Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH)
- Conditions
- Familial Hypercholesterolemia
- Interventions
- Behavioral: FH diagnosis program
- Registration Number
- NCT05284513
- Lead Sponsor
- Geisinger Clinic
- Brief Summary
Diagnosis rates of familial hypercholesterolemia (FH) are low in the United States, despite multiple guidelines and recommendations for screening and treatment of high cholesterol, to prevent heart attacks in those affected. Using a stepped-wedge design, the investigators plan to utilize tools from implementation science to improve uptake, acceptability, and sustainability of FH diagnostic programs in primary care settings. If successful, this study will provide tools generalizable to other health care systems to improve FH diagnosis rates.
- Detailed Description
Familial hypercholesterolemia (FH) is a common genetic disorder (prevalence 1 in 250) that requires lifelong sustained medical care. Evidence-based guidelines for screening and treatment for FH exist. These include universal screening of children ages 9-11, of adolescents ages 18-20, and of adults ages 40 and above; approved diagnostic tools including lipid panels and genetic testing; and recommendations for initiation of lipid lowering medication. FH diagnosis is currently made too late in life, often after a premature heart attack has occurred creating a care gap that results in excess cardiovascular morbidity and mortality. Diagnosing FH in the primary care setting would optimize treatment for individuals with FH and close this care gap. Utilizing tools from implementation science and human centered design, and by considering uptake, acceptability, and sustainability of programs related to FH care should improve earlier diagnosis. Implementation strategies that include insights from patients, clinicians, and healthcare systems are necessary. The long-term goal is to create an effective FH diagnosis program that is practical and sustainable in the real-world setting. The main objective of this project is to determine the uptake of an FH diagnosis program integrated into primary care practices to promote early identification of adult and pediatric patients that is generalizable to other healthcare settings. The research question is, does using a multi-level implementation strategy package, designed to address the specific needs of patients, clinicians, and healthcare systems, improve the diagnosis and activation of care management for individuals with FH. The specific aims are to: 1) to design a clinical trial to assess multi-level implementation strategies for improving FH diagnosis in an integrated health system, 2) compare FH diagnosis rates among primary care clinicians who receive the implementation strategy package versus those who do not, 3) to measure implementation success of an organized FH diagnosis program, and 4) to explore patient-related service and health outcomes related to an FH diagnosis program.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 532
- Primary care clinicians (pediatrician, community medicine, internal medicine) in the Geisinger Healthcare System
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 2 FH diagnosis program Phased rollout to clinic sites across the the Geisinger system using stepped wedge design Phase 4 FH diagnosis program Phased rollout to clinic sites across the the Geisinger system using stepped wedge design Phase 5 FH diagnosis program Phased rollout to clinic sites across the the Geisinger system using stepped wedge design Phase 1 FH diagnosis program Phased rollout to clinic sites across the the Geisinger system using stepped wedge design Phase 3 FH diagnosis program Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
- Primary Outcome Measures
Name Time Method Acceptability (Aim 3) Month 9, 12, 18, 24, 30, 36, 42 Clinician and patient satisfaction and self-efficacy with the FH diagnosis program
Timeliness (Aim 4) Up to 45 months Time to FH screen, time to diagnostic evaluation, time to statin initiation
FH diagnosis rate (Aim 2) Up to 45 months FH diagnosis rate, is achieving both the scheduling of a clinic visit and evidence the clinician, at that visit, has completed evidence-based FH diagnostic evaluation, defined as completing one of: using the FH clinic note to document care, adding FH diagnosis on the problem list, using the FH smart-set (or ordered a genetic test for FH), making a referral to the lipid clinic, or starting a statin for an evidence-based indication
- Secondary Outcome Measures
Name Time Method Problem list diagnosis of FH (Aim 2) Up to 45 months Clinician adds diagnosis of FH to the patients problem list in the electronic health record
Fidelity (Aim 3) Up to 45 months Documentation of adaptations to the FH diagnosis program
Cost (Aim 3) Up to 45 months Cost to implement the implementation strategy package
Initiation medication use (Aim 2) Up to 45 months Initiation of lipid lowering medication by healthcare clinician
Function (Aim 4) Up to 45 months Patient side effects to medications
Lipid measurement (Aim 2) Up to 45 months Order of a lipid panel
Genetic testing (Aim 2) Month 9, 12, 18, 24, 30, 36, 42 Order of a genetic test for FH
FH smartset (Aim 2) Month 9, 12, 18, 24, 30, 36, 42 Clinician uses and completes all field of the FH smartset
Best Practice Alert (Aim 2) Up to 45 months Clinician adheres to and acts on recommendation in the Best Practice Alert
FH Clinic Note (Aim 2) Up to 45 months Clinician completes the FH clinic note
Trial Locations
- Locations (1)
Geisinger Clinic
🇺🇸Multiple Locations, Pennsylvania, United States