Universal Versus Conditional Three-day Follow-up Visit for Children With Unclassified Fever at the Community Level: A Study to be Conducted in Ethiopia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 4,179
- 试验地点
- 1
- 主要终点
- Treatment failure
研究概览
简要总结
Fevers in childhood are common and usually self-resolve. In sub-Saharan Africa, when a febrile child presents to a community health worker (CHW), the child is assessed for malaria, pneumonia, and diarrhea, and other danger signs, according to WHO guidelines for integrated Community Case Management (iCCM) of childhood illnesses. In the cases where 1) there are no danger signs present, and 2) malaria, pneumonia, and diarrhea have been ruled out, the World Health Organization (WHO) recommends that all children be reassessed in 3 days. It is hypothesized that health outcomes for these cases will be equivalent if the CHW advises to come back in 3 days only if symptoms have not resolved. In order to assess this hypothesis, a two-arm cluster-randomized, community-based non-inferiority trial in Southern Nations, Nationalities and People's Regional State (SNNPR) in Southwest Ethiopia will be conducted to assess the non-inferiority of CHW-advised systematic follow-up on day 3 compared to conditional follow-up for non-severe febrile illness in children age 2 to 59 months, in which no cause of fever can be identified and where danger signs are absent.
详细描述
Globally, mortality in children under five years (U5MR) stands at 45.6/1000 live births and it is estimated that 6.3 million children under five (U5) die each year. Despite a seemingly impressive global decline in U5MR, Sub-Saharan Africa is the only region that has registered increasing under-five mortality in several of its countries. Most deaths are caused by pneumonia (15%), diarrhea (9%), and malaria (7%); diseases with symptoms that overlap, making differential diagnosis difficult. In response, many countries in sub-Saharan Africa have scaled up integrated community case management (iCCM) targeting malaria, pneumonia and diarrhea in children U5. The programs typically train community health workers (CHWs) to assess, classify and treat uncomplicated cases of pneumonia, diarrhea and malaria and refer children with danger signs and malnutrition. While mortality impact of iCCM has been difficult to demonstrate, there is clear evidence that it can increase the treatment rate among sick children.
In Ethiopia, U5MR stands at 68/1000 live births and it is estimated that 205,000 children under the age of five die each year. iCCM implementation started in February 2011 as part of Ethiopia's Health Extension Program (HEP), and over 38,000 female CHWs - locally referred to as Health Extension Workers (HEWs) - have been trained and deployed to communities throughout the country to provide preventive and curative health services. There are typically two HEWs assigned to a sub-district with a population of approximately 5,000. The HEWs are supervised by health centers that oversee 5 health posts each (with 2 HEWs in each). As of 2014, 29,900 of the HEWs had been trained in iCCM using the WHO guidelines.
As per the WHO ICCM guidelines, children treated for an illness and those with unclassified fever and without danger signs (for whom treatment should be withheld), should be counseled to have a follow-up visit after three days to assess treatment compliance and illness resolution. This is either done through a return visit to the health post or through a home visit by the CHW through a systematic follow-up visit. However, febrile illness is common in childhood, and is often due to viruses or other self-resolving illnesses. In a large proportion of cases fever resolves rapidly, generally within 48 hours, and almost always within 96 hours. It is suggested from a number of studies that it is safe to withhold medical treatment for children with unclassified fever. In Ethiopia, HEWs follow the integrated management of neonatal and childhood illness (IMNCI) manual which stipulates that caregivers of children seen by HEWs should only return when the child fails to respond to treatment, by way of conditional follow-up to the health post, instead of the WHO recommended iCCM guideline. There is limited evidence on which of the two recommendations is safer for the child and it is unclear whether caregivers and HEWs would comply better with the systematic follow-up advice compared to the conditional follow-up advice, and whether the systematic follow-up visit is even necessary.
The purpose of this research is therefore to assess the non-inferiority of HEW-advised systematic follow-up on day 3 compared to conditional follow-up for non-severe febrile illness in children age 2 to 59 months, in which no cause of fever can be identified and where danger signs are absent.
Methodology
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 59 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-severe febrile illness that is classified by HEW as unspecific fever
排除标准
- •Malaria, pneumonia, diarrhoea diagnosis
- •Symptoms requiring referral
研究组 & 干预措施
Conditional follow-up
Health extension workers will be trained to counsel caregivers of children with unclassified fever that they should have a conditional follow-up visit, ie. only to come back for re-assessment after 2 days if the child still has fever or is sick. This is in line with national IMNCI guidelines.
干预措施: Conditional follow-up (Behavioral)
Systematic follow-up arm
Health extension workers will be trained to counsel caregivers of children with unclassified fever that they should come back for a systematic follow-up visit after 2 days, even if the child has recovered.
干预措施: Systematic follow-up (Behavioral)
结局指标
主要结局
Treatment failure
时间窗: Day 7
Proportion of children with non-severe febrile illness who, after initial evaluation by a HEW using iCCM algorithm, are not treated for malaria, pneumonia, or diarrhea and who subsequently decline clinically (defined as death, hospitalization, or the development of one or more danger signs).
次要结局
- Proportion of caregivers who spontaneously re-present to HEWs(Day 0-7)
- Hospital admission rate(Day 0-7)
- Illness classification among children with unresolved illness(Day 7)
- Secondary treatment(Day 0-7)
- Proportion of caregivers who present to HEWs for the follow-up visit on Day 3(Day 3)
