Equitable Implementation of Cascade Screening for Familial Hypercholesterolemia

Completed

• Conditions: Familial Hypercholesterolemia
• Interventions: Other: Cascade Screening

• 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

Arm && Interventions

Group	Intervention	Description
Family Heart Foundation-mediated implementation strategy	Cascade Screening	The Family Heart Foundation (FHF)-mediated implementation strategy will be designed and then iterated upon during mini-pilots. As part of this strategy, the patient would be contacted by a FHF patient navigator. The patient navigator would ask to set up a time to talk to the patient to talk about options for contacting family members, introduce them to the services they can provide to the patient and/or family members and obtain some details about the patient's family. The patient would come up with a plan to either contact their family members directly or have the patient navigator contact them. Family members will be offered FH screening at no cost by blood lipid panel. The patient and/or family members will be able to contact the patient navigator at any time with questions.
Penn-mediated implementation strategy	Cascade Screening	The Penn-mediated implementation strategy will be designed and then iterated upon during mini-pilots. As part of this strategy, the patients would receive text messages and/or emails containing information about FH and cascade screening from Penn Medicine. This would include a request for the patient to identify first-degree biological relatives. They would be given a choice of either contacting their family members directly or sharing their contact information so someone from Penn Medicine can contact them. If the proband chooses to contact their family members, they receive educational information to share with them. Family members would be offered FH screening at no cost by blood lipid panel.

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