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Population impact of a high cardiovascular risk management program delivered by village doctors in rural China: design and rationale of a large, cluster-randomized controlled trial.

ABSTRACT: The high-risk strategy has been proven effective in preventing cardiovascular disease; however, the population benefits from these interventions remain unknown. This study aims to assess, at the population level, the effects of an evidence-based high cardiovascular risk management program delivered by village doctors in rural China.The study will employ a cluster-randomized controlled trial in which a total of 120 villages in five northern provinces of China, will be assigned to either intervention (60 villages) or control (60 villages). Village doctors in intervention villages will be trained to implement a simple evidence-based management program designed to identify, treat and follow-up as many as possible individuals at high-risk of cardiovascular disease in the village. The intervention will also include performance feedback as well as a performance-based incentive payment scheme and will last for 2 years. We will draw two different (independent) random samples, before and after the intervention, 20 men aged?50 years and 20 women aged?60 years from each village in each sample and a total of 9,600 participants from 2 samples to measure the study outcomes at the population level. The primary outcome will be the pre-post difference in mean systolic blood pressure, analyzed with a generalized estimating equations extension of linear regression model to account for cluster effect. Secondary outcomes will include monthly clinic visits, provision of lifestyle advice, use of antihypertensive medications and use of aspirin. Process and economic evaluations will also be conducted.This trial will be the first implementation trial in the world to evaluate the population impact of the high-risk strategy in prevention and control of cardiovascular disease. The results are expected to provide important information (effectiveness, cost-effectiveness, feasibility and acceptability) to guide policy making for rural China as well as other resource-limited countries.The trial is registered at ClinicalTrials.gov (NCT01259700). Date of initial registration is December 13, 2010.

SUBMITTER: Yan LL

PROVIDER: S-EPMC3986438 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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Population impact of a high cardiovascular risk management program delivered by village doctors in rural China: design and rationale of a large, cluster-randomized controlled trial.

Yan Lijing L LL Fang Weigang W Delong Elizabeth E Neal Bruce B Peterson Eric D ED Huang Yining Y Sun Ningling N Yao Chen C Li Xian X MacMahon Stephen S Wu Yangfeng Y

BMC public health 20140411

<h4>Background</h4>The high-risk strategy has been proven effective in preventing cardiovascular disease; however, the population benefits from these interventions remain unknown. This study aims to assess, at the population level, the effects of an evidence-based high cardiovascular risk management program delivered by village doctors in rural China.<h4>Methods</h4>The study will employ a cluster-randomized controlled trial in which a total of 120 villages in five northern provinces of China, w ...[more]

PMID: 24721435

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Project description: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.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.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.The trial was registered in the clinicaltrials.gov database on 30 December, 2011 and the registration number is NCT01503814.

Project description:BackgroundThe Cardiovascular Health Awareness Program (CHAP) uses volunteers to provide cardiovascular disease (CVD) and diabetes screening in a community setting, referrals to primary care providers, and locally available programs targeting lifestyle modification. CHAP has been adapted to target older adults residing in social housing, a vulnerable segment of the population. Older adults living in social housing report poorer health status and have a higher burden of a multitude of chronic illnesses, such as CVD and diabetes. The study objective is to evaluate whether there is a reduction in unplanned CVD-related Emergency Department (ED) visits and hospital admissions among residents of social seniors' housing buildings receiving the CHAP program for 1 year compared to residents in matched buildings not receiving the program.Methods/designThis is a pragmatic, cluster randomized controlled trial in community-based social (subsidized) housing buildings in Ontario and Quebec. All residents of 14 matched pairs (intervention/control) of apartment buildings will be included. Buildings with 50-200 apartment units with the majority of residents aged 55+ and a unique postal code are included. All individuals residing within the buildings at the start of the intervention period are included (intention to treat, open cohort). The intervention instrument consists of CHAP screens for high blood pressure using automated blood pressure monitors and for diabetes using the Canadian Diabetes Risk (CANRISK) assessment tool. Monthly drop-in sessions for screening/monitoring are held within a common area of the building. Group health education sessions are also held monthly. Reports are sent to family doctors, and attendees are encouraged to visit their family doctor. The primary outcome measure is monthly CVD-related ED visits and hospitalizations over a 1-year period post randomization. Secondary outcomes are all ED visits, hospitalizations, quality of life, cost-effectiveness, and participant experience.DiscussionIt is anticipated that CVD-related ED visits and hospitalizations will decrease in the intervention buildings. Using the volunteer-led CHAP program, there is significant opportunity to improve the health of older adults in social housing.Trial registrationClinicalTrials.gov,NCT03549845. Registered on 15 May 2018. Updated on 21 May 2019.

