Degenerative Joint Disease, Osteoarthritis
Conditions
Keywords
Osteoarthritis, Total Knee Replacement, total Knee Arthroplasty, Post operative recovery, TKA, Post-operative recovery TKR, Care Navigator
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.
Interventions
BEHAVIORALCare 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.
OTHERStandard 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
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in WOMAC Physical Function | 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
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction | Measured at 6 months post TKA | Percentage of patients in each study arm who reported being very satisfied with the results of TKA |
| Range of Motion | 6 months after TKA | Percentage of participants able to bend knee at least 120 degrees |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from a tertiary academic medical center in Boston, MA
Participants by arm
| Arm | Count |
|---|---|
| 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
Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.
Subjects assigned to the usual Care group will receive current standard of post-operative care | 154 |
| Usual Care Group Subjects in the Usual Care group receive the current standard post-operative TKA care
Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.
Subjects assigned to the usual Care group will receive current standard of post-operative care | 154 |
| Total | 308 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 14 | 15 |
| Overall Study | Withdrawal by Subject | 7 | 3 |
Baseline characteristics
| Characteristic | Usual Care Group | Care Navigator Intervention Group | Total |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 8 | 66 years STANDARD_DEVIATION 8 | 66 years STANDARD_DEVIATION 8 |
| BMI | 31 kg/m^2 STANDARD_DEVIATION 6 | 31 kg/m^2 STANDARD_DEVIATION 6 | 31 kg/m^2 STANDARD_DEVIATION 6 |
| Region of Enrollment United States | 154 participants | 154 participants | 308 participants |
| Sex: Female, Male Female | 93 Participants | 93 Participants | 186 Participants |
| Sex: Female, Male Male | 61 Participants | 61 Participants | 122 Participants |
| WOMAC Pain score | 40 units on a scale STANDARD_DEVIATION 19 | 42 units on a scale STANDARD_DEVIATION 16 | 41 units on a scale STANDARD_DEVIATION 18 |
| WOMAC Physical Function score | 41 units on a scale STANDARD_DEVIATION 19 | 42 units on a scale STANDARD_DEVIATION 16 | 41 units on a scale STANDARD_DEVIATION 17 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 154 | 0 / 154 |
| serious Total, serious adverse events | 0 / 154 | 1 / 154 |
Outcome results
Primary
Change in WOMAC Physical Function
The change in functional status will be measured using the WOMAC Physical Function scale at Baseline and 6 months
Time frame: Change in functional status from baseline to 6 months
Population: The WOMAC Physical Function scale is scaled from 0 to 100, with 100 worst. Change in function was calculated as the WOMAC Physical Function score at 6 months minus the WOMAC Physical Function score at baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Care Navigator Intervention Group | Change in WOMAC Physical Function | -30 units on a scale |
| Usual Care Group | Change in WOMAC Physical Function | -27 units on a scale |
Secondary
Range of Motion
Percentage of participants able to bend knee at least 120 degrees
Time frame: 6 months after TKA
Population: Percentage of participants who self-reported on their 6 month questionnaire that they were able to bend their index knee to greater than 120 degrees
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Care Navigator Intervention Group | Range of Motion | 70 percentage of participants |
| Usual Care Group | Range of Motion | 72 percentage of participants |
Secondary
Satisfaction
Percentage of patients in each study arm who reported being very satisfied with the results of TKA
Time frame: Measured at 6 months post TKA
Population: The proportion of participants who reported being very satisfied with the results of TKA was assessed using a 5-item Likert scale on the 6 month follow-up questionnaire
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Care Navigator Intervention Group | Satisfaction | 80 percentage of participants |
| Usual Care Group | Satisfaction | 72 percentage of participants |