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

NCT01540851 | Completed Results

• 1 other identifier: 2010p002597
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief 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. 1.To establish whether "Care Navigator" intervention improves functional outcomes as compared with the "Usual Care" treatment six months after TKA surgery.
2. 2.To establish whether "Care Navigator" intervention is cost effective six months after TKA surgery.
3. 3.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.
4. 4.Addition of a Care Navigator is cost-effective.

Conditions

Osteoarthritis; Degenerative Joint Disease

Keywords

Osteoarthritis; Total Knee Replacement; total Knee Arthroplasty; Post operative recovery, TKA; Post-operative recovery TKR; Care Navigator

Outcome Measures

Primary Outcomes (1)

• Change in WOMAC Physical Function

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

  Change in functional status from baseline to 6 months

Secondary Outcomes (2)

• Satisfaction

  Measured at 6 months post TKA

• Range of Motion

  6 months after TKA

Study Arms (2)

Care Navigator Intervention Group

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

Behavioral: Care Navigator

Usual Care Group

ACTIVE COMPARATOR

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

Other: Standard Post-Operative TKA Care

Interventions

Care Navigator 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.

Care Navigator Intervention Group

Standard Post-Operative TKA Care OTHER

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

Usual Care Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• Losina E, Collins JE, Daigle ME, Donnell-Fink LA, Prokopetz JJ, Strnad D, Lerner V, Rome BN, Ghazinouri R, Skoniecki DJ, Katz JN, Wright J. The AViKA (Adding Value in Knee Arthroplasty) postoperative care navigation trial: rationale and design features. BMC Musculoskelet Disord. 2013 Oct 12;14:290. doi: 10.1186/1471-2474-14-290.

  PMID: 24119081 BACKGROUND

• Losina E, Collins JE, Wright J, Daigle ME, Donnell-Fink LA, Strnad D, Usiskin IM, Yang HY, Lerner V, Katz JN. Postoperative Care Navigation for Total Knee Arthroplasty Patients: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2016 Sep;68(9):1252-9. doi: 10.1002/acr.22829. Epub 2016 Jul 28.

  PMID: 26714179 RESULT

MeSH Terms

Conditions

Osteoarthritis; Joint Diseases

Condition Hierarchy (Ancestors)

Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Elena Losina, PhD
• Organization: Brigham and Women's Hospital

elosina@partners.org

617-732-6928

Study Officials

• Elena Losina, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Principal Investigator

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: February 29, 2012
• Study Start: July 24, 2011
• Primary Completion: May 10, 2014
• Study Completion: May 10, 2014
• Last Updated: February 9, 2018
• Results First Posted: February 19, 2016

Record last verified: 2018-01

Locations

US (1)