ATI Evidence-based Guide Investigating Clinical Services

NCT ID: NCT02285868

Last Updated: 2019-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators goal is to provide a mechanism that allows for a better understanding of patient outcomes following rehabilitation. This includes functional outcomes measured by standardized and validated tools from the published literature. It incorporates comorbidities and patient demographic characteristics. It includes measures of general health as well along with activities of daily living and behavioral health aspects. Measures of quality and satisfaction and use of Net Promoter Scores also are included. All of these components come together to form a remarkably comprehensive picture of patients and their associated outcomes. This is a unique milestone in rehabilitative care and will act to inform and direct evidence-based approaches and treatment guidelines.

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. Subsequent reporting can be risk adjusted to any variable collected which yields robust insights as to idiopathic patient conditions. However, no PHI information will be available.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a retrospective, longitudinal, observational registry study to provide a unique and effective mechanism to acquire real-world data on patients receiving physical therapy in a variety of settings, regardless of disorder being treated.

In addition to the standard visit/data collection, patients in the AEGIS™ Registry will also be asked to complete a Quality of Life Questionnaire (SF-12) and a standardized functional outcome instrument. Generally, the following will be available:

Patient Initial Assessment for Physical Therapy:

* De-identified Protected Health Information in accordance to 45 CFR 164.514
* Diagnosis and history Baseline functional outcome measure(s)
* DASH (Disabilities of the Arm, Shoulder and Hand)
* Modified Oswestry (lumbar spine)
* Knee Outcome Survey
* Foot \& Ankle Ability Measure
* Lower Extremity Functional Scale
* Neck Disability Index Questionnaire
* Pain rating
* Global Rating of Change Scale
* Baseline Quality of Life Questionnaire (SF-12)

Patient Start of Care:

* Patient information (age, BMI, sex, de-identified Protected Health Information in accordance to 45 CFR 164.514)
* Medical/surgical history
* Therapy review (diagnosis, therapy)
* Treatment plan

Ongoing Patient Assessment:

* De-identified Protected Health Information in accordance to 45 CFR 164.514
* Treatment plan update(s)
* Concurrent (every 10th visit) administration of functional outcome measure(s)
* Concurrent (every 10th visit) administration of Quality of Life Questionnaire (SF-12)
* Patient Satisfaction
* Mailed to discharged patient within a week of discharge from physical therapy with a self-addressed, stamped return envelope Insurance Information
* Insurance carriers
* Insurance coverage

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spine Osteoarthritis Shoulder Impingement Syndrome Knee Osteoarthritis Hip Osteoarthritis Osteoarthritis Carpal Tunnel Syndrome Fracture Sprain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm, Shoulder and Hand injuries

Pre- and post-treatment outcomes of care as measured by the DASH (Disabilities of the Arm, Shoulder and Hand) via physical therapy

No interventions assigned to this group

Lumbar spine injuries

Pre- and post-treatment outcomes of care as measured by the Modified Oswestry (lumbar spine) via physical therapy

No interventions assigned to this group

Knee injuries

Pre- and post-treatment outcomes of care as measured by the Knee Outcome Survey via physical therapy

No interventions assigned to this group

Foot and ankle injuries

Pre- and post-treatment outcomes of care as measured by the Foot \& Ankle Ability Measure via physical therapy

No interventions assigned to this group

Hip and lower extremity injuries

Pre- and post-treatment outcomes of care as measured by the Lower Extremity Functional Scale via physical therapy

No interventions assigned to this group

Neck injuries

Pre- and post-treatment outcomes of care as measured by the Neck Disability Index Questionnaire via physical therapy

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Anyone (over the age of 16, all sexes, and diagnoses) receiving physical therapy

Exclusion Criteria

* Is under age 16
* Has no more than 2 visits/treatment experiences
* Is seen only for an evaluation
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ATI Holdings, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chris Stout, PsyD

Role: PRINCIPAL_INVESTIGATOR

ATI and College of Medicine, University of Illinois at Chicago

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ATI

Bolingbrook, Illinois, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chris Stout, PsyD

Role: CONTACT

6302962222 ext. 7606

David Nelson

Role: CONTACT

6302962222

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chris E Stout, PsyD

Role: primary

630-296-2222 ext. 7606

David Nelson

Role: backup

6302962222

References

Explore related publications, articles, or registry entries linked to this study.

