Equitable Implementation of Cascade Screening for Familial Hypercholesterolemia

Northwestern University22 enrolled

Overview

Design, refine, and pilot the two implementation approaches using behavioral economics and then seek further feedback prior to the proposed clinical trial, consistent with these recommendations. Aim 1. Co-design both implementation strategies using behavioral economics in partnership with the Family Heart Foundation and key partners from diverse backgrounds. Aim 2. Pilot strategies with 20 patients with high cholesterol and/or with familial hypercholesterolemia (FH) to ascertain feasibility, acceptability, appropriateness.

Aim 1. Conduct interviews with patients with high cholesterol and/or FH and clinicians to identify common barriers and facilitators for individuals to engage in cascade screening. These activities will occur in the first 7 months and will serve as inputs into the design of the implementation strategies to ensure that strategies address determinants identified in the interviews. Aim 2. To maximize success, pilot test the implementation strategies and the planned data collection approaches.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Familial Hypercholesterolemia

Interventions

Cascade ScreeningOTHER

FH is a genetic condition that causes high LDL cholesterol starting at birth. When one individual with FH is diagnosed, it is important that biological family members are also screened, since there is a 50% chance that each first-degree relative will have also inherited FH. More distant relatives may also have inherited FH. This evidence-based process is known as cascade screening.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with high cholesterol and/or FH (i.e., probands; Aim 1 Interviews, Aim 2 Pilot Testing Strategies, Aim 2 Interviews). Adults aged 18 and older with clinically diagnosed FH and/or high cholesterol who are treated within Penn Medicine. * Family Members (Aim 2 Pilot Testing Strategies, Aim 2 Interviews). Adults aged 18 and older who have a family member who has been identified as a patient with high cholesterol and/or FH who is treated within Penn Medicine (i.e., family members of probands). Exclusion Criteria: \- none

Locations (1)

University of Pennsylvania, Perelman School of Medicine

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Aim 1 Qualitative Interview Outcome: Perspectives on cascade screening

We will learn about the perspectives on cascade screening from clinicians and patients with high cholesterol and/or FH (probands) via qualitative interview.

Time frame: 1-time interview to last 1 hour

Aim 2 Mini-Pilot Outcome: Engagement

We define engagement as the number of patients with FH and/or high cholesterol (probands) who respond to at least one outreach attempt.

Time frame: 3 months

Aim 2 Mini-Pilot Outcome: Reach

We define reach as the proportion of probands who have at least one family member who completes cascade screening.

Time frame: 3 months

Aim 2 Mini-Pilot Outcome: Perspectives on implementation strategies

We will learn about the perspectives on the implementation strategies (health system-mediated, Family Heart Foundation-mediated) - including their perceived acceptability, appropriateness, and feasibility - of patients with high cholesterol and/or FH (probands) and family members via qualitative interview.

Time frame: 1-time interview to last approximately 15-30 minutes

Data from ClinicalTrials.gov

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