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临床试验/NCT04582474
NCT04582474已完成不适用

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

Foundation for Innovative New Diagnostics, Switzerland4 个研究点 分布在 1 个国家目标入组 335 人开始时间: 2020年9月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
335
试验地点
4
主要终点
Point estimates of the percentage of dengue consultations performed using the dengue module, with 95% confidence intervals

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
6 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Neonates (0-2 months) and children ≤ 6 month for operational reasons such as difficulties with blood draw
  • Patients with severe disease requiring urgent care

研究组 & 干预措施

Dengue module and rapid diagnostic tests

Experimental

干预措施: Dengue module and rapid diagnostic tests (Other)

结局指标

主要结局

Point estimates of the percentage of dengue consultations performed using the dengue module, with 95% confidence intervals

时间窗: 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

时间窗: 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.

次要结局

  • Estimate of the operational characteristic, Efficacy, of the dengue module: percentage of forms emitted from the module received in the surveillance system(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.(4 months)
  • Estimate of operational characteristic, Completeness, of the dengue module: percentage of fields that are completed.(4 months)
  • Positive predictive value of dengue rapid diagnostic test(4 months)

研究者

发起方
Foundation for Innovative New Diagnostics, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (4)

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