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

Lead Research Organisation: University of Oxford
Department Name: Clinical Trial Service Unit

Abstract

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.

Technical Summary

Background: Reducing the gap between evidence and practice is likely to lead to substantial reductions in the burden of CVD worldwide. Over the past few years, there has been a growing interest in innovative models of care delivery that make better use of technological advances, in particular IT to provide evidence-based cardiovascular care. However, despite the intuitive appeal of such systems, the evidence for their effectiveness, cost-effectiveness and sustainability is limited.

Methods: We propose to conduct a large-scale cluster RCT to test the hypothesis that a low-cost technology-assisted and community-based programme of evidence-based cardiovascular management will reduce the risk of serious cardiovascular events by at least 20% in high-risk individuals. 306 rural health clinics in Iran will be randomised to intervention or control. In both arms, community health workers (CHW) will be trained to use bespoke android applications and point-of-care diagnostics to screen about 55,000 rural dwellers for cardiovascular risk factors. In the control arm, management will be left to the discretion of CHWs, patients and doctors. In the intervention arm, CHWs will be use the more advanced version of the tablet-PC application, which provides an estimation of absolute CVD risk, supports decision-making for prescription of a cardiovascular pollypill if no contraindications, referral of a smaller proportion of patients to doctors for further review and treatment optimisation, and follow-up and adherence management. To avoid biases in follow-up, outcomes will be collected in all 55,000 participants but randomised comparisons will be among those at high CVD risk.

Potential outcomes: To our best knowledge, this will be the largest and longest trial of its kind that is powered to detect modest but clinically important outcomes with huge impacts on provision of low-cost effective care for millions of people worldwide.

Planned Impact

In this large-scale trial, we will comprehensively evaluate a multi-dimensional intervention directly relevant to the current health policy agenda of Iran and many other LMIC. The proposed intervention will be integrated into an existing rural community-based healthcare system and will include components directed to health workforce reengineering, the provision of evidence-based care delivery and the use of innovative smartphone digital health technologies and affordable drugs.

Such a system-wide approach and proposed evaluation framework has many advantages, including its potential scalability not only to other settings, but also to a broader range of health conditions that could be managed in similar ways. Beyond transferrable knowledge for CVD prevention, the principals of the intervention evaluated could be used in the future to provide non-physician cover for other diseases (such as diabetes, cancers, mental disorders or pain management) where protocol-based long-term disease management is possible.

We believe there is a high likelihood of a positive health outcome (i.e. a cost-effective reduction in serious CVD events) that will provide a robust evidence base on which to base policy and investment decisions of governments and other relevant stakeholders. If found to be effective and cost-effective, the approaches being investigated by this proposed research will have direct implications for day-to-day healthcare provisions of millions of Iranians and potentially large populations in other countries. To our knowledge, this project would be the first-ever trial to investigate the clinical impact of a comprehensive IT-facilitated rural community healthcare service that is long enough and large enough to assess its impact on important clinical outcomes (although similar studies are currently being developed by our group and others elsewhere).

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