Adoption and scale-up of the cardiovascular Polypill: a realist institutional analysis

Efforts to promote the adoption and scale-up of health system innovations must contend with the existing institutional context. But there are no commonly used frameworks to ensure that the insights of actors involved in such institutional efforts connect to one another. To test and modify a potential framework-the 'four-by-four' framework-we interviewed researcher-entrepreneurs involved in the unfolding story of the cardiovascular Polypill. The framework has four types/levels of institutions that affect adoption and scale-up: (1) informal institutions (L1, e.g. social norms), (2) formal institutions (L2, e.g. government policies and regulation), (3) organizational structures (L3, e.g. organizational boards and mission) and (4) everyday exchange (L4, e.g. service delivery), vis-à-vis four potential entrepreneurial strategies in response: (1) abide by existing institutions, (2) evade them, (3) alter them and/or (4) exit entrepreneurial action. Using this framework, we conducted a realist-informed analysis to understand how context (i.e. institutions) and mechanism (i.e. entrepreneurial strategies) influence each other to shape outcomes (i.e. adoption and scale-up). We found that researcher-entrepreneurs began with efforts to abide with existing institutions but encountered institutional obstacles at each level. Efforts to abide were followed by seeking to evade and/or alter unfavourable institutions, with greater success evading and/or altering lower (L3 and L4) than upper (L1 and L2) institutions. Exit considerations followed the failure of the evade or alter strategy. Shifts between strategies were propelled by 'learning'. The 'four-by-four' framework can be used as a scaffold to generate narratives of adoption or scale-up efforts, a sensitizing tool to prospectively map out contingencies and a matrix to synthesize narratives and experiences across multiple innovations or settings. Used in these ways, the 'four-by-four' framework can help to optimize the transferability and cumulation of insights on how to promote the adoption and scale-up of health system innovations.