ICU-related Out of Pocket Expenses (ICOPE)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNat Intensive Care Surveillance - MORU

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

354 Participants
are grouped into 2 trial groups
Group A: Mechanically Ventilated
Group B: Not Mechanically Ventilated

Trial outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nat Intensive Care Surveillance - MORU

Lead sponsor

Mahidol Oxford Tropical Medicine Research Unit

Collaborator

Nepal Intensive Care Research Foundation

Collaborator

Critical Care Society of Kenya

Collaborator

Research, Education And Criticalcare Health Trust, Pakistan

Collaborator

Association of Anesthesiologists of Uganda (AAU)

Collaborator

Kumasi Centre for Collaborative Research in Tropical Medicine (KCCR)

Collaborator

Doctors with Africa - CUAMM

Collaborator