Using Patient Feedback to Improve the Ways we Communicate Information Regarding Glycemic Control to Patients With Poorly Controlled Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- For Phase I of the Study: Metrics Used to Understand Diabetes Control
研究概览
简要总结
In this two-phase mixed methods study, the investigators will first use patient feedback from semi-structured interviews to explore the ways in which patients with diabetes understand their diabetes and assess their disease control. The investigators will also use these interviews to elicit patient feedback on promising alternative communication formats to the hemoglobin A1C (A1C). In the second phase of the study, the investigators will test new formats to communicate information regarding diabetes control to patients with poorly controlled diabetes. This phase will be a three arm RCT comparing the effect of A1C (standard medical information) versus two alternative formats on several participant outcomes, primarily glycemic control at 6 months post-intervention.
详细描述
The noted importance of understanding glycemic control is concerning given studies estimating that only 25% of patients understand the hemoglobin A1C value (A1C). The A1C is a blood test value reflecting average blood sugars over the previous 3 months and is used as both a clinical indicator of diabetes control with guideline-set targets and as a communication format to express level of disease control to patients.Past work has demonstrated the potential effectiveness of translating poorly understood medical values, like the A1C, into more universally understood forms. We believe applications can be used to address the problem of the poorly understood A1C. This study is two-phase mixed methods approach. We will design alternative communication formats to convey the information provided by the A1C to patients and evaluate the effectiveness of these formats in improving glycemic control, increasing patient understanding of their diabetes control, and altering patient behaviors. In Phase I of the study,we will use patient feedback from semi-structured interviews with 17-25 patients with diabetes to explore the ways in which patients assess and gauge their diabetes control, as well as to elicit patient feedback on promising communication formats. Potential alternative communication formats include categories represented by color-based scales (red/yellow/green), comparisons to averages or norms, trajectories of control over time and modified medical terminology (i.e., changing the name of the test). In phase II, patients with poorly controlled diabetes will be randomized to receive information on their glycemic control through one of three study arms, A1C (control) or one of two experimental format arms (chosen based on phase I results) and the effects of these different communication formats will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults who report a diagnosis of diabetes
排除标准
- •People without diabetes
- •For Phase II:
- •Inclusion Criteria
- •Adults seen at University of Pennsylvania primary care practice with a diagnosis of diabetes documented in the electronic health record and a recent hemoglobin A1C >8 %
- •No diabetes
- •No A1C or recent A1C <8%
结局指标
主要结局
For Phase I of the Study: Metrics Used to Understand Diabetes Control
时间窗: 4 months
Identification of common factors patients use to understand their diabetes and diabetes control via a qualitative analysis of the patient interview responses
For Phase II of the Study: Change in Hemoglobin A1C
时间窗: 6 months following enrollment
Change in A1C between enrollment and 6-months compared between study arms.
次要结局
- For Phase II of the Study: Understanding of diabetes control(At the time of enrollment)
- For Phase I of the study: Feedback on alternative formats(4 months)
研究者
Anjali Gopalan
Robert Wood Johnson Clinical Scholar
University of Pennsylvania
