Team based collaborative care model, facilitated by a mHealth enabled and trained nurse, for management of heart failure in India (TIME-HF): design and rationale of a parallel group, open label, multi-centric cluster randomized controlled trial

Abstract

Background: Heart failure (HF) is a debilitating condition associated with enormous public health burden. Management of HF is complex as it requires care and coordination with different cadres of health care providers. In resource poor settings, physician driven initiatives to improve HF management is difficult due to multiple barriers. We propose to develop a team based collaborative care model (CCM), facilitated by a trained nurse, for management of HF with the support of mHealth and evaluate their acceptability and effectiveness in Indian setting. Methods: The proposed study will use mixed-methods research for assessment. A formative qualitative research will identify barriers and facilitators for implementing CCM for the management of HF and develop components of the intervention. Subsequently, a cluster randomised controlled trial (RCT) involving 22 centres (tertiary hospitals) with more than 1500 HF patients will be conducted to assess the effectiveness of the CCM in improving the overall survival as well as days alive and out of hospital (DAOH) at two-years (CTRI/2021/11/037797). The DAOH will be calculated by subtracting days in hospital and days from death until end of study follow-up from the total follow-up time. Poisson regression with a robust variance estimate and an offset term to account for clustering will be employed in the analyses of DAOH. A rate ratio and its 95% confidence interval (CI) will be estimated. The scalability of the proposed intervention model will be assessed through economic analyses (cost-effectiveness) and the acceptability of the intervention at both the provider and patient level will be understood through process evaluation. Potential Impact: The TIME-HF trial will provide evidence on whether a nurse-led team based CCM with mHealth support is effective in improving the clinical outcomes of HF in India. The findings may change the practice of management of HF in financially constrained low and middle-income countries.