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Cost of ICUICOPENCT07439692

ICU-related Out of Pocket Expenses (ICOPE)

An observational study of Cost of ICU and Out of Pocket Expenses, run by Nat Intensive Care Surveillance - MORU at 44 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cost of ICU, Out of Pocket Expenses
How many people
354 participants
Where
44 sitesin 12 countries
Study dates
1 Dec 2024to 31 Jul 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients admitted to the participating ICUs during a predefined window of 14 days and expected to have a duration of stay >24 hours will be eligible for the study.

Who may be able to join

  • All patients admitted to the participating ICUs during a predefined window of 14 days and expected to have a duration of stay >24 hours will be eligible for the study.

Who cannot join

  • lack informed consent.

Trial locations and contacts

44 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

44 sites in 12 countries

Uganda10 sites, 10 recruiting
  • St.Mary's Hospital Lacor

    Gulu, Northern Region

    Recruiting
  • Case Hospital

    Kampala, Central Region

    Recruiting
  • Kawempe National Referral Hospital

    Kampala, Central Region

    Recruiting
  • Nsambya hospital

    Kampala, Central Region

    Recruiting
  • TMR International Hospital

    Kampala, Central Region

    Recruiting
  • Uganda Martyrs Hospital Lubaga

    Kampala, Central Region

    Recruiting
  • Nakasero Hospital

    Kampala, Kampala

    Recruiting
  • Mulago Specialized Referral Hospital

    Kampala

    Recruiting
  • Mbale Regional Referral Hospital

    Mbale, Eastern Region

    Recruiting
  • Mbarara Regional Referral Hospital

    Mbarara, Western Region

    Recruiting

Other trials in Uganda

Nepal6 sites, 6 recruiting
  • Chitwan Medical College (CMC) Teaching Hospital

    Bharatpur, Bagmati

    Recruiting
  • Birat Nursing Home

    Biratnagar, Koshi, 56700

    Recruiting
  • B&C Medical College Teaching Hospital and Research Center

    Jhapa, Koshi

    Recruiting
  • Civil Hospital

    Kathmandu, Bagmati, 44600

    Recruiting
  • HAMS Hospital

    Kathmandu, Bagmati, 44600

    Recruiting
  • Tribhuvan University Teaching Hospital

    Kathmandu, Bagmati, 44600

    Recruiting

Other trials in Nepal

Bangladesh5 sites, 5 recruiting
  • Apollo Imperial Hospital

    Chittagong, Chattogram Division, 4000

    Recruiting
  • Chattogram Medical College Hospital

    Chittagong, Chattogram Division, 4000

    Recruiting
  • CSCR

    Chittagong, Chattogram Division, 4000

    Recruiting
  • 250 Bedded General Hospital

    Chittagong, Chittagong, 4000

    Recruiting
  • Bangladesh Institute of Applied Health Sciences (BIAHS)

    Dhaka, Dhaka Division, 1000

    Recruiting

Other trials in Bangladesh

India5 sites, 5 recruiting
  • Apollo Main Hospital

    Chennai, Tamil Nadu, 600006

    Recruiting
  • Amrita Institute of Medical Sciences

    Kochi, Kerala, 682041

    Recruiting
  • JSS Medical College, Mysore

    Mysore, Karnataka

    Recruiting
  • All India Institute of Medical Sciences (AIIMS)

    New Delhi, National Capital Territory of Delhi, 110001

    Recruiting
  • Bharati Hospital and Research Centre

    Pune, Maharashtra, 411043

    Recruiting

Other trials in India

Kenya5 sites, 5 recruiting
  • Kisii Teaching and Referral Hospital

    Kisii, Kisii County, 40200

    Recruiting
  • AKU Mombasa

    Mombasa, Mombasa County, 80100

    Recruiting
  • Aga Khan University Hospital, Nairobi

    Nairobi, Nairobi County, 00100

    Recruiting
  • Nakuru Level 5 Hospital

    Nakuru, Nakuru County, 20100

    Recruiting
  • Nyeri County Referral Hospital

    Nyeri, Nyeri County, 10100

    Recruiting

Other trials in Kenya

Afghanistan4 sites, 4 recruiting
  • Wazir Akbar Khan Hospital

    Kabul, Kabul, 1001-1008

    Recruiting
  • Ibne-e-Sina Emergency Hospital

    Kabul, Kabul, 1001

    Recruiting
  • Sheikh Zayed Hospital

    Kabul, Kabul, 1001

    Recruiting
  • Rabia Balkhi Hospital

    Kabul, Kabul

    Recruiting

Other trials in Afghanistan

Pakistan3 sites, 3 recruiting
  • Ziauddin Hospital North Nazimabad Campus

    Karachi, Sindh, 74700

    Recruiting
  • Ziauddin Hospital Clifton Campus

    Karachi, Sindh, 75600

    Recruiting
  • Lady Reading Hospital (LRH)

