Adding Value in Knee Arthroplasty Post-total Knee Replacement (TKR) Care Navigator Trial
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA), Orthopedic |
| Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 2/11/2018 |
| Start Date: | July 24, 2011 |
| End Date: | May 10, 2014 |
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.
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.
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.
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.
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
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