Translating Information on Comparative Effectiveness Into Practice (TRICEP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 550
- 试验地点
- 12
- 主要终点
- Patient Satisfaction and knowledge
研究概览
简要总结
The goal of this study is to test the relative merits of a decision aid for diabetes medications that we have developed - Diabetes Medication Choice Cards- versus usual care in translating comparative effectiveness research (CER) into real world clinics. This study will involve about 20 primary care practice sites affiliated with Mayo Health System, Park Nicollet, or Hennepin County Medical Center. There will be no recruiting done at the Mayo Clinic.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Patient Satisfaction and knowledge
时间窗: baseline to 12 months
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).
次要结局
- Physician adoption and satisfaction with the decision aid.(baseline to 12 months)
研究者
Victor Montori
Principal Investigator
Mayo Clinic