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Adding Value in Knee Arthroplasty Post-total Knee Replacement (TKR) Care Navigator Trial (AViKA)

2018年1月16日 更新者:Elena Losina、Brigham and Women's Hospital

Adding Value in Knee Arthroplasty Post TKR Care Navigator Trial

The objectives of this research are to:

Conduct a proof of concept randomized controlled trial with up to 300 patients undergoing primary total knee replacement (TKA) at Brigham and Women's Hospital (BWH). The trial will compare a "Care Navigator" post-discharge intervention versus "Usual Care" post discharge management of patients undergoing TKA. The intervention will focus on the challenging process of transitions from the acute care hospital to inpatient or outpatient rehabilitation, and from inpatient rehabilitation to home.

The principal goals of the trial are:

  1. To establish whether "Care Navigator" intervention improves functional outcomes as compared with the "Usual Care" treatment six months after TKA surgery.
  2. To establish whether "Care Navigator" intervention is cost effective six months after TKA surgery.

The investigators hypothesize that:

  1. Incorporating the Care Navigator role into the "Usual Care" treatment will increase TKA patients' rate of adherence to the rehabilitation protocol and improve functional outcomes.
  2. Addition of a Care Navigator is cost-effective.

研究概览

详细说明

The "Post-TKA Care Navigator" proof of concept intervention will be implemented as a randomized controlled trial. The investigators aim to identify and enroll a cohort of up to 300 subjects who have decided to undergo total knee replacement (TKA) at BWH. Subjects will be patients of the five orthopedic surgeons at Brigham and Women's Hospital who perform the most TKAs: Drs. Wright, Brick, Ready, Martin and Thornhill. Subjects will be followed from about two weeks prior to the operation to six months after discharge.

The investigators will assign patients into two groups, at random: 1) receiving current standard of post-operative care and 2) adding "Post-TKA Care Navigator". The role of the Care Navigator will be to follow up with patients via frequent telephone conversations, ranging from weekly during the first month to bi-weekly for the next 6 weeks to monthly by the 14th week post op. subjects assigned to the care navigator will receive up to 10 telephone calls over a period of 5 months. The goal of the Care Navigator would be to ensure or encourage compliance with physical therapy, triage patient concerns, questions and complaints, and identify those patients that require a call from a clinician to address a problem in the recovery process. For those issues that can be resolved easily at home the navigator would suggest strategies. The value of the post-TKA Care Navigator will be assessed by comparing functional status, satisfaction with surgery, utilization of health care, adherence to physical therapy, range of knee motion and intervention costs across the two randomized groups.

研究类型

介入性

注册 (实际的)

308

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Brigham & Women's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Scheduled to undergo primary TKA at Brigham & Women's Hospital
  • Osteoarthritis is the principal underlying diagnosis
  • Age >=40 at the projected date of TKA
  • English-speaking

Exclusion Criteria:

  • Osteoarthritis is not the principal underlying diagnosis (e.g. inflammatory arthritis)
  • Dementia
  • Psychological issues that preclude participation, as identified by participating surgeons
  • Non-English speaker
  • Diagnosis other than Osteoarthritis or secondary Osteoarthritis
  • Age < 40 at the projected date of TKA
  • Lives in a nursing home
  • Implantation of Unicompartamental Knee Arthroscopy or Interpositional Arthroplasty
  • Bilateral TKA in same admission (simultaneous)or planned bilateral within 6 months

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Care Navigator Intervention Group
Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively
Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharge from the hospital for 5 months after their total knee replacement.
有源比较器:Usual Care Group
Subjects in the Usual Care group receive the current standard post-operative TKA care
Subjects assigned to the Standard Post-Operative TKA Care group will receive the current standard of care for post-operative care

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in WOMAC Physical Function
大体时间:Change in functional status from baseline to 6 months
The change in functional status will be measured using the WOMAC Physical Function scale at Baseline and 6 months
Change in functional status from baseline to 6 months

次要结果测量

结果测量
措施说明
大体时间
Satisfaction
大体时间:Measured at 6 months post TKA
Percentage of patients in each study arm who reported being very satisfied with the results of TKA
Measured at 6 months post TKA
Range of Motion
大体时间:6 months after TKA
Percentage of participants able to bend knee at least 120 degrees
6 months after TKA

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2011年7月24日

初级完成 (实际的)

2014年5月10日

研究完成 (实际的)

2014年5月10日

研究注册日期

首次提交

2012年2月21日

首先提交符合 QC 标准的

2012年2月23日

首次发布 (估计)

2012年2月29日

研究记录更新

最后更新发布 (实际的)

2018年2月9日

上次提交的符合 QC 标准的更新

2018年1月16日

最后验证

2018年1月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Care Navigator的临床试验

3
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