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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-24

Study Completion Date

2014-05-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prediction of Outcomes Following Total Knee Replacement- Pilot

NCT04328701

Osteoarthritis, Knee Knee Replacement

UNKNOWN NA

Prediction of Outcomes Following Total Knee Replacement

NCT01370421

Osteoarthritis

COMPLETED

Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses

NCT04850300

Total Knee Arthroplasty

ACTIVE_NOT_RECRUITING PHASE3

Progressive Rehabilitation Following Total Knee Arthroplasty

NCT01537328

Osteoarthritis

COMPLETED NA

Testing Implementation of Total Joint Replacement Rehabilitation Quality Indicator Toolkits

NCT06208553

Arthroplasty, Replacement, Hip Arthroplasty, Replacement, Knee

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis Degenerative Joint Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Care Navigator

Intervention Type BEHAVIORAL

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.

Usual Care Group

Subjects in the Usual Care group receive the current standard post-operative TKA care

Group Type ACTIVE_COMPARATOR

Standard Post-Operative TKA Care

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No