ClinicalTrials.gg
RecruitingNCT07439692ICOPEUpdated Feb 27, 2026

ICU-related Out of Pocket Expenses (ICOPE)

An observational study in Cost of ICU and Out of Pocket Expenses, sponsored by Nat Intensive Care Surveillance - MORU. Recruiting at 44 sites in 12 countries. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Nat Intensive Care Surveillance - MORU · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
354
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Cost of ICU
  • Out of Pocket Expenses

Keywords

  • OOPE
  • ICU-cost
  • LMIC
  • Critical Care
03

In context

Lead sponsor

Nat Intensive Care Surveillance - MORU is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

lack .

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
354 participants (estimated)
Patient registry
No

Groups and cohorts

  • Mechanically Ventilated

    Patients who received invasive mechanical ventilation during the course of their ICU stay

  • Not Mechanically Ventilated

    Patients who did not receive invasive mechanical ventilation during the course of their ICU stay

06

What researchers measure

Primary outcomes

  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).

    Time frame: 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

    Time frame: Throughout ICU stay, an average of 7 days

Secondary outcomes

  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.

    Time frame: 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

    Time frame: Throughout ICU stay, an average of 7 days

Other outcomes

  1. Proportion of direct medical versus direct non-medical costs in the total OOPEs

    Direct costs are expressed as expenditure during ICU treatment by households and consist of two main categories: direct medical cost and direct non-medical cost. Direct medical costs referring to direct payments made by individuals to healthcare providers at the time of service use. These include those costs that are consumed for healthcare resources during ICU care. These exclude any prepayment for health services, for example in the form of taxes or specific insurance premiums or contributions and where possible, net of any reimbursement to the individual who made the payments. Direct non-medical costs includes transportation, lodging, food items, informal payments and tips, payments incurred by caregivers and family for helping the patients during treatment.

    Time frame: Throughout ICU stay, an average of 7 days

  2. Patient family socio-economic status (SES) or income

    Annual income refers to the total amount of money earned by a household over the course of a year (i,.e. last 12 months preceding this survey time). This income can come from various sources, such as salary or wages from employment, profits from a business, rental income, investment income, land, or any other source of income received over the course of a year.

