Understanding the Impact of Innovations in the Regulation of Kenya's health facilities

Health systems in low and middle income countries (LMIC) are increasingly pluralistic, involving a wide mix of public, not-for-profit and for-profit providers. Regulation should be a key foundation of the Government's stewardship role of these heterogeneous facilities, but performance of this function is generally weak, with serious consequence for patient safety and quality of care.

There has been little evaluation of strategies to strengthen regulation in LMIC, a notable exception being the Kenya Patient Safety Impact Evaluation (KePSIE), a collaboration between the Kenyan Ministry of Health and the World Bank. This randomised controlled trial is assessing the impact of a set of innovative regulatory interventions in public and private facilities in 3 Kenyan counties. These comprise the use of the Joint Health Inspections Checklist (JHIC), which synthesises the areas covered by all the regulatory Boards and Councils; increased inspection frequency; risk-based inspections where warnings, sanctions and time to re-inspection depend on inspection scores; and display of regulatory results outside facilities.

The KePSIE trial will provide a rigorous quantitative assessment of these regulatory strategies. However, such regulatory interventions are highly complex, requiring behaviour change by regulatory managers, front line inspection staff, health facilities, and clients. To understand the effectiveness of the intervention and why aspects do (or do not) work it is therefore essential to investigate the mechanisms and processes involved, the degree to which they are implemented effectively, and the reasons for the level of implementation observed. Other important dimensions include legitimacy, potential for corruption and regulatory costs. We will therefore conduct a companion study to enhance our understanding of the effectiveness of these regulatory innovations, and to consider their wider implications for the creation of a cost-effective, sustainable and equitable regulatory system.

The research will begin with a review of key documents and records related to regulatory implementation, with the review updated periodically during the study. We will also systematically collate media articles from Kenyan newspapers and relevant social media concerning health facility regulation. Following a period of familiarisation with regulation by shadowing inspectors on their regular duties, we will undertake a set of in-depth interviews (IDIs) with a wide range of stakeholders including national regulators, county and sub-county managers, inspectors, facility owners/ staff, and Community Health Committee members. IDIs will cover their perceptions and experiences of regulatory implementation under the current regulatory system and the KePSIE regulatory innovations; their views on the legitimacy of regulatory systems, in terms of fairness and acceptability; perceptions of corruption; and perceptions of community views on facility regulation. We will also conduct patient exit interviews to assess community member understanding of the regulatory scores displayed outside facilities. Finally, we will assess the incremental costs of the KePSIE interventions compared to those of the current regulatory system, from the perspectives of both the regulating agencies and the health facilities.

The results are expected to make an important contribution to the limited evidence base on regulation and regulatory reform. The findings will be of substantial benefit to those concerned with regulatory reform and the improvement of quality and safety more generally in Kenya and other LMIC settings.

Innovative approaches are needed to enhance health facility regulation in LMIC, with an urgent need to learn from the risk-based and responsive regulation strategies used elsewhere. However, implementation and evaluation of such interventions is very limited, with the notable exception of the strategies being tested under the Kenya Patient Safety Impact Evaluation (KePSIE), a randomised controlled trial in 3 Kenyan counties. Drawing on the principles for the evaluation of complex interventions, this study will complement the KePSIE trial by providing an in-depth understanding of the effects of these regulatory innovations, and assess factors influencing their scalability and sustainability. The research will draw on a well-articulated theory of change, and will employ a mix of both quantitative and qualitative data:
- A document, records and media review will detail the extent of implementation and highlight implementation issues
- Non-participant observation with inspection staff will familiarise research staff with the regulatory context
- Around 100 in-depth interviews (IDIs) will be conducted with purposively selected stakeholders involved in regulatory policy, management and inspection; with health facility staff/ owners; and with Community Health Committee members. IDIs will cover perceptions and experiences of regulatory implementation; views on the legitimacy of regulatory systems, in terms of fairness and acceptability; perceptions of corruption; and perceptions of community views on facility regulation.
- Patient exit interviews will be conducted with 360 clients across 30 facilities to assess community member understanding of inspection score signs displayed outside facilities.
- The incremental financial and economic costs of the KePSIE interventions will be compared to those of the current regulatory system, from the perspectives of both the regulating agencies, and the health facilities in terms of their compliance costs.

The results are expected to benefit three key groups: Kenyan stakeholders, international stakeholders, 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 safety and quality of care, and for legitimate private providers to benefit through enhanced guidance on improving their services, less uncertainty around inspection, a reduction in competition from unqualified, unlicensed and poor quality providers, and reduced corruption payments.

Kenyan stakeholders
The Kenyan stakeholders most directly responsible for regulatory policy and implementation are the Ministry of Health (MOH), and the regulatory Boards and Councils. Within the MOH, the most important audience will be the Department of Health Standards Quality Assurance and Regulation (DHSQAR), which has responsibility for standards, oversight and coordination of regulatory matters. Statutory responsibility for inspection and enforcement of regulation lies with the seven national regulatory Boards and Councils. They will benefit directly from the study findings in their deliberations on whether and how to continue and scale up the KePSIE interventions across Kenya, and in understanding what modifications would be required to ensure a scalable and sustainable regulatory reform.

Following promulgation of a new Constitution in 2010, responsibility for health no longer lies solely with national bodies. In 2013 responsibility for health service delivery was devolved to 47 newly formed semi-autonomous counties. While regulatory roles were retained at the national level, their implementation clearly also concerns County Governments. Moreover, discussions are underway on sharing some supervisory functions with the counties. County actors will therefore also be important research beneficiaries, using the findings to participate in discussion of regulatory policy and to design complementary strategies at county level.

Regulation does not take place in isolation, but also has important links to other health system functions in Kenya, specifically healthcare financing and facility accreditation, as more effective regulatory implementation may reduce the need for separate costly audits for facility empanelment. In that regard, the findings will also be relevant to the National Hospital Insurance Fund (NHIF) and the Kenyan Accreditation Service (KENAS), and will help them understand how regulatory interventions can complement their own activities.

Finally, the Kenyan public will benefit from improved patient safety standards and quality of care, resulting from strengthened implementation of regulation. Knowing the most effective interventions to scale-up would mean better prioritization and improved use of available resources.

International stakeholders
The challenges of poor health facility regulation are widely shared in most countries in the developing world. Given the very limited evidence base on both the operation of regulation, and the consequences of reforms, the results are likely to be of substantial interest to other country health ministries, regulatory agencies, and financing bodies. Bilateral and multilateral development partners operating in Kenya and beyond with an interest in quality improvement, and universal health coverage more general, will also be important research users, potentially drawing on these findings to shape their strategies in this area, provide support to other countries, and prioritise their funding allocations.

Academic community
The final group of users will be academic researchers and students, as described under "Academic Beneficiaries".