Cost-Effectiveness of Web-Based Follow Ups

This study has been completed.

Sponsor:

Collaborator:

The Physicians' Services Incorporated Foundation

Information provided by (Responsible Party):

Dianne Bryant, University of Western Ontario, Canada

ClinicalTrials.gov Identifier:

NCT01079572

First received: March 1, 2010

Last updated: February 6, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	March 1, 2010
Last Updated Date	February 6, 2013
Start Date ^ICMJE	February 2010
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 2, 2010)	Cost-effectiveness [ Time Frame: one year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01079572 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 2, 2010)	Harris Hip Score [ Time Frame: one year ] [ Designated as safety issue: No ] Western Ontario and McMaster Osteoarthritis Index (WOMAC) [ Time Frame: one year ] [ Designated as safety issue: No ] SF-12 [ Time Frame: one year ] [ Designated as safety issue: No ] Adverse events [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Cost-Effectiveness of Web-Based Follow Ups
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research
Condition ^ICMJE	Osteoarthritis in the Knee Joint Osteoarthritis in the Hip Joint
Intervention ^ICMJE	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 Arm (s)	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 *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	260
Completion Date	March 2011
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01079572
Other Study ID Numbers ^ICMJE	PSI-2010-01
Has Data Monitoring Committee	No
Responsible Party	Dianne Bryant, University of Western Ontario, Canada
Study Sponsor ^ICMJE	University of Western Ontario, Canada
Collaborators ^ICMJE	The Physicians' Services Incorporated Foundation
Investigators ^ICMJE	Not Provided
Information Provided By	University of Western Ontario, Canada
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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