Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FH diagnosis program, Implementation strategy package: Develop and implement tools for quality monitoring, Implementation strategy package: Develop educational materials, Implementation strategy package: Conduct educational outreach visits.
- Who it may be relevant to
- Registry conditions: Familial Hypercholesterolemia. Basic parameters: from 26 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral FH diagnosis program
Uptake of screening, diagnosis, and initiation of care management for FH - Behavioral Implementation strategy package: Develop and implement tools for quality monitoring
EHR tools to order labs, record results, and document FH care - Behavioral Implementation strategy package: Develop educational materials
Education regarding guidelines for identification and treatment of FH - Behavioral Implementation strategy package: Conduct educational outreach visits
Continuing medical education (CME) material for FH that is presented to - Behavioral Implementation strategy package: Intervene with clinicians and patients to enhance
Notify patients simultaneously with clinicians about the need for screening - Behavioral Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions
Clinical lipid champions - Behavioral Implementation strategy package: Audit and provide feedback
Provide aggregate level feedback to clinics on diagnosing FH - Behavioral Implementation strategy package: Stage implementation scale up
Develop the timeline for the stepped-wedge rollout to primary care
Primary outcome measures
- FH diagnosis rate (Aim 2) [Time frame: Up to 45 months]
- Acceptability (Aim 3) [Time frame: Month 9, 12, 18, 24, 30, 36, 42]
- Timeliness (Aim 4) [Time frame: Up to 45 months]
Secondary outcome measures (12)
- Initiation medication use (Aim 2) [Time frame: Up to 45 months]
- Lipid measurement (Aim 2) [Time frame: Up to 45 months]
- Genetic testing (Aim 2) [Time frame: Month 9, 12, 18, 24, 30, 36, 42]
- Problem list diagnosis of FH (Aim 2) [Time frame: Up to 45 months]
- FH smartset (Aim 2) [Time frame: Month 9, 12, 18, 24, 30, 36, 42]
- Best Practice Alert (Aim 2) [Time frame: Up to 45 months]
- FH Clinic Note (Aim 2) [Time frame: Up to 45 months]
- Fidelity (Aim 3) [Time frame: Up to 45 months]
- Cost (Aim 3) [Time frame: Up to 45 months]
- Function (Aim 4) [Time frame: Up to 45 months]
- Function (Aim 4) [Time frame: Up to 45 months]
- Function (Aim 4) [Time frame: Up to 45 months]
Eligibility criteria
Inclusion criteria
- Primary care clinicians (pediatrician, community medicine, internal medicine) in the Geisinger Healthcare System
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Geisinger Clinic — Multiple Locations
Publications
- Jones LK, Romagnoli KM, Schubert TJ, Clegg K, Kirchner HL, Hu Y, Cawley D, Norelli V, Williams MS, Gidding SS, Rahm AK. Using implementation science to develop a familial hypercholesterolemia screening program in primary care: The CARE-FH study. J Clin Lipidol. 2024 Mar-Apr;18(2):e176-e188. doi: 10.1016/j.jacl.2024.01.001. Epub 2024 Jan 4. PMID 38228467
Identifiers
NCT: NCT05284513 · 2021-0927 · 1R61HL161775