- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04050319
ATI Evidence-based Guide Investigating Medical and Preventative Services
Utilization and Effectiveness of Sports Medicine Services
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Musculoskeletal (MSK) and sports related injuries are highly prevalent across active and athletic populations and represent a substantial source of healthcare utilization, time loss from participation and a limitation in performance. Often these injuries vary from mechanism, acuity, and severity, ranging from acute traumatic events to chronic overuse conditions. Effective management of these sports-related injuries requires a coordinated effort aimed at helping athletes restore function, minimize the risk of re-injury and facilitating a safe return to sport. Sports Medicine rehabilitation is a widely recognized as a key component of nonoperative care, with evidence that supports the role of athletic trainers to support athletes in improving patient related outcomes, functional performance and return to sport timelines. However, variability does exist in how care is delivered across the sports medicine setting, providers and injury types which may influence both outcomes and resource utilization, underscoring the need to understand how value is achieved within sports medicine rehabilitation.
To address these priorities, investigators from ATI and the University of South Carolina are interested in evaluating how standard-of-care within sports medicine is delivered and how variation in care delivery mechanisms relates to clinical outcomes, value and service utilization. In this retrospective study, The investigators will conduct secondary analyses of existing standard-of-care documentation within ATI's sports medicine EMR, without altering clinical care or interacting with patients. Key variables of interest include: (1) injury and patient characteristics (ie. body region, surgical v. non-surgical status, acuity); (2) functional and performance outcomes (ie. patient reported outcomes, return to sport status); (3) utilization metrics (ie. number of visits, duration of care and frequency); (4) care delivery characteristics (ie. interventions, neuromuscular training, manual therapy and modality use); and delivery care (ie. in clinic, hybrid). By examining how the above variables interact, this study aims to better characterize rehabilitation of athletes receiving sports medicine services and identifying opportunities to optimize outcomes and value.
Investigators have previously used ATI clinical outcomes resources to characterize care patterns, evaluate outcomes and measurement properties, and explore predictors of utilization behaviors such as canceled visits. The present protocol extends this work by leveraging existing standard-of-care EMR documentation to evaluate patient characteristics, interventions delivered, utilization management patterns, and clinical and objective/functional outcomes in routine outpatient care, producing evidence to inform clinical effectiveness, quality improvement, implementation efforts, and policy-relevant value questions.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
-
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Illinois
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Downers Grove, Illinois, États-Unis, 60515
- ATI
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
Care setting and timeframe: Received sports medicine services at ATI Physical Therapy, with documentation available in the ATI Sports Medicine EMR, on or after January 1, 2018, through the date of data extraction.
Age range: Sports participants including middle school, high school and collegiate aged including adolescents through young adults that have been documented in the EMR.
Record availability: Have an EMR record that includes the minimum data elements necessary to address the study objectives (e.g., episode identifiers/dates sufficient to define an episode of care, diagnosis/body region, utilization variables, and at least one routinely collected outcome measure when applicable to the specific analysis).
Standard-of-care data: Data were collected as part of routine clinical care/documentation prior to and independent of this research study.
Exclusion Criteria:
The record is outside the eligible timeframe or does not reflect sports medicine care at ATI.
The record is a duplicate or cannot be reliably linked within the data source to a single episode/patient for analysis.
The record lacks the minimum necessary variables required for the specific analysis (e.g., missing episode dates needed to define utilization metrics; missing baseline/discharge outcome for analyses requiring change scores).
The data are corrupted, internally inconsistent (e.g., impossible dates), or otherwise unsuitable for analysis after standard data cleaning.
The record cannot be adequately coded/de-identified for analysis and reporting under the study's privacy/confidentiality procedures.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Numerical Rating Scale (NRS)
Délai: Baseline (Day 1 at Evaluation), throughout patient's episode of care asked each visit, on average up to 12 weeks
|
Subjective; Patients rate pain on a scale from 0 (no pain) to 10 (worst pain imaginable).
|
Baseline (Day 1 at Evaluation), throughout patient's episode of care asked each visit, on average up to 12 weeks
|
|
Single Assessment Numeric Evaluation (SANE)
Délai: Administered at initial evaluation, and every 4th visit for the patient's episode of care (on average 12 weeks).
|
Subjective, Patient-perceived overall function or pain related to a specific condition compared to pre-injury.
0% (least possible) to 100% (most possible/normal)
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Administered at initial evaluation, and every 4th visit for the patient's episode of care (on average 12 weeks).
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Chris Stout, PsyD, ATI
Publications et liens utiles
Publications générales
- Herring SA. The team physician and return-to-play issues: a consensus statement. Medicine & Science in Sports & Exercise. 2002;34(7):1212-1214.
- Martin CL, Greene J, David RB, Kliethermes S, Naylor J, Kucera K. Athletic Trainers as Outpatient Rehabilitation Providers: An Analysis of Role, Value, and Insurance Reimbursement in a Large Academic Healthcare System. Journal of Athletic Training. 2025;1(aop)
- Patel DR, Yamasaki A, Brown K. Epidemiology of sports-related musculoskeletal injuries in young athletes in United States. Translational pediatrics. 2017;6(3):160.
- Brenner JS, Watson A. Overuse injuries, overtraining, and burnout in young athletes. Pediatrics. 2024;153(2):e2023065129.
- Coronado VG, Haileyesus T, Cheng TA, et al. Trends in sports-and recreation-related traumatic brain injuries treated in US emergency departments: the National Electronic Injury Surveillance System-All Injury Program (NEISS-AIP) 2001-2012. The Journal of head trauma rehabilitation. 2015;30(3):185-197.
- Rui P, Ashman JJ, Akinseye A. Emergency department visits for injuries sustained during sports and recreational activities by patients aged 5-24 years, 2010-2016. 2019
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Blessures et Blessures
- Fractures, Os
- Entorses et foulures
- Qualité des soins de santé, accès et évaluation
- Techniques d'investigation
- Méthodes épidémiologiques
- Techniques et procédures de diagnostic
- Diagnostic
- Collecte de données
- Mécanismes d'évaluation des soins de santé
- Qualité des soins de santé
- Santé publique
- Environnement et santé publique
- Services de santé
- Conseils de soins de santé
- Services de santé préventifs
- Services de diagnostic
- Enquêtes sur la santé
- Enquêtes et questionnaires
- Pratique de santé publique
- Dépistage de masse
Autres numéros d'identification d'étude
- SOR08012019
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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