Laos Out-Of-Pocket Costs: an Observational Study on the Impact of Severe Childhood Illness on the Health, Wealth and Wellbeing of Household Members in Lao People's Democratic Republic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Mean total out-of-pocket (OOP) expenses
研究概览
简要总结
This will be a prospective longitudinal study of children attending hospital for treatment of a severe illness with community follow-up in Lao People's Democratic Republic (Lao PDR). The study aims to summarise and describe short-term health and economic impacts of a severe childhood illness requiring hospital admission, from a household perspective.
详细描述
This study aims to measure the out-of-pocket (OOP) expenses for households related to a severe acute illness/injury in children under five years presenting to hospitals in Lao PDR. Financial protection will be measured by determining proportions of households led to catastrophic health expenditures and impoverishment from OOP expenses, with further equity analyses across wealth quintiles, geographical residence, sex, parental education and ethnic subpopulations. Physical health and mental wellbeing outcomes of participants and household members will also be assessed to determine the multifaceted impact of severe childhood disease on a household.
Participants will be recruited in outpatients, the emergency department (ED) or during hospital admission. Information on the participant's illness will be collected through health records where available. Household demographic data, financial costs and coping strategies associated with illness and health/wellbeing outcomes will be collected through parent/caregiver structured questionnaires. These will be conducted during presentation to outpatients/ED or during admission on the wards, with follow-up at 2 weeks and at 2 months post-presentation or post-discharge.
Average total household out-of-pocket (OOP) expenses associated with the illness will be presented for the study population. An equity analysis will be performed by disaggregating and comparing mean/median OOP costs across wealth quintiles, sex, geographical location, parental education and ethnic groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child is aged between 1 month -14 years 11 months at the time of admission/presentation to outpatient / ED / hospital
- •Child presents to or is admitted to hospital at one of the participating study site hospitals within the time period of the study
- •Child presents with symptoms of acute illness that started within the last 2 weeks (14 days) prior to hospital presentation. This will include children with a chronic illness but with new onset of symptoms within last 2 weeks.
- •Child is assessed by a health officer at the participating study site hospital and is deemed to have a "severe" illness/injury. A "severe" illness/injury will be defined as a child showing any emergency signs as outlined in the WHO Pocketbook, second edition:
- •OR Requires hospital admission/transfer to another health facility for further investigations and/or treatment for their acute illness/injury that cannot be performed in an outpatient setting or ED. This may include but is not limited to: transfer to another hospital with intensive care unit (ICU), intravenous (IV) medication or fluids; enteral nutrition; oxygen therapy; surgery.
- •Parent/guardian has provided written informed consent, and will be available for the duration of the study follow-up period.
排除标准
- •Child <1 month or >14 years 11 months at time of presentation to hospital
- •Child with symptoms that started >2 weeks (>14 days) prior to hospital presentation
- •Child admitted to the neonatal intensive care unit (NICU)
- •Child admitted to hospital for a planned procedure or planned treatment of a chronic medical condition (eg. Tonsillectomy, replacement of ventriculoperitoneal shunt or percutaneous endoscopic gastronomy (PEG) tube, tune up for cystic fibrosis, chemotherapy, palliative care),
- •Child already enrolled into this study from a previous hospital admission
- •Child discharged prior to screening and informed consent processes by study team members.
结局指标
主要结局
Mean total out-of-pocket (OOP) expenses
时间窗: 2 months
Total OOP expenses are the combined total of direct (medical and non-medical) OOP expenses and indirect costs per household. Data will be collected from a parent/guardian questionnaire developed for the study and expenses will be calculated from onset of symptoms up to 2 months post-discharge from hospital; presented in Lao kip (LAK) and US dollars (USD). Outcome will be presented as mean total OOP expenses per household. Direct medical OOP costs include: consultation fees, fees for diagnostics, medicine and other treatment/remedy costs, hospital bed fees, transfer costs, insurance co-pay if applicable. Direct non-medical OOP costs include: travel costs for patient and accompanying carer/household member/s, daily living expenses for patient and accompanying carer/household member/s including food, childcare costs for other children at home, lodging. Indirect costs include: travel time, loss of income incurred from the cessation or reduction of work productivity.
次要结局
- Total number and percentage of households experiencing CHE set at 10% monthly household expenditure (CHE10m)(2 months)
- Health outcome of participating children - total number and percentage of deaths(2 months)
- Health outcome of participating children - mean change in nutritional status(2 months)
- Total number and percentage of households experiencing Impoverishment Health Expenditure (IHE) set at international poverty line (IHE-i)(2 months)
- Median number of coping strategies used by households(2 months)
- Health and wellbeing outcomes of primary caregivers - total number and percentage of primary caregivers with worse nutritional status(2 months)
- Total number and percentage of households experiencing CHE set at 40% monthly CTP (CHE40m)(2 months)
- Total number and percentage of households experiencing Impoverishment Health Expenditure (IHE) set at national poverty line (IHE-n)(2 months)
- Health outcomes of participating children - mean length of hospital admission(2 months)
- Health and wellbeing outcomes of participant household members - median number of household members with same illness as participant child(2 months)
- Health and wellbeing outcomes of primary caregiver - mean change in quality of life score (physical health)(2 months)
- Total number and percentage of households experiencing Catastrophic Health Expenditure (CHE) set at 10% total annual household expenditure (CHE10a)(2 months)
- Total number and percentage of households experiencing CHE set at 40% annual capacity to pay (CHE40a)(2 months)
- Health outcome of participating children - total number and percentage of participating children reporting each recovery status(at 2 months post-discharge from hospital)
- Health outcome of participating children - total number of children returning to ED/hospital(2 months)
- Health outcome of participating children - total number and percentage with moderate to severe wasting(2 months)
- Health and wellbeing outcomes of participant household members - median number of deaths(2 months)
- Health and wellbeing outcomes of primary caregiver - mean change in quality of life score (environment)(2 months)
- Health outcome of participating children - total number and percentage of children not admitted to hospital or early discharge from hospital(2 months)
- Health and wellbeing outcomes of primary caregiver - mean change in quality of life score (psychological health)(2 months)
- Health and wellbeing outcomes of primary caregiver - mean change in quality of life score (social relationships)(2 months)