Personalized Disease Prevention (PDP): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 660
- 试验地点
- 2
- 主要终点
- Change in quality-adjusted life expectancy
研究概览
简要总结
This study will evaluate whether patients and their providers benefit from an evidence-based decision tool to help prioritize preventive (and select chronic disease management) services based on their potential to improve quality-adjusted life expectancy, individualized for patient risk factors. The study seeks to enroll 600 patients and 60 primary care providers. Half of providers will be assigned to an intervention to utilize the decision tool with approximately 10 high-priority patients each (patients of particular interest to the research study, on whom follow-up outcomes will be collected), and half will be assigned to usual care.
Surveys will be administered at baseline and approximately 6 months later; electronic health records data on preventive service utilization will be collected; and optional qualitative interviews may be conducted.
详细描述
The study will evaluate whether patients and their providers benefit from an evidence-based decision tool to help prioritize preventive services based on their potential to improve quality-adjusted life expectancy, individualized for patient risk factors. This partially-blinded study seeks to enroll 600 patients and 60 primary care providers. Half of providers will be assigned to an intervention to utilize the decision tool with approximately 10 high-priority patients each (patients of particular interest to the research study, on whom follow-up outcomes will be collected) and half will be assigned to usual care. It is hypothesized that quality-adjusted life expectancy will increase by more in high-priority patients who receive the intervention, as compared with a control group.
Objectives:
Primary objective: To measure whether use of individualized preventive care recommendations is likely to help patients live a longer, healthier life.
Secondary objectives:
- To measure whether use of individualized preventive care recommendations is likely to help patients live a longer life
- To assess comprehension of the decision tool
- To assess readiness to change
- To assess use of shared decision-making
- To measure outcomes for specific preventive services
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 (Investigator)
盲法说明
With the exception of the study biostatistician(s) and a safety assessor(s), all Co-Investigators participating in the randomized trial will be blinded to outcomes and safety events by study arm.
The nature of the randomized trial requires interaction with participants throughout the study (e.g., ongoing feedback from intervention arm providers, qualitative interviews with patients and providers), the assignment of participants to the intervention vs. control arm will be unblinded for the entire study team. Only the stratification of outcomes and safety events by study arm will be blinded.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in quality-adjusted life expectancy
时间窗: 6 months
Change in quality-adjusted life expectancy for high-priority patients in the intervention arm, as compared with the control arm.
次要结局
- Change in life expectancy(Through study completion, approximately 2 to 3 years on average)
- Service least likely to improve quality-adjusted life expectancy(Within 3 business days of baseline encounter)
- Weight loss(6 months (12 months and all follow-up time points may be assessed))
- Systolic blood pressure(6 months (12 months and all follow-up time points may be assessed))
- Shared decision-making(Within 3 business days of baseline encounter)
- Service most likely to improve quality-adjusted life expectancy(Within 3 business days of baseline encounter)
- True age(Within 3 business days of baseline encounter)
- Readiness to change (bottom-ranked)(Within 3 business days of baseline encounter)
- Change in quality-adjusted life expectancy(Through study completion, approximately 2 to 3 years on average)
- Readiness to change (top-ranked)(Within 3 business days of baseline encounter)
- HbA1c(6 months (12 months and all follow-up time points may be assessed))
- Cardiovascular disease risk(6 months (12 months and all follow-up time points may be assessed))
- Healthy diet(6 months (12 months and all follow-up time points may be assessed))
- Breast cancer screening(6 months (12 months and all follow-up time points may be assessed))
- LDL cholesterol(6 months (12 months and all follow-up time points may be assessed))
- Physical activity(6 months (12 months and all follow-up time points may be assessed))
- Alcohol misuse(6 months (12 months and all follow-up time points may be assessed))
- Tobacco cessation(6 months (12 months and all follow-up time points may be assessed))
- Cervical cancer screening(6 months (12 months and all follow-up time points may be assessed))
- Colorectal cancer screening(6 months (12 months and all follow-up time points may be assessed))
- Lung cancer screening(6 months (12 months and all follow-up time points may be assessed))
- Total cholesterol(6 months (12 months and all follow-up time points may be assessed))
研究者
Glen Taksler
Staff, Cleveland Clinic and Associate Professor of Medicine, Cleveland Clinic Lerner College of Medicine
The Cleveland Clinic