A qualitative evaluation of a simplified cardiovascular management program in Tibet, China.

BACKGROUND: The simplified cardiovascular management (SimCard Study) program was a cluster randomized controlled trial conducted in Tibet, China to evaluate a multifaceted intervention consisting of appropriate medication prescriptions and lifestyle recommendations delivered by village doctors. The intervention was effective in improving the management of cardiovascular diseases in resource-limited settings. The aim of this qualitative study was to examine stakeholder feedback and to inform future research and scaling up. METHOD: A total of 28 face-to-face individual interviews were conducted. The interviews were conducted in 6 out of 14 intervention villages by 2 interviewers who speak the local language. Participants included 18 community members at high risk of CVD, 6 village doctors, 2 local project coordinators, and 2 county officials. Interview guides were used to facilitate the interview covering the focus of perceived usefulness and content of the intervention, fidelity to the intervention, and potential scalability of the intervention. Qualitative interviews were coded using thematic analysis. RESULTS: The average age of the participants was 41 years and 70% were female. Our findings showed that the intervention was delivered according to the protocol and was described as a useful program for CVD management by both high-risk individuals and village doctors. However, lack of knowledge among high-risk individuals, insufficient availability of healthcare providers, inadequate financial incentive, and incomplete infrastructure such as difficulty in transportation and cell phone signal were identified as the main barriers to successful implementation and scale-up. CONCLUSION: The intervention was implemented in line with the protocol and provided substantial benefits for relevant community members and health professionals. However, multiple health system barriers need to be addressed for successful scale-up in rural China. TRIAL REGISTRATION: Unique identifier: NCT01503814 . Registered 11 December 2011.

A Cluster-Randomized, Controlled Trial of a Simplified Multifaceted Management Program for Individuals at High Cardiovascular Risk (SimCard Trial) in Rural Tibet, China, and Haryana, India.

BACKGROUND: In rural areas in China and India, the cardiovascular disease burden is high but economic and healthcare resources are limited. This study (the Simplified Cardiovascular Management Study [SimCard]) aims to develop and evaluate a simplified cardiovascular management program delivered by community health workers with the aid of a smartphone-based electronic decision support system. METHODS AND RESULTS: The SimCard study was a yearlong cluster-randomized, controlled trial conducted in 47 villages (27 in China and 20 in India). Recruited for the study were 2086 individuals with high cardiovascular risk (aged ≥40 years with self-reported history of coronary heart disease, stroke, diabetes mellitus, and/or measured systolic blood pressure ≥160 mm Hg). Participants in the intervention villages were managed by community health workers through an Android-powered app on a monthly basis focusing on 2 medication use and 2 lifestyle modifications. In comparison with the control group, the intervention group had a 25.5% (P<0.001) higher net increase in the primary outcome of the proportion of patient-reported antihypertensive medication use pre- and post-intervention. There were also significant differences in certain secondary outcomes: aspirin use (net difference: 17.1%; P<0.001) and systolic blood pressure (-2.7 mm Hg; P=0.04). However, no significant changes were observed in the lifestyle factors. The intervention was culturally tailored, and country-specific results revealed important differences between the regions. CONCLUSIONS: The results indicate that the simplified cardiovascular management program improved quality of primary care and clinical outcomes in resource-poor settings in China and India. Larger trials in more places are needed to ascertain the potential impacts on mortality and morbidity outcomes. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01503814.

A cluster-randomized controlled trial to evaluate the effects of a simplified cardiovascular management program in Tibet, China and Haryana, India: study design and rationale.

BACKGROUND: In resource-poor areas of China and India, the cardiovascular disease burden is high, but availability of and access to quality healthcare is limited. Establishing a management scheme that utilizes the local infrastructure and builds healthcare capacity is essential for cardiovascular disease prevention and management. The study aims to develop, implement, and evaluate the feasibility and effectiveness of a simplified, evidence-based cardiovascular management program delivered by community healthcare workers in resource-constrained areas in Tibet, China and Haryana, India. METHODS/DESIGN: This yearlong cluster-randomized controlled trial will be conducted in 20 villages in Tibet and 20 villages in Haryana. Randomization of villages to usual care or intervention will be stratified by country. High cardiovascular disease risk individuals (aged 40 years or older, history of heart disease, stroke, diabetes, or measured systolic blood pressure of 160 mmHg or higher) will be screened at baseline. Community health workers in the intervention villages will be trained to manage and follow up high-risk patients on a monthly basis following a simplified '2+2' intervention model involving two lifestyle recommendations and the appropriate prescription of two medications. A customized electronic decision support system based on the intervention strategy will be developed to assist the community health workers with patient management. Baseline and follow-up surveys will be conducted in a standardized fashion in all villages. The primary outcome will be the net difference between-group in the proportion of high-risk patients taking antihypertensive medication pre- and post-intervention. Secondary outcomes will include the proportion of patients taking aspirin and changes in blood pressure. Process and economic evaluations will also be conducted. DISCUSSION: To our knowledge, this will be the first study to evaluate the effect of a simplified management program delivered by community health workers with the help of electronic decision support system on improving the health of high cardiovascular disease risk patients. If effective, this intervention strategy can serve as a model that can be implemented, where applicable, in rural China, India, and other resource-constrained areas. TRIAL REGISTRATION: The trial was registered in the clinicaltrials.gov database on 30 December, 2011 and the registration number is NCT01503814.