Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-03 @ 8:26 AM
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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055013', 'term': 'Osteoarthritis, Spine'}, {'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D013180', 'term': 'Sprains and Strains'}], 'ancestors': [{'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100000}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-01', 'studyFirstSubmitDate': '2014-11-04', 'studyFirstSubmitQcDate': '2014-11-05', 'lastUpdatePostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in functional status', 'timeFrame': '60 days'}], 'secondaryOutcomes': [{'measure': 'Change in global health status', 'timeFrame': '60 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Orthopedic rehabilitation', 'Rehabilitation outcomes', 'Physical therapy', 'Physical therapy outcomes'], 'conditions': ['Spine Osteoarthritis', 'Shoulder Impingement Syndrome', 'Knee Osteoarthritis', 'Hip Osteoarthritis', 'Osteoarthritis', 'Carpal Tunnel Syndrome', 'Fracture', 'Sprain']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Institute of Medicine, Committee on Quality of Health Care in America. Crossing the Quality Chasm: A new Health System for the 21st Century. Washington, DC: National Academy; 2001.'}, {'type': 'BACKGROUND', 'citation': 'Straus SE, Glasziou P, Richardson WS, Haynes RB. Evidence-Based Medicine: How to Practice and Teach EBM. 4th ed. Edinburgh: Elsevier Churchill Livingstone; 2011.'}, {'pmid': '1404801', 'type': 'BACKGROUND', 'citation': 'Evidence-Based Medicine Working Group. Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA. 1992 Nov 4;268(17):2420-5. doi: 10.1001/jama.1992.03490170092032. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Bithell C. Evidence-based physiotherapy: Some thoughts on "best evidence". Physiotherapy. 2000; 86: 58-60.'}, {'pmid': '20179464', 'type': 'BACKGROUND', 'citation': 'Stillwell SB, Fineout-Overholt E, Melnyk BM, Williamson KM. Evidence-based practice, step by step: asking the clinical question: a key step in evidence-based practice. Am J Nurs. 2010 Mar;110(3):58-61. doi: 10.1097/01.NAJ.0000368959.11129.79.'}, {'pmid': '23431214', 'type': 'BACKGROUND', 'citation': 'Bernhardsson S, Larsson ME. Measuring evidence-based practice in physical therapy: translation, adaptation, further development, validation, and reliability test of a questionnaire. Phys Ther. 2013 Jun;93(6):819-32. doi: 10.2522/ptj.20120270. Epub 2013 Feb 21.'}, {'pmid': '10866876', 'type': 'BACKGROUND', 'citation': "Wilt TJ. Uncertainty in prostate cancer care: the physician's role in clearing the confusion. JAMA. 2000 Jun 28;283(24):3258-60. doi: 10.1001/jama.283.24.3258. No abstract available."}, {'pmid': '10612327', 'type': 'BACKGROUND', 'citation': 'Woolf SH. The need for perspective in evidence-based medicine. JAMA. 1999 Dec 22-29;282(24):2358-65. doi: 10.1001/jama.282.24.2358.'}, {'pmid': '21629165', 'type': 'BACKGROUND', 'citation': 'Croft P, Malmivaara A, van Tulder M. The pros and cons of evidence-based medicine. Spine (Phila Pa 1976). 2011 Aug 1;36(17):E1121-5. doi: 10.1097/BRS.0b013e318223ae4c. No abstract available.'}, {'pmid': '11159626', 'type': 'BACKGROUND', 'citation': "Sterne JA, Davey Smith G. Sifting the evidence-what's wrong with significance tests? BMJ. 2001 Jan 27;322(7280):226-31. doi: 10.1136/bmj.322.7280.226. No abstract available."}, {'pmid': '10866211', 'type': 'BACKGROUND', 'citation': 'Risch NJ. Searching for genetic determinants in the new millennium. Nature. 2000 Jun 15;405(6788):847-56. doi: 10.1038/35015718.'}, {'pmid': '22144612', 'type': 'BACKGROUND', 'citation': 'Jasny BR, Chin G, Chong L, Vignieri S. Data replication & reproducibility. Again, and again, and again .... Introduction. Science. 2011 Dec 2;334(6060):1225. doi: 10.1126/science.334.6060.1225. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Seligman MEP, Levant R. Managed care policies rely on inadequate science. Prof Psychol Res Pr. 1998; 29: 211-212.'}, {'pmid': '32285130', 'type': 'DERIVED', 'citation': 'Lutz AD, Brooks JM, Chapman CG, Shanley E, Stout CE, Thigpen CA. Risk Adjustment of the Modified Low Back Pain Disability Questionnaire and Neck Disability Index to Benchmark Physical Therapist Performance: Analysis From an Outcomes Registry. Phys Ther. 2020 Apr 17;100(4):609-620. doi: 10.1093/ptj/pzaa019.