跳至主要内容
临床试验/NCT03519087
NCT03519087终止不适用

Informed Decisions and Patient Outcomes: An Interdisciplinary Approach to Chronic Hip Pain

Ohio State University2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2018年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
112
试验地点
2
主要终点
Treatment Plan

研究概览

简要总结

The investigators aim to understand how interdisciplinary care influences decisions, expectations, and outcomes for patients with non-arthritic hip disease (NAHD). Patients presenting to the Ohio State University Wexner Medical Center (OSUWMC) Hip Preservation Clinic will be approached for participation. All participants will proceed with their scheduled, standard-care physician evaluation. Participants without NAHD will be excluded. Participants will then be randomized to receive a same-day physical therapist (PT) evaluation. This PT evaluation is not a standard-care practice in the clinic, this was added for research. All participants will complete expectation surveys before and after their evaluation(s). The clinicians will discuss their recommended plan with the patient and the patient will record a final treatment decision and outcome expectations. Participants will then be randomized to either receive posture and movement training (PMT) for 3 weeks or undergo a 3-week wait period. All participants will be required to withhold any treatment during this 3-week period (except PMT in the PMT group). The 3-week wait period for the no-PMT group is aligned with current clinical processes for time from physician evaluation to start of treatment. All participants may proceed with any further interventions (including PMT) after the 3-week period, but none will be provided/required as part of research. Patient-reported outcomes and clinical tests will be recorded before and after the 3-week period, and 3 and 6 months later. Adding a PT evaluation to the physician visit provides no additional risk because the PT evaluation includes similar clinical tests to the physician and movement analysis during tasks participants complete during daily life. Clinical tests before/after the 3-week intervention period may produce muscle soreness that should resolve within 2 days. Understanding how interdisciplinary care influences expectations and outcomes can inform clinicians regarding the effectiveness of interdisciplinary collaboration.

详细描述

The clinical evaluation by the physician is standard-of-care and performed as part of potential participants' scheduled appointment. Participants in this study will complete a HIPAA authorization to allow data from their clinical evaluation by the physician to be utilized for this study, including any imaging the physician used in their clinical evaluation and the evaluation note entered into the participant's electronic health record. The physician notes are standardized, allowing streamlined data analysis from the electronic health record.

Research activities to occur the same day as the informed consent process include randomization to receive or not receive a clinical evaluation by a physical therapist along with surveys for treatment decisions, expected outcomes, and patient-reported function. A small sub-group of patients will also complete interviews to identify how they felt about their evaluation that day. The HIPAA authorization will also allow the data from the physical therapy evaluation and any subsequent posture and movement training at OSUWMC to be utilized for this study.

Regardless of randomization to receive or not receive a same-day physical therapy evaluation in the physician clinic, all participants will be randomized to receive posture and movement training (PMT) or undergo a 3-week wait period. Participants who are randomized to receive PMT as part of this research study will schedule based on their availability, twice weekly for 3 weeks with an OSUWMC Sports Medicine physical therapist who also hold IRB-approved status as research personnel. Participants will be made aware during the informed consent process that any PMT they receive as part of this study will be their responsibility to pay for using either self-pay or insurance-based methods.

Participants who refuse randomization to receive PMT will be offered to participate in the observational group. These participants proceed with the same baseline and follow-up testing, but continue with their treatment-of-choice rather than an assigned treatment during the 3-week intervention period.

All participants will complete baseline and follow-up biomechanical and clinical follow-up testing in the Motion Analysis and Performance Laboratory. Biomechanical testing involves using 3-dimensional motion capture techniques to analyze movement during 3 functional tasks including walking, sit-to-stand, and a forward tap-down. Clinical testing involves obtaining anthropometric measures, hip strength, patient-reported function, and planned treatment decisions with respective expected outcomes. A small sub-group of patients will also complete interviews at these testing sessions to identify how they feel about the intervention (wait or posture & movement training).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Over 18 years old NAHD diagnosis

排除标准

  • Osteoporosis or rheumatoid arthritis
  • Systemic health condition
  • Legal representative required for treatment decisions
  • Bilateral symptoms
  • Current spine, hip, knee, or ankle surgery or major injury*
  • Pregnancy
  • Total hip arthroplasty candidate (Tönnis grade > 2)
  • Periacetabular osteotomy candidate (lateral center edge angle<20, anterior center edge angle<18, acetabular index >10)
  • Participants with history of spine, hip, knee, or ankle surgery or major injury will be evaluated by the physician to determine appropriateness for evaluation (and treatment) by a physical therapist

结局指标

主要结局

Treatment Plan

时间窗: Post-evaluation, same-day (approximately 5-10min after evaluation)

Participants will indicate their planned treatment(s)

Decisional Conflict

时间窗: Pre-evaluation, 10min Post-evaluation

Participants will report decisional conflict related to their treatment plan. Decisional conflict was measured using the Decisional Conflict Scale ranging from 0 (no conflict, better outcome) to 100 (high conflict, worse outcome).

次要结局

  • Themes From Provider Interviews(Pre-enrollment (2-7days before patient participant recruitment began), Post-enrollment (1-7 days after patient participant recruitment ended))
  • Participant Protocol Opinions(20min post-evaluation, 4 weeks post-evaluation)
  • Decisional Conflict(10min post-evaluation, 4-week laboratory visit)
  • Patient-reported Hip Function(10min post-evaluation, 4-week laboratory visit)
  • Movement Mechanics(Baseline laboratory visit, 4-week laboratory visit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephanie Di Stasi

Assistant Professor

Ohio State University

研究点 (2)

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