AzTrials
AzTrials

Primary Body Region (Arranged Most Common to Least)AEGISNCT02285868

ATI Evidence-based Guide Investigating Clinical Services

An observational study of Primary Body Region (Arranged Most Common to Least) and Lumbar/SI, run by ATI Holdings, LLC at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The goal of this study is to evaluate how standard-of-care outpatient rehabilitation is delivered and how variation in care delivery mechanisms relates to clinical outcomes, service utilization, and value in patients receiving physical or occupational therapy. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
How many people
4,000,000 participants
Where
1 siteUnited States
Study dates
24 Feb 2026to 24 Feb 2029
How long will I take part?
1 Year
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: All patients presenting ith orthopedic rehabilitation needs

This study involves retrospective secondary analysis of existing standard-of-care documentation from ATI's outpatient rehabilitation EMR. There will be no prospective data collection, no recruitment, and no interaction with patients.

After a patient's episode of care is completed (discharge or last recorded visit), the PI will identify eligible encounters based on prespecified inclusion/exclusion criteria (e.g., outpatient PT/OT services at ATI on or after January 1, 2016.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • ATI Physical Therapy and Institute for Musculoskeletal Advancement

    Downers Grove, Illinois, 60515

Other trials in United States

About this study

Official title: ATI Evidence-Based Guide Investigating Clinical Services: Rehabilitation and Physical Therapy Patient Outcomes Registry

The goal of this study is to evaluate how standard-of-care outpatient rehabilitation is delivered and how variation in care delivery mechanisms relates to clinical outcomes, service utilization, and value in patients receiving physical or occupational therapy. The study will focus on patients with musculoskeletal (MSK) conditions receiving physical or occupational therapy.

The focus is to use existing standard-of-care documentation in a physical therapy (PT) electronic medical record (EMR) to evaluate patient characteristics, interventions delivered, utilization management, and clinical outcomes in routine outpatient PT care, in order to generate evidence to improve clinical effectiveness and quality of care. Researchers will compare different care delivery mechanisms to see if variations lead to significant differences in outcomes.

Read more

Participants will have their standard-of-care documentation analyzed, including routine clinical measures, objective/functional measures, and patient-reported outcomes. They will not be directly involved in research interventions or randomization. This study does not involve a research intervention, randomization, or alteration of clinical care. It is a retrospective cohort study analyzing existing standard-of-care documentation from ATI's physical therapy EMR.

Data are collected via the investigators proprietary electronic medical record system and are synthetic to the clinical process that is, the data are collected in real-time with patients and the scores are immediately provided to the treating therapist as well as archived for later Registry and scientific use.

Read the detailed description

Musculoskeletal (MSK) conditions are prevalent1 and contribute substantially to healthcare utilization and cost. Physical therapy is a non-surgical, non-pharmacological intervention that can be clinically effective and cost-effective for many MSK presentations, with a large proportion of patients improving without requiring escalation of care. In the context of evolving reimbursement and value-based care pressures, it is increasingly important to understand the clinical effectiveness, utilization patterns, and value implications of PT as delivered in routine outpatient practice. (1-6)

To address these priorities, investigators from ATI and the University of South Carolina are interested in evaluating how standard-of-care outpatient rehabilitation is delivered and how variation in care delivery mechanisms relates to clinical outcomes, service utilization, and value. In this retrospective study, we will conduct secondary analyses of existing standard-of-care documentation within ATI's PT EMR, without altering clinical care or interacting with patients. Care delivery mechanisms of interest include, but are not limited to: (1) delivery mode (in-clinic, telehealth, remote therapeutic moderating (RTM), and hybrid models when documented); (2) use of care extenders (PTAs/Technicians) when identifiable in documentation; (3) specialty service lines and provider qualifications (e.g., Women's Health, Hand Therapy, Vestibular Therapy, Work Comp/Work Hardening, advanced training/certifications); and (4) types of interventions delivered (e.g., exercise therapy, manual therapy, therapeutic modalities), as documented as part of routine care. (7-9)

ATI is a large national outpatient MSK provider delivering physical and occupational therapy services. Investigators have previously used ATI clinical outcomes resources (e.g., the ATI EMR) 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. (4,10-13)

This study is a retrospective cohort study existing standard-of-care documentation from the ATI physical therapy EMR (including routinely collected clinical measures, objective/functional measures, and patient-reported outcomes) for patients receiving physical or occupational therapy beginning January 1, 2016. All interventions referenced in the dataset represent usual care delivered as part of clinical practice and were not assigned for research purposes.

