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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 人开始时间: 2026年2月24日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
4,000,000
试验地点
1
主要终点
Change in functional status

研究概览

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

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

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)

研究者

发起方
ATI Holdings, LLC
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Natalie Myers

Director of Research

ATI Holdings, LLC

研究点 (1)

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