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

QBSafe：一项旨在改善 2 型糖尿病患者护理的新型干预措施的随机试验。

• 批准号: 10446533
• 负责人: Kasia Joanna Lipska
• 金额: $ 30.52万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10446533
• 关键词: Achievement; Acute; Adverse effects; Attention; Caring; Chronic; Client satisfaction; Clinical; Clinical Trials; Clinical effectiveness; Cluster randomized trial; Collection; Complications of Diabetes Mellitus; Data; Data Collection; Diabetes Mellitus; Disease; Emergency Care; Enrollment; Event; Future; Glycosylated hemoglobin A; Goals; Guidelines; Health; Healthcare; High Prevalence; Hypoglycemia; Intervention; Lead; Life; Measures; Methods; Minority Groups; Mission; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; Office Visits; Outcome; Outcome Measure; Participant; Patient Care; Patient Outcomes Assessments; Patients; Performance; Personal Satisfaction; Persons; Primary Health Care; Procedures; Psychosocial Factor; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Regimen; Research; Rewards; Safety; Self Management; Surveys; Testing; Time; Treatment Efficacy; Visit; Work; Workload; analog; base; clinical encounter; clinical outcome measures; comparison intervention; contextual factors; cost; design; diabetes control; diabetes distress; diabetes management; feasibility research; feasibility testing; glycemic control; health care service utilization; improved; interest; medication administration; novel; patient oriented; programs; randomized trial; recruit; response; satisfaction; social health determinants; success; treatment as usual; treatment planning

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.

项目摘要：2型患者的临床指南，绩效指标和临床试验 糖尿病（DM2）传统上专注于达到某些水平的血糖控制。但是，什么时候 血糖控制是糖尿病护理的主要重点，患者健康和健康的重要方面可能是 被忽视或被低估。对于血糖控制不良的患者，临床医生通常会通过加剧而做出反应 该方案经常不关注这对患者的工作负载，他们的能力 治疗计划或涉及的背景因素。结果，糖尿病及其治疗可能会破坏 干扰有价值的活动和兴趣（即引起令人担忧的“疾病侵入性”），实际上担心 一个人的感觉或功能。我们计划的目的是促进DM2护理的范式转变：从 将HBA1C目标达到全人方法，以应对每个患者的情况并减少 疾病侵入性。在这里，我们建议测试一种新颖的干预措施，以治疗专注于生活质量的DM2， 治疗负担（药物给药，成本和监测），安全性（减少不良影响）和 避免未来事件（急性和慢性糖尿病并发症） - QBSAFE方法。我们有 先前开发了一个议程设置套件（询问），以便患者在常规办公室访问中使用。问 由（a）一组对话卡组成 与他们的处境有关，并与他们的临床分享以获取他们的意见； （b）材料 帮助临床医生应对患者的担忧。我们建议在 康涅狄格州纽黑文的联邦合格医疗中心，将10位初级保健临床医生和144个随机分配 他们的DM2和HBA1C的患者> 8％以接受或不带QBSAFE的常规护理以实现 以下内容：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的临床有效性在DM2患者的护理中。 AIM 2：由于确定的试验需要一些机械效率的证据，因此我们将为该试验提供动力 估计有或不进行qbsafe询问的通常护理可以改善的程度：AIM 2A：患者报告 结果，主要是疾病的侵入性（疾病侵入性评分量表）以及糖尿病困扰 （糖尿病遇险量表），治疗烧伤（治疗负担问卷），低血糖症和全球 干预后6个月的生活质量（1-项目模拟量表）。 AIM 2B：测量的临床结果 随着基线至6个月之间HBA1C的变化。 AIM 2C：以（a）评级为中心的患者中心糖尿病 临床相遇的视听记录（包括总花费的时间和讨论QBSAF 域）和（b）患者满意度（使用卧床CAHPS调查）和临床满意度（使用 竞选后的调查）与遭遇的发生方式。这项工作将为A提供必要的初步数据 多中心随机试验，以确定糖尿病护理中QBSAFE问的临床有效性。