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Eighty percent of people with FH are undiagnosed, particularly minoritized populations including Black or African American people, Asian or Asian American people, and women across racial groups. Family cascade screening is an evidence-based practice that can increase diagnosis and improve health outcomes but is rarely implemented in routine practice, representing an important care gap. In pilot work, we leveraged best practices from behavioral economics and implementation science\u2014including mixed-methods contextual inquiry with clinicians, patients, and health system constituents\u2014to co-design two patient-facing implementation strategies to address this care gap: (a) an automated health system-mediated strategy and (b) a nonprofit foundation-mediated strategy with contact from a foundation-employed care navigator. This trial will test the comparative effectiveness of these strategies on completion of cascade screening for relatives of individuals with FH, centering equitable reach.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We will conduct a hybrid effectiveness-implementation type III randomized controlled trial testing the comparative effectiveness of two strategies for implementing cascade screening with 220 individuals with FH (i.e., probands) per arm identified from a large northeastern health system. The primary implementation outcome is reach, or the proportion of probands with at least one first-degree biological relative (parent, sibling, child) in the USA who is screened for FH through the study. Our secondary implementation outcomes include the number of relatives screened and the number of relatives meeting the American Heart Association criteria for FH. Our secondary clinical effectiveness outcome is post-trial proband cholesterol level. We will also use mixed methods to identify implementation strategy mechanisms for implementation strategy effectiveness while centering equity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>We will test two patient-facing implementation strategies harnessing insights from behavioral economics that were developed collaboratively with constituents. This trial will improve our understanding of how to implement evidence-based cascade screening for FH, which implementation strategies work, for whom, and why. Learnings from this trial can be used to equitably scale cascade screening programs for FH nationally and inform cascade screening implementation efforts for other genetic disorders.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov, NCT05750667. Registered 15 February 2023\u2014retrospectively registered,\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT05750667\">https:\/\/clinicaltrials.gov\/study\/NCT05750667<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13012-024-01355-x","type":"journal-article","created":{"date-parts":[[2024,4,9]],"date-time":"2024-04-09T05:02:28Z","timestamp":1712638948000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Family cascade screening for equitable identification of familial hypercholesterolemia: study protocol for a hybrid effectiveness-implementation type III randomized controlled trial"],"prefix":"10.1186","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-1747-2999","authenticated-orcid":false,"given":"Christina","family":"Johnson","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3174-2552","authenticated-orcid":false,"given":"Jinbo","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5761-9267","authenticated-orcid":false,"given":"Mary P.","family":"McGowan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8098-1990","authenticated-orcid":false,"given":"Eric","family":"Tricou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Card","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy R.","family":"Pettit","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8718-5674","authenticated-orcid":false,"given":"Tamar","family":"Klaiman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9245-9876","authenticated-orcid":false,"given":"Daniel J.","family":"Rader","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3389-6707","authenticated-orcid":false,"given":"Kevin G.","family":"Volpp","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6056-6071","authenticated-orcid":false,"given":"Rinad S.","family":"Beidas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,4,9]]},"reference":[{"issue":"6568","key":"1355_CR1","doi-asserted-by":"publisher","first-page":"659","DOI":"10.1126\/science.abn0184","volume":"374","author":"EK Proctor","year":"2021","unstructured":"Proctor EK, Geng E. 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In compliance with National Institutes of Health requirements, the other participating institution (Northwestern University) has agreed to rely on a single IRB (sIRB). The University of Pennsylvania IRB is the designated sIRB. A reliance agreement was executed between the University of Pennsylvania IRB and Northwestern University IRB. The Family Heart Foundation does not have its own IRB, so the University of Pennsylvania IRB oversees study activities at the Family Heart Foundation. Informed consent will be obtained from: all participants who complete a lipid panel through the study; all legal guardians of relatives ages 2\u201317 who are interested in completing screening for the child; and all participants who complete qualitative interviews. Assent will be obtained from youth relatives (ages 7\u201317) whose legal guardians express interest in having them complete screening. Informed consent was waived by the IRB of record for probands for participation in cascade screening and assent was waived for relatives ages 2\u20136. Relatives who participate in the study but do not obtain a new lipid panel will receive an opt-out-framed, modified informed consent form.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare the following competing interests: DJR is the Chief Scientific Advisor and immediate past Chair of the Board at the Family Heart Foundation; and is on the Scientific Advisory Board of Alnylam Pharmaceuticals, Novartis, and Verve Therapeutics. He is a founder of VascularStrategies, and is a consultant for Regeneron Pharmaceuticals, Inc. KGV is a part-owner of VALHealth, a behavioral economics consulting firm, and receives research funding from Independence Blue Cross and research funding and consulting support from the American Heart Association, none of which are related to the work described in this manuscript.\u00a0RSB is the principal at Implementation Science & Practice, LLC. She receives royalties from Oxford University Press, consulting fees from United Behavioral Health and OptumLabs. She is currently an appointed member of the National Advisory Mental Health Council and the NASEM study, \"Blueprint for a national prevention infrastructure for behavioral health disorders,\" and serves on the advisory boards for AIM Youth Mental Health Foundation and the Klingenstein Third Generation Foundation outside of the submitted work. RSB is also an Associate Editor of Implementation Science and all decisions on the publication were made by other Senior Editors. The remaining authors (CJ, JC, MPM, ET, MC, ARP, TK) declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"30"}}