ATI Evidence-based Guide Investigating Clinical Services

Osteoarthritis Clinical Trial

— AEGIS  

Official title:

ATI Evidence-based Guide Investigating Clinical Services: Rehabilitation and Physical Therapy Patient Outcomes Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02285868
• Other study ID #: ATI EGIS01012015
• Status: Recruiting
• Start date: November 2014
• Est. completion date: January 2024

Study information

• Verified date: July 2019
• Source: ATI Holdings, LLC
• Contact: Chris Stout, PsyD
• Phone: 6302962222
• Email: chris.stout[@]atipt.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Fracture
• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee
• Osteoarthritis, Spine
• Shoulder Impingement Syndrome
• Spine Osteoarthritis
• Spondylarthritis
• Sprain
• Syndrome

Locations

Country	Name	City	State
United States	ATI	Bolingbrook	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
ATI Holdings, LLC

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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

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. — View Citation

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. — View Citation

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.

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. — View Citation

Risch NJ. Searching for genetic determinants in the new millennium. Nature. 2000 Jun 15;405(6788):847-56. Review. — View Citation

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

Sterne JA, Davey Smith G. Sifting the evidence-what's wrong with significance tests? BMJ. 2001 Jan 27;322(7280):226-31. Review. — View Citation

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. — View Citation

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

Wilt TJ. Uncertainty in prostate cancer care: the physician's role in clearing the confusion. JAMA. 2000 Jun 28;283(24):3258-60. — View Citation

Woolf SH. The need for perspective in evidence-based medicine. JAMA. 1999 Dec 22-29;282(24):2358-65. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in functional status		60 days
Secondary	Change in global health status		60 days