Health Care EconomicsLOOPNCT05239104
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
An observational study of Health Care Economics and Child Health, run by Murdoch Childrens Research Institute at 1 site in Laos.
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). Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Health Care Economics, Child Health, Cost of Illness
- How many people
- 400 participants
- Where
- 1 siteLaos
- Study dates
- 1 Nov 2022to 10 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Laos1 site
Lao-Oxford-Mahosot-Hospital Wellcome Trust Research Unit (LOMWRU)
Vientiane
About this study
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
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.
Read the 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.
- Being tested
- No intervention
- Keywords
- health behaviour, health equity, poverty, hospital costs, developing countries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study with no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (23)
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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
Measured: 2 months
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
Measured: at 2 weeks post-discharge from hospital
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
Measured: at 2 months post-discharge from hospital
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: At enrolment (day 0)
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Nov 2022
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Health Care EconomicsStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
- Responsible party
- Sponsor
- Investigators
- Fiona Russell, BMBS FRACP MPHTM PhD, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239104
- Sponsor's protocol ID
- 81864
- Acronym
- LOOP
- Status last verified
- May 2024
- First submitted
- 3 Feb 2022
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Beginning 0 (zero) months following analysis and article publication, individual participant data (IPD) will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access. • Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices) will be made available
Publications
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.
PubMed 27231544Barennes 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.
PubMed 26327558Wagstaff 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.
PubMed 29248367Xu 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.
PubMed 12867110Xu 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.
PubMed 17630440Grepin 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.
PubMed 33416439Memirie 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.
PubMed 28589003Wagstaff 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.
PubMed 29248366Wagstaff 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.
PubMed 23765700Hogan DR, Stevens GA, Hosseinpoor AR, Boerma T. Monitoring universal health coverage within the Sustainable Development Goals: development and baseline data for an index of essential health services. Lancet Glob Health. 2018 Feb;6(2):e152-e168. doi: 10.1016/S2214-109X(17)30472-2. Epub 2017 Dec 13.
PubMed 29248365Alam K, Mahal A. Economic impacts of health shocks on households in low and middle income countries: a review of the literature. Global Health. 2014 Apr 3;10:21. doi: 10.1186/1744-8603-10-21.
PubMed 24708831Bodhisane 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.
PubMed 31842882Barasa EW, Ayieko P, Cleary S, English M. Out-of-pocket costs for paediatric admissions in district hospitals in Kenya. Trop Med Int Health. 2012 Aug;17(8):958-61. doi: 10.1111/j.1365-3156.2012.03029.x. Epub 2012 Jun 21.
PubMed 22716184Sultana 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.
PubMed 33906852Alamgir NI, Naheed A, Luby SP. Coping strategies for financial burdens in families with childhood pneumonia in Bangladesh. BMC Public Health. 2010 Oct 19;10:622. doi: 10.1186/1471-2458-10-622.
PubMed 20955627
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05239104
- Acronym / sponsor ID
- LOOP / 81864
- Keywords
- health behaviour, health equity, poverty, hospital costs, developing countries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children aged 1 month - 14 years 11 months with a severe illness/injury | – | Other: No interventionChildren 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. |
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study with no intervention | Other | Children aged 1 month - 14 years 11 months with a severe illness/injury |
Primary outcome
Mean total out-of-pocket (OOP) expenses
Time frame: 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.
