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

Abstract

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.

There are many guides to developing research proposals, and ingredients for implementation research grant proposals have been suggested by Proctor et al.[1]. However, among the challenges facing a new investigator in trying to get research funding is the relative paucity of model grant applications [2, 3]. This is particularly true when the field being entered is a newly developing discipline; implementation science is such a discipline and it is still evolving [4]. Although the publication of protocols from such grant applications has become more common, the actual grant application and its iterations have not. Our goal is not only to provide an example of an implementation research grant application, but also to illustrate this process further by making available the different iterations and the critiques as well. In so doing, we take the process one step further by illustrating how the research team revised the application in response to the critiques. Each funding agency has its own application procedures. These procedures may differ in the details, but are similar. Some require ‘letters of intent’ or ‘concept papers’ while others do not. The revised application is in Additional file 1. We have included in the six other additional files labeled: Additional files 2, 3, 4, 5, 6 and 7.’ This process lasted from May 2013 to March 2014. Of note, in the middle of the process, the funding agency changed its requirements between initial and revised submissions in terms of the length of the narrative, reducing it from 25 to 15 pages.

Proctor et al. identified ten ingredients of a successful implementation research grant proposal [1]. These ingredients are listed in Table 1. All ten ingredients were included in our application to varying degrees. No claims are made that this is the optimal proposal that could be written on the subject, merely that it suffices, i.e., it was good enough to have been funded successfully [5], and they are highlighted in Table 1. It is the hope of the authors that making this material available, with all its imperfections, will foster development of this crucially important discipline. It should also be stated that the process of submission and review resulted in what we believe is a much improved proposal.

Table 1 Ten key ingredients for implementation research proposals (modified from Proctor EK et al.[1])