Clinical trial NCT05430191: Equitable Implementation of Cascade Screening for Familial Hypercholesterolemia
Official title: Leveraging Behavioral Economics to Equitably Implement Cascade Screening in Individuals With Familial Hypercholesterolemia in Partnership With the Family Heart Foundation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Familial Hypercholesterolemia
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Family Heart Foundation
name: University of Pennsylvania
First posted: 2022-06-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Aim 1 (Interviews). We will conduct interviews with 15 patients with high cholesterol and/or FH to understand barriers and facilitators to cascade screening. 17 clinicians are being interviewed through our sister protocol in an effort to reduce interview burden on clinicians. Duration of participation will last the length of one qualitative interview.

Aim 2 (Pilot Testing Strategies). Participants will include 20 patients with high cholesterol and/or FH. At least half will identify as racial and/or ethnic minorities (i.e., Black or African American, Asian), female, and/or have low income. Patients will be randomized to receive the Penn- or FHF-mediated strategy. Duration of participation will last up to 3 months for each participant.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Aim 1 Qualitative Interview Outcome: Perspectives on cascade screening
timeFrame: 1-time interview to last 1 hour
measure: Aim 2 Mini-Pilot Outcome: Engagement
timeFrame: 3 months
measure: Aim 2 Mini-Pilot Outcome: Reach
timeFrame: 3 months
measure: Aim 2 Mini-Pilot Outcome: Perspectives on implementation strategies
timeFrame: 1-time interview to last approximately 15-30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania, Perelman School of Medicine
state: Pennsylvania
Study officials:
References: