Improving the Quality of Care for Children With Acute Malnutrition: Cluster Randomised Controlled Trial in West Nile Region, Uganda
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Cure rate
研究概览
简要总结
This is a cluster RCT in 6 health centres in Uganda, testing supportive supervision to improve health outcomes and quality of care of children with malnutrition
详细描述
Introduction Malnutrition in children is highly prevalent in West Nile Region. According to a recent analysis of data available from the health management information system (HMIS) and official registers, the health outcomes of children suffering from malnutrition and treated at health center (HC) level in Arua Region are not reaching the international standards (75% cured rate as for the international SPHERE standards). This despite the availability of clear national guidelines for treatment, thus suggesting possible deficiencies in the quality of care provided. Lack of supportive supervision may be one of the reason explaining substandard outcomes.
Methods This is a cluster randomised controlled trail (RCT) with health centers (HC) as unit of randomisation. The six largest HC in Arua district will be randomised in two groups, intervention (quality improvement group) and control. The intervention will aim at improving the quality of care provided at HC level, and as a consequence, the health outcomes of children. The main intervention will consist of enhances nutritional supervision (high frequency supervision, specific to nutritional services), while the control will be standard care (no intervention). Complementary intervention will include training and networking activities for HC staff. Outcomes of the study will include: health outcomes (recovered, non recovered, defaulters, transferred, died); process outcomes (satisfaction and knowledge of staff); cost outcomes (cost for the health system and for the families) and equity outcomes (access to care and health outcomes by wealth quintile).
Relevance of the study The study will inform, with a robust design, about the efficacy and cost-efficacy of a quality improvement intervention for ameliorating the health of children suffering from malnutrition in Uganda.
Currently no other study with RCT design explored the efficacy of supportive supervision as a quality improvement intervention. This study will therefore fill an important knowledge gap.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the primary outcomes, the study sample will consists of children with malnutrition treated at in health center (HC) in Arua district
- •Inclusion Criteria:
- •Children 6 months-5 years
- •Diagnosis of SAM or MAM according to National criteria (10) SAM: weight-for-height <- 3 standard deviation (SD) from the mean based on the WHO 2006 standards (11).
- •MAM: weight-for-height <- 2 and > -3 standard deviation (SD) from the mean based on the WHO 2006 growth reference standards .
排除标准
- •Not matching the above criteria for SAM and MAM
- •Refusal to participate/ consent
- •Unable to adhere to study follow up procedures
研究组 & 干预措施
Experimental
Supportive supervision
干预措施: Supportive supervision (Other)
Control
No intervention
结局指标
主要结局
Cure rate
时间窗: 12- 16 weeks
Rate of cured among children diagnosed with acute malnutrition (SAM and MAM) Cured/discharged is defined as Weight-for-height \> -2 standard deviation (SD) from the mean based on the World Health Organisation (WHO) 2006 standards (11) on 2 consecutive visits and no oedema.
次要结局
- Rate of transferred to ITC (inpatient treatment center)(12- 16 weeks)
- Rate of defaulted(12- 16 weeks)
- Equity outcomes(study start, than every month up to 15 months)
- Rate of transferred to OTC (outpatient treatment center)(12- 16 weeks)
- Cost(study start, than every month up to 15 months)
- Staff satisfaction score(study start, month 6 and month 15)
- Dead rate(12- 16 weeks)
- Rate of Not cured(12- 16 weeks)
- Quality of data(study start, than every month up to 15 months)
研究者
Marzia Lazzerini
PhD
WHO Collaborating Centre for Maternal and Child Health, Trieste