Cost Effectiveness Analysis of Critical Care in Resource Limited Setting

Critical Illness Clinical Trial

— CEACCLR  

Official title:

Cost Effectiveness of Intensive Care in a Low Resource Setting: Prospective Cohort of Medical Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556476
• Other study ID #: CCUS-2435/11
• Status: Completed
• Phase: N/A
• First received: September 18, 2015
• Last updated: September 21, 2015
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: September 2015
• Source: University of Sarajevo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bosnia: Federal Ministry of Health
• Study type: Observational

Clinical Trial Summary

The purpose of this study was to examine the cost effectiveness of critical care in a middle income country with limited resources.

The main study hypothesis was that critical care is cost effective in low resources setting.

Description:

The investigators objective was to calculate the cost effectiveness of treatment of critically ill patients in a medical ICU of a middle income country with limited access to ICU resources.

Methods: Consecutive critically ill medical patients treated in a recently established medical ICU in Sarajevo, Bosnia and Herzegovina, were prospectively recorded and a subsequent cost utility analysis of intensive care in comparison to hospital ward treatment from the perspective of health care system was performed. Incremental cost effectiveness was calculated using estimates of ICU versus non-ICU treatment effectiveness based on a formal systematic review of published studies. Decision analytic modeling was used to compare treatment alternatives. Sensitivity analyses of the key model parameters were performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients treated between June 1 2011 and June 29 2012 in the medical ICU

Exclusion Criteria:

• Patients who stayed in the ICU less than 24 hours and

• hospital readmissions

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness

Intervention

Procedure:
• mechanical ventilation
ventilator support for the patients presenting with acute respiratory failure
• neuromuscular blockade
paralysis of the skeletal muscles in order to optimize mechanical ventilation, especially during ARDS
• renal replacement therapy
the procedures used to treat acute kidney injury
• non-invasive ventilation
Procedure used for ventilation support in patients with congestive heart failure, pulmonary edema, COPD and some other conditions.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sarajevo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival	mortality was recorded one year after hospital discharge and subtracted from the value od 100% in order to get one year survival	one year after hospital release	No
Secondary	mortality		30 days and 60 days after critical illness onset and one year after hospital release	No
Secondary	health related quality of life (HRQOL)	HRQOL was assessed using EQ5D-3L questionnaire	one year after hospital release	No