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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

354

participants targeted

Target at P75+ for all trials

Timeline

1mo left

Started Dec 2024

Geographic Reach

12 countries

44 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

Study Progress92%

Dec 2024Jul 2026

Study Start

First participant enrolled

December 1, 2024

Completed

1.1 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2026

Completed

1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed

1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

January 16, 2026

Last Update Submit

February 23, 2026

Conditions

Cost of ICU Out of Pocket Expenses

Keywords

OOPEICU-costLMICCritical Care

Outcome Measures

Primary Outcomes (2)

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).
Throughout ICU stay, an average of 7 days
Relative risk of CHE
Relative risk of catastrophic health expenditure for ventilated versus non-ventilated groups
Throughout ICU stay, an average of 7 days

Secondary Outcomes (2)

Risk factors for CHE
Throughout ICU stay, an average of 7 days
Frequency of different coping strategies
Throughout ICU stay, an average of 7 days

Other Outcomes (3)

Proportion of direct medical versus direct non-medical costs in the total OOPEs
Throughout ICU stay, an average of 7 days
Patient family socio-economic status (SES) or income
Throughout ICU stay, an average of 7 days
Paying structures
Throughout ICU stay, an average of 7 days

Study Arms (2)

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

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

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.

You may not qualify if:

lack informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Mahidol Oxford Tropical Medicine Research Unitcollaborator
Nepal Intensive Care Research Foundationcollaborator
Critical Care Society of Kenyacollaborator
Research, Education And Criticalcare Health Trust, Pakistancollaborator
Association of Anesthesiologists of Uganda (AAU)collaborator
Doctors with Africa - CUAMMcollaborator
Nat Intensive Care Surveillance - MORUlead
Kumasi Centre for Collaborative Research in Tropical Medicine (KCCR)collaborator

Study Sites (44)

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

Jhapa, 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