Clinical trial NCT05239104: 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 Laos
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Care Economics
Child Health
Cost of Illness
Burden of Illness
Keywords: health behaviour
health equity
poverty
hospital costs
developing countries
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
First posted: 2022-02-14
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged between 1 month - 14 years 11 months with a "severe" illness/injury who is admitted or presented to outpatient/ED/ward at one of the participating study site hospitals in Lao PDR.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mean total out-of-pocket (OOP) expenses
timeFrame: 2 months
Secondary outcomes:
measure: Total number and percentage of households experiencing Catastrophic Health Expenditure (CHE) set at 10% total annual household expenditure (CHE10a)
timeFrame: 2 months
measure: Total number and percentage of households experiencing CHE set at 10% monthly household expenditure (CHE10m)
timeFrame: 2 months
measure: Total number and percentage of households experiencing CHE set at 40% annual capacity to pay (CHE40a)
timeFrame: 2 months
measure: Total number and percentage of households experiencing CHE set at 40% monthly CTP (CHE40m)
timeFrame: 2 months
measure: Total number and percentage of households experiencing Impoverishment Health Expenditure (IHE) set at international poverty line (IHE-i)
timeFrame: 2 months
measure: Total number and percentage of households experiencing Impoverishment Health Expenditure (IHE) set at national poverty line (IHE-n)
timeFrame: 2 months
measure: Median number of coping strategies used by households
timeFrame: 2 months
measure: Health outcomes of participating children - mean length of hospital admission
timeFrame: 2 months
measure: Health outcome of participating children - total number and percentage of deaths
timeFrame: 2 months
measure: Health outcome of participating children - total number and percentage of participating children reporting each recovery status
timeFrame: at 2 weeks post-discharge from hospital
measure: Health outcome of participating children - total number and percentage of participating children reporting each recovery status
timeFrame: at 2 months post-discharge from hospital
measure: Health outcome of participating children - total number of children returning to ED/hospital
timeFrame: 2 months
measure: Health outcome of participating children - mean change in nutritional status
timeFrame: 2 months
measure: Health outcome of participating children - total number and percentage with moderate to severe wasting
timeFrame: At enrolment (day 0)
measure: Health outcome of participating children - total number and percentage with moderate to severe wasting
timeFrame: 2 months
measure: Health outcome of participating children - total number and percentage of children not admitted to hospital or early discharge from hospital
timeFrame: 2 months
measure: Health and wellbeing outcomes of participant household members - median number of household members with same illness as participant child
timeFrame: 2 months
measure: Health and wellbeing outcomes of participant household members - median number of deaths
timeFrame: 2 months
measure: Health and wellbeing outcomes of primary caregivers - total number and percentage of primary caregivers with worse nutritional status
timeFrame: 2 months
measure: Health and wellbeing outcomes of primary caregiver - mean change in quality of life score (physical health)
timeFrame: 2 months
measure: Health and wellbeing outcomes of primary caregiver - mean change in quality of life score (psychological health)
timeFrame: 2 months
measure: Health and wellbeing outcomes of primary caregiver - mean change in quality of life score (social relationships)
timeFrame: 2 months
measure: Health and wellbeing outcomes of primary caregiver - mean change in quality of life score (environment)
timeFrame: 2 months
Other outcomes:
Locations:
city: Vientiane
country: Lao People's Democratic Republic
facility: Lao-Oxford-Mahosot-Hospital Wellcome Trust Research Unit (LOMWRU)
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Fiona Russell, BMBS FRACP MPHTM PhD
role: PRINCIPAL_INVESTIGATOR
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