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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

Tracking Information
First Submitted Date November 4, 2014
First Posted Date November 7, 2014
Last Update Posted Date January 9, 2018
Study Start Date November 2014
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 5, 2014)
Change in functional status [ Time Frame: 60 days ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02285868 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 5, 2014)
Change in global health status [ Time Frame: 60 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ATI Evidence-based Guide Investigating Clinical Services
Official Title ATI Evidence-based Guide Investigating Clinical Services: Rehabilitation and Physical Therapy Patient Outcomes Registry
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
Study Type Observational [Patient Registry]
Study Design Observational Model: Ecologic or Community
Time Perspective: Other
Target Follow-Up Duration 2 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients presenting ith orthopedic rehabilitation needs
Condition
  • Spine Osteoarthritis
  • Shoulder Impingement Syndrome
  • Knee Osteoarthritis
  • Hip Osteoarthritis
  • Osteoarthritis
  • Carpal Tunnel Syndrome
  • Fracture
  • Sprain
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 5, 2014)
100000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2024
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Chris Stout, PsyD 6302962222 ext 7606 chris.stout@atipt.com
Contact: David Nelson 6302962222 David.Nelson@atipt.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02285868
Other Study ID Numbers ATI EGIS01012015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ATI Holdings, LLC
Study Sponsor ATI Holdings, LLC
Collaborators Not Provided
Investigators
Principal Investigator: Chris Stout, PsyD ATI and College of Medicine, University of Illinois at Chicago
PRS Account ATI Holdings, LLC
Verification Date January 2018