Project description:BackgroundPoor child feces management (CFM) is believed to be an important source of exposure to enteric pathogens that contribute to a large disease burden in low-income settings. While access to sanitation facilities is improving, national surveys indicate that even households with latrines often do not safely dispose of their child's feces. Working with caregivers in rural Odisha, India, we co-developed an intervention aimed at improving safe disposal of child feces and encouraging child latrine use at an earlier age. We describe the rationale for the intervention and summarize the protocol for a cluster randomized trial (CRT) to evaluate its effectiveness at changing CFM practices.MethodsThe intervention consists of six behavior change strategies together with hardware provision: wash basin and bucket with lid to aid safe management of soiled nappies and a novel latrine training mat to aid safe disposal and latrine training. The intervention will be offered at the village level to interested caregivers of children < 5 years of age by a community-based organization. Following a baseline survey, 74 villages were randomly allocated to either intervention or control arm. The primary outcome is caregiver reported safe disposal of child feces after last defecation, either by the caregiver disposing of the child's feces into the latrine or the child using the latrine, measured approximately four to six months following intervention delivery. Secondary outcomes include fecal contamination of household drinking water and the childs' hands. A process evaluation will also be conducted to assess intervention fidelity and reach, and explore implementer and participant feedback.DiscussionThis study addresses a crucial knowledge gap in sanitation by developing a scalable intervention to improve safe management of child feces. The behavior change strategies were designed following the Risks, Attitudes, Norms, Abilities and Self-Regulation (RANAS) approach, which has shown to be effective for other environmental behavior change interventions in low-income settings. The latrine training mat hardware is a novel design developed cooperatively and manufactured locally. The evaluation follows a rigorous CRT study design assessing the impact of the intervention on CFM behavior change, as well as fecal contamination of two sources of potential exposure.Trial registrationThis trial is registered at ISRCTN: ISRCTN15831099.

Project description:Blood lipids have major cardiovascular and public health implications. Lipid-lowering drugs are prescribed based in part on categorization of patients into normal or abnormal lipid metabolism, yet relatively little emphasis has been placed on: (1) the accuracy of current lipid measures used in clinical practice, (2) the reliability of current categorizations of dyslipidemia states, and (3) the relationship of advanced lipid characterization to other cardiovascular disease biomarkers. To these ends, we developed the Very Large Database of Lipids (NCT01698489), an ongoing database protocol that harnesses deidentified data from the daily operations of a commercial lipid laboratory. The database includes individuals who were referred for clinical purposes for a Vertical Auto Profile (Atherotech Inc., Birmingham, AL), which directly measures cholesterol concentrations of low-density lipoprotein, very low-density lipoprotein, intermediate-density lipoprotein, high-density lipoprotein, their subclasses, and lipoprotein(a). Individual Very Large Database of Lipids studies, ranging from studies of measurement accuracy, to dyslipidemia categorization, to biomarker associations, to characterization of rare lipid disorders, are investigator-initiated and utilize peer-reviewed statistical analysis plans to address a priori hypotheses/aims. In the first database harvest (Very Large Database of Lipids 1.0) from 2009 to 2011, there were 1 340 614 adult and 10 294 pediatric patients; the adult sample had a median age of 59 years (interquartile range, 49-70 years) with even representation by sex. Lipid distributions closely matched those from the population-representative National Health and Nutrition Examination Survey. The second harvest of the database (Very Large Database of Lipids 2.0) is underway. Overall, the Very Large Database of Lipids database provides an opportunity for collaboration and new knowledge generation through careful examination of granular lipid data on a large scale.

