Improving Diagnosis and Clinical Management of Familial Hypercholesterolemia Through Integrated Machine Learning, Implementation Science, and Behavioral Economics
概览
- 阶段
- 不适用
- 干预措施
- Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluation
- 疾病 / 适应症
- Familial Hypercholesterolemia
- 发起方
- University of Pennsylvania
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- Proportion of flagged patients diagnosed with FH (familial hypercholesterolemia) as a result of the intervention
- 状态
- Enrolling By Invitation
- 最后更新
- 上个月
概览
简要总结
The goal of this study is to identify individuals at high risk of FH, and to encourage the appropriate diagnosis and treatment of individuals at high risk of FH through the use of implementation science and behavioral economics principles.
Phase 1: Applying the FIND FH tool to the health system EHR and gathering data for pilot development; Phase 2: Pilot development and implementation; Phase 3: Conduct a large-scale pragmatic trial consistent with recommendations and learnings from the pilots in Phase 2
详细描述
Phase 1: Aim 1: Adjusting and refining the application of the FIND FH tool to the UPHS EHR database Aim 2: Identifying the barriers and facilitators to making a diagnosis of FH and initiating or intensifying therapy for individuals with FH through qualitative interviews with clinicians and patients and creating a behavioral roadmap to inform the implementation approaches to test in the pilots Phase 2: Aim 1: Co-design implementation strategies using behavioral economics in partnership with the Family Heart Foundation Aim 2: Pilot implementation strategies with an enrollment goal of 80 patients total (40 per pilot) who have been flagged by the FIND FH tool as having probable FH to ascertain feasibility, acceptability, and appropriateness Phase 3: Conduct a large-scale pragmatic trial consistent with recommendations and learnings from the pilots in Phase 2
研究者
入排标准
入选标准
- •Must be a patient at Penn Medicine
- •Must have been flagged by the FIND FH tool as having a high probability of FH
- •First language is English
- •Resides in PA or NJ
排除标准
- •Already have been clinically diagnosed with FH using the proper ICD-10 code
- •Currently see a lipid specialist at Penn Medicine
- •Pass study clinician's Study Validity Check
研究组 & 干预措施
Patients without a primary care physician within the UPHS health system
Patients without a primary care physician within the UPHS health system will receive direct outreach from the study team to invite them to schedule a visit with a lipid specialist for a formal evaluation of FH.
干预措施: Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluation
Patients with a primary care physician within the UPHS health system
For patients with a primary care physician within the UPHS health system, their primary care physicians will be asked to review and sign physician referrals to a lipid specialist and invite patients to schedule a visit with a lipid specialist for a formal evaluation of FH.
干预措施: Testing centralized referral mechanism for PCPs
Patients with a primary care physician within the UPHS health system
For patients with a primary care physician within the UPHS health system, their primary care physicians will be asked to review and sign physician referrals to a lipid specialist and invite patients to schedule a visit with a lipid specialist for a formal evaluation of FH.
干预措施: Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluation
结局指标
主要结局
Proportion of flagged patients diagnosed with FH (familial hypercholesterolemia) as a result of the intervention
时间窗: Day 1 - post intervention study visit
Patients will be evaluated for familial hypercholesterolemia (FH), an underdiagnosed genetic type of high cholesterol. An FH diagnosis will be defined using the Dutch Lipid Clinic Network Diagnostic (DLCN) Criteria for FH (Unlikely, Possible, Probable, Definite). The clinician will also make a clinical assessment of FH informed by the DLCN score and clinical expertise from the appointment.
次要结局
- Proportion of patients that have a change to their lipid management because of the intervention(Day 1 - post intervention study visit)
- Proportion of patients that have a change to their lipid management among patients that were candidates for a change to their lipid management because of the intervention(Day 1 - post intervention study visit)