Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 7:36 AM
Study NCT ID:
NCT07439692
Status:
RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ICU-related Out of Pocket Expenses (ICOPE)
Sponsor:
Nat Intensive Care Surveillance - MORU
Organization:
Study Overview
Official Title:
ICU-related Out of Pocket Expenses (ICOPE) - A Multinational Prospective Study In African And Asian Countries.
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICOPE
Brief Summary:
The ICU-related Out-of-Pocket Expenses (ICOPE) study is a multinational, prospective observational study conducted in African and Asian countries to quantify ICU-related out-of-pocket expenditures and catastrophic health expenditure among patients and families. The study will include all patients admitted to participating ICUs during a predefined 14-day recruitment window, provided they have an ICU stay longer than 24 hours and informed consent is obtained. A minimum sample size of 354 patients is planned, including both ventilated and non-ventilated patients. Participants will be followed until ICU discharge, with additional follow-up at 30 days and 6 months after admission, resulting in a total study duration of 18 months. The primary objective is to quantify ICU-related out-of-pocket costs and assess the proportion of patients experiencing catastrophic health expenditure, comparing ventilated and non-ventilated groups, while secondary objectives include identifying risk factors for catastrophic expenditure and documenting coping strategies used by families to manage ICU costs.
Detailed Description:
Increasing availability and access to ICU care in LMICs Availability and utilization of intensive care unit (ICU)-level care is increasing in low- and middle-income countries (LMICs). In parallel, there is a rise in the financial burden for service providers, but also for patients and their families. Even in LMIC healthcare systems which offer government funded healthcare, ICU is associated with considerable costs which impact patients' households. As such, stakeholders seeking to expand access to health services must consider the financial burden associated with critical care becoming routinely available. In fact, increasing health coverage is paradoxically associated with worsening out of pocket expenses.¹ Achieving universal health coverage, including financial risk protection, is a target of the 3rd Sustainable Development Goal.²,³ Critical care relates both to acute conditions (injury, trauma, infection, etc.) and chronic diseases. Return on investment for these conditions may be different leading to cost-effectiveness considerations.
ICU costs ICU admission is often unexpected, the treatment and interventions needed are usually unpredictable and length of stay frequently prolonged. In fact, a single ICU admission can cost from few hundreds to more than one hundred thousand US dollars.⁴ Thus ICU care often results in spiraling costs, which if not absorbed by welfare or insurance systems, directly fall on the patient and family. Costs can be classified as direct and indirect costs, with direct cost further divided in 'medical' and 'non-medical' domains. Direct medical costs include any daily fixed costs for the ICU bed, consumables (eg. medications, laboratory tests, nutrition, fluids, bandaging, ventilation circuits) which often fall at the pocket of patients and families. Studies assessing ICU direct costs are available from LMICs such as Brazil, Thailand, Vietnam and India.⁵-⁸ Direct non-medical costs include transportation and accommodation. In addition, indirect costs arise such as loss of income for patients, especially ones employed without sick leave cover. For families and caregivers, income loss and productivity loss are associated with time spent being at the hospital with their relatives.
Out of pocket and catastrophic health expenditure ICU care in LMICs is mostly funded by a mixed system of public welfare, insurance coverage and out of pocket expenditure (OOPE). Insurance penetration and government support remains low in most LMICs. OOPE in healthcare is defined as any direct outlay by households, including gratuities and in-kind payments, where the primary intent is to contribute to the restoration or enhancement of an individual's health. OOPE can include direct medical and direct non-medical costs, but does not include pre-paid fees for health-related taxes or insurance.² OOPEs constitute around 60% of total health expenditure in India⁹ and 67% in Bangladesh.¹⁰ Yet, while some data is available on cost burden of specific conditions such as chronic liver failure¹¹ or organophosphorus poisoning,¹² data on ICU-related OOPE in LMICs remains extremely scarce.
ICU-related OOPEs may rapidly lead to household debt and for some families, cross the threshold into catastrophic health expenditure (CHE).¹³,¹⁴ The incidence of catastrophic spending on health is reported on the basis of out-of-pocket expenditures exceeding conventional thresholds of 10% or 25% of household total annual income.¹⁵ CHE thus refers to any expenditure for medical treatment that can pose a threat towards a household's financial ability to maintain its subsistence needs.³ Across countries, the mean incidence of catastrophic out-of-pocket payments at (considering the 10% threshold) is 9.2%.¹⁵ This incidence was already increasing before the COVID-19 pandemic, with more than one in ten care episodes resulting in catastrophic spending in South Asia in 2010.¹⁶,¹⁷ At the global level in 2010 some 808 million people incurred CHE, with a great concentration in Asia and Africa.
