Designing and evaluating provider results-based financing for tuberculosis care in Georgia: understanding costs, mechanisms of effect and impact

Tuberculosis remains one of the world's biggest killers, and Georgia is among the countries where the TB burden is high. Georgia has low TB treatment success rates, indicating that people are not completing treatment, thus posing a risk to their health and to their families and communities. Untreated TB cases lead to the development of drug resistance, which is a huge challenge for the country, for the region and the world. The GoG recognises the importance of this public health problem. Significant achievements in TB control were made during the last decade, including improvements to TB case detection and treatment. Nevertheless, challenges related to timely initiation of treatment, patients' poor adherence to treatment and lower than targeted treatment success rates remain.
A number of factors could potentially explain the poor control of TB cases in Georgia, including health system (provider) related factors, such as demotivation of health care providers and delayed TB detection, and patient related factors, such as failure to seek treatment, and poor adherence to treatment. In an attempt to address these barriers, Georgia has provided patient adherence support to all TB patients since 2007, with the support of the Global Fund (GF). This includes monetary incentives to encourage continuous treatment and to cover transportation costs.
Notwithstanding the introduction of incentives for patients, treatment adherence remains low and the attention has shifted to the incentives available for service providers. In Georgia, primary care facilities are predominantly privately owned and paid by capitation, without tying incentives to their performance (e.g. for case detection and referral). These providers must provide TB treatment in their mandate, but this mandate will shortly expire. Although the GoG is paying referral specialists salaries for the provision of TB services through its vertical programme, it has limited capacity for monitoring and leverage over the performance of these providers, and salaries are low compared to other specialists.
The GoG is therefore planning to introduce a provider RBF intervention in pilot areas in 2017. The pilots intend to explore the potential of a provider intervention, in addition to the already existing patient incentives, to increase the motivation of both public and private providers in improving patient adherence and treatment outcomes. From a research perspective, the introduction of this scheme provides an opportunity for embedded development and research, working closely with the national programme and policy makers, and leveraging Global Fund support and influence.
The main goal of the research is to participate in problem analysis during the design phase and provide evidence on the implementation and effects of the new supply side RBF scheme on adherence and treatment success rates, on the cost of the intervention, and how it works in different contexts in Georgia (including wider health system effects, intended or not).
To achieve this goal, we will engage with policymakers and programme managers during the process of designing and developing the intervention. By doing so we will ensure that the design is theory-led, engage policy makers from an early stage and develop and document the iterative and participative learning process between policy makers and researchers.
As well as informing policy in Georgia, the results are expected to enrich global policy debates on RBF and TB programming, including through public-private partnerships, as well as feeding into academic debate on how to combine realist evaluation techniques with trials and cost-effectiveness analysis.

The study will first inform how the problem is conceptualised and the intervention is designed in collaboration with the policy makers at national level. Once piloting is started, the research will seek to answer the following research questions:
(1) What is the impact of provider-focused Results Based Financing (RBF) on patients' adherence to tuberculosis treatment and treatment outcomes of both Drug-Susceptible (DS) and MDR patients in Georgia?
The impact of RBF will be evaluated using a quasi-experimental trial design. Eligible facilities will be randomly selected in 20 districts, then randomly allocated to intervention and control groups. The study population will include nurses and physicians involved in TB primary care and TB patients (DS & MDR-TB cases), who provide TB treatment to approximately 500 patients, which represents 12% of the expected total newly registered TB patients. The intervention will be RBF with provider incentives, complementing the existing patients' incentives. The comparison will be of intervention (RBF) and control groups (existing funding model), considering the variety of the contexts (e.g. semi-urban/urban, and public/private facilities). The outcome measures will be adherence to TB treatment and treatment success rate.
(2) Is the RBF intervention cost-effective?
Cost-effectiveness analysis will generate evidence on the costs of the intervention by comparing the existing model with the added supply side RBF intervention.
(3) How does it work, for whom and in which conditions? and (4) How should RBF be modified to optimise national roll-out for this and possibly other health services?
To identify the mechanisms of change and the context factors that enhance or undermine the effectiveness of the RBF intervention, we will carry out realist case studies in a sub-set of sites. This theory-informed trial design will allow us to assess how and why the RBF scheme leads to the observed results, for whom and in which conditions.

The beneficiaries of this research will be TB patients, nurses and physicians involved in TB care, health facility managers, policy-makers, community members and the scientific community, in Georgia, the region and globally.
The aim of the proposed research is to support the design and to evaluate the impact, cost-effectiveness and mechanisms of change of a provider Results Based Financing (RBF) scheme focused on strengthening Tuberculosis (TB) outpatient care services (which complements already existing demand-side incentives for TB patients), delivered through public and private providers in Georgia, a lower-middle-income country (LMIC). To do so, we will develop and implement an innovative theory-informed trial design.
Underlying the RBF scheme is the hypothesis of policymakers that it will provide increased motivation to healthcare providers in both public and private facilities at primary and secondary care level and will also help to persuade the private providers to retain TB services in future. Because of the resulting behaviour change of providers, TB patients will receive health services that are of better quality and more responsive to their needs, which in turn will lead to better adherence to treatment and treatment success.
Our research will contribute to the RBF scheme in two ways, (i) by supporting the design of an appropriate intervention, including elaboration of the underlying problems and expected pathways of change, and (ii) assessing its impact and cost-effectiveness and identifying the factors that support or undermine its effectiveness in different settings, as well as documenting intended or unintended system effects and why they come about.
The research is envisaged to contribute to narrowing the knowledge gap existing around RBF interventions, such as their application in public/private settings and their cost-effectiveness, and to provide a clearer understanding of the underlying mechanisms of change, the conditions of success and the wider (negative and positive) consequences of RBF schemes. The research will also produce methodological innovation regarding the use of realist evaluation alongside cost-effectiveness analysis and in general theory-informed trial designs, which will primarily be shared with research communities operating in the areas of health systems research, health financing and economics, communicable disease control, and programme evaluation.
The evidence produced through this research will be used by national policy-makers to reform the financing of primary health schemes in a way that improves efficiency, quality and sustainability of services. Through a participatory learning process, the policy-makers will improve their understanding of the RBF model application in a changing context. This will provide important evidence to inform the national rollout and possible expansion of RBF to other services, such as the maternal and child health services and management of chronic diseases, based on the findings concerning impact, cost-effectiveness and conditions of success.
Additionally, findings will be beneficial for other LMICs, particularly for those with a similar vertical organization of TB services (most of the former Socialist countries of Eastern and Central Europe and Central Asia) and for countries where private providers play an important role in the provision of TB services. Using the communication strategies outlined above, we will inform the development of RBF for TB and related service delivery in other contexts - highlighting positive and negative findings, as well as contextual barriers and enablers, and the wider systems effects and resource implications (which are crucial to scalability and sustainability). The implications for the provider/patient interaction will be a key focus area, as will be focusing on vulnerable patient groups and the MDR patients.