Protocol for serious fall injury adjudication in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study

David A. Ganz, Albert L. Siu, Jay Magaziner, Nancy K. Latham, Thomas G. Travison, Nancy P. Lorenze, Charles Lu, Rixin Wang, Erich J. Greene, Cynthia L. Stowe, Lea N. Harvin, Katy L.B. Araujo, Jerry H. Gurwitz, Yuri Agrawal, Rosaly Correa-De-Araujo, Peter Peduzzi, Thomas M. Gill, Shalender Bhasin, Thomas M. Gill, David B. ReubenSiobhan McMahon, Nancy K. Latham, Shehzad Basaria, Brooke Brawley, Richard Eder, Amy Larson, Lori Goehring, Molly Lukas, Scott Margolis, Thomas W. Storer, Martha B. Carnie, Priscilla Gazarian, Maureen Fagan, Peter Peduzzi, James Dziura, Denise Esserman, Erich J. Greene, Geraldine Hawthorne-Jones, Heather Allore, Margaret Doyle, Brian Funaro, Nancy Lorenze, Bridget Mignosa, Michael E. Miller, Thomas G. Travison, Peter Charpentier, Katy Araujo, Dorothy Baker, Joanne M. McGloin, Charles Lu, Haseena Rajeevan, Liliya Katsovich, Rixin Wang, Amy Shelton, Eleni Skokos, Sui Tang, Mara Abella, Carol Gordon, Teresita Pennestri, Luann Bianco, Rina Castro, Sabina Rubeck, Kenneth Rando, Barbara Foster, Karen Wu, David Nock, Crysta Collins, Leo Sherman, Stephen C. Waring, Erica Chopskie, Heather Larsen, Allise Taran, Joseph Bianco, Margaret Hoberg, Jeremy Rich, Vivian Chavez, Christine Moore, Janelle Howe, Rosario Garcia, Jocelyn Nunez, Samuel Ho, Yan Chen, Albert W. Wu, Jeremy D. Walston, Yuri Agrawal, Patti Ephraim, Tiffany Campbell, Michael Albert, Bimal Ashar, Bernard Birnbaum, Sajida Chaudry, La Toya Edwards, Scott Feeser, Naaz Hussain, Amrish Joseph, Kimberly Larsen, Alice Lee, Obafemi Okuwobi, Tara Scheck, Robert Wallace, Carri Casteel, Angela Shanahan, Julie Weldon, Anita Leveke, Charles Keller, Jeffrey Reist, Neil Alexander, Jocelyn Wiggins, Karen Burek, Tina Ledesma, Linda V. Nyquist, Nancy Gallagher, Catherine Hanson, Fred Ko, Albert L. Siu, Rosanne M. Leipzig, Christian Espino, Ravishankar Ramaswamy, Deborah West, Deborah Matza, Patricia Dykes, Hilary Stenvig, Kety Florgomes, Taylor Christiansen, Alejandra Salazar, Laura Frain, Ariela Orkaby, Jonathan Bean, Yvette Wells, Cathy Foskett, Jerry H. Gurwitz, Allison Richards, Azraa Amroze, Lawrence Garber, Peggy Preusse, Anne McDonald, Susan L. Greenspan, Mary Anne Ferchak, Madeline Rigatti, Joseph Madia, Elena Volpi, Roxana Hirst, Eloisa Martinez, Mukaila Raji, Jay Magaziner, David A. Ganz, Pamela W. Duncan, Chad Boult, James Goodwin, Todd Manini, Kevin P. High, Lea Harvin, Cindy Stowe, Sergei Romashkan, Rosaly Correa-De-Araujo, Lyndon Joseph, Marcel Salive, Evan C. Hadley, Steven B. Clauser, David Buchner, Terry Fulmer, Susan Ellenberg, Bonita Lynn Beattie, Abby C. King, Cynthia J. Brown, Laurence Rubenstein, Mary Anne Sterling, Thomas Prohaska, Laurence Friedman

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

Background: This paper describes a protocol for determining the incidence of serious fall injuries for Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE), a large, multicenter pragmatic clinical trial with limited resources for event adjudication. We describe how administrative data (from participating health systems and Medicare claims) can be used to confirm participant-reported events, with more time- and resource-intensive full-text medical record data used only on an "as-needed" basis. Methods: STRIDE is a pragmatic cluster-randomized controlled trial involving 5451 participants age ≥ 70 and at increased risk for falls, served by 86 primary care practices in 10 US health systems. The STRIDE intervention involves a nurse falls care manager who assesses a participant's underlying risks for falls, suggests interventions using motivational interviewing, and then creates, implements and longitudinally follows up on an individualized care plan with the participant (and caregiver when appropriate), in partnership with the participant's primary care provider. STRIDE's primary outcome is serious fall injuries, defined as a fall resulting in: (1) medical attention billable according to Medicare guidelines with a) fracture (excluding isolated thoracic vertebral and/or lumbar vertebral fracture), b) joint dislocation, or c) cut requiring closure; OR (2) overnight hospitalization with a) head injury, b) sprain or strain, c) bruising or swelling, or d) other injury determined to be "serious" (i.e., burn, rhabdomyolysis, or internal injury). Two sources of data are required to confirm a serious fall injury. The primary data source is the participant's self-report of a fall leading to medical attention, identified during telephone interview every 4 months, with the confirmatory source being (1) administrative data capturing encounters at the participating health systems or Medicare claims and/or (2) the full text of medical records requested only as needed. Discussion: Adjudication is ongoing, with over 1000 potentially qualifying events adjudicated to date. Administrative data can be successfully used for adjudication, as part of a hybrid approach that retrieves full-text medical records only when needed. With the continued refinement and availability of administrative data sources, future studies may be able to use administrative data completely in lieu of medical record review to maximize the quality of adjudication with finite resources. Trial registration: ClinicalTrials.gov (NCT02475850).

Original languageEnglish (US)
Article number14
JournalInjury Epidemiology
Volume6
Issue number1
DOIs
StatePublished - Apr 15 2019

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. A representative of one of the sponsors (Rosaly Correa-De-Araujo, MD, MS, PhD, National Institute on Aging) was involved in the design of the adjudication protocol and preparation of the paper. The participation of this individual or the materials should not be interpreted as representing the official viewpoint of the U.S. Department of Health and Human Services, the National Institutes of Health or the National Institute on Aging, except where noted. Additional support was provided by the Boston Claude D. Pepper Older Americans Independence Center (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). TMG is the recipient of an Academic Leadership Award (K07AG043587) from the National Institute on Aging.

Publisher Copyright:
© 2019 The Author(s).

Keywords

  • Adjudication
  • Falls
  • Injuries

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