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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Degenerative Joint Disease
• Intervention / Treatment: Behavioral: Care Navigator; Other: Standard Post-Operative TKA Care

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.

• Study Type: Interventional
• Enrollment (Actual): 308
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in WOMAC Physical Function	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction	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	Percentage of participants able to bend knee at least 120 degrees	6 months after TKA

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Publications and helpful links

General Publications

• Losina E, Collins JE, Daigle ME, Donnell-Fink LA, Prokopetz JJ, Strnad D, Lerner V, Rome BN, Ghazinouri R, Skoniecki DJ, Katz JN, Wright J. The AViKA (Adding Value in Knee Arthroplasty) postoperative care navigation trial: rationale and design features. BMC Musculoskelet Disord. 2013 Oct 12;14:290. doi: 10.1186/1471-2474-14-290.
• Losina E, Collins JE, Wright J, Daigle ME, Donnell-Fink LA, Strnad D, Usiskin IM, Yang HY, Lerner V, Katz JN. Postoperative Care Navigation for Total Knee Arthroplasty Patients: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2016 Sep;68(9):1252-9. doi: 10.1002/acr.22829. Epub 2016 Jul 28.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2011
• Primary Completion (Actual): May 10, 2014
• Study Completion (Actual): May 10, 2014

Study Registration Dates

• First Submitted: February 21, 2012
• First Submitted That Met QC Criteria: February 23, 2012
• First Posted (Estimate): February 29, 2012

Study Record Updates

• Last Update Posted (Actual): February 9, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Osteoarthritis; Total Knee Replacement; total Knee Arthroplasty; Post-operative recovery TKR; Post operative recovery, TKA; Care Navigator
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases
• Other Study ID Numbers: 2010p002597