1. Protocol for serious fall injury adjudication in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study
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Julie Weldon, Bridget M. Mignosa, Jocelyn Wiggins, Scott Margolis, Maureen Fagan, Molly Lukas, Heather G. Allore, Obafemi Okuwobi, David Buchner, Pamela W. Duncan, Abby C. King, Jocelyn Nunez, Lawrence Garber, Jeffrey Reist, Albert W. Wu, Sajida Saeed Chaudry, Neil B. Alexander, Cindy Stowe, Kevin P. High, Rosaly Correa-de-Araujo, Haseena Rajeevan, Fred C. Ko, Nancy K. Latham, Katy Araujo, Anita Leveke, Luann Bianco, Crysta Collins, Rixin Wang, Ariela R. Orkaby, Christian Espino, Carol Gordon, Linda V. Nyquist, Lori Goehring, Rosanne M. Leipzig, La Toya Edwards, Cathy Foskett, Deborah Matza, Roxana Hirst, Mukaila Raji, Robert B. Wallace, Scott Feeser, Mary Anne Sterling, Christine Moore, David B. Reuben, Mara Abella, Michael Albert, Geraldine Hawthorne-Jones, Steven B. Clauser, Susan L. Greenspan, Bimal Ashar, Brian Funaro, Patricia C. Dykes, Bernard Birnbaum, Evan C. Hadley, Siobhan K McMahon, Denise Esserman, Erich J. Greene, Amy Shelton, Jonathan F. Bean, Thomas R. Prohaska, Joanne M. McGloin, Marcel Salive, Bonita Lynn Beattie, Sabina Rubeck, Deborah West, Ravishankar Ramaswamy, Peggy Preusse, Thomas G. Travison, Mary Anne Ferchak, Azraa Amroze, Kenneth Rando, Martha B. Carnie, Susan S. Ellenberg, Vivian Chavez, Cynthia J. Brown, Alice Lee, Patti L. Ephraim, Charles Lu, Richard Eder, Amy Larson, Terry Fulmer, Rosario Garcia, Alejandra Salazar, Janelle Howe, Laurence Z. Rubenstein, Peter Peduzzi, Yan Chen, Samuel Ho, Erica Chopskie, Sui Tang, Thomas W. Storer, Teresita Pennestri, Charles Keller, Sergei Romashkan, Taylor Christiansen, Amrish Joseph, Eleni A. Skokos, Lea Harvin, Catherine Hanson, Tiffany Campbell, Liliya Katsovich, Joseph Bianco, Stephen C. Waring, Shalender Bhasin, Kimberly Larsen, James Goodwin, Thomas M. Gill, Angela Shanahan, Allison Richards, David A. Ganz, Anne McDonald, Karen Burek, Jerry H. Gurwitz, Leo Sherman, Dorothy I. Baker, Madeline Rigatti, Albert L. Siu, Nancy Gallagher, Hilary Stenvig, Margaret Hoberg, Joseph Madia, Jeremy N. Rich, Barbara Foster, Michael Miller, Nancy P. Lorenze, Rina Castro, Katy L. B. Araujo, Carri Casteel, Lyndon Joseph, Tara Scheck, Todd M. Manini, Laurence Friedman, Karen Wu, Laura Frain, Jay Magaziner, Yvette Wells, Allise Taran, Eloisa Martinez, Jeremy D. Walston, Tina Ledesma, James Dziura, Margaret Doyle, Naaz Hussain, Lea N. Harvin, Priscilla K. Gazarian, Brooke Brawley, Charles Boult, Yuri Agrawal, Peter Charpentier, Kety Florgomes, Shehzad Basaria, Elena Volpi, Cynthia L. Stowe, David Nock, and Heather Larsen
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Physical Injury - Accidents and Adverse Effects ,Clinical Trials and Supportive Activities ,Poison control ,Suicide prevention ,Occupational safety and health ,Study Protocol ,03 medical and health sciences ,STRIDE Investigators ,0302 clinical medicine ,Clinical Research ,030225 pediatrics ,Injury prevention ,medicine ,030212 general & internal medicine ,Adjudication ,Injuries ,business.industry ,lcsh:Public aspects of medicine ,Medical record ,Head injury ,lcsh:Medical emergencies. Critical care. Intensive care. First aid ,lcsh:RA1-1270 ,Injuries and accidents ,lcsh:RC86-88.9 ,General Medicine ,Health Services ,medicine.disease ,3. Good health ,Good Health and Well Being ,Telephone interview ,Public Health and Health Services ,Falls ,Patient Safety ,Medical emergency ,business - 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). Electronic supplementary material The online version of this article (10.1186/s40621-019-0190-2) contains supplementary material, which is available to authorized users.
- Published
- 2019
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