Sport MedicineNCT04050319
ATI Evidence-based Guide Investigating Medical and Preventative Services
An observational study of Sport Medicine, run by ATI Holdings, LLC at 1 site in United States.
Trial summary
To use existing standard-of-care documentation in a sports medicine electronic medical record (EMR) to evaluate patient characteristics, interventions delivered, utilization management, and clinical outcomes in routine sports medicine care, in order to generate evidence to improve clinical effectiveness and quality of… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sport Medicine
- What is being tested?
- Screening and diagnosis if injured
- How many people
- 550,000 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2026to 23 Apr 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals receiving medical and/or preventative services when part of an organized sports team.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utilization and Effectiveness of Sports Medicine Services
To use existing standard-of-care documentation in a sports medicine electronic medical record (EMR) to evaluate patient characteristics, interventions delivered, utilization management, and clinical outcomes in routine sports medicine care, in order to generate evidence to improve clinical effectiveness and quality of care.
Read the detailed description
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.
- Conditions
- Sport Medicine
- Being tested
- Screening and diagnosis if injured
- Keywords
- concussions, Fractures, Instability, Sprains, Strains
- Medical subject headings
- Fractures, Bone, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening and diagnosis if injuredDiagnostic test
Also called athletic training
Athletic Training and Physical Therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
Subjective; Patients rate pain on a scale from 0 (no pain) to 10 (worst pain imaginable).
Measured: 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)
Subjective, Patient-perceived overall function or pain related to a specific condition compared to pre-injury. 0% (least possible) to 100% (most possible/normal)
Measured: Administered at initial evaluation, and every 4th visit for the patient's episode of care (on average 12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start23 Apr 2026
- Primary completion23 Apr 2029 (estimated)
- Study completion23 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sport MedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 550,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- ATI Holdings, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Natalie Myers, ATI Holdings, LLC
- Investigators
- Chris Stout, PsyD, Study chair, ATI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050319
- Sponsor's protocol ID
- SOR08012019
- Status last verified
- Apr 2026
- First submitted
- 5 Aug 2019
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Aggregated non-Private Health Information and non-Health Insurance Portability and Accountability Act data may potentially be made available upon request.
Publications
The team physician and return-to-play issues: a consensus statement. Med Sci Sports Exerc. 2002 Jul;34(7):1212-4. doi: 10.1097/00005768-200207000-00025. No abstract available.
PubMed 12131265Martin CL, Greene J, Bell DR, Kliethermes S, Naylor J, Kucera K. Athletic Trainers as Outpatient Rehabilitation Providers: An Analysis of Role, Value, and Insurance Reimbursement in a Large Academic Health Care System. J Athl Train. 2026 Jan 16;61(1):13-20. doi: 10.4085/1062-6050-0171.25. eCollection 2026 Jan.
PubMed 41561423Patel DR, Yamasaki A, Brown K. Epidemiology of sports-related musculoskeletal injuries in young athletes in United States. Transl Pediatr. 2017 Jul;6(3):160-166. doi: 10.21037/tp.2017.04.08.
PubMed 28795006Brenner JS, Watson A; COUNCIL ON SPORTS MEDICINE AND FITNESS. Overuse Injuries, Overtraining, and Burnout in Young Athletes. Pediatrics. 2024 Jan 1;153(2):e2023065129. doi: 10.1542/peds.2023-065129.
PubMed 38247370Coronado VG, Haileyesus T, Cheng TA, Bell JM, Haarbauer-Krupa J, Lionbarger MR, Flores-Herrera J, McGuire LC, Gilchrist J. 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. J Head Trauma Rehabil. 2015 May-Jun;30(3):185-97. doi: 10.1097/HTR.0000000000000156.
PubMed 25955705Rui P, Ashman JJ, Akinseye A. Emergency Department Visits for Injuries Sustained During Sports and Recreational Activities by Patients Aged 5-24 Years, 2010-2016. Natl Health Stat Report. 2019 Nov;(133):1-15.
PubMed 32510307
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization and Effectiveness of Sports Medicine Services
- ClinicalTrials.gov ID
- NCT04050319
- Acronym / sponsor ID
- SOR08012019
- Conditions
- Sport Medicine
- Keywords
- concussions, Fractures, Instability, Sprains, Strains
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 550,000 participants (estimated)
- Lead sponsor
- ATI Holdings, LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- 23 Apr 2029 (estimated)
- Study completion
- 23 Apr 2029 (estimated)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To use existing standard-of-care documentation in a sports medicine electronic medical record (EMR) to evaluate patient characteristics, interventions delivered, utilization management, and clinical outcomes in routine sports medicine care, in order to generate evidence to improve clinical effectiveness and quality of care.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals receiving medical and/or preventative services when part of an organized sports team.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening and diagnosis if injuredAlso: athletic trainingAthletic Training and Physical Therapy | Diagnostic test | – |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: 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).
Single Assessment Numeric Evaluation (SANE)
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 12131265The team physician and return-to-play issues: a consensus statement. Med Sci Sports Exerc. 2002 Jul;34(7):1212-4. doi: 10.1097/00005768-200207000-00025. No abstract available.
- Background: PubMed 41561423Martin CL, Greene J, Bell DR, Kliethermes S, Naylor J, Kucera K. Athletic Trainers as Outpatient Rehabilitation Providers: An Analysis of Role, Value, and Insurance Reimbursement in a Large Academic Health Care System. J Athl Train. 2026 Jan 16;61(1):13-20. doi: 10.4085/1062-6050-0171.25. eCollection 2026 Jan.
- Background: PubMed 28795006Patel DR, Yamasaki A, Brown K. Epidemiology of sports-related musculoskeletal injuries in young athletes in United States. Transl Pediatr. 2017 Jul;6(3):160-166. doi: 10.21037/tp.2017.04.08.
- Background: PubMed 38247370Brenner JS, Watson A; COUNCIL ON SPORTS MEDICINE AND FITNESS. Overuse Injuries, Overtraining, and Burnout in Young Athletes. Pediatrics. 2024 Jan 1;153(2):e2023065129. doi: 10.1542/peds.2023-065129.
- Background: PubMed 25955705Coronado VG, Haileyesus T, Cheng TA, Bell JM, Haarbauer-Krupa J, Lionbarger MR, Flores-Herrera J, McGuire LC, Gilchrist J. 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. J Head Trauma Rehabil. 2015 May-Jun;30(3):185-97. doi: 10.1097/HTR.0000000000000156.
- Background: PubMed 32510307Rui P, Ashman JJ, Akinseye A. Emergency Department Visits for Injuries Sustained During Sports and Recreational Activities by Patients Aged 5-24 Years, 2010-2016. Natl Health Stat Report. 2019 Nov;(133):1-15.
- Individual participant dataSharing planned: Undecided. Aggregated non-Private Health Information and non-Health Insurance Portability and Accountability Act data may potentially be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Stout, PsyD study chair
ATI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sport Medicine, run by ATI Holdings, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) (time frame: Baseline (Day 1 at Evaluation), throughout patient's episode of care asked each visit, on average up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04050319, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.