Comparison of Ways to Prepare Patients for Decisions About Joint Replacement Surgery

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Behavioral: Patient decision aid; Behavioral: Usual care

• Registration Number: NCT00911638
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

Ministries of Health consider wait lists for total joint replacement a top priority. Research priorities to manage wait lists indicate the need to establish benchmarks that consider patient preferences. However, patients' preferences for hip or knee replacements are strongly associated with their misperceptions of the indicators for, and the risks and benefits of, these procedures. These misperceptions can be corrected with the use of patient decision aids. When decision aids are used in combination with assessing surgical eligibility, there may be a reduction in unnecessary referrals for surgery either because the patient is ineligible or because the eligible candidates make informed decisions to forgo this option. The primary study objective is to evaluate the effect of patient decision aids (PtDAs) on total wait times (wait times for surgical consultation, plus wait times for surgery) when used in combination with a general practitioner run clinic to screen patients with hip or knee osteoarthritis for surgical eligibility. Major secondary objectives include determining (a) the effect of PtDAs on surgery rates within two years, (b) the effect of PtDAs on decision quality, and (c) cost-effectiveness of PtDAs for total joint arthroplasty.

Detailed Description

This was not indicated as required.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-05-29
• Study First Submitted QC: 2009-05-29
• Study First Posted: 2009-06-02
• Primary Completion: 2012-01
• Study Completion: 2017-05
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 343

Inclusion Criteria

• Patients referred for surgical consultation for hip or knee osteoarthritis
• WOMAC and HKPT scores indicate that pain and functional criteria are rated as moderate or severe, or there is radiographic evidence of joint damage

Exclusion Criteria

• Patients with inflammatory arthritis
• Patients who have had previous TJA
• Patients unable to understand video/DVD decision aids due to deafness, blindness, cognitive impairment, or language barrier

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Patient decision aid	Patient decision aid	Patient decision aid focused on treatment options for osteoarthritis of the hip or knee and preference report for surgeons. The patient decision aid used is from the Informed Medical Decisions Foundation
1: Patient decision aid	Usual care	Patient decision aid focused on treatment options for osteoarthritis of the hip or knee and preference report for surgeons. The patient decision aid used is from the Informed Medical Decisions Foundation
2: Usual care	Usual care	Usual patient educational resources for patients undergoing hip or knee replacement surgery.

Primary Outcome Measures

Name	Time	Method
Total wait time for surgery	September 2010

Secondary Outcome Measures

Name	Time	Method
Surgery rates determined by the proportion of patients who proceed to surgery within 2 years	January 2012
Decision quality, the extent to which patients decisions are informed and values-based	September 2010
Cost effectiveness (including estimated effects on quality adjusted life expectancy and costs)	December 2017	This phase was delayed to have 5 years of follow-up data on all participants

Trial Locations

Locations (2)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Queensway Carleton Hospital; 🇨🇦 Ottawa, Ontario, Canada