Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatments patient decision aid, usual care
Phase phase 3
Sponsor Ottawa Hospital Research Institute
Collaborator Foundation for Informed Medical Decision Making
Start date May 2008
End date January 2012
Trial size 340 participants
Trial identifier NCT00911638, FIMDM Research Grant 0099-1, OHRI-2006724

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(Experimental)
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
patient decision aid non applicable
Patients will receive i) Patient education:usual take home education brochure from recruiting hospital ii)a video/DVD PtDA for either hip (Treatment choices for hip osteoarthritis) or knee (Treatment choices for knee osteoarthritis) © Health Dialog 2005. iii) a personal decision form:an interactive form used by patients after the DVD to elicit their knowledge, values, preferred option, and perceptions of the decision making process. iv) Referred onward to the surgeon with their preferences for surgery using a standardized report of their clinical findings plus decisional data (knowledge, values, preference).
usual care non applicable
Patients will receive i) the usual take-home educational brochure available at the recruiting hospital describing preparation for surgery after the decision is made, recovery after surgery, and discharge plans. ii) Referral onward to surgeon with a standardized report of clinical findings only
(Active Comparator)
Usual patient educational resources for patients undergoing hip or knee replacement surgery.
usual care non applicable
Patients will receive i) the usual take-home educational brochure available at the recruiting hospital describing preparation for surgery after the decision is made, recovery after surgery, and discharge plans. ii) Referral onward to surgeon with a standardized report of clinical findings only

Primary Outcomes

Measure
Total wait time for surgery
time frame: September 2010

Secondary Outcomes

Measure
Surgery rates determined by the proportion of patients who proceed to surgery within 2 years
time frame: January 2012
Decision quality, the extent to which patients decisions are informed and values-based
time frame: September 2010
Cost effectiveness (including estimated effects on quality adjusted life expectancy and costs)
time frame: January 2016

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Are Patient Decision Aids for Total Joint Replacement Cost-effective and do They Optimize the Surgical Referral Process From Primary Care?
Principal investigator Dawn Stacey, RN PhD
Description This was not indicated as required.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Ottawa Hospital Research Institute.