Primary Objective: To use existing standard-of-care documentation in a physical therapy (PT) electronic medical record (EMR) to evaluate patient characteristics, interventions delivered, utilization management, and clinical outcomes in routine outpatient PT care, in order to generate evidence to improve clinical effectiveness and quality of care

Specific Aims Clinical Research (effectiveness in real-world practice)

1)Use retrospective EMR data to evaluate the real-world effectiveness of standard-of-care PT services (including prevention programs, interventions, and educational efforts) for prevalent MSK conditions by examining changes in routinely captured clinical outcomes, objective/functional measures, and patient-reported outcomes over an episode of care.

Heath Policy (Value, cost-efficiency, and care pathways) Use retrospective EMR data to examine PT utilization management and its association with quality, effectiveness, and cost-efficiency across care pathways and practice patterns (e.g., visit authorization patterns, visit frequency, episode duration, time to evaluation, gaps in care, and discharge disposition). When available within the data environment, analyses will also evaluate downstream indicators of value such as opioid utilization, return to function/work/sport, and relationships between outcomes and utilization/cost to inform value-based care and payer-relevant questions.

Implementation and Quality Improvement (Adoption + data quality) Evaluate implementation and sustainability of routine clinical practices by assessing patterns of adoption of assessments/interventions, variation in care delivery, completeness of outcome capture (PROMs/objective tests), patient satisfaction, and resource/service utilization-informing strategies to improve consistent data capture and quality.

Sports Medicine (Athlete lifecycle + RTS decision-making) Among sports/athlete episodes (as identifiable in the EMR), evaluate the effectiveness of sports medicine rehabilitation services across the athlete lifecycle-including risk screening where captured, rehabilitation outcomes, and criteria-based return-to-sport/return-to-function outcomes when documented.

Keywords
Orthopedic rehabilitation, Rehabilitation outcomes, Physical therapy, Physical therapy outcomes, occupational therapy, Standard of care
Medical subject headings
Neurologic Manifestations, Fibromyalgia, Headache, Lymphedema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02285868
Study groupRoleWhat they receive
Arm, Shoulder and Hand injuriesPre- and post-treatment outcomes of care as measured by the DASH (Disabilities of the Arm, Shoulder and Hand) via physical therapy
Lumbar spine injuriesPre- and post-treatment outcomes of care as measured by the Modified Oswestry (lumbar spine) via physical therapy
Knee injuriesPre- and post-treatment outcomes of care as measured by the Knee Outcome Survey via physical therapy
Foot and ankle injuriesPre- and post-treatment outcomes of care as measured by the Foot \& Ankle Ability Measure via physical therapy
Hip and lower extremity injuriesPre- and post-treatment outcomes of care as measured by the Lower Extremity Functional Scale via physical therapy
Neck injuriesPre- and post-treatment outcomes of care as measured by the Neck Disability Index Questionnaire via physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in functional status

    Measured: 60 days

Secondary outcomes (1)
  1. Change in global health status

    Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2014 (estimated)
  2. Study start24 Feb 2026
  3. Primary completion24 Feb 2029 (estimated)
  4. Study completion24 Feb 2029 (estimated)

Resources

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
4,000,000 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT02285868
Sponsor's protocol ID
ATI EGIS01012015
Acronym
AEGIS
Status last verified
Mar 2026
First submitted
4 Nov 2014
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Denninger TR, Cook CE, Chapman CG, McHenry T, Thigpen CA. The Influence of Patient Choice of First Provider on Costs and Outcomes: Analysis From a Physical Therapy Patient Registry. J Orthop Sports Phys Ther. 2018 Feb;48(2):63-71. doi: 10.2519/jospt.2018.7423. Epub 2017 Oct 26.

    PubMed 29073842
  • Lutz AD, Brooks JM, Chapman CG, Shanley E, Stout CE, Thigpen CA. Risk Adjustment of the Modified Low Back Pain Disability Questionnaire and Neck Disability Index to Benchmark Physical Therapist Performance: Analysis From an Outcomes Registry. Phys Ther. 2020 Apr 17;100(4):609-620. doi: 10.1093/ptj/pzaa019.

