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

Child Health Clinical Trial

— LOOP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05239104
• Other study ID #: 81864
• Status: Completed
• Start date: November 1, 2022
• Est. completion date: January 10, 2024

Study information

• Verified date: May 2024
• Source: Murdoch Childrens Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 10, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Health
• Cost of Illness

Intervention

Other:
• No intervention
This is an observational study with no intervention

Locations

Country	Name	City	State
Lao People's Democratic Republic	Lao-Oxford-Mahosot-Hospital Wellcome Trust Research Unit (LOMWRU)	Vientiane

Sponsors (2)

Lead Sponsor	Collaborator
Murdoch Childrens Research Institute	Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit

Country where clinical trial is conducted

Lao People's Democratic Republic, 

References & Publications (17)

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Barennes H, Frichittavong A, Gripenberg M, Koffi P. Evidence of High Out of Pocket Spending for HIV Care Leading to Catastrophic Expenditure for Affected Patients in Lao People's Democratic Republic. PLoS One. 2015 Sep 1;10(9):e0136664. doi: 10.1371/journal.pone.0136664. eCollection 2015. — View Citation

Bodhisane S, Pongpanich S. The impact of National Health Insurance upon accessibility of health services and financial protection from catastrophic health expenditure: a case study of Savannakhet province, the Lao People's Democratic Republic. Health Res Policy Syst. 2019 Dec 16;17(1):99. doi: 10.1186/s12961-019-0493-3. — View Citation

Cederholm T, Bosaeus I, Barazzoni R, Bauer J, Van Gossum A, Klek S, Muscaritoli M, Nyulasi I, Ockenga J, Schneider SM, de van der Schueren MA, Singer P. Diagnostic criteria for malnutrition - An ESPEN Consensus Statement. Clin Nutr. 2015 Jun;34(3):335-40. doi: 10.1016/j.clnu.2015.03.001. Epub 2015 Mar 9. — View Citation

Gray AZ, Morpeth M, Duke T, Peel D, Winter C, Satvady M, Sisouk K, Prasithideth B, Detleuxay K. Improved oxygen systems in district hospitals in Lao PDR: a prospective field trial of the impact on outcomes for childhood pneumonia and equipment sustainability. BMJ Paediatr Open. 2017 Aug 31;1(1):e000083. doi: 10.1136/bmjpo-2017-000083. eCollection 2017. — View Citation

Grepin KA, Irwin BR, Sas Trakinsky B. On the Measurement of Financial Protection: An Assessment of the Usefulness of the Catastrophic Health Expenditure Indicator to Monitor Progress Towards Universal Health Coverage. Health Syst Reform. 2020 Dec 1;6(1):e1744988. doi: 10.1080/23288604.2020.1744988. — View Citation

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Memirie ST, Metaferia ZS, Norheim OF, Levin CE, Verguet S, Johansson KA. Household expenditures on pneumonia and diarrhoea treatment in Ethiopia: a facility-based study. BMJ Glob Health. 2017 Jan 18;2(1):e000166. doi: 10.1136/bmjgh-2016-000166. eCollection 2017. — View Citation

Sultana M, Alam NH, Ali N, Faruque ASG, Fuchs GJ, Gyr N, Chisti MJ, Ahmed T, Gold L. Household economic burden of childhood severe pneumonia in Bangladesh: a cost-of-illness study. Arch Dis Child. 2021 Jun;106(6):539-546. doi: 10.1136/archdischild-2020-320834. Epub 2021 Apr 27. — View Citation

Wagstaff A, Flores G, Hsu J, Smitz MF, Chepynoga K, Buisman LR, van Wilgenburg K, Eozenou P. Progress on catastrophic health spending in 133 countries: a retrospective observational study. Lancet Glob Health. 2018 Feb;6(2):e169-e179. doi: 10.1016/S2214-109X(17)30429-1. Epub 2017 Dec 13. — View Citation

Wagstaff A, Flores G, Smitz MF, Hsu J, Chepynoga K, Eozenou P. Progress on impoverishing health spending in 122 countries: a retrospective observational study. Lancet Glob Health. 2018 Feb;6(2):e180-e192. doi: 10.1016/S2214-109X(17)30486-2. Epub 2017 Dec 13. Erratum In: Lancet Glob Health. 2018 Jan 15;: — View Citation

Wagstaff A, Lindelow M. Are health shocks different? Evidence from a multishock survey in Laos. Health Econ. 2014 Jun;23(6):706-18. doi: 10.1002/hec.2944. Epub 2013 Jun 13. — View Citation

Xu K, Evans DB, Carrin G, Aguilar-Rivera AM, Musgrove P, Evans T. Protecting households from catastrophic health spending. Health Aff (Millwood). 2007 Jul-Aug;26(4):972-83. doi: 10.1377/hlthaff.26.4.972. — View Citation

Xu K, Evans DB, Kawabata K, Zeramdini R, Klavus J, Murray CJ. Household catastrophic health expenditure: a multicountry analysis. Lancet. 2003 Jul 12;362(9378):111-7. doi: 10.1016/S0140-6736(03)13861-5. — View Citation

