Pilot Trial of a Risk-informed Shared-decision Engagement Strategy
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Presence of a DPP referral or new metformin prescription
概览
简要总结
The goal of this clinical trial is to learn if knowing risk for diabetes can help adult patients with prediabetes take steps to get care and prevent diabetes. The main questions it aims to answer are:
- Does a shared-decision making visit with a health care team member to talk about the participant's diabetes risk increase participants' taking steps to prevent diabetes?
- Does a simple message in the patient portal about the participant's diabetes risk increase participants' taking steps to prevent diabetes?
Researchers will compare the visit with usual care at the clinic to see if the visit increases participants' taking steps to prevent diabetes. Separately, the researchers will compare the patient message with usual care at the clinic to see if the message increases participants' taking steps to prevent diabetes.
Participants will:
- Complete surveys at the beginning of the study and up to 2 additional surveys
- If the participant falls into the shared decision-making group, the participant will have one 30-minute visit with a healthcare team member to talk about risk of diabetes and how to lower it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •prediabetes based on most recent HbA1c (5.7-6.4%) or fasting plasma glucose (100-125 mg/dL) in prior 12 months
- •active patient portal account (MyChart)
- •patient receiving primary care at Johns Hopkins Community Physicians in Frederick
- •have overweight or obesity (BMI ≥ 25 kg/m2)
排除标准
- •have diabetes (HbA1c \> 6.4% in prior 6 months or on diabetes registry)
- •have dementia
- •previously participated in the Diabetes Prevention Program (DPP)
研究组 & 干预措施
Risk-Informed Shared Decision-Making Engagement Strategy
Participants will have one visit with a healthcare team member to talk about the participant's risk of diabetes and how to lower it.
干预措施: Risk Informed Shared Decision-Making Strategy (RISE) (Other)
Low Touch Messaging Strategy
Participants receive a simple message in the patient portal describing the participant's level of risk of diabetes and tips on how to lower the risk
干预措施: Low Touch Messaging Strategy (LTM) (Other)
Usual Care
Participants will continue with usual care at the clinic
结局指标
主要结局
Presence of a DPP referral or new metformin prescription
时间窗: From randomization to 3 months after randomization
Prediabetes treatment uptake - Presence of a DPP referral or new metformin prescription based on electronic health record data
次要结局
- Proportion of patients enrolled in the DPP(Referral to 6 months after DPP referral)
- Proportion of patients who complete ≥ 9 months of the DPP(From enrollment to 12 months of follow-up)
- Weight change (kg)(From enrollment to 12 months)
- Metformin adherence(From enrollment to 12 months)
- Hemoglobin A1c change(From enrollment to 12 months)
- Patient Activation Measure(From enrollment to 3 months and from enrollment to 12 months)