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Protocol
Process evaluation protocol for a cluster randomised trial of a complex, nurse-led intervention to improve hypertension management in India
  1. Nikhil Srinivasapura Venkateshmurthy1,2,
  2. Kevin Mc Namara3,
  3. Harriet Koorts1,
  4. Sailesh Mohan2,
  5. Vamadevan S Ajay4,
  6. Devraj Jindal4,
  7. Bhaskara Rao Malipeddi5,
  8. Ambuj Roy6,
  9. Nikhil Tandon7,
  10. Dorairaj Prabhakaran2,
  11. Tony Worsley1,
  12. Ralph Maddison1,
  13. Sharleen O’Reilly1
  1. 1 School of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria, Australia
  2. 2 Centre for Chronic Conditions and Injuries, Public Health Foundation of India, Gurgaon, Haryana, India
  3. 3 School of Medicine, Deakin University, Burwood, Victoria, Australia
  4. 4 Centre for Chronic Disease Control, New Delhi, Delhi, India
  5. 5 Interventional Cardiology, KIMS ICON Hospital, Visakhapatnam, Andhra Pradesh, India
  6. 6 Department of Cardiology, All India Institute of Medical Sciences, New Delhi, Delhi, India
  7. 7 Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi, Delhi, India
  1. Correspondence to Dr Nikhil Srinivasapura Venkateshmurthy; nnikhils{at}deakin.edu.au; nikhil.sv{at}phfi.org

Abstract

Introduction India has high prevalence of hypertension but low awareness, treatment and control rate. A cluster randomised trial entitled ‘m-Power Heart Project’ is being implemented to test the effectiveness of a nurse care coordinator (NCC) led complex intervention to address uncontrolled hypertension in the community health centres (CHCs). The trial’s process evaluation will assess the fidelity and quality of implementation, clarify the causal mechanisms and identify the contextual factors associated with variation in the outcomes. The trial will use a theory-based mixed-methods process evaluation, guided by the Consolidated Framework for Implementation Research.

Methods and analysis The process evaluation will be conducted in the CHCs of Visakhapatnam (southern India). The key stakeholders involved in the intervention development and implementation will be included as participants. In-depth interviews will be conducted with intervention developers, doctors, NCCs and health department officials and focus groups with patients and their caregivers. NCC training will be evaluated using Kirkpatrick’s model for training evaluation. Key process evaluation indicators (number of patients recruited and retained; concordance between the treatment plans generated by the electronic decision support system and treatment prescribed by the doctor and so on) will be assessed. Fidelity will be assessed using Borrelli et al’s framework. Qualitative data will be analysed using the template analysis technique. Quantitative data will be summarised as medians (IQR), means (SD) and proportions as appropriate. Mixed-methods analysis will be conducted to assess if the variation in the mean reduction of systolic blood pressure between the intervention CHCs is influenced by patient satisfaction, training outcome, attitude of doctors, patients and NCCs about the intervention, process indicators etc.

Ethics and dissemination Ethical approval for this study was obtained from the ethics committees at Public Health Foundation of India and Deakin University. Findings will be disseminated via peer-reviewed publications, national and international conference presentations.

Trial registration number NCT03164317; Pre-results.

  • hypertension
  • process evaluation
  • consolidate framework for implementation research
  • India
  • mixed-methods

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/.

https://doi.org/10.1136/bmjopen-2018-027841

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    Footnotes

    • Contributors NSV conceptualised the process evaluation and prepared the first draft of the manuscript. KMN, HK, SM, TW, RM and SO provided critical inputs on the methodology. VSA, DJ, BRM, AR, NT and DP contributed to the development electronic decision support system algorithm. VSA, DJ, NT and DP acquired the funding from Indian Council for Medical Research. All authors read and approved the final version of the manuscript.

    • Funding m-Power Heart Project is funded by the Indian Council of Medical Research (grant number—DHR/5/GIA/2015-16). The funding agency has no role in the design of the study or in the collection, analysis and interpretation of data or in writing the manuscript. NSV has been awarded a scholarship by Deakin University to pursue PhD under Public Health Foundation of India—Deakin India Research Initiative to conduct the study.

    • Competing interests None declared.

    • Ethics approval Ethical approval for this study was obtained from the ethics committees at Public Health Foundation of India (TRC-IEC-362/17.1) and Deakin University (2018-020). The m-Power trial ethical approval was obtained from the Centre for Chronic Disease Control, Delhi ethics committee (CCDC_IEC_01_2017).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Patient consent for publication Not required.