BACKGROUND: Cardiovascular disease (CVD) is the major cause of premature death and disability in India and yet few people at risk of CVD are able to access best practice health care. Mobile health (mHealth) is a promising solution, but very few mHealth interventions have been subjected to robust evaluation in India. OBJECTIVE: The objectives were to develop a multifaceted, mobile clinical decision support system (CDSS) for CVD management and evaluate it for use by public nonphysician health care workers (NPHWs) and physicians in a rural Indian setting. METHODS: Plain language clinical rules were developed based on standard guidelines and programmed into a computer tablet app. The algorithm was validated and field-tested in 11 villages in Andhra Pradesh, involving 11 NPHWs and 3 primary health center (PHC) physicians. A mixed method evaluation was conducted comprising clinical and survey data and in-depth patient and staff interviews to understand barriers and enablers to the use of the system. Then this was thematically analyzed using NVivo 10. RESULTS: During validation of the algorithm, there was an initial agreement for 70% of the 42 calculated variables between the CDSS and SPSS software outputs. Discrepancies were identified and amendments were made until perfect agreement was achieved. During field testing, NPHWs and PHC physicians used the CDSS to screen 227 and 65 adults, respectively. The NPHWs identified 39% (88/227) of patients for referral with 78% (69/88) of these having a definite indication for blood pressure (BP)-lowering medication. However, only 35% (24/69) attended a clinic within 1 month of referral, with 42% (10/24) of these reporting continuing medications at 3-month follow-up. Physicians identified and recommended 17% (11/65) of patients for BP-lowering medications. Qualitative interviews identified 3 interrelated interview themes: (1) the CDSS had potential to change prevailing health care models, (2) task-shifting to NPHWs was the central driver of change, and (3) despite high acceptability by end users, actual transformation was substantially limited by system-level barriers such as patient access to doctors and medicines. CONCLUSIONS: A tablet-based CDSS implemented within primary health care systems has the potential to help improve CVD outcomes in India. However, system-level barriers to accessing medical care limit its full impact. These barriers need to be actively addressed for clinical innovations to be successful. TRIAL REGISTRATION: Clinical Trials Registry of India: CTRI/2013/06/003753; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=6259&EncHid=51761.70513&userN ame=CTRI/2013/06/003753 (Archived by WebCite at http://www.webcitation.org/6UBDlrEuq).
a2291-5222 (Electronic)