Abstract
Background: Fall injuries are a major cause of morbidity and mortality among older adults. We describe the design of a pragmatic trial to compare the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy to an enhanced usual care. Methods: Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) is a 40-month cluster-randomized, parallel-group, superiority, pragmatic trial being conducted at 86 primary care practices in 10 health care systems across United States. The 86 practices were randomized to intervention or control group using covariate-based constrained randomization, stratified by health care system. Participants are community-living persons, ≥70 years, at increased risk for serious fall injuries. The intervention is a comanagement model in which a nurse Falls Care Manager performs multifactorial risk assessments, develops individualized care plans, which include surveillance, follow-up evaluation, and intervention strategies. Control group receives enhanced usual care, with clinicians and patients receiving evidence-based information on falls prevention. Primary outcome is serious fall injuries, operationalized as those leading to medical attention (nonvertebral fractures, joint dislocation, head injury, lacerations, and other major sequelae). Secondary outcomes include all fall injuries, all falls, and well-being (concern for falling; anxiety and depressive symptoms; physical function and disability). Target sample size was 5,322 participants to provide 90% power to detect 20% reduction in primary outcome rate relative to control. Results: Trial enrolled 5,451 subjects in 20 months. Intervention and follow-up are ongoing. Conclusions: The findings of the STRIDE study will have important clinical and policy implications for the prevention of fall injuries in older adults.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1053-1061 |
| Number of pages | 9 |
| Journal | Journals of Gerontology - Series A Biological Sciences and Medical Sciences |
| Volume | 73 |
| Issue number | 8 |
| DOIs | |
| State | Published - Jul 9 2018 |
Bibliographical note
Funding Information:The STRIDE study was funded primarily by the Patient Centered Outcomes Research Institute (PCORI), with additional support from the National Institute on Aging (NIA) at NIH. Funding is provided and the award managed through a cooperative agreement (5U01AG048270) between the NIA and the Brigham and Women’s Hospital. The project is part of the Partnership for Fall Injuries Prevention between the NIA and PCORI. Additional support was provided by the Boston Claude D. Pepper Older Americans Independence Center at Brigham and Women’s Hospital (P30-AG013679); Harvard Catalyst | The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health Award UL1 TR001102) and financial contributions from Harvard University and its affiliated academic healthcare centers; the Claude D. Pepper Older Americans Independence Centers at Yale University (P30AG021342) and by the NIH/National Center for Advancing Translational Sciences Clinical and Translational Science Awards program at Yale University (UL1TR000142). T.M.G. is the recipient of an Academic Leadership Award (K07AG043587) from the National Institute on Aging.
Funding Information:
Peter Peduzzi (Director), PhD, James Dziura, PhD, Denise Esserman, PhD, Erich J. Greene, PhD, Geraldine Hawthorne-Jones, Heather Allore, PhD, Margaret Doyle, Brian Funaro, Nancy Lorenze DNSc, Bridget Mignosa, Michael E. Miller, PhD (Wake Forest), Thomas G. Travison, PhD (Harvard), Peter Charpentier, MPH (Chair of Data Management Committee), Katy Araujo, MPH Yale School of Medicine, New Haven, CT: Geriatric Medicine: Dorothy Baker, PhD Recruitment and Assessment Center: Joanne M. McGloin, MDiv, MS, MBA, Charles Lu, PhD, Haseena Rajeevan, PhD, Liliya Katsovich, MA, MBA, CCRP, Rixin Wang, PhD, Amy Shelton, MPH, Eleni Skokos, BS, MS, Sui Tang, BS, Mara Abella, Carol Gordon, Teresita Pennestri, Luann Bianco, Rina Castro, Sabina Rubeck, Kenneth Rando, Barbara Foster, Karen Wu, David Nock, Crysta Collins, Eloisa Martinez (UTMB), Leo Sherman (Mt. Sinai) Clinical Trial Sites Essentia Health, Duluth, MN Site Principal Investigator: Stephen C. Waring, DVM, PhD, Fall Care Manager: Erica Chopskie, RN, BS, Allise Taran, MPH, Joseph Bianco, MD, Margaret Hoberg, CNP, Hillary Henzler HealthCare Partners, El Segundo, CA Site Principal Investigator: Jeremy Rich, DPM, Fall Care Manger: Vivian Chavez, RN, Christine Moore, Janelle Howe, Rosario Garcia, Jocelyn Nunez, Samuel Ho, MD, Yan Chen, MD Johns Hopkins Medicine, Baltimore, MD Site Principal Investigator: Albert W. Wu, MD, MPH, Jeremy D. Walston, MD, Fall Care Manager: Tiffany Campbell, BSN, RN, BMTCN, OCN, Patti Ephraim, MPH, Yuri Agrawal, MD, Mercy Health Network (Des Moines, IA) and University of Iowa (Iowa City, IA) Site Principal Investigator: Robert Wallace, MD, MSc, Co-Site Principal Investigator: Carri Casteel, PhD, Fall Care Manager: Angela Shanahan, RN-BC, BSN, Julie Weldon MSN RN, Anita Leveke, RN, BSN, CEN, Charles Keller, MD, Jeffrey Reist PharmD