CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 308 enrolled
Drug / intervention
Care Navigator +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01540851
NCT01540851N/ACompleted

Adding Value in Knee Arthroplasty Post TKR Care Navigator Trial

Brigham and Women's Hospital·interventional·Posted Feb 29, 2012·Updated Feb 9, 2018

In Brief

A clinical study evaluating Care Navigator and Standard Post-Operative TKA Care for Osteoarthritis and Degenerative Joint Disease. Completed, enrolled 308 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 29, 2012
Enrollment StartJul 24, 2011
Primary CompletionMay 10, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.3 years ago

Interventions

Care Navigatorbehavioral

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.

Standard Post-Operative TKA Careother

Subjects assigned to the Standard Post-Operative TKA Care group will receive the current standard of care for post-operative care