Understanding the impact, reach and implementation of a health systems intervention to improve diabetes and hypertension care in pluralistic urban public primary care in Bangladesh: a study protocol

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Abstract Introduction In Bangladesh government provision of primary care in rural areas has seen the development of services for non-communicable diseases, particularly hypertension and diabetes (given their substantial rise in recent decades). However, in the context of cities, which are characterised by a plurality of providers that have sprung up to meet the demands of a rapidly growing urban population, such provision is very limited. Methods and analysis We will conduct a mixed-methods study, based on the RE-AIM framework, to understand the 1) reach, 2) effectiveness, 3) adoption, 4) implementation, and 5) maintenance (the five RE-AIM domains) of a health systems intervention to strengthen management processes for hypertension and diabetes within government and non-governmental (NGO-run) primary care facilities. To evaluate the effectiveness of the intervention we will use a quasi-experimental, difference-in-differences design. We will recruit 20 purposively selected urban government-run and NGO-run primary care facilities across Dhaka North and South City Corporation areas. Ten facilities will be purposively allocated to an intervention group and receive training and guidance materials on diabetes and hypertension care, based on the WHO Package of Essential Noncommunicable (PEN) Disease Intervention for Primary Care, and the use of an e-health application for patient records. The remaining facilities will be allocated to the existing care group and receive no intervention inputs, with identical data collection processes carried out in both groups. We aim to collect data on 50 patients visiting each facility during a baseline period and at 6- and 12-months after implementing the intervention. Using a standard linear-regression based approach, we will estimate the difference-in-differences effect of the intervention on a primary outcome measuring how many of eight key management processes were appropriately carried out for each patient visiting the facility at 6- and 12-months after implementing the intervention (with their appropriateness based on what should occur according to the intervention guidelines). We will also analyse the effect of the intervention on each management process separately as secondary outcomes. Alongside this design we will collect a range of additional quantitative and qualitative data to evaluate the other RE-AIM domains, using sequential mixed methods approaches, focusing on understanding potential facilitators and barriers in relation to these domains. Ethics and Dissemination Ethics approval has been received from the Research Governance Committee at the University of Leeds, UK (MREC 21-008) and from the Bangladesh Medical Research Council (BMRCAIREC/20 I 9 -2022 / 485). We will use a variety of channels to share our findings with policy makers, service providers, academicians, and relevant stakeholders. Strengths and Limitations of the Study Strengths This will be the first study to use implementation research methods to understand the delivery of diabetes and hypertension management in the context of the pluralistic urban primary care services of Bangladesh. The use of the RE-AIM framework to structure and plan evaluation will help assess multiple dimensions of implementation under real-world conditions therefore providing detailed insights for decision-making on the potential future scale-up of the National Protocol and Simple App within PHC facilities in urban Bangladesh. Limitations Conducting a randomised trial design for effectiveness evaluation will not be possible due to lack of resources Planning an evaluation for a longer time scale will be difficult due to project funding timelines

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