Evaluating health and social care integration in England's Pioneer programme: The challenges of undertaking research in service delivery and research regulatory systems that are not fit for purpose.

ObjectivesBetter integrated health and social or long-term care is high on government policy agendas in many countries. In England, successive pilot programmes, with related national evaluations, have been introduced to better integrate care to meet the needs of people requiring multi-agency help. However, researchers evaluating such programmes both in England and internationally face a daunting number of challenges produced by service delivery and research regulatory systems. This paper analyses the challenges encountered in seeking to undertake a prospective quasi-experimental evaluation of the impacts of community based multi-disciplinary teams (MDTs) on patient experience and outcomes, as part of a wider evaluation of the Integrated Care and Support Pioneers programme. The paper also identifies a number of general lessons for research commissioners, study site participants, and those tasked with undertaking such evaluative research.MethodsWe reviewed our research activities and timelines from the start of the evaluation. We created a narrative history - using reports to the funder, applications to research and ethics regulatory bodies and correspondence with Pioneer sites, regulatory bodies and data providers - to describe the challenges faced and our approaches to attempting to mitigate them.ResultsWe experienced four key challenges: (1) unrealistic commissioner research specifications; (2) negotiating with and recruiting multiple organisations and services at potential study sites; (3) navigating research ethics and governance systems; and (4) recruiting participants for primary data collection and obtaining (with their consent) their linked routine service use data. The first two challenges resulted from the lack of shared understanding of evaluation feasibility and constraints between local health and care system actors and national level commissioners of evaluation, plus no clear incentive for local sites to participate. The third and fourth challenges were the product of multiple, protracted, and unnecessarily risk-averse research approval processes which affected both the nature and quantity of the data we could collect.ConclusionsWe recommend that major changes are made to the regulation of policy research to enable more robust evaluation to take place and that disproportionately high levels of risk aversion in approval processes for non-interventional, low-risk studies are addressed. In addition, the evaluation commissioning process needs to be far better informed at an early stage about which elements in programmes can feasibly be evaluated before research specifications are advertised.