Addressing Gaps in the Hypertension and Diabetes Care Continuum in Rural Bangladesh through Digital Technology Supported Decentralized Primary Care: Protocol for a Type 2 Effectiveness- Implementation Hybrid Study

Abstract

Background Hypertension and diabetes are interconnected highly prevalent chronic conditions in adults particularly among older adults. They contribute to the very high burden of noncommunicable diseases (NCDs) in low- and middle-income countries (LMICs). The awareness, diagnosis, treatment, and control of these conditions are poor and access to quality care for hypertension and diabetes remains limited, particularly in rural areas. Strengthening primary health care systems for NCD care delivery is critical to addressing this rising burden. Digital health interventions for NCD care have shown promising results in pilot studies, but reliable evidence of their benefits remains elusive. Little is known about how digital technology can be utilized to support decentralized primary care to improve accessibility and bridge the gaps in the care continuum in LMICs. In this study, we aim to generate data on the effectiveness and the cost-effectiveness of multicomponent decentralized primary care on hypertension and diabetes care continuum compared with usual care and to digital health intervention alone in rural Bangladesh, and to evaluate factors influence the implementation of the interventions. Methods We will implement a type 2 effectiveness-implementation hybrid with a dual focus on testing of effectiveness of a digital technology supported decentralized primary care model and implementation strategies. A three-arm mixed-methods quasi-experimental design will be used to evaluate implementation fidelity, processes, and effectiveness outcomes. The study will be implemented in three subdistricts of Dinajpur district, Rangpur division in northern Bangladesh. Multicomponent, decentralized primary care model will include components of healthcare provider training, digital health, decentralization with task shifting, and community-based care. The key interventions in the multicomponent model comprise expanding the scope of screening, routine monitoring, and dispensing of medication refills from a doctor-managed subdistrict level NCD clinic to nonphysician health worker managed village level community clinics, supported by a digital platform (Simple app) for electronic health records, point-of-care support, referrals when indicated, and routine patient follow-up. The digital health only model includes training and support in subdistrict NCD clinic for incorporating the Simple app. The primary endpoint of the study is changes in the treatment success rates for hypertension and diabetes. Discussion Our study is among the first to evaluate the effectiveness and implementation strategy of a decentralized primary care model for integrated hypertension and diabetes management in a LMIC. Using repeated cross-sectional community-based surveys combined with facility-based longitudinal data, our study will provide rich data on clinical and behavioral outcomes, various measures across the care continuum, and implementation processes, including costs. Implementation fidelity and process evaluation will be guided by the UK Medical Research Council guideline on process evaluation of complex intervention, and the WHO’s Noncommunicable Disease Facility-Based Monitoring Guidance, and the RE-AIM framework. We will document the factors that may explain how the interventions influence hypertension and diabetes management and explore barriers and facilitators to delivering and sustaining interventions. The results will have important implications for policy making and programmatic efforts for hypertension and diabetes prevention and management. Trial registration ClinicalTrials.gov, NCT06258473. Registered on 06 February 2024.