Completed projects

Health economic analysis of an intervention program to improve breathing in critically ill patients (BREATH EASE STUDY)
Team:Dr. H. Seidl, Prof. Dr. R. Holle
Funding:Federal Ministry of Education and Health
FKZ 01GY1331
Duration:3 years
Description:Over recent years, specialist breathlessness services have been developed within palliative medicine offering a multi-disciplinary complex intervention integrating evidence-based non-pharmacological and pharmacological interventions to support patients with advanced disease.

Under the leadership of Prof. Dr. Claudia Bausewein – Clinic Director of the Clinic for Palliative Medicine at LMU, Grosshadern – a single-blinded randomized controlled fast track trial is conducted with a waiting group design to evaluate a multi-professional breathlessness service for patients with advanced stages of malignant and non-malignant diseases (www.atemnotambulanz.de).

The IGM is responsible for the economic analysis such as health care use and quality of life.
Objectives:The aim of the study is to evaluate the efficacy and cost-effectiveness of a multi-professional breathlessness service on how to deal and control breathlessness and the quality of life of patients with advanced malignant and chronic diseases.

Primary endpoints are the mastery of breathlessness and the quality of life of the participating patients, measured with the German version of the Chronic Respiratory Disease Questionnaire (CRQ).

Secondary endpoints include the breathlessness severity, the burden of other symptoms, the caregiver burden as well as the costs of health care and health-related quality of life measured by the EuroQol 5D generic instrument.
Methods:It is scheduled to include 216 subjects in the RCT. All resource use data will be retrospectively assessed by the patient. On the basis of the FIMA questionnaire we developed a questionnaire for the patients that can be used in personal and telephone interviews. The resource use will be valued by unit costs and the mean differences in costs between intervention and control group will be estimated.
Cost for the intervention excluding the study related costs will be considered. The costs of the intervention itself will be estimated using local accounting data and information on activity rates.

Generic health-related quality of life of patients and informal carers is measured with the EQ-5D-5L and the EQ visual analogue scale (VAS). The EQ-5D-5L is a standardised instrument applicable to a wide range of health conditions for use as a measure of health outcome and is especially suited to generate quality adjusted life years (QALYs).

We will analyse EQ-5D-5L utility and VAS data among the survivors over time in the two treatment arms.