Equitable Implementation of Cascade Screening for Familial Hypercholesterolemia

Familial Hypercholesterolemia Clinical Trial

Official title:

Leveraging Behavioral Economics to Equitably Implement Cascade Screening in Individuals With Familial Hypercholesterolemia in Partnership With the Family Heart Foundation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05430191
• Other study ID #: 851061
• Status: Completed
• Start date: July 20, 2022
• Est. completion date: June 20, 2023

Study information

• Verified date: September 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Other:
• Cascade Screening
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.

Locations

Country	Name	City	State
United States	University of Pennsylvania, Perelman School of Medicine	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	Family Heart Foundation, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1-time interview to last 1 hour
Primary	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.	3 months
Primary	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.	3 months
Primary	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.	1-time interview to last approximately 15-30 minutes