Clinical trial NCT02285868: ATI Evidence-based Guide Investigating Clinical Services
Official title: ATI Evidence-based Guide Investigating Clinical Services: Rehabilitation and Physical Therapy Patient Outcomes Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spine Osteoarthritis
Shoulder Impingement Syndrome
Knee Osteoarthritis
Hip Osteoarthritis
Osteoarthritis
Carpal Tunnel Syndrome
Fracture
Sprain
Keywords: Orthopedic rehabilitation
Rehabilitation outcomes
Physical therapy
Physical therapy outcomes
Lead sponsor: ATI Holdings, LLC
Sponsor class: INDUSTRY
First posted: 2014-11-07
Enrollment: 100000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting ith orthopedic rehabilitation needs

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.

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

Eligibility 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

Primary outcomes:
measure: Change in functional status
timeFrame: 60 days
Secondary outcomes:
measure: Change in global health status
timeFrame: 60 days
Other outcomes:
Locations:
city: Bolingbrook
country: United States
facility: ATI
state: Illinois
Study officials:
affiliation: ATI and College of Medicine, University of Illinois at Chicago
name: Chris Stout, PsyD
role: PRINCIPAL_INVESTIGATOR
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