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Inj Epidemiol. 2019 Apr 15;6:14. doi: 10.1186/s40621-019-0190-2. eCollection 2019.

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

Collaborators (152)

Bhasin S, Gill TM, Reuben DB, McMahon S, Latham NK, Basaria S, Brawley B, Eder R, Larson A, Goehring L, Lukas M, Margolis S, Storer TW, Carnie MB, Gazarian P, Fagan M, Peduzzi P, Dziura J, Esserman D, Greene EJ, Hawthorne-Jones G, Allore H, Doyle M, Funaro B, Lorenze N, Mignosa B, Miller ME, Travison TG, Charpentier P, Araujo K, Baker D, McGloin JM, Lu C, Rajeevan H, Katsovich L, Wang R, Shelton A, Skokos E, Tang S, Abella M, Gordon C, Pennestri T, Bianco L, Castro R, Rubeck S, Rando K, Foster B, Wu K, Nock D, Collins C, Sherman L, Waring SC, Chopskie E, Larsen H, Taran A, Bianco J, Hoberg M, Rich J, Chavez V, Moore C, Howe J, Garcia R, Nunez J, Ho S, Chen Y, Wu AW, Walston JD, Agrawal Y, Ephraim P, Campbell T, Albert M, Ashar B, Birnbaum B, Chaudry S, Edwards T, Feeser S, Hussain N, Joseph A, Larsen K, Lee A, Okuwobi O, Scheck T, Wallace R, Casteel C, Shanahan A, Weldon J, Leveke A, Keller C, Reist J, Alexander N, Wiggins J, Burek K, Ledesma T, Nyquist LV, Gallagher N, Hanson C, Ko F, Siu AL, Leipzig RM, Espino C, Ramaswamy R, West D, Matza D, Dykes P, Stenvig H, FlorGomes K, Christiansen T, Salazar A, Frain L, Orkaby A, Bean J, Wells Y, Foskett C, Gurwitz JH, Richards A, Amroze A, Garber L, Preusse P, McDonald A, Greenspan SL, Ferchak MA, Rigatti M, Madia J, Volpi E, Hirst R, Martinez E, Raji M, Magaziner J, Ganz DA, Duncan PW, Boult C, Goodwin J, Manini T, High KP, Harvin L, Stowe C, Romashkan S, Correa-De-Araujo R, Joseph L, Salive M, Hadley EC, Clauser SB, Buchner D, Fulmer T, Ellenberg S, Beattie BL, King AC, Brown CJ, Rubenstein L, Sterling MA, Prohaska T, Friedman L.

Author information

1
1Division of Geriatrics, Department of Medicine, David Geffen School of Medicine, David Geffen School of Medicine at UCLA, 11301 Wilshire Boulevard (11G), Los Angeles, CA 90073 USA.
2
2Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA USA.
3
3Icahn School of Medicine at Mount Sinai, New York, NY USA.
4
4Geriatric Research, Education and Clinical Center, James J. Peters VA Medical Center, Bronx, NY USA.
5
5University of Maryland School of Medicine, Baltimore, MD USA.
6
6Brigham and Women's Hospital, Boston, MA USA.
7
7Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School, Boston, MA USA.
8
8Department of Internal Medicine, Yale School of Medicine, New Haven, CT USA.
9
9Yale Center for Medical Informatics, Yale School of Medicine, New Haven, CT USA.
10
10Department of Biostatistics, Yale School of Public Health, New Haven, CT USA.
11
11Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC USA.
12
12Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester, MA USA.
13
13Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, MD USA.
14
14National Institute on Aging, Bethesda, MD USA.

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).

KEYWORDS:

Adjudication; Falls; Injuries

Conflict of interest statement

Competing interestsThe authors declare that they have no competing interests.

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