Zhang S, Sammon PM, King I, Andrade AL, Toscano CM, Araujo SN, Sinha A, Madhi SA, Khandaker G, Yin JK, Booy R, Huda TM, Rahman QS, El Arifeen S, Gentile A, Giglio N, Bhuiyan MU, Sturm-Ramirez K, Gessner BD, Nadjib M, Carosone-Link PJ, Simoes EA, Child JA, Ahmed I, Bhutta ZA, Soofi SB, Khan RJ, Campbell H, Nair H. Cost of management of severe pneumonia in young children: systematic analysis. J Glob Health. 2016 Jun;6(1):010408. doi: 10.7189/jogh.06.010408. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total number and percentage of households experiencing Catastrophic Health Expenditure (CHE) set at 10% total annual household expenditure (CHE10a)	CHE: defined as when the total OOP expenses exceeds a threshold proportion of household expenditures.; CHE10a: The primary CHE threshold will be set at 10% of total annual household expenditure to align with Sustainable Development Goal (SDG) indicator 3.8.2.; OOP expenses and household expenditures will be collected through a study developed questionnaire and CHE10a will be presented as a total number and as a percentage of study participants.	2 months
Secondary	Total number and percentage of households experiencing CHE set at 10% monthly household expenditure (CHE10m)	CHE10m: a secondary CHE threshold will be set at 10% of monthly household expenditure to show the immediate financial impact of the illness OOP expenses and household expenditures will be collected through a study developed questionnaire and CHE10m will be presented as a total number and as a percentage of study participants.	2 months
Secondary	Total number and percentage of households experiencing CHE set at 40% annual capacity to pay (CHE40a)	CHE40a: a secondary CHE threshold will be set at 40% annual capacity to pay (CTP) with previous studies suggesting it more effective at identifying poorer households.; CTP: defined as the total household expenditures minus necessary subsistence expenditures (food, housing, utilities).; OOP expenses and household expenditures will be collected through a study developed questionnaire and CHE40a will be presented as a total number and as a percentage of study participants.	2 months
Secondary	Total number and percentage of households experiencing CHE set at 40% monthly CTP (CHE40m)	CHE40m: a secondary CHE threshold will be set at 40% monthly CTP with previous studies suggesting it more effective at identifying poorer households.; CTP: defined as the total household expenditures minus necessary subsistence expenditures (food, housing, utilities).; OOP expenses and household expenditures will be collected through a study developed questionnaire and CHE40m will be presented as a total number and as a percentage of study participants.	2 months
Secondary	Total number and percentage of households experiencing Impoverishment Health Expenditure (IHE) set at international poverty line (IHE-i)	IHE: defined as households that fall below the poverty line due to the OOP payments associated with the severe illness.; IHE-i: primary threshold will be presented for the international poverty line (US$1.90 per person per day) to align with SDG target 1.1.; OOP expenses will be collected through a study developed questionnaire and IHE-i will be presented as a total number and as a percentage of study participants.	2 months
Secondary	Total number and percentage of households experiencing Impoverishment Health Expenditure (IHE) set at national poverty line (IHE-n)	IHE-n: a secondary threshold will be presented for the national poverty line (LAK 280,910 per person per month) OOP expenses will be collected through a study developed questionnaire and IHE-n will be presented as a total number and as a percentage of study participants.	2 months
Secondary	Median number of coping strategies used by households	Strategies households employ to finance the OOP costs related to the severe illness, defined as: use of savings, borrowing, help from others, asset sales, delayed plans, and/or reduced consumption.; Data will be collected through a study developed questionnaire and will be presented as median number of coping strategies used per household.	2 months
Secondary	Health outcomes of participating children - mean length of hospital admission	Length of hospital admission measured in days Data will be collected from participants' hospital medical records and will be presented as mean length of hospital admission per participant.	2 months
Secondary	Health outcome of participating children - total number and percentage of deaths	Total number of deaths of participating children during study period, presented as total number and percentage of study population.; Data will be collected from parent/guardian report in study developed questionnaire	2 months
Secondary	Health outcome of participating children - total number and percentage of participating children reporting each recovery status	Recovery status defined as level of recovery from serious illness as reported by parent/guardian (full recovery, partial recovery, sicker than when left hospital, death). Recovery status will be presented as total number and percentage of study population reporting each recovery status and then ranked from highest to lowest percentage. Data will be collected from a study developed questionnaire	at 2 weeks post-discharge from hospital
Secondary	Health outcome of participating children - total number and percentage of participating children reporting each recovery status	Recovery status defined as level of recovery from serious illness as reported by parent/guardian (full recovery, partial recovery, sicker than when left hospital, death). Recovery status will be presented as total number and percentage of study population reporting each recovery status and then ranked from highest to lowest percentage. Data will be collected from a study developed questionnaire	at 2 months post-discharge from hospital
Secondary	Health outcome of participating children - total number of children returning to ED/hospital	Total number of participating children returning to ED/hospital as a complication of the initial severe illness.; Data will be collected from parent/guardian report in study developed questionnaire and will be presented as total number and as percentage of study population.	2 months
