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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Elena Losina, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01540851
First received: February 21, 2012
Last updated: January 22, 2016
Last verified: January 2016
History of Changes
  Purpose

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.

Condition Intervention
Osteoarthritis
Degenerative Joint Disease
 Behavioral: Care Navigator
Other: Standard Post-Operative TKA Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adding Value in Knee Arthroplasty Post TKR Care Navigator Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change in WOMAC Physical Function [ Time Frame: Change in functional status from baseline to 6 months ] [ Designated as safety issue: No ]
    The change in functional status will be measured using the WOMAC Physical Function scale at Baseline and 6 months


Secondary Outcome Measures:
  • Satisfaction [ Time Frame: Measured at 6 months post TKA ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Percentage of participants able to bend knee at least 120 degrees
Enrollment: 308
Study Start Date: July 2011
Estimated Study Completion Date: November 2018
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540851

Locations
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Elena Losina, PhD Brigham and Women's Hospital
  More Information

Publications:

Responsible Party: Elena Losina, PhD, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01540851     History of Changes
Other Study ID Numbers: 2010p002597 
Study First Received: February 21, 2012
Results First Received: December 16, 2015
Last Updated: January 22, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Osteoarthritis
Total Knee Replacement
total Knee Arthroplasty
 Post operative recovery, TKA
Post-operative recovery TKR
Care Navigator

Additional relevant MeSH terms:
Osteoarthritis
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 27, 2016