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Completed

NCT Number: NCT01540851

Adding Value in Knee Arthroplasty Post-total Knee Replacement (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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Care Navigator

Behavioral

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.

Standard Post-Operative TKA Care

Other

Subjects assigned to the Standard Post-Operative TKA Care group will receive the current standard of care for post-operative care

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Range of Motion

    Time frame: 6 months after TKA

    Percentage of participants able to bend knee at least 120 degrees

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Adding Value in Knee Arthroplasty Post TKR Care Navigator Trial

Acronym: AViKA

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 29, 2012
Registry last updated
Feb 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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