    PubMed 32285130
  • Lutz AD, Rodriguez S, DeBuck KF, Denninger TR, Myers LM, Myers NL. Work Conditioning: The Appropriate Stepped Physical Therapy Care for Injured Workers in Physically Demanding Roles: A Retrospective Cohort Study. J Occup Environ Med. 2026 May 1;68(5):385-390. doi: 10.1097/JOM.0000000000003611. Epub 2025 Nov 11.

    PubMed 41214483
  • Lutz AD, Windsor BA, Shanley E, Denninger TR, Harrington SE, Thigpen CA. A comparison of treatment signatures of high and low performing physical therapists for patients with lower back pain: analysis of spine care from a physical therapy outcomes registry. Spine J. 2022 May;22(5):847-856. doi: 10.1016/j.spinee.2021.11.008. Epub 2021 Nov 20.

    PubMed 34813956
  • Hawley-Hague H, Lasrado R, Martinez E, Stanmore E, Tyson S. A scoping review of the feasibility, acceptability, and effects of physiotherapy delivered remotely. Disabil Rehabil. 2023 Nov;45(23):3961-3977. doi: 10.1080/09638288.2022.2138574. Epub 2022 Nov 2.

    PubMed 36325612
  • Domingues B, Pereira AP, Pradhan A, Zidde C, Janela D, Marramaque C, Bento V, Yanamadala V, Cohen SP, Belz L, Wang K, Correia FD, Costa F. Digital Versus In-Person Physical Therapy in Adults With Musculoskeletal Conditions: Retrospective Matched-Cohort Analysis of Surgery and Low-Value Surgical Rates. J Med Internet Res. 2025 Dec 17;27:e82573. doi: 10.2196/82573.

    PubMed 41288021
  • Hinman RS, Campbell PK, Kimp AJ, Russell T, Foster NE, Kasza J, Harris A, Bennell KL. Telerehabilitation consultations with a physiotherapist for chronic knee pain versus in-person consultations in Australia: the PEAK non-inferiority randomised controlled trial. Lancet. 2024 Mar 30;403(10433):1267-1278. doi: 10.1016/S0140-6736(23)02630-2. Epub 2024 Mar 7.

    PubMed 38461844
  • Demont A, Bourmaud A, Kechichian A, Desmeules F. The impact of direct access physiotherapy compared to primary care physician led usual care for patients with musculoskeletal disorders: a systematic review of the literature. Disabil Rehabil. 2021 Jun;43(12):1637-1648. doi: 10.1080/09638288.2019.1674388. Epub 2019 Oct 11.

    PubMed 31603709
  • Burge E, Monnin D, Berchtold A, Allet L. Cost-Effectiveness of Physical Therapy Only and of Usual Care for Various Health Conditions: Systematic Review. Phys Ther. 2016 Jun;96(6):774-86. doi: 10.2522/ptj.20140333. Epub 2015 Dec 17.

    PubMed 26678447
  • Lentz TA, Ikeaba U, Alhanti B, Lutz A, George SZ, Cook C, Thigpen C. Self-reported disability trajectories and their predictors among patients receiving care by physical therapists for musculoskeletal conditions: a retrospective analysis of registry data. BMJ Open. 2025 Jun 20;15(6):e099315. doi: 10.1136/bmjopen-2025-099315.

    PubMed 40541444
  • Dieleman JL, Cao J, Chapin A, Chen C, Li Z, Liu A, Horst C, Kaldjian A, Matyasz T, Scott KW, Bui AL, Campbell M, Duber HC, Dunn AC, Flaxman AD, Fitzmaurice C, Naghavi M, Sadat N, Shieh P, Squires E, Yeung K, Murray CJL. US Health Care Spending by Payer and Health Condition, 1996-2016. JAMA. 2020 Mar 3;323(9):863-884. doi: 10.1001/jama.2020.0734.

    PubMed 32125402
  • McConaghy K, Klika AK, Apte SS, Erdemir A, Derwin K, Piuzzi NS. A Call to Action for Musculoskeletal Research Funding: The Growing Economic and Disease Burden of Musculoskeletal Conditions in the United States Is Not Reflected in Musculoskeletal Research Funding. J Bone Joint Surg Am. 2023 Mar 15;105(6):492-498. doi: 10.2106/JBJS.22.00693. Epub 2022 Nov 9.

    PubMed 36574617

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Body Region (Arranged Most Common to Least) and Lumbar/SI, 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.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 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?

Change in functional status (time frame: 60 days). 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 NCT02285868, which also lists 12 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 5 Mar 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in