Improving primary healthcare for non-communicable diseases during annual flooding in Bihar, India: study protocol for a hybrid implementation-effectiveness parallel cluster randomised controlled trial
Year: 2026
Type: article
Study design: Study Protocol
Abstract: BACKGROUND: Non-communicable diseases (NCDs) cause 4.7 million deaths annually in India. Floods increasingly disrupt NCD care, especially in Bihar, one of India's most flood-prone and socioeconomically disadvantaged states. This study aims to strengthen the capacity of the community and primary healthcare systems to improve NCD outcomes during annual flooding in Bihar. METHODS: We describe a type II, hybrid implementation-effectiveness parallel cluster randomised controlled trial with an embedded qualitative process evaluation. A multi-component, co-developed intervention targeting primary care and community settings will be implemented and evaluated over two flood seasons in 26 flood-prone community development blocks in three districts of Bihar. Normalisation Process Theory (NPT) will guide the interpretation and adaptation of the intervention for broader applicability. Data will be collected through baseline and follow-up cross-sectional surveys conducted immediately after and 6 months following each annual flood season. Mixed-methods implementation and effectiveness outcomes will be evaluated using the RE-AIM-QuEST (Reach, Effectiveness, Adoption, Implementation, and Maintenance, Qualitative Evaluation for Systematic Translation) framework. Co-primary outcomes are patient medication adherence and availability of a flood-proof kit with medication and clinical handover information during floods. A preliminary health economic evaluation will estimate the cost-effectiveness of the intervention from a healthcare and societal perspective, with and without the use of early-warning flood forecasting. CONCLUSION: The FUSION (Floods, UnderStanding clImate change and nON communicable disease) trial will generate evidence on effective and scalable strategies to enhance health system and community resilience for the continuity of NCD care during recurrent flooding in India. Findings will inform public health policy and disaster preparedness efforts in similar resource-constrained, climate-vulnerable settings. TRIAL REGISTRATION: CTRI/2025/07/092055 [Registered on 30/07/2025] http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=138142 ; ISCTRN18019775 [Registered on 12/08/2025] https://www.isrctn.com/ISRCTN18019775.
Source: Trials
Authors: Semira Manaseki-Holland, Tanvir Ahmed, Ratna Amrit, Steven Blackburn, Sunny Borgohain, Nupur Bose, Dorairaj Prabhakaran, Ashok Ghosh, Sheila Greenfield, Shasha Han, Linju Joseph, Rachel Jordan, Sue Jowett, Stefan Krause, Nishant Kumar, Suresh Munuswamy, Poornima Prabhakaran, Gavin Roudge, Benjamin Ryan, Ajay Kumar Shahi, Rahul Shidhaye, Ravikant Singh, Manu Muraleedharan Sarojini, Tulika Singh, Ashuthosh Sharma, Alice Sitch, Jissa Vinoda Thulaseedharan, Jacqueline Y. Thompson, Martin Widmann, Brijesh Kumar Yadav, Panniyammakal Jeemon, FUSION collaborative group
Institutions: University of Birmingham, Patliputra University, Mahavir Cancer Institute and Research Centre, Sree Chitra Thirunal Institute for Medical Sciences and Technology, Belmont University, Pravara Institute of Medical Sciences, Indian Institute of Technology Roorkee, National Institute for Health and Care Research, NIHR Birmingham Biomedical Research Centre
Language: English
Subfield: Emergency Medical Services
Field: Health Professions
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,790
Award: G2723990034
OpenAlex ID: W7143958109