Impact and cost-effectiveness evaluation of nutritional supplementation and complementary interventions for tuberculosis treatment outcomes under mukti pay-for-performance model in Madhya Pradesh, India: A study protocol

Background: A “pay-for-performance” (P4P) intervention model for improved tuberculosis (TB) outcomes, called “Mukti,” has been implemented in an underdeveloped tribal area of central India. The target of this project is to improve nutritional status, quality of life (QoL), and treatment outcomes of 1000 TB patients through four interventions: food baskets, personal counseling, peer-to-peer learning and facilitation for linkage to government schemes. The current study aims to assess the success of this model by evaluating its impact and cost-effectiveness using a quasi-experimental approach. Methods: Data for impact assessment have been collected from 1000 intervention and control patients. Study outcomes such as treatment completion, sputum negativity, weight gain, and health-related QoL will be compared between matched samples. Micro costing approach will be used for assessing the cost of routine TB services provision under the national program and the incremental cost of implementing our interventions. A decision and Markov hybrid model will estimate long-term costs and health outcomes associated with the use of study interventions. Measures of health outcomes will be mortality, morbidity, and disability. Cost-effectiveness will be assessed in terms of incremental cost per quality-adjusted life-years gained and cost per unit increase in patient weight in intervention versus control groups. Results: The evidence generated from the present study in terms of impact and cost-effectiveness estimates will thus help to identify not only the effectiveness of these interventions but also the optimal mode of financing such measures. Our estimates on scale-up costs for these interventions will also help the state and the national government to consider scale-up of such interventions in the entire state or country. Discussion: The study will generate important evidence on the impact of nutritional supplementation and other complementary interventions for TB treatment outcomes delivered through P4P financing models and on the cost of scaling up these to the state and national level in India.