Primary Care Strategies to Reduce High Blood Pressure: A Cluster Randomized Trial in Rural Bangladesh, Pakistan and Sri Lanka

Lead Research Organisation: National University of Singapore
Department Name: Duke-NUS Graduate Medical School

Abstract

Cardiovascular diseases (CVD) have become the leading cause of mortality globally. In South Asia, high rates of CVD are
observed at a younger age than in other countries causing a reduction in productive life years with severe economic consequences. High blood pressure (BP) confers the greatest attributable risk to death and disability associated with CVD.

Our Wellcome Trust funded Control of Blood Pressure and Risk Attenuation (COBRA) trial (2004 to 2007) in Karachi, Pakistan, suggested the combined strategy of family based home health education (HHE) delivered by trained community health workers (CHW) plus care of individuals by trained private general practitioners (GP) to optimally manage hypertension had the most marked beneficial impact on BP compared to usual care, or single interventions. However, the COBRA intervention was designed for an urban South Asian setting, where private GPs cater to over 75% of the patients seeking care. Most of South Asia is still rural (73% Bangladesh, 64% Pakistan, 71% India, 85% Sri Lanka) where prevalence of hypertension is high and healthcare infrastructure and provider characteristics are very different compared to the urban setting. The COBRA trial did not evaluate effectiveness of strategies delivered using the public health infrastructure, or generalizability to the rural population in Pakistan. It is also not clear whether any benefit would extend to rural communities in other South Asian countries.

In our ongoing COBRA-BPS feasibility study in Bangladesh, Pakistan, and Sri Lanka, we modified COBRA by developing a comprehensive "multicomponent intervention (MCI)" for effective delivery of hypertension care using the rural predominantly public primary care infrastructure. We also conducted extensive stakeholder consultation and received very favourable response for a full scale trial to evaluate MCI in 3 countries.

We now propose a cluster randomised controlled trial (RCT) on 2550 adults with hypertension in 30 rural communities in Bangladesh, Pakistan and Sri Lanka, to evaluate a comprehensive MCI comprised of specifically comprised 1) home health education (HHE) by government community health workers (CHWs), 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, 3) trained public and private providers in management of hypertension and using a checklist, 4) designated hypertension triage counter and hypertension care coordinators in government clinics, 5) a financing model to compensate for additional health services including targeted subsidies.


A total of 15 communities (5 in each country) will be randomised to MCI and 15 (5 in each country) to usual care in 3
countries. Individuals with hypertension will be followed for 2 years to assess whether MCI compared to usual care is more
effective at lowering BP, and cost effective in terms of preventing CVD related disability and death. We will also interview
stakeholders and conduct serial focus group discussions of patients on their experience with the strategy in relation to
various components of MCI.

If shown to be successful, our findings will be helpful in securing political commitment from stakeholders for up-scaling MCI
strategies at the national level in these South Asian countries. The South-South collaboration and shared experiences will
be very valuable in co-ordinating a regional action plan on NCDs with a focus on hypertension as an entry point. Our trial
will provide direct evidence of the value of using comparable models and platforms for non-communicable disease
management which would extend to other Asian countries with similar ethnic population and healthcare infrastructure.

Technical Summary

We propose a two-year stratified cluster randomised controlled trial (RCT) in 30 rural communities in Bangladesh, Pakistan and Sri Lanka aimed at lowering BP levels of individuals with hypertension (systolic BP >=140 mm Hg or diastolic BP >=90 mm Hg, or on antihypertensive therapy). The RCT will enrol 2550 individuals with hypertension in these communities to evaluate the effectiveness of a "multi-component strategy (MCI)" that includes intervention components 1 through 5 below vs. usual care, which does not include any of these components. The MCI components are:

1. Home health education (HHE) by government community health workers (CHWs), plus
2. blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus
3. Trained public and private providers in management of hypertension and using a checklist, plus
4. designated hypertension care coordinators and hypertension triage counter in government clinics, plus
5. compensation for additional services including targeted subsidies.

Primary effectiveness outcome will be change in systolic BP from baseline to follow-up at 24 months.

