De-implementation of inappropriately tight control (of hypoglycemia) for health: protocol with an example of a research grant application

BACKGROUND: Implementation of practice change is difficult and large scale implementation is particularly difficult. Among the challenges facing the healthcare system in general and healthcare organizations is the overuse of low value care. Improving medication safety also constitutes an attempt to reduce low value or potentially harmful care. Critical issues of overuse of low value practices and medication safety intersect in overtreatment of diabetes. Specifically, (over)intensive glycemic control increases hypoglycemia risk and morbidity without providing meaningful benefit. Our work indicates that among patients with diabetes who are at high risk for hypoglycemia, potential overtreatment is common. The Choosing Wisely Initiative to reduce low value care led by the American Board of Internal Medicine Foundation recommends not to treat most persons over 65 years of age with medications to reduce the A1c<7.5%. For most physicians this involves a change in practice. We will study the implementation of the Veterans Health Administration's Choosing Wisely Initiative (which includes hypoglycemic safety as a targeted condition) with three specific aims: (1) to assess the overall impact, both intended and unintended, of the Choosing Wisely Initiative to reduce overtreatment of diabetes in especially vulnerable populations; (2) to assess the impact of commitment to quality, teaching intensity, and safety culture on likelihood of overtreatment; and (3) to identify configurations of the implementation strategy, provider characteristics and organizational level factors that are associated with successful reduction of overtreatment rates by comparing high and low performers. Because focus on this initiative could have the unintended consequence of paying less attention to poor glycemic control (A1c>9%), we will also assess undertreatment. METHODS/DESIGN: We will take advantage of a natural experiment and use a Type III Hybrid Design that focuses on study of implementation while at the same time observing and gathering information on clinical interventions and outcomes. This mixed methods study will use longitudinal data and qualitative methods including Qualitative Comparative Analyses. DISCUSSION: Our multi-paradigm approach to examining potential mechanisms to explain the variation in reduction of rates of overtreatment will contribute to a better understanding of implementation of national dissemination projects and multi-component interventions in complex systems.