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

Not Applicable

Completed

Conditions: Degenerative Joint Disease
Osteoarthritis

Interventions: Behavioral: Care Navigator
Other: Standard Post-Operative TKA Care

Registration Number: NCT01540851

Lead Sponsor: Brigham and Women's Hospital

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 308

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Care Navigator Intervention Group	Care Navigator	Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively
Usual Care Group	Standard Post-Operative TKA Care	Subjects in the Usual Care group receive the current standard post-operative TKA care

Primary Outcome Measures

Name	Time	Method
Change in WOMAC Physical Function	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

Secondary Outcome Measures

Name	Time	Method
Range of Motion	6 months after TKA	Percentage of participants able to bend knee at least 120 degrees
Satisfaction	Measured at 6 months post TKA	Percentage of patients in each study arm who reported being very satisfied with the results of TKA