We will also quantify the incremental cost-effectiveness of MCI in terms of incremental cost per unit reduction in BP over the two year time period and in terms of incremental cost per CVD DALYs averted based on well-defined relationships between blood pressure reductions and CVD events averted. We will also interview stakeholders and conduct serial focus group discussions of patients on their experience with the strategy in relation to various components of MCI.

Planned Impact

1. Address major public health challenge in South Asia: Hypertension is a major contributor to death and disability from cardiovascular disease (CVD) in South Asia. About 1 in 4 adults suffers from hypertension in Bangladesh, Pakistan, and Sri Lanka. However, there are no specific public health programs at the federal, provincial or district level with the expertise in designing and managing programs for prevention and control of hypertension. The 3 South Asian countries have recently prioritised non-communicable diseases (NCDs) on their national and provincial health agenda. However, operational plan is lacking. Our trial aims to evaluate potentially effective and sustainable comprehensive strategies through the primary care system for managing hypertension in rural Bangladesh, Pakistan and Sri Lanka. If successful, scaling up the interventions would be immensely beneficial to the South Asian region and possibly other low-and middle- income countries (LMICs) in terms of reducing mortality and building human capital.

2. Health Systems Strengthening and Capacity Building for Hypertension (and NCD) care: Our trial is capable of reconfiguring and strengthening the capacity of the health system by establishing a team based approach and referral links with documentation of standardised care to enhance hypertension management. The trial uses hypertension as an entry point into developing rural NCD health services and the HHE component of our intervention is the first-line approach for management of diabetes and other common NCDs. The use of statins among high CVD risk individuals follows an up-to-date comprehensive CVD risk reduction strategy. Models of coordinated care are recommended by the World Health Organisation for communicable disease programs, such as Directly Observed Treatment (DOTS) for tuberculosis, HIV, and management of malaria. However, evidence on using comparable models and platforms for NCD management is scarce. Contrasting the experiences from these 3 countries should provide valuable lessons to implement an action plan, and also validate the usefulness of our approach for other countries in the region and
beyond.

3. Detailed Policy Relevant Economic Evaluation: We plan to conduct both a budgetary impact analysis and a cost-effectiveness analysis (CEA) for Bangladesh, Pakistan and Sri Lanka. The detailed CEA will be performed from the societal, government and participants perspectives. Country specific estimates from government and patients' perspectives will be computed for local applicability. In addition, the analysis from the societal perspective would be performed for 3 countries together to provide estimates with implications for other South Asian countries and other LMICs. This information would be very valuable for seeking political commitment from key stakeholders and is likely to enhance uptake of findings as sustainable provincial/national/regional public health programs.

4. Knowledge Translation and Policy Impact: The trial will provide an opportunity to establish governance structures, mechanisms, and strategies to ensure prompt dissemination and uptake of research findings locally, nationally and regionally. The trial evaluates delivery of hypertension management strategies using the public health infrastructure. If successful, this will serve as a platform for up-scaling other model programs into public health interventions. The engagement of governments in 3 countries with investigators would bring hypertension management agenda into national and regional health focus and also facilitate implementation of NCD control programmes in other LMICs. We will further catalyse the process of research to policy translation in Asia Pacific region and supporting organisations and government contacts, and by involving the key stakeholders from national governments and medical research councils, NGOs, international agencies, and media partners.

Publications

10 25 50

publication icon
Feng L (2019) Regional variation in chronic kidney disease and associated factors in hypertensive individuals in rural South Asia: findings from control of blood pressure and risk attenuation-Bangladesh, Pakistan and Sri Lanka. in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association

 
Description Working with partners in countries on hypertension management guidelines
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Implementation circular/rapid advice/letter to e.g. Ministry of Health
Impact in progress
 
Description JGHI
Amount £2,000,000 (GBP)
Funding ID MR/N006178/1 
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 07/2015 
End 06/2018
 
Title Hypertension treatment algorithm 
Description This a treatment algorithm for blood pressure control developed and refined by study cardiologists, nephrologists, nutritionists, as per NICE guideline 
Type Of Material Improvements to research infrastructure 
Year Produced 2017 
Provided To Others? Yes  
Impact Trial is ongoing. Evaluation of impact will be done after the trial is done. 
URL https://www-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/pmc/articles/PMC5469065/
 
