TY - JOUR
T1 - Trial design of the RICH LIFE Project
T2 - A cluster randomized pragmatic trial comparing the effectiveness of health system only vs health system plus a collaborative/stepped care intervention to reduce hypertension disparities
AU - RICH LIFE Project Investigators
AU - Cooper, Lisa A.
AU - Marsteller, Jill A.
AU - Carson, Kathryn A.
AU - Dietz, Katherine B.
AU - Boonyasai, Romsai T.
AU - Alvarez, Carmen
AU - Ibe, Chidinma A.
AU - Crews, Deidra C.
AU - Yeh, Hsin Chieh
AU - Miller, Edgar R.
AU - Dennison-Himmelfarb, Cheryl R.
AU - Lubomski, Lisa H.
AU - Purnell, Tanjala S.
AU - Hill-Briggs, Felicia
AU - Wang, Nae Yuh
N1 - Funding Information:
The RICH LIFE Project is funded by the National Heart, Lung, and Blood Institute , USA, and Patient-Centered Outcomes Research Institute , USA; grant number UH3HL130688 .
Funding Information:
Lastly, this study is funded by PCORI, administered through NHLBI, precluding us from conducting a cost-assessment or cost-effectiveness analysis. If this intervention is deemed to be effective, future research will incorporate such analyses.
Funding Information:
The investigators would like to acknowledge the following people and organizations for their contributions to patient recruitment, data collection, delivery of the study interventions, and operations of the study: Millie Aquino, Chara Bauer, Deven Brown, Tiffany Campbell, Lisa Carpenter, Maria Collazo, Stacye Cooper, Andria Coryatt, Cynthia Crandall, Keah Crosby, McKenzie Eakin, Dorethia Easley, Lia Escobar-Acosta, Sabrina Elias, Martha Franz, Kenya Ferguson, Minyun Fogg, Jennifer Halbert, Dairy Jennings, Jon Kawatachi, Mary Krob, Jolene Lambertis, Joseph Landavaso, Gee Eun Lee, Stella Marine, Erika McCannon, Krystle McConnell, Margaret Mejia, Theresa Messer, Nancy Molello, Kandice Oakley, Modupe Oduwole, Chibuzo Opara, Princess Osazuwa, Aidan Ottoni-Wilhelm, Helen Owhonda, Sherry Perkins, Jodi Peters, Lauren Phillips, Camila Montejo-Poll, Christine Richardson, Don Ritchie, Denise Saint-Jean, Abhay Singh, Sheryl Sprague, Anita Stokes, Tricia Taylor, Cleonda Thompson, Jodi Watkowski, Gloria Leonard-Witten, Randi Woods, Zehui Zhou, Sisters Together and Reaching, Inc. Johns Hopkins HealthCare, LLC, and i2i Population Health. The authors would also like to thank the members of the Johns Hopkins Center for Health Equity Community Advisory Board for guidance throughout the project and all of the staff, providers, organizational leaders, and patients at participating clinical sites at Berks Community Health Centers, Choptank Community Health System, Johns Hopkins Community Physicians, Park West Health System, and Total Health Care, Inc. for making the completion of this study possible. Lastly, the authors would like to thank the appointed DSMB and Hypertension Disparities Reduction Program Partnership membership for the oversight of this study. The RICH LIFE Project is funded by the National Heart, Lung, and Blood Institute, USA, and Patient-Centered Outcomes Research Institute, USA; grant number UH3HL130688.
Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2020/8
Y1 - 2020/8
N2 - Disparities in the control of hypertension and other cardiovascular disease risk factors are well-documented in the United States, even among patients seen regularly in the healthcare system. Few existing approaches explicitly address disparities in hypertension care and control. This paper describes the RICH LIFE Project (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) design. Methods: RICH LIFE is a two-arm, cluster-randomized trial, comparing the effectiveness of enhanced standard of care, “Standard of Care Plus” (SCP), to a multi-level intervention, “Collaborative Care/Stepped Care” (CC/SC), for improving blood pressure (BP) control and patient activation and reducing disparities in BP control among 1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates; and quarterly webinars in management practices, quality improvement and disparities reduction. Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults). The primary clinical outcome is BP control (<140/90 mm Hg) at 12 months. The primary patient-reported outcome is change from baseline in self-reported patient activation at 12 months. Discussion: This study will provide knowledge about the feasibility of leveraging existing resources in routine primary care and potential benefits of adding supportive community-facing roles to improve hypertension care and reduce disparities. Trial Registration: Clinicaltrials.gov
AB - Disparities in the control of hypertension and other cardiovascular disease risk factors are well-documented in the United States, even among patients seen regularly in the healthcare system. Few existing approaches explicitly address disparities in hypertension care and control. This paper describes the RICH LIFE Project (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) design. Methods: RICH LIFE is a two-arm, cluster-randomized trial, comparing the effectiveness of enhanced standard of care, “Standard of Care Plus” (SCP), to a multi-level intervention, “Collaborative Care/Stepped Care” (CC/SC), for improving blood pressure (BP) control and patient activation and reducing disparities in BP control among 1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates; and quarterly webinars in management practices, quality improvement and disparities reduction. Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults). The primary clinical outcome is BP control (<140/90 mm Hg) at 12 months. The primary patient-reported outcome is change from baseline in self-reported patient activation at 12 months. Discussion: This study will provide knowledge about the feasibility of leveraging existing resources in routine primary care and potential benefits of adding supportive community-facing roles to improve hypertension care and reduce disparities. Trial Registration: Clinicaltrials.gov
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U2 - 10.1016/j.ahj.2020.05.001
DO - 10.1016/j.ahj.2020.05.001
M3 - Article
C2 - 32526534
AN - SCOPUS:85086092178
SN - 0002-8703
VL - 226
SP - 94
EP - 113
JO - American heart journal
JF - American heart journal
ER -