Michigan Medicine, University of Michigan, Ann Arbor, MI Site Principal Investigator: Neil Alexander, MD, Jocelyn Wiggins, BM, BCh, Fall Care Managers: Karen Burek, RN, MS, ANP-BC and Tina Ledesma, RN, BSN, Linda V. Nyquist, PhD, Nancy (Amby) Gallagher, PhD, APRN-BC, Catherine Hanson, BA Mount Sinai Health System, New York, NY Site Principal Investigator: Fred Ko, MD, MS, Albert L. Siu, MD, MPH, Rosanne M. Leipzig, MD, PhD, Christian Espino, BA, Ravishankar Ramaswamy, MD, MS, Fall Care Managers: Deborah West, RN, BS and Deborah Matza, RN, MPH Partners Healthcare, Boston, MA Site Principal Investigator: Patricia Dykes, RN, PhD, MA, Hilary Stenvig, Kety Vanda, Alejandra Salazar, PharmD, Laura Frain, MD, Ariela Orkaby, MD, MPH, Jonathan Bean, MD Fall Care Managers: Yvette Wells, RN and Cathy Foskett, RN Reliant Medical Group, Worcester, MA Site Principal Investigator: Jerry H. Gurwitz, MD, Allison Richards, Lawrence Garber, MD, Fall Care Managers: Peggy Preusse, RN and Anne McDonald, RN University of Pittsburgh Medical Center, Pittsburgh, PA Site Principal Investigator: Susan L. Greenspan, MD, Fall Care Manager: Mary Anne Ferchak, RN, BS, Madeline Rigatti, Joseph Madia University of Texas Medical Branch at Galveston, Galveston, TX Site Principal Investigator: Elena Volpi, MD, Fall Care Manager: Summer Chapman, RN, MSN, Roxana Hirst, MS, CCRP, Eloisa Martinez, BS, CCRP, Mukaila Raji, MD, MS STRIDE Committee Chairs: Clinical Trial Sites: Jerry H. Gurwitz, MD; Outcomes: Jay Magaziner, MSHyg, PhD (University of Maryland) and Albert L. Siu, MD, MPH; Adjudication: David A. Ganz, MD, PhD (UCLA); Steering: Shalender Bhasin, MB, BS Protocol: Thomas M. Gill, MD Screening; Recruitment and Retention: Joanne M. McGloin, M Div, MS, MBA and Thomas M. Gill, MD Data Management and IT: Peter Charpentier, MPH Intervention: David B. Reuben, MD Safety: Shehzad Basaria, MD Falls Care Managers: Siobhan McMahon, PhD, RN (University of Minnesota); National Patient and Stakeholder: Maureen Fagan, DNP, MHA, FNP-BC (Chair), Martha B. Carnie, AS (Co-Chair), Catherine Hanson, BA Physical Components: Pamela W. Duncan, PhD, PT (Wake Forest University) and Thomas W. Storer, PhD FCM Training: Chad Boult, MD, MPH, MBA (Johns Hopkins) and Priscilla Gazarian, PhD, RN Ancillary Studies: James Goodwin, MD (UTMB) and Todd Manini, PhD (University of Florida) Publications: Shalender Bhasin, MB, BS and Peter Peduzzi, PhD Wake Forest University, Winston-Salem NC Kevin P. High, MD, MS, Lea Harvin, Cindy Stowe National Institute on Aging, Bethesda, Maryland: Program Officer: Sergei Romashkan, MD, Scientific Officer: Rosaly Correa-De-Araujo, MD, MS, PhD, Lyndon Joseph, PhD, Marcel Salive, MD, MPH, Evan C. Hadley, MD Patient Centered Outcomes Research Institute (PCORI), Washington, D.C. Steven B. Clauser, PhD, MPA Data and Safety Monitoring Board A 9-member Data and Safety Monitoring Board, appointed by the National institute on Aging, oversaw study’s progress and safety, and included: David Buchner, MD, MPH(Chair); Terry Fulmer, PhD, RN, FAAN; Susan Ellenberg, PhD; Bonita Lynn Beattie, MPT, MHA; Abby C. King, PhD; Cynthia J. Brown, MD, MSPH; Laurence Rubenstein, MD; Mary Anne Sterling, CEA; Thomas Prohaska, PhD; Laurence Friedman, MD Funding Support The STRIDE study was funded primarily by the Patient Centered Outcomes Research Institute (PCORI), with additional support from the National Institute on Aging (NIA) at NIH. Funding is provided and the award managed through a cooperative agreement (5U01AG048270) between the NIA and the Brigham and Women’s Hospital. The project is part of the Partnership for Fall Injuries Prevention between the NIA and PCORI. This research is partially supported by the Boston Claude D. Pepper Older Americans Independence Center at Brigham and Women’s Hospital (P30-AG013679) and Harvard Catalyst | The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health Award UL1 TR001102) and financial contributions from Harvard University and its affiliated academic healthcare centers. Support was also provided by the Claude D. Pepper Older Americans Independence Centers at UCLA (P30AG028748); Yale (P30AG021342); Mt Sinai (P30AG2874106); UTMB (P30AG024832), University of Michigan (P30AG024824) and Wake Forest (P30AG021332). Mt Sinai also received support through a grant from the New York Academy of Medicine. Additional support at Yale University was provided by the NIH/National Center for Advancing Translational Sciences Clinical and Translational Science Awards program (UL1TR000142) and an Academic Leadership Award (K07AG043587) to Dr Gill from the National Institute on Aging. Dr. McMahon was supported by grants KL2TR000113 and UL1TR000114. The University of Michigan also received support from Michigan Medicine, its academic healthcare system. The content of this publication is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Publisher Copyright:
© The Author(s) 2017.
Keywords
- Clinical effectiveness
- Fall prevention
- Nurse falls care managers
- Patient and stakeholders in fall injury prevention research