Understanding and enhancing approaches to quality improvement in small and medium sized private facilities in sub-Saharan Africa

The private sector is a major and growing source of treatment in low- and middle-income countries (LMIC), but there is considerable concern about the safety and quality of care. Recent years have seen fast growth in small and medium sized private clinics, but their regulation is often poor, and relatively little is known about the effectiveness of interventions to improve the quality of care they provide. This project aims to address this evidence gap.

The research takes place in the context of an innovative intervention developed by the international NGO PharmAccess that extends the benefits of clinical standards and stepwise certification to small and medium-sized facilities in LMIC, using standards developed with international accreditation bodies. The PharmAccess model seeks to improve the quality of care that facilities provide as well as to shape the broader healthcare and finance markets and policy environment. There are several components to the model. Health facilities are assessed on a set of "SafeCare" structural quality standards, trained on quality improvement and business skills, and assisted in the development of a quality and business improvement plan. They receive regular mentoring visits and are also connected with the PharmAccess Medical Credit Fund, a social investment fund which facilitates access to bank loans to finance implementation of the plan. The aim is to create a series of virtuous circles, with improvements in SafeCare assessment scores signalling improved quality of care to individual and institutional purchasers, thus increasing demand for health services; and improved business performance ensuring further access to credit, and the sustainability of quality gains.

The research will begin with an analysis of secondary data collected routinely by PharmAccess in Tanzania and Kenya to date to examine changes in the SafeCare assessment scores over time and factors associated with these changes. We will then undertake a randomised controlled trial to evaluate prospectively the impact on quality of care of the roll out of the PharmAccess model to additional private for-profit and faith-based facilities in Tanzania. The trial will assess the effects of the intervention on the quality of care received by patients through comparison of 120 intervention and 120 control facilities after 2 years of implementation. These data will also be used to assess the relationship between SafeCare assessment scores (which measure availability of inputs such as infrastructure, technology and standard operating procedures) and measures of technical and perceived quality of patient care (which concern the interaction between caregivers and patients). Technical quality will be measured through standardised patients (covert actors) and clinical vignettes (overt role-playing), with perceived quality measured through patient interviews. In addition, in-depth interviews will be conducted in 30 intervention facilities and with 8 implementing staff in Tanzania to assess the perceived benefits and costs of participating in the PharmAccess model, and factors affecting quality improvement and business performance. Finally, 30 national level key informants will be interviewed to explore how the PharmAccess model shapes the market for healthcare and healthcare finance, and the policy environment in both Tanzania and Kenya.

The results are expected to make an important contribution to the evidence base on improving private sector care and to the literature on measuring process quality of patient care. The findings will be of substantial benefit to national and international policy makers and programme managers who are interested in private sector healthcare and health systems strengthening more generally, with important implications for all organisations within the health system that require adherence to quality standards (eg, social health insurance programmes, social franchising programmes, regulatory agencies)

Innovative approaches are needed to assess quality and institutionalize quality improvement in private facilities, but rigorous evaluation of such interventions is very limited, with a particular lack of controlled designs. This study will provide new evidence on the PharmAccess model of quality improvement. The research is based on a well-articulated theory of change, linking PharmAccess activities to outputs, outcomes and impacts, and draws on both quantitative and qualitative data:
- to examine changes in adherence to SafeCare standards in participating facilities to date, we will analyse the PharmAccess database which contains SafeCare scores across multiple dimensions, facility characteristics and implementation measures for at least two time points for 300 facilities in Kenya and Tanzania, using panel regression methods to identify factors associated with improvements in scores.
- to evaluate the impact of PharmAccess on process quality of care we will conduct a prospective randomised controlled trial in Tanzania. Intervention facilities will receive the full PharmAccess package, while control facilities receive SafeCare assessments only with no further action. The primary outcome will be technical process quality at follow-up, with secondary outcomes of SafeCare scores, perceived quality, and business performance. The primary outcome will be measured using standardised (covert) patients and clinical role-playing vignettes.
- to understand experiences and perceptions of participating facilities we will conduct in-depth interviews with staff from 30 purposively selected intervention facilities, and 8 implementing staff.
- In addition to improving quality in participating facilities, PharmAccess aims to make the broader market and policy environment more conducive to the operation of a high performing private sector. We will investigate these potential effects through 30 key informant interviews with stakeholders in Kenya and Tanzania

This research will provide new and rigorous evidence on the operation of small and medium sized private providers, their current levels of quality of care, the impact of private sector approaches to quality improvement, the reasons for participation in such programmes, the socio-economic distribution of patient beneficiaries, and the wider impact on the market and policy environment.

The results are expected to benefit four key groups: national stakeholders in Tanzania and Kenya, international stakeholders concerned with the private healthcare sector and health systems more broadly, PharmAccess programmes, and the academic community. In addition, as these groups act on the study's findings, there is clear potential for patients to benefit in terms of improved quality of care, and for private providers to benefit in terms of enhanced facility development. Below we describe the four main beneficiaries in more detail, and indicate their evidence needs and how the project will meet these.
1. National stakeholders in Tanzania and Kenya - Key among these are national and sub-national government bodies responsible for private sector healthcare and Universal Health Coverage (UHC) policy more generally, such as the Ministries of Health, regulatory agencies, and national health insurance organisations. Other national users include non-governmental organisations, such as professional associations, social franchising organisations, and private insurance companies. These groups want to understand better the current operation of the private sector and the nature of quality gaps, especially in the private for-profit sector where national level data are limited, to help target regulatory and other private sector interventions. National stakeholders will also benefit from better information about the relationship between SafeCare standards and process quality. This will allow assessment of the suitability of SafeCare assessments for a wide range of initiatives, from empanelment of facilities for national or private health insurance, to inclusion of SafeCare in social franchising programmes. The Ministries need evidence on the performance of the PharmAccess Programme in improving quality of care to inform prioritisation of national and donor resources. Professional associations will be keen to understand potential impacts on their members. By meeting these needs the project has the potential to strengthen the broader health system in each country, supporting the move towards UHC.
2. International funders, advisors and implementers - This group includes the main donors in this area (eg USAID, DFID, the World Bank, the International Finance Corporation, the Gates Foundation and the Dutch Government), other key advisory bodies (eg WHO), and those involved in implementing private sector programmes (eg Marie Stopes International and JHPIEGO). They will be concerned with the overall impact of the PharmAccess intervention, which socio-economic groups it reaches, and its sustainability. Their future investment and implementation decisions will be informed by rigorously conducted research which adds to the limited body of evidence on strategies to enhance private sector performance.
3. PharmAccess Programmes - An immediate beneficiary of the research will the six African PharmAccess programmes. Their key needs are for (i) better understanding of the factors driving variation in quality improvement across participating facilities, and therefore how the model can be adapted and targeted to reflect this; and (ii) more evidence on the perceived benefits and costs to participating facilities, to assess how to maximise participation, and enhance sustainability by considering the potential for charging facilities for some services.
4. Academic community - The final group of users will be academic researchers and students, as described under "Academic Beneficiaries".