Abstract
BackgroundCardiovascular diseases (CVD) are rising in India resulting in major health system challenges.MethodsEighteen primary health centre (PHC) clusters in rural Andhra Pradesh were randomised over three, 6-month steps to an intervention comprising: (1) household CVD risk assessments by village-based community health workers (CHWs) using a mobile tablet device; (2) electronic referral and clinical decision support for PHC doctors; and (3) a tracking system for follow-up care. Independent data collectors screened people aged ≥ 40 years in 54 villages serviced by the PHCs to create a high CVD risk cohort (based on WHO risk charts and blood pressure thresholds). Randomly selected, independent samples, comprising 15% of this cohort, were reviewed at each 6-month step. The primary outcome was the proportion meeting systolic blood pressure (SBP) targets (<140mmHg).FindingsEight-four percent of the eligible population (n = 62,254) were assessed at baseline (18.4% at high CVD risk). Of those at high risk, 75.3% were followed up over two years. CHWs screened 85.9% of the baseline cohort and doctors followed up 70.0% of all high risk referrals. There was no difference in the proportion of people achieving SBP targets (41.2% vs 39.2%; adjusted odds ratio (OR) 1.01 95% CI 0.76–1.35) or receiving BP-lowering medications in the intervention vs control periods respectively. There was a high discordance in risk scores generated by independent data collectors and CHWs, resulting in only 37.2% of the evaluation cohort exposed to the intervention. This discordance was mainly driven by fluctuating BP values (both normal variability and marked seasonal variations). In the pre-specified high risk concordant subgroup, there was greater use of BP-lowering medications in the intervention period (54.3% vs 47.9%, OR 1.22, 95% CI 1.03–1.44) but no impact on BP control.ConclusionsThe strategy was well implemented with increased treatment rates among high risk individuals assessed by CHWs, however effects on BP were not demonstrated. Use of guideline-recommended BP thresholds for identifying high risk individuals substantially affected the reproducibility of risk assessment, and thus the ability to reliably evaluate the effectiveness of the intervention. In addition, unanticipated seasonal variation in BP in the context of a stepped-wedge trial highlights the inherent risks of this study design.Trial registrationClinical Trials Registry of India CTRI/2013/06/ 003753.
Highlights
Cardiovascular diseases (CVD) are a major cause of premature morbidity and mortality globally, with ischemic heart disease and stroke responsible for 24% of all deaths.[1]
The strategy was well implemented with increased treatment rates among high risk individuals assessed by community health workers (CHWs), effects on blood pressure (BP) were not demonstrated
Use of guidelinerecommended BP thresholds for identifying high risk individuals substantially affected the reproducibility of risk assessment, and the ability to reliably evaluate the effectiveness of the intervention
Summary
Cardiovascular diseases (CVD) are a major cause of premature morbidity and mortality globally, with ischemic heart disease and stroke responsible for 24% of all deaths.[1]. In 2008, the Indian central government launched the National Program for prevention and control of Cancer, Diabetes, Cardiovascular diseases, and Stroke (NPCDCS) with two key areas of focus: early detection of persons with high levels of risk factors and strengthening the health system to tackle non-communicable diseases (NCDs). Despite a national policy being in place and mandated availability of low cost antihypertensive drugs in government formularies, the use of BP lowering treatments in rural India is limited, with few people with hypertension and/or CVD appropriately managed in these settings.[8, 9] Overall only 39% of all individuals either with previous CVD or at high risk of CVD have adequate BP control, indicating large evidence-practice gaps and ineffective current approaches to reducing BPrelated risk.[8]. Cardiovascular diseases (CVD) are rising in India resulting in major health system challenges
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