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Improving Outcomes Using Collaborative Group Clinics to Empower Older Patients (EPIC)

2020年2月27日 更新者:Aanand Naik、Baylor College of Medicine

Improving Outcomes for Multiple Morbidities Using Collaborative Group Clinics to Empower Older Patients

The purpose of this study is to determine if group clinics help older veterans change behaviors with the goal of improving diabetes outcomes.

研究概览

详细说明

Among persons aged 55-84 years, over 65% have one to three common medical conditions (e.g., hypertension, diabetes, arthritis, stroke, heart disease, etc.). Fortunately, large randomized clinical trials have demonstrated the effectiveness of treatment and prevention strategies for many chronic conditions (e.g., dietary modification and medications for hypertension, intensive glucose monitoring with diet and medication regimens for diabetes, etc.). Despite the significant findings from numerous clinical trials, most older persons continue to suffer from uncontrolled hypertension, hyperglycemia, and other predictors of poor health outcomes. Non-compliance with clinical guidelines by providers (i.e. clinical inertia) and non-adherence to doctors' recommendations are typically blamed for these unacceptably poor outcomes. For older adults with several conditions, the processes of patient-clinician collaboration are not well understood. Goal-setting behaviors may improve health care by linking desired outcomes (i.e., reduce risk of heart attacks) to the goals of care (i.e., salt restriction for hypertension control). Furthermore, the process of goal-setting may be more effective if patients internalize the importance of a particular goal and prioritize that goal among multiple clinical problems (i.e., hypertension care for patients with diabetes.

Effective methods of implementing collaborative goals and training patients to negotiate shared goals and goal-directed behaviors with their clinicians have been developed for diabetes control. The effectiveness of these methods may be enhanced through the use of clinics that enroll small groups of subjects with rapid follow-up for several weeks. Group clinics have demonstrated improved outcomes for common chronic conditions. Evidence demonstrating the synergistic benefit of efficient group clinics and collaborative goal-setting is limited. However, an approach combining these methodologies may provide an improved method of rapidly controlling multiple chronic conditions and maintaining control of those chronic conditions over a prolonged time period.

To address the gap in the implementation of effective and efficient medical care, we will develop and test a model of collaborative group clinics that empowers older patients to adopt goal-setting behaviors, increases communication with their health care provider, and improves their diabetes-related outcomes. The objectives are to use a collaborative group clinic to: 1) Improve diabetes process of care outcomes over a 3 month time period; 2) Significantly improve the maintenance of diabetes process of care improvements over a 12 month time period; and 3) Significantly improve use of self-management behaviors for diabetes care.

研究类型

介入性

注册 (实际的)

129

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 90年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Diagnosis of diabetes and hypertension
  • HgA1C value greater than or equal to 7.5
  • Creatinine value less than or equal to 2.0mg/dl
  • SBP greater than or equal to 140

Exclusion Criteria:

  • Prior diagnoses of dementia using ICD-9 codes validated for a VA population

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Group Clinic
Patients in Group Clinic arm will meet every 3rd week for 12 weeks, for a total of 4 visits. At each visit, BP will be measured, home BP and glucose measurements collected. Each visit will include group-based education and feedback sessions, with an individualized process of selecting and modifying process of care goals for systolic BP, H1C, and LDL cholesterol. Short-term health behavior change goals will also be discussed.
Collaborative group clinics to empower older patients to adopt goal-setting behaviors with their health care providers and improve their diabetes-related outcomes.
其他名称:
  • Diabetes Group Clinic
  • Goal-setting Clinic
安慰剂比较:Uusual Care
Older diabetes patients will attend regular clinician visits and one targeted primary care physician visit during the 12 weeks post-enrollment. They will be enrolled in a diabetes education class. Blood pressure, H1C and lipids will be measured at enrollment, 6 weeks , and 12 weeks.
Standard of care for diabetes patients
其他名称:
  • Diabetes usual care

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein
大体时间:12 months
Change in systolic blood pressure; change in Hemoglobin A1C; change in low
12 months

次要结果测量

结果测量
措施说明
大体时间
Attainment of benchmark levels for SBP, A1C, LDL; self-management performance (self-report); completion of group clinic
大体时间:12 months
Attainment of benchmark levels for SBP, A1C, LDL; self-management
12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Aanand D Naik, MD、Baylor College of Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年4月1日

初级完成 (实际的)

2008年4月1日

研究完成 (实际的)

2009年9月1日

研究注册日期

首次提交

2007年5月31日

首先提交符合 QC 标准的

2007年5月31日

首次发布 (估计)

2007年6月1日

研究记录更新

最后更新发布 (实际的)

2020年3月2日

上次提交的符合 QC 标准的更新

2020年2月27日

最后验证

2009年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • H-20437
  • 7U18HS016093 (美国 AHRQ 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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