    Peshawar, Khyber Pakhtunkhwa, 25000

    Recruiting

Other trials in Pakistan

Sierra Leone2 sites, 2 recruiting
  • Connaught Hospital

    Freetown, Western Area

    Recruiting
  • Princess Christian Maternity Hospital

    Freetown, Western Area

    Recruiting

Other trials in Sierra Leone

Ghana1 site, 1 recruiting
  • Komfo Anokye Teaching Hospital (KATH)

    Kumasi, Ashanti Region

    Recruiting

Other trials in Ghana

Malaysia1 site, 1 recruiting
  • International Islamic University Malaysia Medical Centre

    Kuantan, Pahang, 25000

    Recruiting

Other trials in Malaysia

South Africa1 site, 1 recruiting
  • Groote Schuur Hospital

    Cape Town, Western Cape, 7925

    Recruiting

Other trials in South Africa

Sri Lanka1 site, 1 recruiting
  • Teaching hospital Jaffna

    Jaffna, Nothern Province, 40000

    Recruiting

Other trials in Sri Lanka

About this study

Official title: ICU-related Out of Pocket Expenses (ICOPE) - A Multinational Prospective Study In African And Asian Countries.

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.

Read the 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.

Keywords
OOPE, ICU-cost, LMIC, Critical Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07439692
Study groupRoleWhat they receive
Mechanically VentilatedPatients who received invasive mechanical ventilation during the course of their ICU stay
Not Mechanically VentilatedPatients who did not receive invasive mechanical ventilation during the course of their ICU stay

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Out of pocket cost per patient episode until ICU discharge

    Costs per complete patient episode, as actually spent in US dollars and International dollars (purchasing power parity exchange rate) in ventilated versus non-ventilated groups.

    OOPE is defined as the cost incurred by individuals or households at the time of receiving any healthcare services in the ICU, including the component of cost-sharing (the part not covered by a third party like, an insurer) and informal payments (e.g., tips and under-the-table payments), but excluding insurance premiums and any reimbursements from the third-party payers (e.g., the government, a health insurance fund or a private insurance company).

    Measured: Throughout ICU stay, an average of 7 days

  2. Relative risk of CHE

    Relative risk of catastrophic health expenditure for ventilated versus non-ventilated groups

    Measured: Throughout ICU stay, an average of 7 days

Secondary outcomes (2)
  1. Risk factors for CHE

    The following potential risk factors for CHE will be investigated: household income status, patient occupation; marital status; religion; access to safe water; educational status; ownership and location of households (urban vs. rural vs. slum); female-headed households; female-headed households; household size and age/gender of members; geographical location.

    Measured: Throughout ICU stay, an average of 7 days

  2. Frequency of different coping strategies

    Coping strategies are defined as Any mechanisms for OOPE coverage by patient or family member, including:

    • Savings: own income.
    • Medical debt: defined as personal debt derived from healthcare expenditures or paying for medical OOPE by borrowing money from friends or family, institutional loans (banks, etc) or non institutional loans (borrowing from black market).
    • selling of personal property
    • limitation to procurement of medical services or drugs
    • other

    Measured: Throughout ICU stay, an average of 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start1 Dec 2024
  3. Primary completion28 Feb 2026 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

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
354 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07439692
Sponsor's protocol ID
ICOPE V1.0 554-23
Acronym
ICOPE
Status last verified
Feb 2026
First submitted
16 Jan 2026
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After publication of the primary results, on request a FAIR-compliant pooled dataset will be available for secondary analysis, after judgment and approval of scientific quality and validity of the proposed analysis by the CCAA Data Access Committee (email: dac@nicslk.com).

Questions about this trial

What is this clinical trial studying?

An observational study of Cost of ICU and Out of Pocket Expenses, run by Nat Intensive Care Surveillance - MORU at 44 sites in 12 countries.

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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Uganda, Nepal, Bangladesh, India, Kenya and 7 more countries. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr (+393291525693, luigipisani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Out of pocket cost per patient episode until ICU discharge (time frame: Throughout ICU stay, an average of 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Feb 2026.

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