Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH)

Familial Hypercholesterolemia Clinical Trial

— CARE-FH  

Official title:

Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05284513
• Other study ID #: 2021-0927
• Secondary ID: 1R61HL161775
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 9, 2022
• Est. completion date: January 2027

Study information

• Verified date: November 2023
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 532
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Years and older

Eligibility

Inclusion Criteria:

• Primary care clinicians (pediatrician, community medicine, internal medicine) in the Geisinger Healthcare System

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Behavioral:
• FH diagnosis program
Uptake of screening, diagnosis, and initiation of care management for FH
• Implementation strategy package: Develop and implement tools for quality monitoring
EHR tools to order labs, record results, and document FH care
• Implementation strategy package: Develop educational materials
Education regarding guidelines for identification and treatment of FH
• Implementation strategy package: Conduct educational outreach visits
Continuing medical education (CME) material for FH that is presented to
• Implementation strategy package: Intervene with clinicians and patients to enhance
Notify patients simultaneously with clinicians about the need for screening
• Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions
Clinical lipid champions
• Implementation strategy package: Audit and provide feedback
Provide aggregate level feedback to clinics on diagnosing FH
• Implementation strategy package: Stage implementation scale up
Develop the timeline for the stepped-wedge rollout to primary care

Locations

Country	Name	City	State
United States	Geisinger Clinic	Multiple Locations	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Geisinger Clinic	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FH diagnosis rate (Aim 2)	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	Up to 45 months
Primary	Acceptability (Aim 3)	Clinician and patient satisfaction and self-efficacy with the FH diagnosis program	Month 9, 12, 18, 24, 30, 36, 42
Primary	Timeliness (Aim 4)	Time to FH screen, time to diagnostic evaluation, time to statin initiation	Up to 45 months
Secondary	Initiation medication use (Aim 2)	Initiation of lipid lowering medication by healthcare clinician	Up to 45 months
Secondary	Lipid measurement (Aim 2)	Order of a lipid panel	Up to 45 months
Secondary	Genetic testing (Aim 2)	Order of a genetic test for FH	Month 9, 12, 18, 24, 30, 36, 42
Secondary	Problem list diagnosis of FH (Aim 2)	Clinician adds diagnosis of FH to the patients problem list in the electronic health record	Up to 45 months
Secondary	FH smartset (Aim 2)	Clinician uses and completes all field of the FH smartset	Month 9, 12, 18, 24, 30, 36, 42
Secondary	Best Practice Alert (Aim 2)	Clinician adheres to and acts on recommendation in the Best Practice Alert	Up to 45 months
Secondary	FH Clinic Note (Aim 2)	Clinician completes the FH clinic note	Up to 45 months
Secondary	Fidelity (Aim 3)	Documentation of adaptations to the FH diagnosis program	Up to 45 months
Secondary	Cost (Aim 3)	Cost to implement the implementation strategy package	Up to 45 months
Secondary	Function (Aim 4)	Return of genetic result to patient (if ordered and patient undergoes testing)	Up to 45 months
Secondary	Function (Aim 4)	Reduction in lipid level from baseline to end of the study period	Up to 45 months
Secondary	Function (Aim 4)	Patient side effects to medications	Up to 45 months