Clinical trial NCT01540851: Adding Value in Knee Arthroplasty Post-total Knee Replacement (TKR) Care Navigator Trial
Official title: Adding Value in Knee Arthroplasty Post TKR Care Navigator Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Degenerative Joint Disease
Keywords: Osteoarthritis
Total Knee Replacement
total Knee Arthroplasty
Post operative recovery, TKA
Post-operative recovery TKR
Care Navigator
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2012-02-29
Enrollment: 308
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in WOMAC Physical Function
timeFrame: Change in functional status from baseline to 6 months
Secondary outcomes:
measure: Satisfaction
timeFrame: Measured at 6 months post TKA
measure: Range of Motion
timeFrame: 6 months after TKA
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Elena Losina, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.