TY - JOUR
T1 - Effectiveness of the Family Heart Talk Communication Tool in Improving Family Member Screening for Dilated Cardiomyopathy
T2 - Results of a Randomized Trial
AU - Kinnamon, Daniel D.
AU - Jordan, Elizabeth
AU - Haas, Garrie J.
AU - Hofmeyer, Mark
AU - Kransdorf, Evan
AU - Ewald, Gregory A.
AU - Morris, Alanna A.
AU - Owens, Anjali
AU - Lowes, Brian
AU - Stoller, Douglas
AU - Tang, W. H.Wilson
AU - Garg, Sonia
AU - Trachtenberg, Barry H.
AU - Shah, Palak
AU - Pamboukian, Salpy V.
AU - Sweitzer, Nancy K.
AU - Wheeler, Matthew T.
AU - Wilcox, Jane E.
AU - Katz, Stuart
AU - Pan, Stephen
AU - Jimenez, Javier
AU - Aaronson, Keith D.
AU - Fishbein, Daniel P.
AU - Smart, Frank
AU - Wang, Jessica
AU - Gottlieb, Stephen S.
AU - Judge, Daniel P.
AU - Moore, Charles K.
AU - Mead, Jonathan O.
AU - Huggins, Gordon S.
AU - Ni, Hanyu
AU - Burke, Wylie
AU - Hershberger, Ray E.
N1 - Funding Information:
Research reported in this publication was supported by a parent award from the National Heart, Lung, and Blood Institute of the NIH under award R01HL128857 to Dr Hershberger, which included a supplement from the National Human Genome Research Institute. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Funding Information:
The investigators thank the families with DCM who participated in this study, without whom this effort would not be possible. The investigators acknowledge the support of the National Institutes of Health (NIH) program personnel who provided oversight to this study: Patrice Desvigne-Nickens, MD, James Troendle, PhD, Yi-Ping Fu, PhD, from the National Heart, Lung, and Blood Institute, and Lucia Hindorff, PhD, from the National Human Genome Research Institute. These NIH personnel received no direct support from the R01 award noted below. The DCM Precision Medicine Study was supported by computational infrastructure provided by the Ohio State University Division of Human Genetics Data Management Platform and the Ohio Supercomputer Center.
Publisher Copyright:
© 2023 Lippincott Williams and Wilkins. All rights reserved.
PY - 2023/4/25
Y1 - 2023/4/25
N2 - Background: Managing disease risk among first-degree relatives of probands diagnosed with a heritable disease is central to precision medicine. A critical component is often clinical screening, which is particularly important for conditions like dilated cardiomyopathy (DCM) that remain asymptomatic until severe disease develops. Nonetheless, probands are frequently ill-equipped to disseminate genetic risk information that motivates at-risk relatives to complete recommended clinical screening. An easily implemented remedy for this key issue has been elusive. Methods: The DCM Precision Medicine Study developed Family Heart Talk, a booklet designed to help probands with DCM communicate genetic risk and the need for cardiovascular screening to their relatives. The effectiveness of the Family Heart Talk booklet in increasing cardiovascular clinical screening uptake among first-degree relatives was assessed in a multicenter, open-label, cluster-randomized, controlled trial. The primary outcome measured in eligible first-degree relatives was completion of screening initiated within 12 months after proband enrollment. Because probands randomized to the intervention received the booklet at the enrollment visit, eligible first-degree relatives were limited to those who were alive the day after proband enrollment and not enrolled on the same day as the proband. Results: Between June 2016 and March 2020, 1241 probands were randomized (1:1) to receive Family Heart Talk (n=621) or not (n=620) within strata defined by site and self-identified race/ethnicity (non-Hispanic Black, non-Hispanic White, or Hispanic). Final analyses included 550 families (n=2230 eligible first-degree relatives) in the Family Heart Talk arm and 561 (n=2416) in the control arm. A higher percentage of eligible first-degree relatives completed screening in the Family Heart Talk arm (19.5% versus 16.0%), and the odds of screening completion among these first-degree relatives were higher in the Family Heart Talk arm after adjustment for proband randomization stratum, sex, and age quartile (odds ratio, 1.30 [1-sided 95% CI, 1.08-∞]). A prespecified subgroup analysis did not find evidence of heterogeneity in the adjusted intervention odds ratio across race/ethnicity strata (P=0.90). Conclusions: Family Heart Talk, a booklet that can be provided to patients with DCM by clinicians with minimal additional time investment, was effective in increasing cardiovascular clinical screening among first-degree relatives of these patients. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03037632.
AB - Background: Managing disease risk among first-degree relatives of probands diagnosed with a heritable disease is central to precision medicine. A critical component is often clinical screening, which is particularly important for conditions like dilated cardiomyopathy (DCM) that remain asymptomatic until severe disease develops. Nonetheless, probands are frequently ill-equipped to disseminate genetic risk information that motivates at-risk relatives to complete recommended clinical screening. An easily implemented remedy for this key issue has been elusive. Methods: The DCM Precision Medicine Study developed Family Heart Talk, a booklet designed to help probands with DCM communicate genetic risk and the need for cardiovascular screening to their relatives. The effectiveness of the Family Heart Talk booklet in increasing cardiovascular clinical screening uptake among first-degree relatives was assessed in a multicenter, open-label, cluster-randomized, controlled trial. The primary outcome measured in eligible first-degree relatives was completion of screening initiated within 12 months after proband enrollment. Because probands randomized to the intervention received the booklet at the enrollment visit, eligible first-degree relatives were limited to those who were alive the day after proband enrollment and not enrolled on the same day as the proband. Results: Between June 2016 and March 2020, 1241 probands were randomized (1:1) to receive Family Heart Talk (n=621) or not (n=620) within strata defined by site and self-identified race/ethnicity (non-Hispanic Black, non-Hispanic White, or Hispanic). Final analyses included 550 families (n=2230 eligible first-degree relatives) in the Family Heart Talk arm and 561 (n=2416) in the control arm. A higher percentage of eligible first-degree relatives completed screening in the Family Heart Talk arm (19.5% versus 16.0%), and the odds of screening completion among these first-degree relatives were higher in the Family Heart Talk arm after adjustment for proband randomization stratum, sex, and age quartile (odds ratio, 1.30 [1-sided 95% CI, 1.08-∞]). A prespecified subgroup analysis did not find evidence of heterogeneity in the adjusted intervention odds ratio across race/ethnicity strata (P=0.90). Conclusions: Family Heart Talk, a booklet that can be provided to patients with DCM by clinicians with minimal additional time investment, was effective in increasing cardiovascular clinical screening among first-degree relatives of these patients. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03037632.
KW - cardiomyopathy
KW - dilated
KW - health communication
KW - randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85153803573&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85153803573&partnerID=8YFLogxK
U2 - 10.1161/CIRCULATIONAHA.122.062507
DO - 10.1161/CIRCULATIONAHA.122.062507
M3 - Article
C2 - 36938756
AN - SCOPUS:85153803573
SN - 0009-7322
VL - 147
SP - 1281
EP - 1290
JO - Circulation
JF - Circulation
IS - 17
ER -