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

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ClinicalTrials.gov Identifier: NCT04582474

Recruitment Status : Recruiting

First Posted : October 9, 2020

Last Update Posted : October 9, 2020

See Contacts and Locations

Sponsor:

Collaborators:

Ministry of Health, Burkina Faso

Terre des hommes, Burkina Faso & Switzerland

Information provided by (Responsible Party):

Foundation for Innovative New Diagnostics, Switzerland

Tracking Information

First Submitted Date ^ICMJE

September 8, 2020

First Posted Date ^ICMJE

October 9, 2020

Last Update Posted Date

October 9, 2020

Actual Study Start Date ^ICMJE

September 10, 2020

Estimated Primary Completion Date

November 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.
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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Condition ^ICMJE

Dengue

Intervention ^ICMJE

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

Study Arms ^ICMJE

Experimental: Dengue module and rapid diagnostic tests

Intervention: Other: Dengue module and rapid diagnostic tests

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

335

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

December 2020

Estimated Primary Completion Date

November 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

6 Months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

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

Listed Location Countries ^ICMJE

Burkina Faso

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT04582474

Other Study ID Numbers ^ICMJE

FE008

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Responsible Party

Foundation for Innovative New Diagnostics, Switzerland

Study Sponsor ^ICMJE

Foundation for Innovative New Diagnostics, Switzerland

Collaborators ^ICMJE

Ministry of Health, Burkina Faso
Terre des hommes, Burkina Faso & Switzerland

Investigators ^ICMJE

Principal Investigator:

Brice W Bicaba, MD

Ministry of Health, Burkina Faso

PRS Account

Foundation for Innovative New Diagnostics, Switzerland

Verification Date

September 2020

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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