Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-26 @ 8:57 PM
Study NCT ID:
NCT02285868
Status:
UNKNOWN
Last Update Posted:
2019-07-02
First Post:
2014-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ATI Evidence-based Guide Investigating Clinical Services
Sponsor:
ATI Holdings, LLC
Organization:
Study Overview
Official Title:
ATI Evidence-based Guide Investigating Clinical Services: Rehabilitation and Physical Therapy Patient Outcomes Registry
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AEGIS
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.
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: