Abstract
BackgroundMany delivery-system interventions are fundamentally about change in social systems (both planned and unplanned). This systems perspective raises a number of methodological challenges for studying the effects of delivery-system change--particularly for answering questions related to whether the change will work under different conditions and how the change is integrated (or not) into the operating context of the delivery system.MethodsThe purpose of this paper is to describe the methodological and measurement challenges posed by five key issues in delivery-system research: (1) modeling intervention context; (2) measuring readiness for change; (3) assessing intervention fidelity and sustainability; (4) assessing complex, multicomponent interventions; and (5) incorporating time in delivery-system models to discuss recommendations for addressing these issues. For each issue, we provide recommendations for how research may be designed and implemented to overcome these challenges.Results and conclusionsWe suggest that a more refined understanding of the mechanisms underlying delivery-system interventions (treatment theory) and the ways in which outcomes for different classes of individuals change over time are fundamental starting points for capturing the heterogeneity in samples of individuals exposed to delivery-system interventions. To support the research recommendations outlined in this paper and to advance understanding of the "why" and "how" questions of delivery-system change and their effects, funding agencies should consider supporting studies with larger organizational sample sizes; longer duration; and nontraditional, mixed-methods designs.A version of this paper was prepared under contract with the Agency for Healthcare Research and Quality (AHRQ), US Department of Health and Human Services for presentation and discussion at a meeting on "The Challenge and Promise of Delivery System Research," held in Sterling, VA, on February 16-17, 2011. The opinions in the paper are those of the author and do not represent the views or recommendations of AHRQ or the US Department of Health and Human Services.1
Highlights
Many delivery-system interventions are fundamentally about change in social systems
It is increasingly evident that patient outcomes are not solely a function of efficacious clinical interventions and practices
Unlike pharmacologic interventions, which can be controlled in experimental designs, evaluating the effectiveness of different approaches to delivering care poses challenges to many of the traditional tenants of designing and conducting research. This claim stems from the observation that many delivery-system interventions and innovations are fundamentally about change in social systems
Summary
Many delivery-system interventions are fundamentally about change in social systems (both planned and unplanned). Unlike pharmacologic interventions, which can be controlled in experimental designs, evaluating the effectiveness of different approaches to delivering care poses challenges to many of the traditional tenants of designing and conducting research This claim stems from the observation that many delivery-system interventions and innovations are fundamentally about change in social systems (both planned and unplanned). The fidelity with which a given intervention is implemented and practiced by a particular provider or group of providers follows from interrelationships among a range of internal and external factors that constitute the social system surrounding the intervention This systems approach is cited as pivotal to understanding (and solving) a number of quality and safety problems identified in publications such as To Err is Human and Crossing the Quality Chasm [2,3]. These publications encourage health-services researchers to consider greater application of systems-focused theory to questions of how organizational factors shape quality and other patient-related outcomes
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