ATI Evidence-based Guide Investigating Clinical Services (AEGIS)

ATI Holdings, LLC

Status: Unknown

Conditions: Sprain; Osteoarthritis; Hip Osteoarthritis; Fracture; Spine Osteoarthritis; Carpal Tunnel Syndrome; Shoulder Impingement Syndrome; Knee Osteoarthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02285868

ATI EGIS01012015

Details and patient eligibility

About

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.

Full 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

Enrollment: 100,000 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100,000 participants in 6 patient groups

Arm, Shoulder and Hand injuries

Description:

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

Description:

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

Knee injuries

Description:

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

Foot and ankle injuries

Description:

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

Hip and lower extremity injuries

Description:

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

Neck injuries

Description:

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