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Completed

NCT Number: NCT05430191

Equitable Implementation of Cascade Screening for Familial Hypercholesterolemia

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.

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Key information

Conditions

Familial Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania, Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cascade Screening

Other

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.

Primary outcomes

  1. Aim 1 Qualitative Interview Outcome: Perspectives on cascade screening

    Time frame: 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.

  2. Aim 2 Mini-Pilot Outcome: Engagement

    Time frame: 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.

  3. Aim 2 Mini-Pilot Outcome: Reach

    Time frame: 3 months

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

  4. Aim 2 Mini-Pilot Outcome: Perspectives on implementation strategies

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Family Heart Foundation
  • University of Pennsylvania

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 24, 2022
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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