CHE calculation allows to capture financial tensions in households that arise when OOPEs are compensated by selling or mortgaging households assets, borrowing money from lenders, banks, black market, friends or relatives during ICU care. Forty-seven percent of patients with septic shock incurred CHE in a Vietnam hospital, against 13% of patients admitted with dengue shock.⁵ In an Indian neonatal ICU, 56% of families incurred CHE, with one out of five families spending more on a single neonatal ICU admission than their monthly income.¹⁸ Risk factors and coping mechanisms for OOPE and CHE Coping mechanisms for critical care-related OOPE have been inadequately investigated and are largely unknown for adult ICU patients admitted to LMICs hospitals. Many studies focus on non-ICU populations, limit their scope to direct medical costs or are performed in high-income countries. A study on 3100 households in Dhaka, found that marital status, religion, source of care, access to safe water, income quintile and even the location of households had a significant relationship with OOPE.¹⁰ In a study from Thailand performed on 897 ICU patients with severe sepsis or septic shock, age, nosocomial or ICU infection, admission from the emergency department, number of organ failures, ICU length of stay, and fluid balance the first 72 hours were independently associated with ICU costs, although OOPE were not analyzed.¹⁹ Mechanical ventilation was found to be a factor increasing OOPEs in LMICs for pediatric²⁰ patients and total ICU costs in adult patients.⁴,¹⁹ Yet, the influence of the initiation of invasive ventilation on CHE remains to be described.
Impact of costs on ICU care Financial costs are a barrier to both access and continuation of critical care. In a survey of 1465 ICU physicians from 466 ICUs in 16 Asian countries, those from LMICs (notably China, the Philippines, and Bangladesh) reported as more likely to accede to families' requests to withdraw life sustaining treatments in a patient with an otherwise reasonable chance of survival, so as to avoid further medical bills, than those from high-income economies.¹⁸ The large ACCCOS study on COVID-19 ICU African patients reported 9% of treatment limitation with 3% of withdrawal of therapy, although it was not assessed whether the limitation was influenced by financial motives.²¹ A study in India suggested up to 9% of discharge against medical advice patients are due to financial constraints.²²
The knowledge gap In LMICs, where ICU care is increasingly available with limited financial risk protection, there remains limited robust quantitative data linked to OOPEs. Particularly, the actual burden that critical illness has on direct and indirect costs to the patients and their families is unknown. While some data on direct costs is starting to be available,⁵-⁸ there is limited insight into the magnitude of OOPEs and rates of CHE. There is also a lack robust data on risk factors for CHE due to ICU admissions and coping mechanisms in terms of sources of funding for patient families. Organ support, and especially mechanical ventilation that affects almost one out of two patients in the ICU, may be a key driver of OOPEs and CHE rates.
The present project This study seeks to precisely quantify ICU care related OOPEs in several LMICs in both the private and public sector. Context-specific drivers of OOPEs and CHE rates will also be established, while defining coping mechanisms and sources of funding. The impact of organ support, especially invasive mechanical ventilation, will be analyzed as a key potential driver of CHE.
The OOPE study has the following aims:
To quantify ICU care-related out-of-pocket expenditure (OOPE) in African and Asian LMICs and the proportion of patients and families facing catastrophic health expenditure (CHE), comparing patients receiving invasive mechanical ventilation with non-ventilated patients.
To identify risk factors associated with CHE. To identify coping strategies used by households to manage OOPE and CHE.
The following exploratory hypotheses are formulated:
Mechanical ventilation has a doubling effect on the incidence of catastrophic health expenditure.
The risk of CHE and the magnitude of OOPE can be predicted by distinct patient-, disease-, household-, and organizational-related factors.
Distress financing through borrowing from family members is the most frequent coping mechanism in both Asia and Africa.
ICU costs ICU admission is often unexpected, the treatment and interventions needed are usually unpredictable and length of stay frequently prolonged. In fact, a single ICU admission can cost from few hundreds to more than one hundred thousand US dollars.⁴ Thus ICU care often results in spiraling costs, which if not absorbed by welfare or insurance systems, directly fall on the patient and family. Costs can be classified as direct and indirect costs, with direct cost further divided in 'medical' and 'non-medical' domains. Direct medical costs include any daily fixed costs for the ICU bed, consumables (eg. medications, laboratory tests, nutrition, fluids, bandaging, ventilation circuits) which often fall at the pocket of patients and families. Studies assessing ICU direct costs are available from LMICs such as Brazil, Thailand, Vietnam and India.⁵-⁸ Direct non-medical costs include transportation and accommodation. In addition, indirect costs arise such as loss of income for patients, especially ones employed without sick leave cover. For families and caregivers, income loss and productivity loss are associated with time spent being at the hospital with their relatives.
Out of pocket and catastrophic health expenditure ICU care in LMICs is mostly funded by a mixed system of public welfare, insurance coverage and out of pocket expenditure (OOPE). Insurance penetration and government support remains low in most LMICs. OOPE in healthcare is defined as any direct outlay by households, including gratuities and in-kind payments, where the primary intent is to contribute to the restoration or enhancement of an individual's health. OOPE can include direct medical and direct non-medical costs, but does not include pre-paid fees for health-related taxes or insurance.² OOPEs constitute around 60% of total health expenditure in India⁹ and 67% in Bangladesh.¹⁰ Yet, while some data is available on cost burden of specific conditions such as chronic liver failure¹¹ or organophosphorus poisoning,¹² data on ICU-related OOPE in LMICs remains extremely scarce.
