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
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.
Authors
- Sheila Greenfield (ORCID: https://orcid.org/0000-0002-8796-4114)
- Brijesh Kumar Yadav (ORCID: https://orcid.org/0000-0002-1286-7934)
- Panniyammakal Jeemon (ORCID: https://orcid.org/0000-0003-4172-4307)
- Ashuthosh Sharma
- Linju Joseph (ORCID: https://orcid.org/0000-0003-2043-1097)
- Nishant Ganesh Kumar (ORCID: https://orcid.org/0000-0002-0875-5809)
- Ajay Kumar shahi
- Rahul Shidhaye (ORCID: https://orcid.org/0000-0001-9365-7164)
- Steven Blackburn (ORCID: https://orcid.org/0000-0002-2629-3126)
- Jacqueline Thompson (ORCID: https://orcid.org/0000-0002-9775-361X)
- Sunny Borgohain
- Shasha Han (ORCID: https://orcid.org/0000-0001-7388-8125)
- Poornima Prabhakaran (ORCID: https://orcid.org/0000-0003-3134-7026)
- Manu Muraleedharan Sarojini
- Alice Sitch (ORCID: https://orcid.org/0000-0001-7727-4497)
- DORAIRAJ PRABHAKARAN
- Martin Widmann (ORCID: https://orcid.org/0000-0001-5447-5763)
- Tanvir Ahmed (ORCID: https://orcid.org/0000-0001-8147-5136)
- Nupur Bose (ORCID: https://orcid.org/0000-0003-4261-533X)
- Rachel Jordan (ORCID: https://orcid.org/0000-0002-0747-6883)
- Benjamin J. Ryan (ORCID: https://orcid.org/0000-0001-7015-3801)
- Jissa Vinoda Thulaseedharan
- Ashok Ghosh
- Semira Manaseki-Holland
- Suresh Munuswamy
- Gavin Roudge
- Ravikant Singh
- Stefan Krause
- FUSION collaborative group
- Ratna Amrit
- Tulika Singh
- Sue Jowett
Institutions
- National Center for Disease Control (IN)
- Indian Institute of Technology Roorkee (IN)
- Bhabha Hospital (IN)
- Sree Chitra Thirunal Institute for Medical Sciences and Technology (IN)
- Pravara Institute of Medical Sciences (IN)
- Patliputra University (IN)
- Hyderabad Rheumatology Center (IN)
- Cancer Hospital and Research Institute (IN)
- Centre for Chronic Disease Control (IN)
- Mahavir Cancer Institute and Research Centre (IN)
- Doctors Hospital (US)
- NIHR Birmingham Biomedical Research Centre (GB)
- Belmont University (US)
- University of Birmingham (GB)
Publication Details
- Journal
- Trials
- Published
- 2026-03-31
- DOI
- https://doi.org/10.1186/s13063-026-09633-3
- Primary Topic
- Disaster Response and Management
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- National Institute for Health and Care Research