Collaborative Approach to Reach Everyone with Familial Hypercholesterolemia: CARE-FH Protocol

Abstract

The Collaborative Approach to Reach Everyone with Familial Hypercholesterolemia (CARE-FH) study aims to improve diagnostic evaluation rates for FH at Geisinger, an integrated health delivery system. This clinical trial relies upon implementation science to transition the initial evaluation for FH into primary care, attempting to identify individuals prior to the onset of athero-sclerotic cardiovascular disease events. This paper provides the protocol for the CARE-FH study (Registered with ClinicalTrials.gov, number NCT05284513). The first phase of the project focuses on trial design, including the development of implementation strategies to deploy evidence-based guidelines. The second phase will study the intervention, rolled out regionally to internal medicine, community medicine, and pediatric care clinicians using a stepped-wedge design, and analyzing data on diagnostic evaluation rates, and implementation, service, and health outcomes.