Cost-Effectiveness of Web-Based Follow Ups

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ClinicalTrials.gov Identifier: NCT01079572

Recruitment Status : Completed

First Posted : March 3, 2010

Last Update Posted : February 7, 2013

Sponsor:

Collaborator:

The Physicians' Services Incorporated Foundation

Information provided by (Responsible Party):

Dianne Bryant, University of Western Ontario, Canada

Tracking Information

First Submitted Date ^ICMJE

March 1, 2010

First Posted Date ^ICMJE

March 3, 2010

Last Update Posted Date

February 7, 2013

Study Start Date ^ICMJE

February 2010

Actual Primary Completion Date

March 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cost-effectiveness [ Time Frame: one year ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

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 ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 Arms ^ICMJE

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 *

* 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

Actual Enrollment ^ICMJE

260

Original Estimated Enrollment ^ICMJE

1000

Actual Study Completion Date ^ICMJE

March 2011

Actual 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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

Child, Adult, Older Adult

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Canada

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01079572

Other Study ID Numbers ^ICMJE

PSI-2010-01

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

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

PRS Account

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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