Assessing the Influence of Innovation Characteristics on the Implementation Process of an Optimised Tuberculosis Diabetes Integrated Care Package (Opt TBD):A Mixed Method Study Protocol

Background: Tuberculosis with co-morbid diabetes mellitus presents a substantial public health challenge, necessitating immediate and coordinated interventions. Such interventions should be sustainable and have a high acceptance rate in real-world settings. Applying the principles of implementation science is essential to enhance the existing system. This research study aims to assess the influence of innovation characteristics on the implementation of an Optimised TB-diabetes integrated care package. Objectives: The main objectives of this study are to explore the perceptions and experiences of intervention developers; to understand the experiences of health professionals and patients regarding the Opt TBD integrated care package; assess the content validity of the innovation characteristics instrument; and evaluate the influence of intervention characteristics on the implementation process of the Opt TBD integrated care package. Methods: The study will be conducted at thirteen selected TB healthcare facilities across Khyber Pakhtunkhwa and Punjab over a period of 18 months, in three phases. Evaluation will involve qualitative exploration of intervention development, followed by feasibility testing, and finally the definitive implementation of the intervention. The participants will include key stakeholders: intervention developers, TB health professionals, and patients. Conclusion: This study will generate critical insights for the Opt TBD integrated care package, focusing on enhancing contextual relevance and improving adoption rates in practical, real-world settings. Specifically, this research study seeks to identify key implementation challenges, evaluate the fidelity of the intervention, and validate the causal relationships between the characteristics of the innovation and its implementation success.