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Abstract
Introduction Digital health interventions (DHIs) have huge potential as support modalities to identify and manage cardiovascular disease (CVD) risk in resource-constrained settings, but studies assessing them show modest effects. This study aims to identify variation in outcomes and implementation of SMARTHealth India, a cluster randomised trial of an ASHA-managed digitally enabled primary healthcare (PHC) service strengthening strategy for CVD risk management, and to explain how and in what contexts the intervention was effective.
Methods We analysed trial outcome and implementation data for 18 PHC centres and collected qualitative data via focus groups with ASHAs (n=14) and interviews with ASHAs, PHC facility doctors and fieldteam mangers (n=12) Drawing on principles of realist evaluation and an explanatory mixed-methods design we developed mechanism-based explanations for observed outcomes.
Results There was substantial between-cluster variation in the primary outcome (overall: I2=62.4%, p<=0.001). The observed heterogeneity in trial outcomes was not attributable to any single factor. Key mechanisms for intervention effectiveness were community trust and acceptability of doctors’ and ASHAs’ new roles, and risk awareness. Enabling local contexts were seen to evolve over time and in response to the intervention. These included obtaining legitimacy for ASHAs’ new roles from trusted providers of curative care; ASHAs’ connections to community and to qualified providers; their responsiveness to community needs; and the accessibility, quality and appropriateness of care provided by higher level medical providers, including those outside of the implementing (public) subsystem.
Conclusion Local contextual factors were significant influences on the effectiveness of this DHI-enabled PHC service strategy intervention. Local adaptions need to be planned for, monitored and responded to over time. By identifying plausible explanations for variation in outcomes between clusters, we identify potential strategies to strengthen such interventions.
- health systems evaluation
- health services research
- cluster randomized trial
- other study design
- prevention strategies
Data availability statement
Data are available in a public, open access repository. Data are available on the Harvard Dataverse platform and can be accessed here: https://doi.org/10.7910/DVN/NSKFK2.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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- health systems evaluation
- health services research
- cluster randomized trial
- other study design
- prevention strategies
Data availability statement
Data are available in a public, open access repository. Data are available on the Harvard Dataverse platform and can be accessed here: https://doi.org/10.7910/DVN/NSKFK2.
Supplementary materials
Supplementary Data
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Footnotes
Handling editor Stephanie M Topp
Twitter @davidpeiris
Contributors GS, DPr and DPe conceptualised this mixed-methods study. KM, MAM and DPe designed and led qualitative data collection in the field. DPr, GS and BP led the analysis of the qualitative data and conducted the mixed-methods analysis. QL provided statistical analysis and quantitative data management. GS drafted the paper and incorporated feedback. All authors contributed to interpretation of the findings.
Funding This study was funded by an Australian National Health and Medical Research Council (NHMRC) Global Alliances for Chronic Disease Grant (ID1040147). RJ is funded through a Future Leader Fellowship by the National Heart Foundation (Grant number 102059) and the UNSW Scientia Fellowship.
Disclaimer The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests The authors have declared that no competing interests exist. The George Institute for Global Health has a wholly owned social enterprise that is conducting commercial projects that include aspects of the intervention tested in this study.
Provenance and peer review Not commissioned; externally peer reviewed.
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