ATI Evidence-based Guide Investigating Clinical Services

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 16 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02285868
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

ATI Holdings, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Chris Stout, PsyD
Principal Investigator Affiliation ATI and College of Medicine, University of Illinois at Chicago
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Spine Osteoarthritis, Shoulder Impingement Syndrome, Knee Osteoarthritis, Hip Osteoarthritis, Osteoarthritis, Carpal Tunnel Syndrome, Fracture, Sprain
Additional Details

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

Arms & Interventions

Arms

: 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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

ATI, Bolingbrook, Illinois

Status

Recruiting

Address

ATI

Bolingbrook, Illinois, 60440

Site Contact

Chris E Stout, PsyD

[email protected]

630-296-2222 #7606