QBSafe: a randomized trial of a novel intervention to improve care for people living with type 2 diabetes.

项目摘要：2型糖尿病患者的临床指南、性能指标和临床试验 糖尿病（DM 2）传统上集中于实现一定水平的血糖控制。然而当 血糖控制是糖尿病护理的主要焦点，患者健康和幸福的重要方面可能是 被忽视或低估。对于血糖控制不佳的患者，临床医生通常会通过加强 该方案，所有太多的时候没有注意到的工作量，这强加给病人，他们的能力， 治疗计划或相关的背景因素。因此，糖尿病及其治疗可能会破坏和 干扰有价值的活动和利益（即，导致“疾病侵入性”恶化），实际上恶化了 一个人的感觉或功能。我们计划的目标是促进DM 2护理的范式转变：从 达到HbA 1c的目标是一个全人的方法，响应每个病人的情况，并减少 疾病侵入性。在这里，我们建议测试一种新的干预措施来治疗DM 2，重点是生活质量， 治疗负担（给药、费用和监测）、安全性（减少不良反应）和 避免未来事件（急性和慢性糖尿病并发症）-QBSafe方法。我们有 之前开发了一个议程设置工具包（ASK），供患者在日常就诊时使用。的ASK 包括（a）一套对话卡，旨在使患者能够识别QBSafe的各个方面， 与他们的情况相关，并与他们的临床医生分享以获得他们的输入;以及（B）材料， 帮助临床医生回应患者的担忧。我们建议进行一项随机分组试验， 在康涅狄格州纽黑文的联邦合格的医疗保健中心，随机抽取10名初级保健临床医生和144名 他们的DM 2和HbA 1c>8%的患者接受常规护理，有或没有QBSafe ASK，以实现 目标1：确定进行实践所需的研究程序的可行性- 基于随机试验，以确定QBSafe ASK在DM 2患者护理中的临床有效性。 目标2：由于确定性试验需要一些有效性的机制证据，我们将支持这项试验， 估计有和没有QBSAFE ASK的常规护理可以改善的程度：目标2A：患者报告 结果，主要是疾病侵入性（疾病侵入性评定量表），以及糖尿病困扰 （糖尿病痛苦量表）、治疗负担（治疗负担问卷）、低血糖和总体 干预后6个月的生活质量（1项模拟量表）。目标2B：测量临床结局 作为基线和6个月之间HbA 1c的变化。目标2C：通过（a）评级判断以患者为中心的糖尿病 临床就诊的视听记录（包括花费的总时间和讨论QBSafe的时间 领域），和（B）患者满意度（使用门诊CAHPS调查）和临床医生满意度（使用 （一）遭遇后的调查（post-encounter survey）这项工作将提供必要的初步数据， 多中心随机试验，以确定QBSafe ASK在糖尿病护理中的临床有效性。

PROJECT ABSTRACT: Clinical guidelines, performance measures, and clinical trials for patients with type 2 diabetes mellitus (DM2) have traditionally focused on achieving certain levels of glycemic control. Yet, when glycemic control is the main focus of diabetes care, important aspects of patients’ health and wellbeing may be overlooked or undervalued. For patients with poor glycemic control, clinicians typically respond by intensifying the regimen, all too often without attention to the workload this imposes on patients, their capacity to carry out the treatment plan, or the contextual factors involved. As a result, diabetes and its treatment may disrupt and interfere with valued activities and interests (i.e., cause worsening “illness intrusiveness”), and actually worsen how a person feels or functions. The goal of our program is to promote a paradigm shift in DM2 care: from reaching HbA1c targets to a whole-person approach that responds to the situation of each patient and reduces illness intrusiveness. Here, we propose to test a novel intervention to treat DM2 focused on Quality of life, Burden of treatment (medication administration, costs, and monitoring), Safety (reducing adverse effects), and Avoidance of Future Events (acute and chronic diabetes complications) – the QBSafe approach. We have previously developed an Agenda Setting Kit (ASK) for patients to use during their routine office visits. The ASK is comprised of (a) a set of conversation cards designed to enable patients to identify aspects of QBSafe that are pertinent to their situation and to share them with their clinician to obtain their input; and (b) materials that help clinicians respond to patient concerns. We propose to conduct a clustered randomized trial at a federally qualified healthcare center in New Haven, CT, and to randomize 10 primary care clinicians and 144 of their patients with DM2 and HbA1c >8% to receive usual care with or without QBSafe ASK in order to achieve the following: Aim 1: To determine the feasibility of the research procedures necessary to conduct a practice- based randomized trial to determine the clinical effectiveness of QBSafe ASK in the care of patients with DM2. Aim 2: Since a definitive trial will require some mechanistic evidence of efficacy, we will power this trial to also estimate the extent to which usual care with and without QBSAFE ASK can improve: Aim 2A: Patient-reported outcomes, principally illness intrusiveness (Illness Intrusiveness Rating Scale), as well as diabetes distress (Diabetes Distress Scale), treatment burden (Treatment Burden Questionnaire), hypoglycemia, and global quality of life (1-item analogue scale) at 6 months after the intervention. Aim 2B: Clinical outcomes measured as change in HbA1c between baseline and 6 months. Aim 2C: Patient-centered diabetes judged by (a) rating the audiovisual recordings of clinical encounters (including the time spent total and in discussing QBSafe domains), and (b) patient satisfaction (using the ambulatory CAHPS survey) and clinician satisfaction (using post-encounter survey) with how the encounter went. This work will provide necessary preliminary data for a multicenter randomized trial to determine the clinical effectiveness of QBSafe ASK in diabetes care.