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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Ottawa Hospital Research Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Foundation for Informed Medical Decision Making
The Ottawa Hospital
Queensway Carleton Hospital
University of Ottawa
University of Toronto
University of Chicago
Feinberg School of Medicine, Northwestern University
Northwestern University
Dartmouth-Hitchcock Medical Center
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00911638
First received: May 29, 2009
Last updated: March 15, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Behavioral: Patient decision aid and referral onward.
Behavioral: Patient education and referral onward
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Are Patient Decision Aids for Total Joint Replacement Cost-effective and do They Optimize the Surgical Referral Process From Primary Care?

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Total wait time for surgery [ Time Frame: September 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surgery rates determined by the proportion of patients who proceed to surgery within 2 years [ Time Frame: September 2010 ] [ Designated as safety issue: No ]
  • Decision quality, the extent to which patients decisions are informed and values-based [ Time Frame: September 2010 ] [ Designated as safety issue: No ]
  • Cost effectiveness (including estimated effects on quality adjusted life expectancy and costs) [ Time Frame: September 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 340
Study Start Date: May 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patient decision aid and referral onward
Behavioral: Patient decision aid and referral onward.

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 Name: non applicable
Active Comparator: 2
Patient education and referral onward
Behavioral: Patient education and referral onward

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 Name: non applicable

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911638

Locations
Canada, Ontario
Queensway Carleton Hospital
Ottawa, Ontario, Canada, K2H 8P4
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 1J7
Sponsors and Collaborators
Ottawa Hospital Research Institute
Foundation for Informed Medical Decision Making
The Ottawa Hospital
Queensway Carleton Hospital
University of Ottawa
University of Toronto
University of Chicago
Feinberg School of Medicine, Northwestern University
Northwestern University
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Dawn Stacey, RN PhD Ottawa Hospital Research Institute
  More Information

Publications:
Responsible Party: Dr Dawn Stacey, University of Ottawa School of Nursing
ClinicalTrials.gov Identifier: NCT00911638     History of Changes
Other Study ID Numbers: OHRI-2006724, FIMDM Research Grant 0099-1
Study First Received: May 29, 2009
Last Updated: March 15, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
Patient decision aids
Patient preferences
Osteoarthritis
Joint replacement
Waiting times

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 27, 2014