Cost Effectiveness Analysis of Critical Care in Resource Limited Setting (CEACCLR)

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Procedure: mechanical ventilation; Procedure: neuromuscular blockade; Procedure: renal replacement therapy; Procedure: non-invasive ventilation

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 148

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

consecutive critically ill patients treated during one year in a recently established medical ICU at the Sarajevo University Clinical Center.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

ICU patients; The actual cohort of 148 critically ill medical patients that received the treatment in the intensive care unit (ICU). The interventions include interventions that are usually performed within the ICU such as mechanical ventilation, non-invasive ventilation, neuromuscular blockade, renal replacement therapy.

Procedure: mechanical ventilation; ventilator support for the patients presenting with acute respiratory failure; Other Names: ventilator; Procedure: neuromuscular blockade; paralysis of the skeletal muscles in order to optimize mechanical ventilation, especially during ARDS; Other Names: neuromuscular block; Procedure: renal replacement therapy; the procedures used to treat acute kidney injury; Other Names: continuous hemofiltration (CHF) or hemodiafiltration (CHDF); Procedure: non-invasive ventilation; Procedure used for ventilation support in patients with congestive heart failure, pulmonary edema, COPD and some other conditions.; Other Names: continuous positive airway pressure (CPAP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality		30 days and 60 days after critical illness onset and one year after hospital release
health related quality of life (HRQOL)	HRQOL was assessed using EQ5D-3L questionnaire	one year after hospital release

Collaborators and Investigators

• Sponsor: University of Sarajevo
• Investigators: Principal Investigator: Hajrunisa Cubro, MD, Medical ICU University of Sarajevo Clinical Center, Sarajevo, Bosnia and Herzegovina; Study Chair: Ognjen Gajic, MD, MSc, Division of Pulmonary and Critical Care Mayo Clinic Rochester MN USA

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: September 18, 2015
• First Submitted That Met QC Criteria: September 21, 2015
• First Posted (Estimate): September 22, 2015

Study Record Updates

• Last Update Posted (Estimate): September 22, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: critical care; intensive care; health related quality of life; cost benefit analysis
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: CCUS-2435/11