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PPO 18-051 – HSR Study

PPO 18-051
Development and Implementation of Decision Aids to Promote Safe Use of Hypoglycemia-prone Medications in Diabetes: Shared Decision Making around Glycemic Control (A1c) Targets
David C. Aron, MD MS
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, OH
Funding Period: October 2018 - September 2019


Objectives: The problem of overtreatment of diabetes (as assessed by glycohemoglobin [HbA1c or A1c] which provides an estimate of glycemic control) and the related occurrence of hypoglycemia and its complications is common. Among the important factors which account for this problem is the lack of understanding of the appropriate use of hypoglycemia-prone medications (insulin and sulfonylureas) and of the relationship between the benefits versus the risks of intensive glycemic control. The goal of this project is to develop and pilot test decision communication aid(s) and supporting tools to facilitate shared decision making around the individual choice of a target A1 c range for glycemic control and reduce the frequency of hypoglycemia: Specific Aim 1: Develop a decision aid that can be used in a usual patient encounter to inform clinical decision making around glycemic control and the choice of a target for A1c. Specific Aim 2: Conduct a pilot test of the glycemic control target communication decision aids and assess the impact of on the choice of an A1c target, occurrence of hypoglycemia, glycemic control, and the impact on measures of patient involvement, understanding, and satisfaction in decision-making. Research Plan: This pilot project is designed to support preliminary studies required for a large-scale trial of a decision aid that supports shared decision-making about A1c targets. Specifically, we will develop the decision aid, a critical component of the intervention, refine the outcome measures, and obtain data to inform power analyses, essential for the design of a randomized controlled trial. Such a trial will be important not only to test effectiveness of the decision aid itself, but also to assess the performance of a decision aid developed in one context and applied in other similar but not identical contexts. Methodology: Aim 1. We will utilize a rapid cycle/iterative process with concurrent evaluation. This design- centered research approach involves three steps: (1) user-centered observation of current clinical encounters; (2) multidisciplinary synthesis of current practice; and (3) iterative development of decision aid prototypes. Since this approach requires that all types of individuals who will use the decision aid to be involved, patients and clinicians, as well as designers contribute to the development of the decision aid in context. For this aim, a formative evaluation will primarily be qualitative. Aim 2. We will conduct a pilot study (pre-test/post-test design) and assess it using mixed methods – qualitative analysis of interviews as well as a comprehensive series of quantitative surveys and other measures. Clinical Significance: This project has both clinical and research significance. Overtreatment of diabetes in Veterans (and others) is common and is associated with considerable morbidity and mortality. This project is also aligned with the goals of the National Action Plan for Adverse Drug Events, one of which is to reduce hypoglycemia from diabetes agents. This Plan has informed VA's ongoing Choosing Wisely/Hypoglycemia Safety Initiative. From a research perspective, this process tests a novel approach to decision-aid design that addresses the low adoption rate of decision aids. Normalization process theory supports the development of decision aids in the context in which they will be used (honoring the importance of minimizing disruption to the work flow) and by all the stakeholders that will use them (recognizing that patients and clinicians have an important role to play in collaboration).

External Links for this Project

NIH Reporter

Grant Number: I21HX002686-01

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None at this time.

DRA: Diabetes and Other Endocrine Disorders
DRE: Treatment - Observational, TRL - Applied/Translational
Keywords: Decision-Making, Diabetes, Patient Safety
MeSH Terms: None at this time.

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