Cost-Effectiveness of Web-Based Follow Ups

• ClinicalTrials.gov Identifier: NCT01079572
• Recruitment Status: Completed
• First Posted: March 3, 2010
• Last Update Posted: February 7, 2013
• Sponsor: University of Western Ontario, Canada
• Collaborator: The Physicians' Services Incorporated Foundation
• Information provided by (Responsible Party): Dianne Bryant, University of Western Ontario, Canada

Tracking Information

• First Submitted Date: March 1, 2010
• First Posted Date: March 3, 2010
• Last Update Posted Date: February 7, 2013
• Study Start Date: February 2010
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 2, 2010): Cost-effectiveness [ Time Frame: one year ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 2, 2010)

• Harris Hip Score [ Time Frame: one year ]
• Western Ontario and McMaster Osteoarthritis Index (WOMAC) [ Time Frame: one year ]
• SF-12 [ Time Frame: one year ]
• Adverse events [ Time Frame: one year ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cost-Effectiveness of Web-Based Follow Ups
• Official Title: Cost-Effectiveness of Web-Based Follow Up Following Total Joint Arthroplasty

Brief Summary

Complications following total joint arthroplasty are rare, and the majority of follow-up visits are routine. The technology now exists to conduct annual follow-up assessments without having to physically see the patient.

This study will investigate the cost-effectiveness of web-based follow-up assessments compared to standard in-clinic follow-ups. We will also assess patient satisfaction, preference, and the validity of the web-based follow up assessments. Patients coming up to their 1 year follow-up or greater will be randomized to either the web-based group or the usual care group.

Web-based patients will complete all questionnaires using an online database system, and have their x-ray taken at their local radiology facility. The surgeon will review radiographs online. If there are any concerns with the x-ray or responses to questionnaires, arrangements will be made for the patient to be seen at the clinic. Patients in the Usual Care group will come into the clinic for their follow-up assessment and have their x-ray taken at University Hospital as usual.

Online assessment could significantly decrease wait times in orthopaedic clinics, as well as increase availability for OR time and new consultations. This approach could also potentially reduce patient burden by decreasing travel distances, financial burden and time requirements.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Health Services Research

Condition

• Osteoarthritis in the Knee Joint
• Osteoarthritis in the Hip Joint

Intervention

• Other: in-person
  Follow-up appointments will be completed in-person as per usual
• Other: web-based
  Patients who are at least 2 years following knee or hip replacement will complete a questionnaire online and routine x-rays at a PACS enabled imaging center. The patient's surgeon will receive an email from the database summarizing the patient's responses to key questions and will review the x-rays. The surgeon will determine whether the patient needs to be seen in-person.

Study Arms

• Experimental: web-based
  The patient will undergo xrays at the closest PACs enabled imaging centre and will login and answer questions online. The surgeon will review the images and patient responses and determine whether the patient needs to be seen more urgently or a per routine.
  Intervention: Other: web-based
• Active Comparator: in-person
  Patients will attend their follow-up appointments in-person as per usual
  Intervention: Other: in-person

Publications *

• Marsh J, Hoch JS, Bryant D, MacDonald SJ, Naudie D, McCalden R, Howard J, Bourne R, McAuley J. Economic evaluation of web-based compared with in-person follow-up after total joint arthroplasty. J Bone Joint Surg Am. 2014 Nov 19;96(22):1910-6. doi: 10.2106/JBJS.M.01558.
• Marsh JD, Bryant DM, MacDonald SJ, Naudie DD, McCalden RW, Howard JL, Bourne RB, McAuley JP. Feasibility, effectiveness and costs associated with a web-based follow-up assessment following total joint arthroplasty. J Arthroplasty. 2014 Sep;29(9):1723-8. doi: 10.1016/j.arth.2014.04.003. Epub 2014 Apr 13.
• Marsh J, Bryant D, MacDonald SJ, Naudie D, Remtulla A, McCalden R, Howard J, Bourne R, McAuley J. Are patients satisfied with a web-based followup after total joint arthroplasty? Clin Orthop Relat Res. 2014 Jun;472(6):1972-81. doi: 10.1007/s11999-014-3514-0. Epub 2014 Feb 22.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 6, 2013): 260
• Original Estimated Enrollment (submitted: March 2, 2010): 1000
• Actual Study Completion Date: March 2011
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• patients who have had a primary total hip or total knee arthroplasty

Exclusion Criteria:

• patients with osteolysis, or previous complications from their joint replacement

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01079572
• Other Study ID Numbers: PSI-2010-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dianne Bryant, University of Western Ontario, Canada
• Study Sponsor: University of Western Ontario, Canada
• Collaborators: The Physicians' Services Incorporated Foundation
• Investigators: Not Provided
• PRS Account: University of Western Ontario, Canada
• Verification Date: February 2013