Equitable Implementation of Cascade Screening for Familial Hypercholesterolemia

Completed

• Conditions: Familial Hypercholesterolemia

• Registration Number: NCT05430191
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-24
• Study Start: 2022-07-20
• Primary Completion: 2023-06-20
• Study Completion: 2023-06-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aim 1 Qualitative Interview Outcome: Perspectives on cascade screening	1-time interview to last 1 hour	We will learn about the perspectives on cascade screening from clinicians and patients with high cholesterol and/or FH (probands) via qualitative interview.
Aim 2 Mini-Pilot Outcome: Reach	3 months	We define reach as the proportion of probands who have at least one family member who completes cascade screening.
Aim 2 Mini-Pilot Outcome: Engagement	3 months	We define engagement as the number of patients with FH and/or high cholesterol (probands) who respond to at least one outreach attempt.
Aim 2 Mini-Pilot Outcome: Perspectives on implementation strategies	1-time interview to last approximately 15-30 minutes	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.

Trial Locations

Locations (1)

University of Pennsylvania, Perelman School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States