Northwestern University
The goal of this clinical trial is to test two implementation strategies (digital strategy vs. care navigator strategy) to promote family cascade screening for familial hypercholesterolemia (FH) in Penn Medicine patients diagnosed with FH ("probands"). The main questions this study aims to answer are: (1) evaluating the effect of the approaches on reach (proportion of probands who have at least one family member who completes screening), number of family members screened, proband engagement with the study, and proband LDL-C levels; and (2) use mixed methods to identify implementation strategy mechanisms. Participants (probands) will receive messaging that provides education about FH and provides instructions for participating in family cascade screening. A subset of participants will be invited to complete a qualitative interview about their experience receiving the implementation strategy. The research team will compare the arms to evaluate their effectiveness at promoting cascade screening.
The study will test two patient-facing implementation strategies to increase reach of cascade screening with FH probands within Penn Medicine via a 2-arm hybrid type III effectiveness-implementation randomized controlled trial (RCT). This pragmatic RCT will test (a) a digital strategy using automated text messages and emails and (b) a care navigator strategy. Both strategies were designed using insights from behavioral economics. Aim 1: Compare the effect of the study arms on implementation and effectiveness outcomes: reach (primary outcome), or proportion of probands who have at least one fa…
Inclusion Criteria (probands): * Current or recent Penn Medicine patient (i.e., had a visit with a Penn Medicine clinician in the past 2 years) * Age 18 or older * Clinically diagnosed FH * At least one contact method available in the electronic health record * Alive Exclusion criteria: * Participated in a prior FH cascade screening study at Penn Medicine * Does not positively confirm identity * Unreachable by mail, phone, text, and email (i.e., all messages undeliverable) * Those who self-report not having contact information for at least 1 living biological first-degree relative in the US…
FH is a genetic condition that causes very high LDL cholesterol. 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.
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