ICU-related OOPEs may rapidly lead to household debt and for some families, cross the threshold into catastrophic health expenditure (CHE).¹³,¹⁴ The incidence of catastrophic spending on health is reported on the basis of out-of-pocket expenditures exceeding conventional thresholds of 10% or 25% of household total annual income.¹⁵ CHE thus refers to any expenditure for medical treatment that can pose a threat towards a household's financial ability to maintain its subsistence needs.³ Across countries, the mean incidence of catastrophic out-of-pocket payments at (considering the 10% threshold) is 9.2%.¹⁵ This incidence was already increasing before the COVID-19 pandemic, with more than one in ten care episodes resulting in catastrophic spending in South Asia in 2010.¹⁶,¹⁷ At the global level in 2010 some 808 million people incurred CHE, with a great concentration in Asia and Africa.
CHE calculation allows to capture financial tensions in households that arise when OOPEs are compensated by selling or mortgaging households assets, borrowing money from lenders, banks, black market, friends or relatives during ICU care. Forty-seven percent of patients with septic shock incurred CHE in a Vietnam hospital, against 13% of patients admitted with dengue shock.⁵ In an Indian neonatal ICU, 56% of families incurred CHE, with one out of five families spending more on a single neonatal ICU admission than their monthly income.¹⁸ Risk factors and coping mechanisms for OOPE and CHE Coping mechanisms for critical care-related OOPE have been inadequately investigated and are largely unknown for adult ICU patients admitted to LMICs hospitals. Many studies focus on non-ICU populations, limit their scope to direct medical costs or are performed in high-income countries. A study on 3100 households in Dhaka, found that marital status, religion, source of care, access to safe water, income quintile and even the location of households had a significant relationship with OOPE.¹⁰ In a study from Thailand performed on 897 ICU patients with severe sepsis or septic shock, age, nosocomial or ICU infection, admission from the emergency department, number of organ failures, ICU length of stay, and fluid balance the first 72 hours were independently associated with ICU costs, although OOPE were not analyzed.¹⁹ Mechanical ventilation was found to be a factor increasing OOPEs in LMICs for pediatric²⁰ patients and total ICU costs in adult patients.⁴,¹⁹ Yet, the influence of the initiation of invasive ventilation on CHE remains to be described.
Impact of costs on ICU care Financial costs are a barrier to both access and continuation of critical care. In a survey of 1465 ICU physicians from 466 ICUs in 16 Asian countries, those from LMICs (notably China, the Philippines, and Bangladesh) reported as more likely to accede to families' requests to withdraw life sustaining treatments in a patient with an otherwise reasonable chance of survival, so as to avoid further medical bills, than those from high-income economies.¹⁸ The large ACCCOS study on COVID-19 ICU African patients reported 9% of treatment limitation with 3% of withdrawal of therapy, although it was not assessed whether the limitation was influenced by financial motives.²¹ A study in India suggested up to 9% of discharge against medical advice patients are due to financial constraints.²²
The knowledge gap In LMICs, where ICU care is increasingly available with limited financial risk protection, there remains limited robust quantitative data linked to OOPEs. Particularly, the actual burden that critical illness has on direct and indirect costs to the patients and their families is unknown. While some data on direct costs is starting to be available,⁵-⁸ there is limited insight into the magnitude of OOPEs and rates of CHE. There is also a lack robust data on risk factors for CHE due to ICU admissions and coping mechanisms in terms of sources of funding for patient families. Organ support, and especially mechanical ventilation that affects almost one out of two patients in the ICU, may be a key driver of OOPEs and CHE rates.
The present project This study seeks to precisely quantify ICU care related OOPEs in several LMICs in both the private and public sector. Context-specific drivers of OOPEs and CHE rates will also be established, while defining coping mechanisms and sources of funding. The impact of organ support, especially invasive mechanical ventilation, will be analyzed as a key potential driver of CHE.
The OOPE study has the following aims:
To quantify ICU care-related out-of-pocket expenditure (OOPE) in African and Asian LMICs and the proportion of patients and families facing catastrophic health expenditure (CHE), comparing patients receiving invasive mechanical ventilation with non-ventilated patients.
To identify risk factors associated with CHE. To identify coping strategies used by households to manage OOPE and CHE.
The following exploratory hypotheses are formulated:
Mechanical ventilation has a doubling effect on the incidence of catastrophic health expenditure.
The risk of CHE and the magnitude of OOPE can be predicted by distinct patient-, disease-, household-, and organizational-related factors.
Distress financing through borrowing from family members is the most frequent coping mechanism in both Asia and Africa.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: