ATI Evidence-based Guide Investigating Clinical Services (AEGIS)

  • STATUS
    Recruiting
  • End date
    Jan 23, 2024
  • participants needed
    100000
  • sponsor
    ATI Holdings, LLC
Updated on 24 January 2022
treatment guidelines
Accepts healthy volunteers

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

Details
Condition Spine Osteoarthritis, Shoulder Impingement Syndrome, Knee Osteoarthritis, Hip Osteoarthritis, Osteoarthritis, Carpal Tunnel Syndrome, Fracture, Sprain
Clinical Study IdentifierNCT02285868
SponsorATI Holdings, LLC
Last Modified on24 January 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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