A Trial to Establish Realistic Patient Expectations of Total Knee Replacement

NCT01732562 | Completed

• 1 other identifier: 103027
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 1

Brief Summary

Patients from the Joint Replacement Institute scheduled to undergo primary total knee replacement surgery (TKR) will be invited to participate at the Pre Admission Clinic (PAC), University Hospital, London Health Sciences Centre. Baseline questionnaires of preoperative measures and demographic information and a cost analysis will be explored at the PAC for each patient. Patients will be randomized with the treatment group receiving access to a web-based, e-learning intervention. Postoperatively all patients will be asked to complete questionnaires at 6 weeks, 3 months and 1 year after their TKR surgery. Objectives The first primary objective is to compare the effect of two methods of providing patient education on expectations of surgical outcome in total knee replacement (TKR) patients. The second objective is to compare the effect of two methods of providing patient education on satisfaction with surgical outcome in TKR patients. The intervention of interest is an e-learning education program that spans both the preoperative and postoperative time period. The control condition will be the current method of patient education provided at the hospital study site. Hypothesis: Objective One More change in patient expectations will occur between preoperative and one year postoperative in the e-learning educational intervention group. Hypothesis: Objective Two More change in patient satisfaction will occur between preoperative and one year postoperative in the e-learning educational intervention group.

Conditions

Osteoarthritis

Keywords

Primary Total Knee Arthroplasty; Patient Expectations; Patient Satisfaction; Patient Education; e-Learning

Outcome Measures

Primary Outcomes (1)

• Patient Expectations

  Patient Expectations will be measured with four distinct domains using single questions related to pain; ability to perform activities of daily living (ADL); ability to participate in sports and global recovery from surgery. Responses are given using a 0 to four scale, with 0 assigned for a not applicable response option: 1= no, I do not expect surgery to help with my pain/ADL/etc., 2= yes, but just a little, 3= yes, somewhat, 4= yes, a lot.

  Change in Patient Expectations from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.

Secondary Outcomes (1)

• Patient Satisfaction

  Change in Patient Satisfaction from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.

Other Outcomes (8)

• Knee Society Score: Pre-Op

  Change in Knee Society Score: Pre-Op from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Change in KOOS from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.

• Short Form-12 (SF-12) Health Survey

  Change in SF-12 from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.

Study Arms (2)

Control

NO INTERVENTION

Patient receives the standard of care.

Patient e-Learning educational tool

EXPERIMENTAL

Patient receives the standard of care and access to patient e-Learning educational tool.

Other: Patient e-Learning educational tool

Interventions

Patient e-Learning educational tool OTHER

Web based site with videos of TKR surgical animation, demonstrations of exercises and activities following surgery and conversations with surgeons, physiotherapist, occupational therapist and patients.

Also known as: NewKnees.ca

Patient e-Learning educational tool

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• diagnosis of primary or secondary osteoarthritis of the knee
• scheduled for primary total knee replacement by Joint Replacement Institute orthopaedic surgeons at University Hospital, London Health Sciences Centre
• access to a computer (to log on to the web-based e-learning intervention)

You may not qualify if:

• unable to read written English or understand spoken English
• unable to provide informed consent
• diagnosis of rheumatoid arthritis
• scheduled for knee revision, patellar resurfacing, hemiarthroplasty of the knee, unicompartmental (unicondylar) knee arthroplasty or high tibial osteotomy, or knee surgery due to a tumor or trauma
• unable to access a computer (to log on to the web-based e-learning intervention)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Canadian Orthopaedic Foundation: collaborator

Study Sites (1)

London Health Sciences Centre, University hospital

London, Ontario, N6A 5A5, Canada

Location

Related Publications (1)

• Culliton SE, Bryant DM, MacDonald SJ, Hibbert KM, Chesworth BM. Effect of an e-Learning Tool on Expectations and Satisfaction Following Total Knee Arthroplasty: A Randomized Controlled Trial. J Arthroplasty. 2018 Jul;33(7):2153-2158. doi: 10.1016/j.arth.2018.02.040. Epub 2018 Feb 17.

  PMID: 29555496 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Patient Satisfaction

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Bert M Chesworth, PhD

  The University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 26, 2012
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 10, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)