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nData 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.', 'detailedDescription': '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.\n\nIn 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:\n\nPatient Initial Assessment for Physical Therapy:\n\n* De-identified Protected Health Information in accordance to 45 CFR 164.514\n* Diagnosis and history Baseline functional outcome measure(s)\n* DASH (Disabilities of the Arm, Shoulder and Hand)\n* Modified Oswestry (lumbar spine)\n* Knee Outcome Survey\n* Foot \\& Ankle Ability Measure\n* Lower Extremity Functional Scale\n* Neck Disability Index Questionnaire\n* Pain rating\n* Global Rating of Change Scale\n* Baseline Quality of Life Questionnaire (SF-12)\n\nPatient Start of Care:\n\n* Patient information (age, BMI, sex, de-identified Protected Health Information in accordance to 45 CFR 164.514)\n* Medical/surgical history\n* Therapy review (diagnosis, therapy)\n* Treatment plan\n\nOngoing Patient Assessment:\n\n* De-identified Protected Health Information in accordance to 45 CFR 164.514\n* Treatment plan update(s)\n* Concurrent (every 10th visit) administration of functional outcome measure(s)\n* Concurrent (every 10th visit) administration of Quality of Life Questionnaire (SF-12)\n* Patient Satisfaction\n* Mailed to discharged patient within a week of discharge from physical therapy with a self-addressed, stamped return envelope Insurance Information\n* Insurance carriers\n* Insurance coverage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients presenting ith orthopedic rehabilitation needs', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anyone (over the age of 16, all sexes, and diagnoses) receiving physical therapy\n\nExclusion Criteria:\n\n* Is under age 16\n* Has no more than 2 visits/treatment experiences\n* Is seen only for an evaluation'}, 'identificationModule': {'nctId': 'NCT02285868', 'acronym': 'AEGIS', 'briefTitle': 'ATI Evidence-based Guide Investigating Clinical Services', 'organization': {'class': 'INDUSTRY', 'fullName': 'ATI Holdings, LLC'}, 'officialTitle': 'ATI Evidence-based Guide Investigating Clinical Services: Rehabilitation and Physical Therapy Patient Outcomes Registry', 'orgStudyIdInfo': {'id': 'ATI EGIS01012015'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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'}, {'label': 'Lumbar spine injuries', 'description': 'Pre- and post-treatment outcomes of care as measured by the Modified Oswestry (lumbar spine) via physical therapy'}, {'label': 'Knee injuries', 'description': 'Pre- and post-treatment outcomes of care as measured by the Knee Outcome Survey via physical therapy'}, {'label': 'Foot and ankle injuries', 'description': 'Pre- and post-treatment outcomes of care as measured by the Foot \\& Ankle Ability Measure via physical therapy'}, {'label': 'Hip and lower extremity injuries', 'description': 'Pre- and post-treatment outcomes of care as measured by the Lower Extremity Functional Scale via physical therapy'}, {'label': 'Neck injuries', 'description': 'Pre- and post-treatment outcomes of care as measured by the Neck Disability Index Questionnaire via physical therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60440', 'city': 'Bolingbrook', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chris E Stout, PsyD', 'role': 'CONTACT', 'email': 'chris.stout@atipt.com', 'phone': '630-296-2222', 'phoneExt': '7606'}, {'name': 'David Nelson', 'role': 'CONTACT', 'email': 'David.Nelson@atipt.com', 'phone': '6302962222'}], 'facility': 'ATI', 'geoPoint': {'lat': 41.69864, 'lon': -88.0684}}], 'centralContacts': [{'name': 'Chris Stout, PsyD', 'role': 'CONTACT', 'email': 'chris.stout@atipt.com', 'phone': '6302962222', 'phoneExt': '7606'}, {'name': 'David Nelson', 'role': 'CONTACT', 'email': 'David.Nelson@atipt.com', 'phone': '6302962222'}], 'overallOfficials': [{'name': 'Chris Stout, PsyD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ATI and College of Medicine, University of Illinois at Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ATI Holdings, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}