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ATI Evidence-based Guide Investigating Clinical Services (AEGIS)

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ClinicalTrials.gov Identifier: NCT02285868
Recruitment Status : Recruiting
First Posted : November 7, 2014
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
ATI Holdings, LLC

Brief 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.


Condition or disease
Spine Osteoarthritis Shoulder Impingement Syndrome Knee Osteoarthritis Hip Osteoarthritis Osteoarthritis Carpal Tunnel Syndrome Fracture Sprain

Detailed 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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100000 participants
Observational Model: Ecologic or Community
Time Perspective: Other
Target Follow-Up Duration: 2 Months
Official Title: ATI Evidence-based Guide Investigating Clinical Services: Rehabilitation and Physical Therapy Patient Outcomes Registry
Study Start Date : November 2014
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024


Group/Cohort
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
Lumbar spine injuries
Pre- and post-treatment outcomes of care as measured by the Modified Oswestry (lumbar spine) via physical therapy
Knee injuries
Pre- and post-treatment outcomes of care as measured by the Knee Outcome Survey via physical therapy
Foot and ankle injuries
Pre- and post-treatment outcomes of care as measured by the Foot & Ankle Ability Measure via physical therapy
Hip and lower extremity injuries
Pre- and post-treatment outcomes of care as measured by the Lower Extremity Functional Scale via physical therapy
Neck injuries
Pre- and post-treatment outcomes of care as measured by the Neck Disability Index Questionnaire via physical therapy



Primary Outcome Measures :
  1. Change in functional status [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. Change in global health status [ Time Frame: 60 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients presenting ith orthopedic rehabilitation needs
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285868


Contacts
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Contact: Chris Stout, PsyD 6302962222 ext 7606 chris.stout@atipt.com
Contact: David Nelson 6302962222 David.Nelson@atipt.com

Locations
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United States, Illinois
ATI Recruiting
Bolingbrook, Illinois, United States, 60440
Contact: Chris E Stout, PsyD    630-296-2222 ext 7606    chris.stout@atipt.com   
Contact: David Nelson    6302962222    David.Nelson@atipt.com   
Sponsors and Collaborators
ATI Holdings, LLC
Investigators
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Principal Investigator: Chris Stout, PsyD ATI and College of Medicine, University of Illinois at Chicago

Additional Information:

Publications:
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.
Straus SE, Glasziou P, Richardson WS, Haynes RB. Evidence-Based Medicine: How to Practice and Teach EBM. 4th ed. Edinburgh: Elsevier Churchill Livingstone; 2011.
Bithell C. Evidence-based physiotherapy: Some thoughts on "best evidence". Physiotherapy. 2000; 86: 58-60.
Seligman MEP, Levant R. Managed care policies rely on inadequate science. Prof Psychol Res Pr. 1998; 29: 211-212.

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Responsible Party: ATI Holdings, LLC
ClinicalTrials.gov Identifier: NCT02285868     History of Changes
Other Study ID Numbers: ATI EGIS01012015
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Keywords provided by ATI Holdings, LLC:
Orthopedic rehabilitation
Rehabilitation outcomes
Physical therapy
Physical therapy outcomes

Additional relevant MeSH terms:
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Syndrome
Osteoarthritis
Osteoarthritis, Knee
Carpal Tunnel Syndrome
Osteoarthritis, Hip
Shoulder Impingement Syndrome
Osteoarthritis, Spine
Spondylarthritis
Disease
Pathologic Processes
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Shoulder Injuries
Spondylitis
Spinal Diseases
Bone Diseases