Trial Outcomes & Findings for Adding Value in Knee Arthroplasty Post-total Knee Replacement (TKR) Care Navigator Trial (NCT NCT01540851)

NCT ID: NCT01540851

Last Updated: 2018-02-09

Results Overview

The change in functional status will be measured using the WOMAC Physical Function scale at Baseline and 6 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 308 participants
• Primary outcome timeframe: Change in functional status from baseline to 6 months
• Results posted on: 2018-02-09

Participant Flow

Subjects were recruited from a tertiary academic medical center in Boston, MA

Participant milestones

Measure	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	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
Overall Study STARTED	154	154
Overall Study COMPLETED	133	136
Overall Study NOT COMPLETED	21	18

Reasons for withdrawal

Measure	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	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
Overall Study Lost to Follow-up	14	15
Overall Study Withdrawal by Subject	7	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Care Navigator Intervention Group n=154 Participants 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	Usual Care Group n=154 Participants 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	Total n=308 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 8 • n=5 Participants	67 years STANDARD_DEVIATION 8 • n=7 Participants	66 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	93 Participants n=7 Participants	186 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	61 Participants n=7 Participants	122 Participants n=5 Participants
Region of Enrollment United States	154 participants n=5 Participants	154 participants n=7 Participants	308 participants n=5 Participants
BMI	31 kg/m^2 STANDARD_DEVIATION 6 • n=5 Participants	31 kg/m^2 STANDARD_DEVIATION 6 • n=7 Participants	31 kg/m^2 STANDARD_DEVIATION 6 • n=5 Participants
WOMAC Physical Function score	42 units on a scale STANDARD_DEVIATION 16 • n=5 Participants	41 units on a scale STANDARD_DEVIATION 19 • n=7 Participants	41 units on a scale STANDARD_DEVIATION 17 • n=5 Participants
WOMAC Pain score	42 units on a scale STANDARD_DEVIATION 16 • n=5 Participants	40 units on a scale STANDARD_DEVIATION 19 • n=7 Participants	41 units on a scale STANDARD_DEVIATION 18 • n=5 Participants

PRIMARY outcome

Timeframe: 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

The change in functional status will be measured using the WOMAC Physical Function scale at Baseline and 6 months

Outcome measures

Measure	Care Navigator Intervention Group n=133 Participants 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	Usual Care Group n=136 Participants 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
Change in WOMAC Physical Function	-30 units on a scale Interval -33.0 to -27.0	-27 units on a scale Interval -30.0 to -23.0

SECONDARY outcome

Timeframe: 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

Percentage of patients in each study arm who reported being very satisfied with the results of TKA

Outcome measures

Measure	Care Navigator Intervention Group n=133 Participants 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	Usual Care Group n=136 Participants 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
Satisfaction	80 percentage of participants	72 percentage of participants

SECONDARY outcome

Timeframe: 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

Percentage of participants able to bend knee at least 120 degrees

Outcome measures

Measure	Care Navigator Intervention Group n=133 Participants 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	Usual Care Group n=136 Participants 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
Range of Motion	70 percentage of participants	72 percentage of participants

Adverse Events

Care Navigator Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Care Navigator Intervention Group n=154 participants at risk 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	Usual Care Group n=154 participants at risk 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
General disorders Death	0.00% 0/154	0.65% 1/154 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Elena Losina, PhD

Brigham and Women's Hospital

Phone: 617-732-6928

Email: elosina@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place