Adding Value in Knee Arthroplasty Post-total Knee Replacement (TKR) Care Navigator Trial (AViKA)
|ClinicalTrials.gov Identifier: NCT01540851|
Recruitment Status : Completed
First Posted : February 29, 2012
Results First Posted : February 19, 2016
Last Update Posted : February 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Degenerative Joint Disease||Behavioral: Care Navigator Other: Standard Post-Operative TKA Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||308 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Adding Value in Knee Arthroplasty Post TKR Care Navigator Trial|
|Actual Study Start Date :||July 24, 2011|
|Actual Primary Completion Date :||May 10, 2014|
|Actual Study Completion Date :||May 10, 2014|
Active Comparator: 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
Behavioral: Care Navigator
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.
Active Comparator: Usual Care Group
Subjects in the Usual Care group receive the current standard post-operative TKA care
Other: 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
- Change in WOMAC Physical Function [ Time Frame: 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
- Satisfaction [ Time Frame: Measured at 6 months post TKA ]Percentage of patients in each study arm who reported being very satisfied with the results of TKA
- Range of Motion [ Time Frame: 6 months after TKA ]Percentage of participants able to bend knee at least 120 degrees
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540851
|United States, Massachusetts|
|Brigham & Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Elena Losina, PhD||Brigham and Women's Hospital|