Study to Test Use of a Decision Aid in a Clinical Visit to Help Patients Choose a Diabetes Medication (TRICEP)
Translating Information on Comparative Effectiveness Into Practice (TRICEP)
研究概览
详细说明
To conduct a cluster-randomized practical trial to evaluate the impact of our decision aid (Diabetes Medication Choice Cards) versus usual care as strategies to translate CER into practice among patients with poorly controlled diabetes in need of drug intensification (Hemoglobin Alc (HbA1c) > 7.3%). Patient outcomes including reaching glycemic control target (HbA1c less than or equal to 7.3%), medication choice and adherence, satisfaction and knowledge. From the physician perspective, we will be measuring physician adoption and satisfaction with the decision aid.
To identify, describe, and explain factors that promote or inhibit the uptake of complex interventions such as decision aids in practices participating in the trial.
To conduct an exploratory analysis of the ability of patients to adhere to the medications chosen while exploring the factors that enable or hinder the patients' ability to incorporate these medications into their routine.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Minnesota
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Albert Lea、Minnesota、美国、56007
- Albert Lea Medical Center
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Kasson、Minnesota、美国、55944
- Mayo Clinic Kasson
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Mankato、Minnesota、美国、56002
- Mayo Clinic Health System- Immanual St. Joseph's
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Minneapolis、Minnesota、美国、55415
- Hennepin County Medical Center
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Saint Louis Park、Minnesota、美国、55416
- Park Nicollet Institute
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Wisconsin
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La Crosse、Wisconsin、美国、54601
- Mayo Clinic Health System-Franciscan Healthcare
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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:
- 18 years of age and older
- Have a diagnosis of Type 2 diabetes mellitus and on diabetes medication
- Have a diagnosis of Type 2 diabetes mellitus for 1 year or more if not currently on diabetes medication
- Recognize their primary care provider as their main diabetes care provider
- Use 0, 1, 2, or 3 oral hypoglycemic agents
- Have a recent HbA1c measure (within 12 months) of greater than 7.3, with priority to patients with rising HbA1c levels.
Exclusion Criteria:
- Not available for follow-up for 12 months after study visit.
- Unable to read and speak English.
- Has major barriers to providing written informed consent.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Usual Care
Clinicians will present diabetes medication options to patients, in their usual way.
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实验性的：Diabetes Medication Decision Aid
In the decision aid arm, clinicians will use the diabetes medication decision aid cards (if they choose) when discussing diabetes medication options with their patients.
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Clinician uses the Diabetes Medication Choice Cards to inform and engage patient in discussing the issues they find relevant in choosing a new diabetes medication.
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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 |
|---|---|---|
|
Patient Satisfaction and knowledge
大体时间：baseline to 12 months
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Primary outcome is to evaluate the impact of our decision aid (Diabetes Medication Choice Cards) versus usual care as strategies to translate CER into practice among patients with poorly controlled diabetes in need of drug intensification (Hemoglobin A1c (HbA1c) > 7.3%).
Patient outcomes include satisfaction with use of the decision aid and knowledge, compared to the control, usual care group (by written survey at point of care and follow-up).
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baseline to 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Physician adoption and satisfaction with the decision aid.
大体时间：baseline to 12 months
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Brief post-visit surveys will be completed by the clinicians, directly following clinical visit.
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baseline to 12 months
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合作者和调查者
赞助
出版物和有用的链接
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
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.