Personalized Disease Prevention (PDP): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 721
- 试验地点
- 1
- 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
- •Provider eligibility criteria. Any attending physician, nurse practitioner or physician assistant practicing in internal medicine or family medicine.
- •Patient eligibility criteria. This study define 2 types of patients, "eligible" patients and "high-priority" patients. "Eligible" patients are a broadly-defined group of patients of the intervention arm providers, for whom the providers will be able to access individualized preventive care recommendations. Eligible patients are subject to a waiver of informed consent. "High-priority" patients are a more narrowly-defined subset of eligible patients, who will be contacted by the study team for follow-up.
- •Eligible patients will have the following inclusion criteria:
- •A provider assigned to the intervention arm of the RCT is the patient's primary care physician (PCP) of record in the EHR.
- •Aged 40-75 years.
- •High-priority patients are defined as eligible patients who also meet all of the following inclusion criteria:
- •A modifiable lifestyle factor with a large impact on quality-adjusted life expectancy, assessed by ≥1 of the following:
- •current smoker
- •BMI ≥30.0 kg/m^2
- •BP ≥140/90 mmHg
- •10-year ASCVD risk ≥10%
- •alcohol/week >4.2 oz (98 g) for female or >8.4 oz (196 g) for male
- •Eligible for a high number of preventive services, assessed by ≥3 of the following. Factor(s) used to satisfy criteria 1 also count toward satisfying criteria 2:
- •current smoker
- •BMI ≥27.0 kg/m^2
- •systolic BP >130 mmHg
- •10-year ASCVD risk ≥7.5%
- •HbA1c ≥7.5%
- •alcohol/week >4.2 oz (98 g) for female or >8.4 oz (196 g) for male
- •Overdue or due soon for colorectal cancer screening, as of date that study team confirms "high-priority" eligibility criteria
- •Overdue or due soon for lung cancer screening, as of date that study team confirms "high-priority" eligibility criteria
- •Overdue for breast cancer screening for ≥1 year, as of date that study team confirms "high-priority" eligibility criteria
- •Overdue for osteoporosis screening for ≥1 year, as of date that study team confirms "high-priority" eligibility criteria
- •Ongoing primary care in the health system, defined as ≥2 visits with a primary care provider in the prior 730 days.
- •The term "primary care provider" is defined as an attending physician, nurse practitioner or physician assistant in the Department of Internal Medicine or Department of Family Medicine with an established patient panel.
- •The term "visit" is defined as an in-person or virtual visit encounter.
- •An eligible encounter with the patient's primary care physician (PCP) of record in the EHR. "Eligible encounter" is defined as follows:
- •An annual wellness visit (sometimes called a physical) with scheduled length of 40 minutes, or for some practice sites or departments, 30 minutes. These encounters typically focus on preventive care and are more likely to allow enough time to engage in shared decision-making.
- •For patients without an annual wellness visit in the prior 2 years, a visit with scheduled length at least 30 minutes, or a shorter length directly related to at least one service relevant to the research study (e.g., the EHR notes field indicates that a patient is scheduled for a follow-up of hypertension).
- •Eligible patients have the following
排除标准
- •, defined as ≥1 of the following:
- •Cancer in the past 3 years (other than non-melanoma skin)
- •Diagnosis of alcohol abuse in past 3 years
- •History of myocardial infarction
- •History of stroke
- •End-stage renal disease
- •Moderate-severe congestive heart failure (moderate-severe may be ignored if needed to facilitate automatic data extraction)
- •Moderate-severe chronic obstructive pulmonary disease (moderate-severe may be ignored if needed to facilitate automatic data extraction)
- •Other comorbidity with limited life expectancy, in the opinion of ≥2 members of the study team.
- •Inability to communicate or limited communication (speaking, reading, writing) in the English language.
- •In addition to the above, high-priority eligible patients also have the following exclusion criteria, defined as ≥1 of the following:
- •Known current pregnancy.
- •Known acute care need that is likely to limit time available for discussion of preventive care.
- •The first primary care encounter since a hospitalization, surgery or emergency department utilization.
- •There will be no exclusion from the study on the basis of race or ethnicity.
研究组 & 干预措施
Usual care
Control arm: Participants will not receive individualized preventive care recommendations (decision tool).
Individualized preventive care recommendations (decision tool)
Intervention arm: Providers will receive individualized preventive care recommendations (decision tool) for eligible patients, and discuss them with patients using shared decision-making.
干预措施: Individualized preventive care recommendations (decision tool) (Behavioral)
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
- 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)
- HbA1c(6 months (12 months and all follow-up time points may be assessed))
- 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))
- Readiness to change (bottom-ranked)(Within 3 business days of baseline encounter)
- Shared decision-making(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)
- 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))
- Change in quality-adjusted life expectancy(12 months)
- Change in life expectancy(6 months)
- Change in life expectancy(12 months)
研究者
Glen Taksler
Staff
The Cleveland Clinic