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临床试验/NCT02285868
NCT02285868
进行中(未招募)
不适用

ATI Evidence-Based Guide Investigating Clinical Services: Rehabilitation and Physical Therapy Patient Outcomes Registry

ATI Holdings, LLC1 个研究点 分布在 1 个国家目标入组 4,000,000 人2026年2月24日

概览

阶段
不适用
干预措施
Arm, Shoulder and Hand injuries
疾病 / 适应症
未指定
发起方
ATI Holdings, LLC
入组人数
4000000
试验地点
1
主要终点
Change in functional status
状态
进行中(未招募)
最后更新
上个月

概览

简要总结

The goal of this study is to evaluate how standard-of-care outpatient rehabilitation is delivered and how variation in care delivery mechanisms relates to clinical outcomes, service utilization, and value in patients receiving physical or occupational therapy. The study will focus on patients with musculoskeletal (MSK) conditions receiving physical or occupational therapy.

The focus is to use existing standard-of-care documentation in a physical therapy (PT) electronic medical record (EMR) to evaluate patient characteristics, interventions delivered, utilization management, and clinical outcomes in routine outpatient PT care, in order to generate evidence to improve clinical effectiveness and quality of care. Researchers will compare different care delivery mechanisms to see if variations lead to significant differences in outcomes.

Participants will have their standard-of-care documentation analyzed, including routine clinical measures, objective/functional measures, and patient-reported outcomes. They will not be directly involved in research interventions or randomization. This study does not involve a research intervention, randomization, or alteration of clinical care. It is a retrospective cohort study analyzing existing standard-of-care documentation from ATI's physical therapy EMR.

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.

详细描述

Musculoskeletal (MSK) conditions are prevalent1 and contribute substantially to healthcare utilization and cost. Physical therapy is a non-surgical, non-pharmacological intervention that can be clinically effective and cost-effective for many MSK presentations, with a large proportion of patients improving without requiring escalation of care. In the context of evolving reimbursement and value-based care pressures, it is increasingly important to understand the clinical effectiveness, utilization patterns, and value implications of PT as delivered in routine outpatient practice. (1-6) To address these priorities, investigators from ATI and the University of South Carolina are interested in evaluating how standard-of-care outpatient rehabilitation is delivered and how variation in care delivery mechanisms relates to clinical outcomes, service utilization, and value. In this retrospective study, we will conduct secondary analyses of existing standard-of-care documentation within ATI's PT EMR, without altering clinical care or interacting with patients. Care delivery mechanisms of interest include, but are not limited to: (1) delivery mode (in-clinic, telehealth, remote therapeutic moderating (RTM), and hybrid models when documented); (2) use of care extenders (PTAs/Technicians) when identifiable in documentation; (3) specialty service lines and provider qualifications (e.g., Women's Health, Hand Therapy, Vestibular Therapy, Work Comp/Work Hardening, advanced training/certifications); and (4) types of interventions delivered (e.g., exercise therapy, manual therapy, therapeutic modalities), as documented as part of routine care. (7-9) ATI is a large national outpatient MSK provider delivering physical and occupational therapy services. Investigators have previously used ATI clinical outcomes resources (e.g., the ATI EMR) to characterize care patterns, evaluate outcomes and measurement properties, and explore predictors of utilization behaviors such as canceled visits. The present protocol extends this work by leveraging existing standard-of-care EMR documentation to evaluate patient characteristics, interventions delivered, utilization management patterns, and clinical and objective/functional outcomes in routine outpatient care, producing evidence to inform clinical effectiveness, quality improvement, implementation efforts, and policy-relevant value questions. (4,10-13) This study is a retrospective cohort study existing standard-of-care documentation from the ATI physical therapy EMR (including routinely collected clinical measures, objective/functional measures, and patient-reported outcomes) for patients receiving physical or occupational therapy beginning January 1, 2016. All interventions referenced in the dataset represent usual care delivered as part of clinical practice and were not assigned for research purposes. Primary Objective: To use existing standard-of-care documentation in a physical therapy (PT) electronic medical record (EMR) to evaluate patient characteristics, interventions delivered, utilization management, and clinical outcomes in routine outpatient PT care, in order to generate evidence to improve clinical effectiveness and quality of care Specific Aims Clinical Research (effectiveness in real-world practice) 1)Use retrospective EMR data to evaluate the real-world effectiveness of standard-of-care PT services (including prevention programs, interventions, and educational efforts) for prevalent MSK conditions by examining changes in routinely captured clinical outcomes, objective/functional measures, and patient-reported outcomes over an episode of care. Heath Policy (Value, cost-efficiency, and care pathways) Use retrospective EMR data to examine PT utilization management and its association with quality, effectiveness, and cost-efficiency across care pathways and practice patterns (e.g., visit authorization patterns, visit frequency, episode duration, time to evaluation, gaps in care, and discharge disposition). When available within the data environment, analyses will also evaluate downstream indicators of value such as opioid utilization, return to function/work/sport, and relationships between outcomes and utilization/cost to inform value-based care and payer-relevant questions. Implementation and Quality Improvement (Adoption + data quality) Evaluate implementation and sustainability of routine clinical practices by assessing patterns of adoption of assessments/interventions, variation in care delivery, completeness of outcome capture (PROMs/objective tests), patient satisfaction, and resource/service utilization-informing strategies to improve consistent data capture and quality. Sports Medicine (Athlete lifecycle + RTS decision-making) Among sports/athlete episodes (as identifiable in the EMR), evaluate the effectiveness of sports medicine rehabilitation services across the athlete lifecycle-including risk screening where captured, rehabilitation outcomes, and criteria-based return-to-sport/return-to-function outcomes when documented.

注册库
clinicaltrials.gov
开始日期
2026年2月24日
结束日期
2029年2月24日
最后更新
上个月
研究类型
Observational
性别
All

研究者

发起方
ATI Holdings, LLC
责任方
Principal Investigator
主要研究者

Natalie Myers

Director of Research

ATI Holdings, LLC

入排标准

入选标准

  • This study involves retrospective secondary analysis of existing standard-of-care documentation from ATI's outpatient rehabilitation EMR. There will be no prospective data collection, no recruitment, and no interaction with patients.
  • After a patient's episode of care is completed (discharge or last recorded visit), the PI will identify eligible encounters based on prespecified inclusion/

排除标准

  • (e.g., outpatient PT/OT services at ATI on or after January 1, 2016.

研究组 & 干预措施

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

结局指标

主要结局

Change in functional status

时间窗: 60 days

次要结局

  • Change in global health status(60 days)

研究点 (1)

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