Project description:Background:Suboptimal breastfeeding contributes to >800,000 global child deaths annually. Optimal breastfeeding includes early initiation (EI) and exclusive breastfeeding (EBF) for the first 6 mo. Objectives:We tested the hypothesis that an intervention targeting context and infant age-specific barriers to EI and EBF will achieve a higher EI and EBF prevalence than those of women participating in the concurrently conducted 2015 Zimbabwe Demographic Health Survey (Z-DHS). Methods:We designed an intervention to promote EI and EBF, and implemented it within the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial in rural Zimbabwe. Intervention modules were delivered at 4 perinatal time points by government-employed village health workers. We compared EI and EBF prevalence among SHINE women who provided outcomes at 1 mo (n = 2442) and 3 mo (n = 2728), with women in the 2015 Z-DHS. Results:In cross-sectional analyses EI prevalence was 86.6% and 64.3% in the SHINE and Z-DHS samples, respectively; absolute difference (95% CI) = 22.4% (17.5%, 27.3%). EBF prevalence was similarly high (>80%) in both surveys during the first month of life; during 1 to <2 mo, 2 to <3 mo, 3 to <4 mo, 4 to <5 mo, and 5 to <6 mo, EBF prevalence was, respectively, 85%, 90%, 90%, 84%, and 75% in SHINE, and 71%, 65%, 35%, 26%, and 25% in Z-DHS; absolute difference (95% CI) = 50.2% (34.7%, 65.7%) at 5 to <6 mo. Cesarean delivery, mother's belief that intimate partner violence was sometimes justifiable, and having a male infant negatively modified the effects of the intervention. Conclusions:The SHINE intervention achieved a high prevalence of EI and EBF. Concurrently addressing gender norms will be critical to make further progress. Formative studies to identify context- and infant age-specific barriers to EI and EBF may inform improvement of breastfeeding practices elsewhere. Important work remains to scale up this intervention beyond a research setting. SHINE was registered at www.clinicaltrials.gov as NCT01824940.

Project description:BackgroundNo studies, particularly quantitative analyses, have been conducted regarding the workload of village doctors in the National Essential Public Health Services (NEPHS) program and differences in service delivery by village doctors, according to region and services. In this study, we developed a quantitative analysis approach to measure the workload of NEPHS provided by village doctors in six provinces of China in 2016. We aimed to identify areas and services of the NEPHS needing improvement, so as to implement targeted measures to ensure adequate delivery of NEPHSs in rural remote underserved areas.MethodsBased on survey data from 300 town hospital centers (THCs) located in 60 counties in the six selected provinces, we calculated village doctors' share of workload under the NEPHS using the equivalent value (EV) model. To define the workload and corresponding EV of each NEPHS, a series of five meetings was held with THC managers, public health workers, family physicians, nurses and village doctors. Field observations were conducted to verify the workload and EV of each service.ResultsVillage doctors' share of the workload under the NEPHS program was 43.71% across the 300 sampled THCs in six provinces. The village doctors' workload shares for different NEPHS ranged from 17.14 to 57.00%. The percentage workload undertaken by village doctors under the NEPHS program varied across different provinces, with the highest proportion 63.4% and the lowest 28.5%.ConclusionsThe total NEPHS workload assigned to village doctors by THCs in the six sampled provinces exceeded the Chinese government's requirement of 40%, but the workload proportion in some provinces was less than 40%. In addition, the percentage workload for some NEPHS undertaken by village doctors was lower than others. We suggest conducting district-level analysis of the workload among village doctors under the NEPHS program using the EV method, to identify areas and services needing improvement, to implement targeted measures to expand and promote health service provision in China's rural underserved areas.

Dataset Information

Population impact of a high cardiovascular risk management program delivered by village doctors in rural China: design and rationale of a large, cluster-randomized controlled trial.

Publications

Population impact of a high cardiovascular risk management program delivered by village doctors in rural China: design and rationale of a large, cluster-randomized controlled trial.

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