Abstract
BACKGROUND: Stroke is a leading cause of disability and the fifth leading cause of death in the USA. Intravenous alteplase is a highly effective clot-dissolving stroke treatment that must be given in a hospital setting within a time-sensitive window. To increase the use of intravenous alteplase in stroke patients, many US counties enacted policies mandating emergency medical service (EMS) paramedics to bypass local emergency departments and instead directly transport patients to specially equipped stroke centers. The objective of this mixed-methods study is to evaluate the effectiveness of policy enactment as an implementation strategy, how differences in policy structures and processes impact effectiveness, and to explore how the county, hospital, and policy factors explain variation in implementation and clinical outcomes. This paper provides a detailed description of an Agency for Healthcare Quality and Research (AHRQ)-funded protocol, including the use of the Consolidated Framework for Implementation Research (CFIR) in the qualitative design. METHODS/DESIGN: We will construct the largest-ever national stroke database of Medicare enrollees (~ 1.5 million stroke patients) representing 896 policy counties paired with 1792 non-policy counties, then integrate patient-, hospital-, county-, and state-level covariates from eight different data sources. We will use a difference-in-differences analysis to estimate the overall effect of the policy enactment on intravenous alteplase use (implementation outcome) as well as key patient outcomes. We will also quantitatively examine if variation in the context (urban/rural status) and variation in policy features affect outcomes. Finally, a CFIR-informed multiple case study design will be used to interview informants in 72 stakeholders in 24 counties to identify and validate factors that enable policy effects. DISCUSSION: Policies can be potent implementation strategies. However, the effects of EMS bypass policies to increase intravenous alteplase use have not been rigorously evaluated. By learning how context and policy structures impact alteplase implementation, as well as the barriers and facilitators experienced by stakeholders responsible for policy enactment, the results of this study will inform decisions regarding if and how EMS bypass policies should spread to non-policy counties, and if indicated, creation of a "best practices" toolkit.