Secondary	Health outcome of participating children - mean change in nutritional status	Change in nutritional status defined as change in weight-for-height score presented as standard deviation (or z-score) from outpatient/ED presentation or hospital discharge. The z-score are compared to reference population z-scores as defined in WHO global database growth charts.; Data will be collected through anthropometry measures (height and weight) and will be presented as mean difference in z-score for study population from start to end of study period.	2 months
Secondary	Health outcome of participating children - total number and percentage with moderate to severe wasting	Number of participants with wasting defined as weight-for-height score presented as standard deviation <-2 (z-score <-2).; Data will be collected through anthropometry measures (height and weight) and will be presented as total number and as percentage of study population.	At enrolment (day 0)
Secondary	Health outcome of participating children - total number and percentage with moderate to severe wasting	Number of participants with wasting defined as weight-for-height z-score <-2. Data will be collected through anthropometry measures (height and weight) and will be presented as total number and as percentage of study population.	2 months
Secondary	Health outcome of participating children - total number and percentage of children not admitted to hospital or early discharge from hospital	Total number of participants with patient/caregiver decision to not be admitted to hospital from outpatients/ED or discharge early from hospital against medical advice.; Data will be collected from parent/guardian report in study developed questionnaire or participants' hospital medical records and will be presented as total number as percentage of study population.	2 months
Secondary	Health and wellbeing outcomes of participant household members - median number of household members with same illness as participant child	Number of household members with same illness as participant. Data will be collected from parent/guardian report in study developed questionnaire and presented as median number of sick household members per household.	2 months
Secondary	Health and wellbeing outcomes of participant household members - median number of deaths	Number of deaths of household members within each household during study period.; Data will be collected from parent/guardian report in study developed questionnaire and presented as median number of deaths of household members per household.	2 months
Secondary	Health and wellbeing outcomes of primary caregivers - total number and percentage of primary caregivers with worse nutritional status	Primary caregivers with worse nutritional status, defined as unintentional weight loss of >5% from recruitment stage; and/or primary caregivers that are pushed into category of underweight (BMI < 18 kg/m2) from recruitment stage.; Data will be collected from anthropometry measures (height and weight) of primary caregivers and will be presented as total number and as a percentage of primary caregivers.	2 months
Secondary	Health and wellbeing outcomes of primary caregiver - mean change in quality of life score (physical health)	The WHO Quality of Life - abbreviated version tool (WHOQOL-BREF) is a short-version of the WHOQOL-100, a validated tool developed by WHO to assess quality of life. The WHOQOL-BREF is a 26-item questionnaire assessing four domains contributing to quality of life (physical health, psychological health, social relationships, environment). Each domain will produce a score from 0-100, with a higher score indicating a higher quality of life for that domain.; The WHOQOL-BREF questionnaire will be conducted with the primary caregiver. Score for the physical health domain will be presented as mean difference in scores from start to end of study period.	2 months
Secondary	Health and wellbeing outcomes of primary caregiver - mean change in quality of life score (psychological health)	The WHO Quality of Life - abbreviated version tool (WHOQOL-BREF) is a short-version of the WHOQOL-100, a validated tool developed by WHO to assess quality of life. The WHOQOL-BREF is a 26-item questionnaire assessing four domains contributing to quality of life (physical health, psychological health, social relationships, environment). Each domain will produce a score from 0-100, with a higher score indicating a higher quality of life for that domain.; The WHOQOL-BREF questionnaire will be conducted with the primary caregiver. Score for the psychological health domain will be presented as mean difference in scores from start to end of study period.	2 months
Secondary	Health and wellbeing outcomes of primary caregiver - mean change in quality of life score (social relationships)	The WHO Quality of Life - abbreviated version tool (WHOQOL-BREF) is a short-version of the WHOQOL-100, a validated tool developed by WHO to assess quality of life. The WHOQOL-BREF is a 26-item questionnaire assessing four domains contributing to quality of life (physical health, psychological health, social relationships, environment). Each domain will produce a score from 0-100, with a higher score indicating a higher quality of life for that domain.; The WHOQOL-BREF questionnaire will be conducted with the primary caregiver. Score for the social relationships domain will be presented as mean difference in scores from start to end of study period.	2 months
Secondary	Health and wellbeing outcomes of primary caregiver - mean change in quality of life score (environment)	The WHO Quality of Life - abbreviated version tool (WHOQOL-BREF) is a short-version of the WHOQOL-100, a validated tool developed by WHO to assess quality of life. The WHOQOL-BREF is a 26-item questionnaire assessing four domains contributing to quality of life (physical health, psychological health, social relationships, environment). Each domain will produce a score from 0-100, with a higher score indicating a higher quality of life for that domain.; The WHOQOL-BREF questionnaire will be conducted with the primary caregiver. Score for the environment domain will be presented as mean difference in scores from start to end of study period.	2 months