator: Brice W Bicaba, MD Ministry of Health, Burkina Faso
More Information
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Responsible Party: Foundation for Innovative New Diagnostics, Switzerland
ClinicalTrials.gov Identifier: NCT04582474    
Other Study ID Numbers: FE008
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Foundation for Innovative New Diagnostics, Switzerland:
Non-malarial fevers
Clinical decision support tools
Rapid diagnostic test
Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Vector Borne Diseases
Infections
Virus Diseases
 Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral