Improving Outcomes Using Collaborative Group Clinics to Empower Older Patients (EPIC)
Improving Outcomes for Multiple Morbidities Using Collaborative Group Clinics to Empower Older Patients
研究概览
地位
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
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
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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.
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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:
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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.
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Standard of care for diabetes patients
其他名称:
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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
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Change in systolic blood pressure; change in Hemoglobin A1C; change in low
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12 months
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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
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Attainment of benchmark levels for SBP, A1C, LDL; self-management
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12 months
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合作者和调查者
合作者
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
一般刊物
- Teal CR, Haidet P, Balasubramanyam AS, Rodriguez E, Naik AD. Measuring the quality of patients' goals and action plans: development and validation of a novel tool. BMC Med Inform Decis Mak. 2012 Dec 27;12:152. doi: 10.1186/1472-6947-12-152.
- Naik AD, Palmer N, Petersen NJ, Street RL Jr, Rao R, Suarez-Almazor M, Haidet P. Comparative effectiveness of goal setting in diabetes mellitus group clinics: randomized clinical trial. Arch Intern Med. 2011 Mar 14;171(5):453-9. doi: 10.1001/archinternmed.2011.70.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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