23 secondary outcomes
Total number and percentage of households experiencing Catastrophic Health Expenditure (CHE) set at 10% total annual household expenditure (CHE10a)
Time frame: 2 months
Total number and percentage of households experiencing CHE set at 10% monthly household expenditure (CHE10m)
Time frame: 2 months
Total number and percentage of households experiencing CHE set at 40% annual capacity to pay (CHE40a)
Time frame: 2 months
Total number and percentage of households experiencing CHE set at 40% monthly CTP (CHE40m)
Time frame: 2 months
Total number and percentage of households experiencing Impoverishment Health Expenditure (IHE) set at international poverty line (IHE-i)
Time frame: 2 months
Total number and percentage of households experiencing Impoverishment Health Expenditure (IHE) set at national poverty line (IHE-n)
Time frame: 2 months
Median number of coping strategies used by households
Time frame: 2 months
Health outcomes of participating children - mean length of hospital admission
Time frame: 2 months
Health outcome of participating children - total number and percentage of deaths
Time frame: 2 months
Health outcome of participating children - total number and percentage of participating children reporting each recovery status
Time frame: at 2 weeks post-discharge from hospital
Health outcome of participating children - total number and percentage of participating children reporting each recovery status
Time frame: at 2 months post-discharge from hospital
Health outcome of participating children - total number of children returning to ED/hospital
Time frame: 2 months
Health outcome of participating children - mean change in nutritional status
Time frame: 2 months
Health outcome of participating children - total number and percentage with moderate to severe wasting
Time frame: At enrolment (day 0)
Health outcome of participating children - total number and percentage with moderate to severe wasting
Time frame: 2 months
Health outcome of participating children - total number and percentage of children not admitted to hospital or early discharge from hospital
Time frame: 2 months
Health and wellbeing outcomes of participant household members - median number of household members with same illness as participant child
Time frame: 2 months
Health and wellbeing outcomes of participant household members - median number of deaths
Time frame: 2 months
Health and wellbeing outcomes of primary caregivers - total number and percentage of primary caregivers with worse nutritional status
Time frame: 2 months
Health and wellbeing outcomes of primary caregiver - mean change in quality of life score (physical health)
Time frame: 2 months
Health and wellbeing outcomes of primary caregiver - mean change in quality of life score (psychological health)
Time frame: 2 months
Health and wellbeing outcomes of primary caregiver - mean change in quality of life score (social relationships)
Time frame: 2 months
Health and wellbeing outcomes of primary caregiver - mean change in quality of life score (environment)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Background: PubMed 27231544Zhang 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.
- Background: PubMed 26327558Barennes 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.
- Background: PubMed 29248367Wagstaff 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.
- Background: PubMed 12867110Xu 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.
- Background: PubMed 17630440Xu 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.
- Background: PubMed 33416439Grepin 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.
- Background: PubMed 28589003Memirie 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.
- Background: PubMed 29248366Wagstaff 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.
- Background: PubMed 23765700Wagstaff 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.
- Background: PubMed 29248365Hogan DR, Stevens GA, Hosseinpoor AR, Boerma T. Monitoring universal health coverage within the Sustainable Development Goals: development and baseline data for an index of essential health services. Lancet Glob Health. 2018 Feb;6(2):e152-e168. doi: 10.1016/S2214-109X(17)30472-2. Epub 2017 Dec 13.
- Background: PubMed 24708831Alam K, Mahal A. Economic impacts of health shocks on households in low and middle income countries: a review of the literature. Global Health. 2014 Apr 3;10:21. doi: 10.1186/1744-8603-10-21.
- Background: PubMed 31842882Bodhisane 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.
- Individual participant dataSharing planned: Yes. Beginning 0 (zero) months following analysis and article publication, individual participant data (IPD) will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access. • Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices) will be made available
Related trials for Health Care Economics
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
Recruiting
Recovery Legal Care Trial
Firearm Injury, Injury Traumatic
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis, Clinical Phenotype
Enrolling by invitation
TimelyCare - A Proactive Primary Care Model: Delivering the Right Care at the Right Time for Individuals at Risk of High Care Consumption
Multimorbidity, Integrated Care
Active, not recruiting
Recovery Legal Care Pilot
Firearm Injury, Economic Problems
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Russell, BMBS FRACP MPHTM PhD principal investigator
Murdoch Childrens Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Care Economics and Child Health, run by Murdoch Childrens Research Institute at 1 site in Laos.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Laos. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean total out-of-pocket (OOP) expenses (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05239104, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.