Title COBRA full scale study data 
Description The database include data on demographics, health, health cost, BP, anthropometrics and lab tests.The data collected will be available for sharing on a dependently available basis. As the custodian of data, the Chief Investigator (Prof. Tazeen) will review and approve any requests for individual anonymized (and irreversibly de-identified) patient data from external investigators.The Chief Investigator will authorize sharing the anonymized data set upon submission of requests (aims and analytic plans) from potential users. This data will be available for use by other researchers after publication of the study's major objectives. 
Type Of Material Database/Collection of data 
Year Produced 2019 
Provided To Others? No  
Impact the effectiveness and cost-effectiveness of multicomponent intervention on blood pressure will be evaluation based on the data. 
 
Description New collaborations among academic institutes across South Asia to enhance hypertension care delivery in public health sector and it evaluation 
Organisation International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Country Bangladesh 
Sector Charity/Non Profit 
PI Contribution By way of the trial, we have organized a systemic and structured approach of adhering to standardized guidelines for management of hypertension. This includes a process of discussion and feedback from experts on any local issues that require adaption which is generally minor and after consensus of experts not only from the country but the region. Each country has a National Advisory Committee with representatives from professional societies, academia and government, which is important for dissemination and future uptake of the findings. These collaborations also institutionalise our efforts and are key for success. The collaborations are relevant to both the grants listed as one was a feasibility study that led to the full scale study.
Collaborator Contribution The time and intellectual contribution of partners and experience and connections they bring of working in the countries where the trial is ongoing
Impact Outcomes are in progress as full scale study has not been completed yet.
Start Year 2014
 
Title multicomponent primary care strategies on lowering blood pressure 
Description The multi-component interventions (MCI) is comprised of all the following five components: 1) home health education (HHE) by government community health workers (CHWs), plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus 3) training public and private providers in management of hypertension and using a checklist, plus 4) designating hypertension triage counter and hypertension care coordinators in government clinics, plus 5) a financing model to compensate for additional health services and provide subsidies to low income individuals with poorly controlled hypertension. With the research funding from MRC/Wellcome Trust/DfiD, UK, recruitment of participants has just been completed, and evaluation of intervention is in progress. 
Type Management of Diseases and Conditions
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2015
Development Status Under active development/distribution
Clinical Trial? Yes
Impact still at early stage of evaluation . 
URL https://clinicaltrials.gov/show/NCT02341651
 
Description National Advisory Committee 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact National Advisory Committees have been established in each COBRA-BPS country. These committees now need to communicate with key officials and groups to plan the role out of improved blood pressure control policies beyond the trial sites.

In Bangladesh, NAC is held every 6 months and the most important issue they have addressed was lack of adequate medication supply and limited cooperation of civil surgeons.
In Pakistan, the role of an NAC is taken by a dissemination committee and includes Director General Health, local govt. and professional societies representatives. They have proposed presenting the trial objectives at govt. level. They have met 3 times and meetings are held every 6 months.
In Sri Lanka, NAC understood the lack of accessibility and inadequate compliance/adherence in hypertension management. Members of COBRA-BPS are invited to sit on NCD planning projects of World Bank.
Year(s) Of Engagement Activity 2016,2017
 
Description Policy Forum on Hypertension and Cardiometabolic Diseases- Impact on Health Systems in Sri Lanka, Bangladesh, Pakistan, and Regional Countries 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact More than 50 people including leading hypertension researchers, global health agencies, and policymakers attended this policy forum on Hypertension and Cardiometabolic Diseases. The aim is to uncover: what steps are being taken in each country to prevent, detect, treat hypertension and related co-morbidities (especially diabetes) to reduce cardiovascular risk on individuals, populations, health systems, and economies.The proposed hypertension forum will provide an avenue to establish links with other national and regional frameworks on health systems as well as policy initiatives with the food industry and other health promotion activities for NCDs as they are developed or updated.
Year(s) Of Engagement Activity 2018
URL https://www.facebook.com/cobra.bps/