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

NCT01540851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2018-02-09

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Care 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.

OTHER

Standard 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 & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Elena Losina, PhD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-24
Primary Completion
2014-05-10
Completion
2014-05-10

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01540851 on ClinicalTrials.gov