Adding Value in Knee Arthroplasty Post TKR Care Navigator Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 308
- 试验地点
- 2
- 主要终点
- Change in WOMAC Physical Function
研究概览
简要总结
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:
- To establish whether "Care Navigator" intervention improves functional outcomes as compared with the "Usual Care" treatment six months after TKA surgery.
- To establish whether "Care Navigator" intervention is cost effective six months after TKA surgery.
The investigators hypothesize that:
- 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.
- Addition of a Care Navigator is cost-effective.
详细描述
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Osteoarthritis is not the principal underlying diagnosis (e.g. inflammatory arthritis)
- •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
研究组 & 干预措施
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
干预措施: Care Navigator (Behavioral)
Usual Care Group
Subjects in the Usual Care group receive the current standard post-operative TKA care
干预措施: Standard Post-Operative TKA Care (Other)
结局指标
主要结局
Change in WOMAC Physical Function
时间窗: 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
次要结局
- Range of Motion(6 months after TKA)
- Satisfaction(Measured at 6 months post TKA)
研究者
Elena Losina
PhD, Principal Investigator
Brigham and Women's Hospital