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Clinical Trials/NCT05430191
NCT05430191
Completed
Not Applicable

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

Northwestern University1 site in 1 country22 target enrollmentJuly 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Familial Hypercholesterolemia
Sponsor
Northwestern University
Enrollment
22
Locations
1
Primary Endpoint
Aim 1 Qualitative Interview Outcome: Perspectives on cascade screening
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 20, 2022
End Date
June 20, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rinad Beidas

Ralph Seal Paffenbarger Professor and Chair, Department of Medical Social Sciences

Northwestern University

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

  • Not provided

Outcomes

Primary Outcomes

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.

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.

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.

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.

Study Sites (1)

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