The AViKA (Adding Value in Knee Arthroplasty) postoperative care navigation trial: rationale and design features

Abstract

Background: Utilization of total knee arthroplasty is increasing rapidly. A substantial number of total knee arthroplasty recipients have persistent pain after surgery. Our objective was to design a randomized controlled trial to establish the efficacy of a motivational-interviewing-based telephone intervention aimed at improving patient outcomes and satisfaction following total knee arthroplasty.

Methods/design: The study was conducted at Brigham and Women's Hospital in Boston, Massachusetts. The study focused on individuals 40 years or older with a primary diagnosis of osteoarthritis who were scheduled for total knee arthroplasty. The study compared two management strategies over the first six months postoperatively: 1) enhanced postoperative care with frequent follow-up by a care navigator; 2) usual postoperative care. Those who were randomized into the enhanced postoperative care arm received ten calls from a trained non-clinician care navigator over the first six postoperative months. The navigator used motivational interviewing techniques to engage patients in discussions related to their rehabilitation goals, including patient's plans for and confidence in achieving those goals. Patients in the usual care arm received standard postoperative management and received no navigator phone calls. Patients in both arms were assessed at baseline, three months, and six months postoperatively.

Discussion: The primary outcome of the study was improvement in function as measured by the difference in Western Ontario and McMaster Universities Osteoarthritis Index function score between preoperative (baseline) status and six months postoperatively. Data were collected to identify factors that may be related to total knee arthroplasty outcomes, including preoperative pain, pain catastrophizing, self-efficacy, and depression. A formal economic analysis is also planned to determine the cost-effectiveness of the care navigator as a component of total knee arthroplasty care.

Trial registration: ClinicalTrials.gov NCT01540851.

Figures

Figure 1

AViKA treatment arms. This figure depicts the two treatment arms of the AViKA study: the care navigator arm and the usual care arm. Patients in both arms received questionnaires at baseline and post-operative months three and six. Patients in the care navigator arm also receive regular phone calls from the care navigator. The time points designated in parenthesis indicate the post-operative time point (that is, “Call from care navigator (week 4)” indicates that the care navigator called the patient one month after the date of the patient’s TKA).