A trial of low-cost, technology-assisted, integrated care delivery programme to prevent serious cardiovascular events in disadvantaged populations.

Cardiovascular diseases (CVD) have become a major cause of disease burden in low- and middle-income countries (LMIC). More worryingly, within these countries, those in the lower socioeconomic classes are less likely to be utilising evidence-based therapies and they tend to be disproportionately affected by CVD. There are several barriers to more widespread and equitable implementation of evidence-based care and these barriers can be found at different levels of the healthcare systems. It has been suggested that innovative solutions that incorporate the whole care delivery system and use new digital technologies that assist with high-quality delivery of recurrent tasks may be more successful in increasing the capacity of rural healthcare systems in the delivery of effective and affordable medical care for disadvantaged populations than the prevailing doctor and hospital-centred models of care. In this large-scale collaborative project between the George Institute for Global Health, the Non-Communicable Disease Research Center at the University of Tehran and several other partners, we will implement and evaluate the effectiveness and cost-effectiveness of a multifaceted intervention that targets at least three components of the health system (health workforce, health information and communication, medical technologies). After adaptation of this previously tested intervention into the existing rural healthcare system in Iran, we will conduct a large-scale cluster randomised study of 306 rural communities to rigorously measure the effect of the intervention on clinically important cardiovascular outcomes. A number of enabling features of the Iranian healthcare system allow implementation and reliable evaluation of such disruptive solutions today at lower trial costs but with the potential of transforming CVD management worldwide. These include: a well-functioning and large network of community health workers in Iran who have prescribing authority for essential drugs and who have sufficient time to help with rapid screening and recruitment of patients into the trial; reliable access to affordable drugs at the intervention sites only with only a low risk of treatment contamination; a validated cause-specific national death register, well-established hospitalisations records, and free village landline telephones for efficient patient follow-up with almost no attrition; reliable communication infrastructure such as mobile networks for remote and near real-time study site monitoring; and government policies which stress the need for extending the role of community health workers in better and affordable management of non-communicable diseases for disadvantaged populations. After about 5 years, we expect the outcome of the study, which includes process and economic evaluation, to lead to the formulation of locally relevant policy recommendations with the potential to positively impact on the healthcare of millions in Iran on a daily basis, with wider applicability for other LMICs. The research team in this collaboration provides broad skills and a unique and substantial track record in rigorous large-scale clinical trials, statistics, engineering and computer programming, qualitative methods and health economics that are required for effective and efficient implementation of the research programme.