The research aims to co-design, implement and evaluate a contextually relevant, patient-centered, equity promoting, simple technology leveraged innovative health system intervention to improve care for people with Multiple Long-Term Conditions (MLTC) in India and Nepal. Our research will be carried out in different phases. In phase 1, we will carry out extensive formative research to quantify the burden of MLTC in India and Nepal through case mix assessment and analysis of existing national and sub-national data sets. We will identify best practice care models for MLTC through a systematic review. We will understand barriers and explore potential solutions to seeking care for MLTC at primary care level through interviews and community conversations with various stakeholders.
The results of phase 1 research will inform our co-design workshops. We will run 18 co-design workshops, in research sites in India and Nepal over 3-months, with patients and caregivers, community groups, healthcare providers, researchers, policy makers and technology developers. The main output will be the co-designed health system intervention, its implementation and evaluation plan. This will ensure the intervention is patient-centered, culturally relevant, and seamlessly integrates with existing healthcare systems. The co-designed intervention will be piloted for six months in a total of six primary health centres in India and Nepal. Through the pilot, we will obtain insights on acceptability, feasibility and fidelity of the intervention and its implementation, recruitment and retention rates of the participants and data on costs and quality of life.
The pilot will provide valuable insights to refine the design and implementation of the full-scale cluster randomised controlled trial. The full scale cluster RCT will be implemented in 102 primary health centres across India and Nepal. Half the primary health centres will receive co-designed intervention whereas the other half will receive enhanced care. The co-designed intervention will consist of electronic decision support, assisted telemedicine and patient-facing mHealth application. The trial will be implemented for 24 months. The primary outcome will be quality of life measured using EQ-5D-5L. The various secondary outcomes include change in risk factors (blood pressure, blood sugar, lipids, etc.), quality of life measured using SF-12, lifestyle behaviors (diet, physical activity, tobacco and alcohol use) and various implementation outcomes. The results will be widely disseminated to inform policy changes, optimize healthcare delivery, and ultimately, empower individuals living with MLTC to lead healthier and more fulfilling lives.