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

NCT05239104 | Completed

• 1 other identifier: 81864
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Care Economics; Child Health; Cost of Illness; Burden of Illness

Keywords

health behaviour; health equity; poverty; hospital costs; developing countries

Outcome Measures

Primary Outcomes (1)

• Mean total out-of-pocket (OOP) expenses

  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.

  2 months

Secondary Outcomes (23)

• 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 10% monthly household expenditure (CHE10m)

  2 months

• Total number and percentage of households experiencing CHE set at 40% annual capacity to pay (CHE40a)

  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 international poverty line (IHE-i)

  2 months

Study Arms (1)

Children aged 1 month - 14 years 11 months with a severe illness/injury

Children aged 1 month - 14 years 11 months presenting to hospital with symptoms of an acute "severe" illness/injury that started within the last 2 weeks. "Severe" defined as a child showing emergency signs or requiring hospital admission for treatment.

Other: No intervention

Interventions

No intervention OTHER

This is an observational study with no intervention

Children aged 1 month - 14 years 11 months with a severe illness/injury

Eligibility Criteria

• Age: 1 Month - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit: collaborator

Study Sites (1)

Lao-Oxford-Mahosot-Hospital Wellcome Trust Research Unit (LOMWRU)

Vientiane, Laos

Location

Related Publications (17)

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Study Officials

• Fiona Russell, BMBS FRACP MPHTM PhD

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: November 1, 2022
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Will be available from date summary data is published
• Access Criteria: Requests to access IPD are to be made with the principal investigator who will review requests and share IPD with supporting information as ethically appropriate. All IPD will be de-identified

Locations

LA (1)