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

Are Patient Decision Aids for Total Joint Replacement Cost-effective and do They Optimize the Surgical Referral Process From Primary Care?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00911638
Enrollment
343
Registered
2009-06-02
Start date
2008-05-31
Completion date
2017-05-31
Last updated
2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Patient decision aids, Patient preferences, Osteoarthritis, Joint replacement, Waiting times

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.

Interventions

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).

BEHAVIORALUsual care

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

Sponsors

Foundation for Informed Medical Decision Making
CollaboratorOTHER
The Ottawa Hospital
CollaboratorOTHER
Queensway Carleton Hospital
CollaboratorOTHER
University of Ottawa
CollaboratorOTHER
University of Toronto
CollaboratorOTHER
University of Chicago
CollaboratorOTHER
Northwestern University Feinberg School of Medicine
CollaboratorOTHER
Northwestern University
CollaboratorOTHER
Dartmouth-Hitchcock Medical Center
CollaboratorOTHER
Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Total wait time for surgerySeptember 2010

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026