Complex interventions to implement a diabetic retinopathy care pathway in the public health system in Kerala: the Nayanamritham study protocol

INTRODUCTION: Using a type 2 hybrid effectiveness-implementation design, we aim to pilot a diabetic retinopathy (DR) care pathway in the public health system in Kerala to understand how it can be scaled up to and sustained in the whole state. METHODS AND ANALYSIS: Currently, there is no systematic DR screening programme in Kerala. Our intervention is a teleophthalmology pathway for people with diabetes in the non-communicable disease registers in 16 family health centres. The planned implementation strategy of the pathway will be developed based on the discrete Expert Recommendations for Implementing Change taxonomy. We will use both quantitative data from a cross-sectional study and qualitative data obtained from structured interviews, surveys and group discussions with stakeholders to report the effectiveness of the DR care pathway and evaluation of the implementation strategy. We will use logistic regression models to assess crude associations DR and sight-threatening diabetic retinopathy and fractional polynomials to account for the form of continuous covariates to predict uptake of DR screening. The primary effectiveness outcome is the proportion of patients in the non-communicable disease register with diabetes screened for DR over 12 months. Other outcomes include cost-effectiveness, safety, efficiency, patient satisfaction, timeliness and equity. The outcomes of evaluation of the implementation strategies include acceptability, feasibility, adoption, appropriateness, fidelity, penetration, costs and sustainability. Addition of more family health centres during the staggered initial phase of the programme will be considered as a sign of acceptability and feasibility. In the long term, the state-wide adoption of the DR care pathway will be considered as a successful outcome of the Nayanamritham study. ETHICS AND DISSEMINATION: The study was approved by Indian Medical Research Council (2018-0551) dated 13 March 2019. Study findings will be disseminated through scientific publications and the report will inform adoption of the DR care pathway by Kerala state in future. TRIAL REGISTRATION NUMBER: ISRCTN28942696.