Overview

This trial is active, not recruiting.

Conditions osteoarthritis, degenerative joint disease
Treatment care navigator
Sponsor Brigham and Women's Hospital
Start date July 2011
End date March 2014
Trial size 300 participants
Trial identifier NCT01540851, 2010p002597

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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
(Active Comparator)
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

Primary Outcomes

Measure
Functional Status
time frame: Change in baseline function at 6 months

Secondary Outcomes

Measure
Satisfaction and cost effectiveness
time frame: Measured at 3 & 6 months post TKA
Range of Motion
time frame: Baseline, 3 and 6 months after TKA

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title Adding Value in Knee Arthroplasty Post TKR Care Navigator Trial
Principal investigator Elena Losina, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.