ICU out-of-pocket expenses and financial burden
ICU-related Out of Pocket Expenses (ICOPE) - A Multinational Prospective Study In African And Asian Countries.
Nat Intensive Care Surveillance - MORU · NCT07439692
This study will see how much patients and families in selected African and Asian hospitals pay out of pocket when someone is admitted to the ICU and how often those costs cause catastrophic financial hardship.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 354 (estimated) |
| Sex | All |
| Sponsor | Nat Intensive Care Surveillance - MORU (other) |
| Locations | 44 sites (Kabul, Kabul and 43 other locations) |
| Trial ID | NCT07439692 on ClinicalTrials.gov |
What this trial studies
ICOPE is a multinational prospective observational study enrolling all patients admitted to participating ICUs during a predefined 14-day recruitment window who are expected to stay longer than 24 hours. A minimum sample of 354 patients, including both ventilated and non-ventilated patients, will be followed until ICU discharge with additional follow-up at 30 days and 6 months to capture costs. The primary outcomes are total ICU-related out-of-pocket expenditure and the proportion of patients experiencing catastrophic health expenditure, with direct comparisons between ventilated and non-ventilated groups. Secondary analyses will identify risk factors for high out-of-pocket spending and catastrophic expenditure across participating LMIC sites.
Who should consider this trial
Good fit: Ideal candidates are patients admitted to a participating ICU during the 14-day recruitment window who are expected to remain in ICU for more than 24 hours and who (or whose legally authorized representative) can give informed consent.
Not a fit: Patients admitted outside participating ICUs, those with ICU stays under 24 hours, or those without available informed consent are not eligible and will not benefit directly from the study data collection.
Why it matters
Potential benefit: If successful, the results could help policymakers and funders design financial protections and target subsidies so fewer households face catastrophic costs after ICU care.
How similar studies have performed: Prior cross-sectional and retrospective work in LMICs has documented high out-of-pocket and catastrophic spending for hospital and critical care, but large prospective multicountry ICU-specific cohorts like this are relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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: lack informed consent.
Where this trial is running
Kabul, Kabul and 43 other locations
- Wazir Akbar Khan Hospital — Kabul, Kabul, Afghanistan (RECRUITING)
- Ibne-e-Sina Emergency Hospital — Kabul, Kabul, Afghanistan (RECRUITING)
- Sheikh Zayed Hospital — Kabul, Kabul, Afghanistan (RECRUITING)
- Rabia Balkhi Hospital — Kabul, Kabul, Afghanistan (RECRUITING)
- Apollo Imperial Hospital — Chittagong, Chattogram Division, Bangladesh (RECRUITING)
- Chattogram Medical College Hospital — Chittagong, Chattogram Division, Bangladesh (RECRUITING)
- CSCR — Chittagong, Chattogram Division, Bangladesh (RECRUITING)
- 250 Bedded General Hospital — Chittagong, Chittagong, Bangladesh (RECRUITING)
- Bangladesh Institute of Applied Health Sciences (BIAHS) — Dhaka, Dhaka Division, 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, India (RECRUITING)
- Bharati Hospital and Research Centre — Pune, Maharashtra, India (RECRUITING)
- All India Institute of Medical Sciences (AIIMS) — New Delhi, National Capital Territory of Delhi, India (RECRUITING)
- Apollo Main Hospital — Chennai, Tamil Nadu, India (RECRUITING)
- Kisii Teaching and Referral Hospital — Kisii, Kisii County, Kenya (RECRUITING)
- AKU Mombasa — Mombasa, Mombasa County, Kenya (RECRUITING)
- Aga Khan University Hospital, Nairobi — Nairobi, Nairobi County, Kenya (RECRUITING)
- Nakuru Level 5 Hospital — Nakuru, Nakuru County, Kenya (RECRUITING)
- Nyeri County Referral Hospital — Nyeri, Nyeri County, Kenya (RECRUITING)
- International Islamic University Malaysia Medical Centre — Kuantan, Pahang, Malaysia (RECRUITING)
- Chitwan Medical College (CMC) Teaching Hospital — Bharatpur, Bagmati, Nepal (RECRUITING)
- Civil Hospital — Kathmandu, Bagmati, Nepal (RECRUITING)
- HAMS Hospital — Kathmandu, Bagmati, Nepal (RECRUITING)
- Tribhuvan University Teaching Hospital — Kathmandu, Bagmati, Nepal (RECRUITING)
- Birat Nursing Home — Biratnagar, Koshi, Nepal (RECRUITING)
- B&C Medical College Teaching Hospital and Research Center — Jhapa, Koshi, Nepal (RECRUITING)
- Lady Reading Hospital (LRH) — Peshawar, Khyber Pakhtunkhwa, Pakistan (RECRUITING)
- Ziauddin Hospital North Nazimabad Campus — Karachi, Sindh, Pakistan (RECRUITING)
- Ziauddin Hospital Clifton Campus — Karachi, Sindh, 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, South Africa (RECRUITING)
- Teaching hospital Jaffna — Jaffna, Nothern Province, 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)
Study contacts
- Study coordinator: Dr
- Email: luigipisani@gmail.com
- Phone: +393291525693
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cost of ICU, Out of Pocket Expenses, OOPE, ICU-cost, LMIC, Critical Care