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Completed

NCT Number: NCT00911638

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Behavior Health Behavior Joint Diseases Musculoskeletal Diseases Patient Preference Patient Satisfaction Rheumatic Diseases Treatment Adherence and Compliance

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queensway Carleton Hospital, Ottawa, Ontario, Canada

Loading trial locations.

About this study

This was not indicated as required.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Decision Aid

Behavioral

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).

Other names: non applicable

Usual Care

Behavioral

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

Other names: non applicable

Primary outcomes

  1. Total wait time for surgery

    Time frame: September 2010

Secondary outcomes

  1. Surgery rates determined by the proportion of patients who proceed to surgery within 2 years

    Time frame: January 2012

  2. Decision quality, the extent to which patients decisions are informed and values-based

    Time frame: September 2010

  3. Cost effectiveness (including estimated effects on quality adjusted life expectancy and costs)

    Time frame: December 2017

    This phase was delayed to have 5 years of follow-up data on all participants

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Dartmouth-Hitchcock Medical Center
  • Foundation for Informed Medical Decision Making
  • Northwestern University
  • Queensway Carleton Hospital
  • The Ottawa Hospital
  • University of Chicago
  • University of Ottawa
  • University of Toronto

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2017
First posted
Jun 2, 2009
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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