Clinical trial NCT05284513: Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH)
Official title: Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Familial Hypercholesterolemia
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-03-17
Enrollment: 532
Sex: ALL
Minimum age (years): 26
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped-wedge design
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: FH diagnosis rate (Aim 2)
timeFrame: Up to 45 months
measure: Acceptability (Aim 3)
timeFrame: Month 9, 12, 18, 24, 30, 36, 42
measure: Timeliness (Aim 4)
timeFrame: Up to 45 months
Secondary outcomes:
measure: Initiation medication use (Aim 2)
timeFrame: Up to 45 months
measure: Lipid measurement (Aim 2)
timeFrame: Up to 45 months
measure: Genetic testing (Aim 2)
timeFrame: Month 9, 12, 18, 24, 30, 36, 42
measure: Problem list diagnosis of FH (Aim 2)
timeFrame: Up to 45 months
measure: FH smartset (Aim 2)
timeFrame: Month 9, 12, 18, 24, 30, 36, 42
measure: Best Practice Alert (Aim 2)
timeFrame: Up to 45 months
measure: FH Clinic Note (Aim 2)
timeFrame: Up to 45 months
measure: Fidelity (Aim 3)
timeFrame: Up to 45 months
measure: Cost (Aim 3)
timeFrame: Up to 45 months
measure: Function (Aim 4)
timeFrame: Up to 45 months
measure: Function (Aim 4)
timeFrame: Up to 45 months
measure: Function (Aim 4)
timeFrame: Up to 45 months
Other outcomes:
Locations:
city: Multiple Locations
country: United States
facility: Geisinger Clinic
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Laney K Jones, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Geisinger Clinic
name: Samuel S Gidding, MD
role: PRINCIPAL_INVESTIGATOR
References: