Abstract
BackgroundVery few studies having decision support systems as an intervention report on patient outcomes for cardiovascular disease in the Western world. The potential role of decision support system for the management of blood pressure among Indian hypertensives remains unclear. We propose a cluster randomised trial that aims to test the effectiveness and cost effectiveness of DSS among Indian hypertensive patients.MethodsThe trial design is a cluster randomised community intervention trial, in which the participants would be adult male and female hypertensive patients, in the age group of 35 to 64 years, reporting to the Primary Health Care centres of Mahabubnagar district, Andhra Pradesh, India. The objective of the study is to test the effectiveness and compare the cost effectiveness and cost utility among hypertensive subjects randomized to receive either decision support system or a chart based algorithmic support system in urban and rural areas of a district in the state of Andhra Pradesh, India (baseline versus 12 months follow up). The primary outcome would be a comparison of the systolic blood pressure at 0 and 12 months among hypertensive patients randomized to receive the decision support system or the chart based algorithmic support system. Computer generated randomisation and an investigator and analyser blinded method would be followed. 1600 participants; 800 to each arm; each arm having eight clusters of hundred participants each have been recruited between 01 August 2011 - 01 March 2012. A twelve month follow up will be completed by March 2013 and results are expected by April 2013.DiscussionThis cluster randomized community intervention trial on DSS will enable policy makers to find out the effectiveness, cost effectiveness and cost utility of decision support system for management of blood pressure among hypertensive patients in India. Most of the previous studies on decision support system have focused on physician performance, adherence and on preventive care reminders. The uniqueness of the proposed study lies in finding out the effectiveness of a decision support system on patient related outcomes.Trial registrationCTRI/2012/03/002476, Clinical Trial Registry - India.
Highlights
Very few studies having decision support systems as an intervention report on patient outcomes for cardiovascular disease in the Western world
We propose a cluster randomised trial that aims to test the effectiveness and cost effectiveness of Decision support systems (DSS) among Indian hypertensive patients
The chart based algorithmic support system will have the guidelines and lifestyle advices printed as a poster format which would be pasted on the wall of the Primary Health Care centers (PHCs) clinics
Summary
Very few studies having decision support systems as an intervention report on patient outcomes for cardiovascular disease in the Western world. Compared with all other countries, India suffers the highest loss in Potentially Productive Years of Life Lost (PPYLL), due to deaths from cardiovascular disease in people aged 35–64 years (9Á2 million PPYLL in 2000, with a projected loss of 17.9 million PPYLL by 2030) [1]. The global and regional burden of disease and risk factors study (2001), in a systematic analysis of population health data for attributable deaths and attributable disease burden, has ranked Hypertension in South Asia as second only to child underweight for age [5]. The rates for hypertension in % are projected to go up to 22.9 and 23.6 for Indian males and females respectively by 2025 [6]. Recent studies from India have shown the prevalence of hypertension to be 25% in urban and 10% in rural subjects in India [3,7,8,9]
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