The Added Value of a Mobile Application of Community Case Management on Under-5 Referral, Re-consultation and Hospitalization Rates in Malawi: a Pragmatic Stepped-wedge Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,995
- 主要终点
- Health worker initiated referral of children to higher-level health facilities
研究概览
简要总结
Community Case Management (CCM) is a clinical decision aid used by frontline Health Surveillance Assistants (HSAs) in Malawi to manage uncomplicated cases of pneumonia and malaria (amongst other conditions). Children identified has having complicated illness are urgently referred to larger health facilities better equipped to clinically manage these more complex presentations. There is evidence to suggest HSAs are missing opportunities to refer seriously ill children, and parents/caregivers are failing to comply with urgent referral recommendations when given; reducing the overall effectiveness of the CCM strategy. Use of mobile technology for deploying CCM has been demonstrated in prior research as feasible to evaluate, acceptable to health workers and parents/caregivers and improving health worker fidelity to the guidelines, but it is unknown if this translates into increased referral and referral completion rates. This trial seeks to evaluate the added value of a purpose developed mobile solution for CCM, called Supporting LIFE electronic Community Case Management (SL eCCM App) on HSA referral and parent/caregiver health seeking behavior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Parents/caregivers aged ≥18 years with spoken fluency in Chichewa, Tonga and Tumbuka
- •Children aged ≥2 months to <5 years
- •Able/willing to give voluntary verbal consent
排除标准
- •Parents/caregivers aged <18 years
- •Children aged <2 months or ≥5 years
- •Children who are convulsing or unconscious/unresponsive at presentation
- •Parents/caregivers unable/unwilling to give voluntary verbal consent
研究组 & 干预措施
Paper-based CCM (Standard Care)
Children are assessed and treated according to the WHO and UNICEFs paper-based Community Case Management decision aid for Malawi for a minimum of 2 and a maximum of 7-weeks. Clinical assessment is guided by the paper-based 'Sick Child Form' presented in English, and clinical data is recorded by Health Surveillance Assistants manually in the Village Clinic Register.
干预措施: Standard care (Other)
SL eCCM App + paper CCM
Health Surveillance Assistants use the Supporting LIFE electronic Community Case Management App (SL eCCM App) deployed on a smartphone and replicating paper-based CCM guidelines to assess and treat children in conjunction with standard care, for a minimum of 2-weeks and maximum of 7-weeks. Clinical data is recorded in both the SL eCCM App and Village Clinic Register.
干预措施: Supporting LIFE electronic Community Case Management (Other)
结局指标
主要结局
Health worker initiated referral of children to higher-level health facilities
时间窗: at the index visit (study enrollment)
Attendance/non-attendance of parent/caregivers given urgent referral recommendation at higher-level health facilities
时间窗: 7-days post-enrollment
次要结局
- Acceptability of the SL eCCM App to HSAs and parents/caregivers(<2-weeks post-enrollment)
- Household-level costs associated with healthcare seeking behavior(< 2-weeks post-enrollment)
- Barriers and facilitators to parent/caregiver compliance with referral recommendations(<2-weeks post-enrollment)
研究者
Matthew Thompson
Professor, Department of Family Medicine
University of Washington