    Time frame: Throughout ICU stay, an average of 7 days

  3. Paying structures

    Paying structures and models by country

    Time frame: Throughout ICU stay, an average of 7 days

07

Study locations

44 of 44 sites recruiting
  • Wazir Akbar Khan Hospital
    Kabul, Kabul 1001-1008, Afghanistan
    Recruiting
  • Ibne-e-Sina Emergency Hospital
    Kabul, Kabul 1001, Afghanistan
    Recruiting
  • Sheikh Zayed Hospital
    Kabul, Kabul 1001, Afghanistan
    Recruiting
  • Rabia Balkhi Hospital
    Kabul, Kabul, Afghanistan
    Recruiting
  • Apollo Imperial Hospital
    Chittagong, Chattogram Division 4000, Bangladesh
    Recruiting
  • Chattogram Medical College Hospital
    Chittagong, Chattogram Division 4000, Bangladesh
    Recruiting
  • CSCR
    Chittagong, Chattogram Division 4000, Bangladesh
    Recruiting
  • 250 Bedded General Hospital
    Chittagong, Chittagong 4000, Bangladesh
    Recruiting
  • Bangladesh Institute of Applied Health Sciences (BIAHS)
    Dhaka, Dhaka Division 1000, Bangladesh
    Recruiting
  • Komfo Anokye Teaching Hospital (KATH)
    Kumasi, Ashanti Region, Ghana
    Recruiting
  • JSS Medical College, Mysore
    Mysore, Karnataka, India
    Recruiting
  • Amrita Institute of Medical Sciences
    Kochi, Kerala 682041, India
    Recruiting
  • Bharati Hospital and Research Centre
    Pune, Maharashtra 411043, India
    Recruiting
  • All India Institute of Medical Sciences (AIIMS)
    New Delhi, National Capital Territory of Delhi 110001, India
    Recruiting
  • Apollo Main Hospital
    Chennai, Tamil Nadu 600006, India
    Recruiting
  • Kisii Teaching and Referral Hospital
    Kisii, Kisii County 40200, Kenya
    Recruiting
  • AKU Mombasa
    Mombasa, Mombasa County 80100, Kenya
    Recruiting
  • Aga Khan University Hospital, Nairobi
    Nairobi, Nairobi County 00100, Kenya
    Recruiting
  • Nakuru Level 5 Hospital
    Nakuru, Nakuru County 20100, Kenya
    Recruiting
  • Nyeri County Referral Hospital
    Nyeri, Nyeri County 10100, Kenya
    Recruiting
  • International Islamic University Malaysia Medical Centre
    Kuantan, Pahang 25000, Malaysia
    Recruiting
  • Chitwan Medical College (CMC) Teaching Hospital
    Bharatpur, Bagmati, Nepal
    Recruiting
  • Civil Hospital
    Kathmandu, Bagmati 44600, Nepal
    Recruiting
  • HAMS Hospital
    Kathmandu, Bagmati 44600, Nepal
    Recruiting
  • Tribhuvan University Teaching Hospital
    Kathmandu, Bagmati 44600, Nepal
    Recruiting
  • Birat Nursing Home
    Biratnagar, Koshi 56700, Nepal
    Recruiting
  • B&C Medical College Teaching Hospital and Research Center
    Jhāpā, Koshi, Nepal
    Recruiting
  • Lady Reading Hospital (LRH)
    Peshawar, Khyber Pakhtunkhwa 25000, Pakistan
    Recruiting
  • Ziauddin Hospital North Nazimabad Campus
    Karachi, Sindh 74700, Pakistan
    Recruiting
  • Ziauddin Hospital Clifton Campus
    Karachi, Sindh 75600, Pakistan
    Recruiting
  • Connaught Hospital
    Freetown, Western Area, Sierra Leone
    Recruiting
  • Princess Christian Maternity Hospital
    Freetown, Western Area, Sierra Leone
    Recruiting
  • Groote Schuur Hospital
    Cape Town, Western Cape 7925, South Africa
    Recruiting
  • Teaching hospital Jaffna
    Jaffna, Nothern Province 40000, Sri Lanka
    Recruiting
  • Case Hospital
    Kampala, Central Region, Uganda
    Recruiting
  • Kawempe National Referral Hospital
    Kampala, Central Region, Uganda
    Recruiting
  • Nsambya hospital
    Kampala, Central Region, Uganda
    Recruiting
  • TMR International Hospital
    Kampala, Central Region, Uganda
    Recruiting
  • Uganda Martyrs Hospital Lubaga
    Kampala, Central Region, Uganda
    Recruiting
  • Mbale Regional Referral Hospital
    Mbale, Eastern Region, Uganda
    Recruiting
  • Nakasero Hospital
    Kampala, Kampala, Uganda
    Recruiting
  • St.Mary's Hospital Lacor
    Gulu, Northern Region, Uganda
    Recruiting
  • Mbarara Regional Referral Hospital
    Mbarara, Western Region, Uganda
    Recruiting
  • Mulago Specialized Referral Hospital
    Kampala, Uganda
    Recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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).

Supporting information: Study protocol, Informed consent form

Time frame: After publication of the primary results

Access criteria: 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).

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2024 (actual). Primary completion is estimated for Feb 2026, 14 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 16, 2026
First posted
Feb 27, 2026
StartActual
Dec 1, 2024
Primary completionEst.
Feb 28, 2026
CompletionEst.
Jul 31, 2026
Last update
Feb 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07439692
Lead sponsor
Nat Intensive Care Surveillance - MORU
Collaborators
Mahidol Oxford Tropical Medicine Research Unit, Nepal Intensive Care Research Foundation, Critical Care Society of Kenya, Research, Education And Criticalcare Health Trust, Pakistan, Association of Anesthesiologists of Uganda (AAU), Kumasi Centre for Collaborative Research in Tropical Medicine (KCCR), Doctors with Africa - CUAMM
Responsible party
Luigi Pisani (Dr, Nat Intensive Care Surveillance - MORU) — Principal investigator
First posted
Feb 27, 2026
Start date
Dec 1, 2024
Primary completion
Feb 28, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Feb 27, 2026

Study contacts

Dr
Contact
luigipisani@gmail.com
+393291525693

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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