Institute of Medicine, Committee on Quality of Health Care in America. Crossing the Quality Chasm: A new Health System for the 21st Century. Washington, DC: National Academy; 2001.

Reference Type BACKGROUND

Straus SE, Glasziou P, Richardson WS, Haynes RB. Evidence-Based Medicine: How to Practice and Teach EBM. 4th ed. Edinburgh: Elsevier Churchill Livingstone; 2011.

Reference Type BACKGROUND

Evidence-Based Medicine Working Group. Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA. 1992 Nov 4;268(17):2420-5. doi: 10.1001/jama.1992.03490170092032. No abstract available.

Reference Type BACKGROUND
PMID: 1404801 (View on PubMed)

Bithell C. Evidence-based physiotherapy: Some thoughts on "best evidence". Physiotherapy. 2000; 86: 58-60.

Reference Type BACKGROUND

Stillwell SB, Fineout-Overholt E, Melnyk BM, Williamson KM. Evidence-based practice, step by step: asking the clinical question: a key step in evidence-based practice. Am J Nurs. 2010 Mar;110(3):58-61. doi: 10.1097/01.NAJ.0000368959.11129.79.

Reference Type BACKGROUND
PMID: 20179464 (View on PubMed)

Bernhardsson S, Larsson ME. Measuring evidence-based practice in physical therapy: translation, adaptation, further development, validation, and reliability test of a questionnaire. Phys Ther. 2013 Jun;93(6):819-32. doi: 10.2522/ptj.20120270. Epub 2013 Feb 21.

Reference Type BACKGROUND
PMID: 23431214 (View on PubMed)

Wilt TJ. Uncertainty in prostate cancer care: the physician's role in clearing the confusion. JAMA. 2000 Jun 28;283(24):3258-60. doi: 10.1001/jama.283.24.3258. No abstract available.

Reference Type BACKGROUND
PMID: 10866876 (View on PubMed)

Woolf SH. The need for perspective in evidence-based medicine. JAMA. 1999 Dec 22-29;282(24):2358-65. doi: 10.1001/jama.282.24.2358.

Reference Type BACKGROUND
PMID: 10612327 (View on PubMed)

Croft P, Malmivaara A, van Tulder M. The pros and cons of evidence-based medicine. Spine (Phila Pa 1976). 2011 Aug 1;36(17):E1121-5. doi: 10.1097/BRS.0b013e318223ae4c. No abstract available.

Reference Type BACKGROUND
PMID: 21629165 (View on PubMed)

Sterne JA, Davey Smith G. Sifting the evidence-what's wrong with significance tests? BMJ. 2001 Jan 27;322(7280):226-31. doi: 10.1136/bmj.322.7280.226. No abstract available.

Reference Type BACKGROUND
PMID: 11159626 (View on PubMed)

Risch NJ. Searching for genetic determinants in the new millennium. Nature. 2000 Jun 15;405(6788):847-56. doi: 10.1038/35015718.

Reference Type BACKGROUND
PMID: 10866211 (View on PubMed)

Jasny BR, Chin G, Chong L, Vignieri S. Data replication & reproducibility. Again, and again, and again .... Introduction. Science. 2011 Dec 2;334(6060):1225. doi: 10.1126/science.334.6060.1225. No abstract available.

Reference Type BACKGROUND
PMID: 22144612 (View on PubMed)

Seligman MEP, Levant R. Managed care policies rely on inadequate science. Prof Psychol Res Pr. 1998; 29: 211-212.

Reference Type BACKGROUND

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.

Reference Type DERIVED
PMID: 32285130 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ATI EGIS01012015

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fitness and Exercise for People With Arthritis
NCT00252070 COMPLETED PHASE2/PHASE3
Health Promotion of People With Disabilities
NCT00164489 COMPLETED PHASE2/PHASE3
Yoga for Rheumatoid Arthritis
NCT00349869 COMPLETED NA
Foot Core Exercise Training with Telerehabilitation
NCT06667856 ENROLLING_BY_INVITATION NA