Abstract

BackgroundPatients with type 2 diabetes (T2DM) often have poor glycemic control on first-line pharmacologic therapy and require treatment intensification. Intensification decisions can be difficult because of many available options and their many benefits and risks. The American Diabetes Association recommends patient-centered, evidence-based tools supporting shared decision-making between patients and clinicians. We developed a patient decision aid (PDA) targeting decisions about treatment intensification for T2DM. Our objective was to determine the effectiveness of this PDA for patients with T2DM on metformin who require treatment intensification.MethodsThis study was a pragmatic randomized controlled trial conducted in 27 US primary care and endocrinology clinics. Subjects were English-speaking adults with T2DM receiving metformin with persistent hyperglycemia who were recommended to consider medication intensification. Subjects were randomized to receive either the PDA or usual care (UC). Main outcome measures were change in knowledge, decisional self-efficacy, and decisional conflict.ResultsOf 225 subjects enrolled, 114 were randomized to the PDA and 111 to UC. Mean [SD] age was 52 [1] years, time since T2DM diagnosis was 6 [+/−6] years, 45.3 % were male, and most (55.5 %) were non-Caucasian. Compared to UC, PDA users had significantly larger knowledge gains (35.0 % [22.3] vs 9.9 % [22.2]; P < 0.0001) and larger improvements in self-efficacy (3.7 [16.7] vs−3.9 [19.2]; P < 0.0001) and decisional conflict (−22.2 [20.6] vs−7.5 [16.6]; P < 0.0001).ConclusionsThe PDA resulted in substantial and significant improvements in knowledge, decisional conflict and decisional self-efficacy. Decisional conflict scores after PDA use were within the range that correlates with effective decision-making. This PDA has the potential to facilitate shared-decision-making for patients with T2DM.Trial registration NCT02110979 Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-016-1262-4) contains supplementary material, which is available to authorized users.

Highlights

  • Patients with type 2 diabetes (T2DM) often have poor glycemic control on first-line pharmacologic therapy and require treatment intensification

  • All subjects were followed for approximately 6 weeks after randomization except for 20 who were lost to follow-up (PDA group, n = 15; usual care group, n = 5)

  • Fewer subjects in the patient decision aid (PDA) versus usual care (UC) group reported having some college education (26.3 % vs 39.6 %, respectively), and fewer had a history of a yeast or urinary tract infection (UTI)

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Summary

Introduction

Patients with type 2 diabetes (T2DM) often have poor glycemic control on first-line pharmacologic therapy and require treatment intensification. Intensification decisions can be difficult because of many available options and their many benefits and risks. We developed a patient decision aid (PDA) targeting decisions about treatment intensification for T2DM. Our objective was to determine the effectiveness of this PDA for patients with T2DM on metformin who require treatment intensification. Improving knowledge can promote diabetes self-efficacy, reduce decisional conflict, improve selfmanagement behaviors [1, 11, 12], improve medication adherence [13, 14] and glycemic control [15,16,17], which should lead to improved clinical outcomes

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