Assessment of the impact of heart failure on household economic well-being: a protocol [version 1; peer review: 2 approved]

Background: Heart failure (HF), which is an emerging public health issue, adversely affects the strained health system in India. Additionally, the adverse impact of HF on the economic well-being of affected individuals and their families has been narrated in various anecdotal reports, with affected individuals and their dependents pushed into poverty. However, there is limited research quantifying how HF impacts the economic well-being of households from low- and middle-income countries. Methods: We describe the methods of a detailed economic impact assessment of HF at the household level in India. The study will be initiated across 20 hospitals in India. The selected centres represent different regions in India stratified based on the prevailing stages of epidemiological transition levels (ETLs). We will collect data from 1800 patients with acute decompensated HF and within 6-15 months follow-up from the time of initial admission. The data that we intend to collect will consist of a) household healthcare expenditure including out-of-pocket expenditure, b) financing mechanisms used by households and (c) the impoverishing effects of health expenditures including distress financing and catastrophic health expenditure. Trained staff at each centre will collect relevant data by using a validated and structured interview schedule. The study will have 80% power to detect an 8% difference in the proportion of households experiencing catastrophic health expenditures between two ETL groups. After considering a non-response rate of 5%, the target sample size is approximately 600 patients from each group and the total sample size is 1800 patients with heart failure. Impact: The results from our study will help policy makers in understanding the micro-economic impact of HF in India and aid in allocation of appropriate resources for prevention and control of HF.