Osteoarthritis Clinical Trial
Official title:
Feasibility Study: Does Screening Plus Patient Decision Aids Reduce Unnecessary Surgical Referrals for Total Joint Arthroplasty in Practices With Long Waiting Lists for Surgical Consults?
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 study objective is to pilot test the feasibility of a trial evaluating the effects of
patient decision aids on reducing unnecessary surgical referrals for total joint
replacement, when used in combination with a general practitioner run clinic to screen
patients with hip or knee osteoarthritis for surgical eligibility.
The investigators expect to provide evidence of feasibility (e.g. ease of recruiting
patients, delivering the interventions, measuring patient outcomes) and sample size needed
for a larger scale study. This study should also provide evidence for planning
implementation of the interventions and standardized training across other centers.
Background:
Current research priorities to manage wait times for total joint arthroplasty (TJA) indicate
the need to establish benchmarks that consider patient preferences. Among clinically
appropriate candidates for this procedure, patients' preferences for surgery is very low;
between 8.5 and 14.9% of clinically ideal candidates were definitely willing to consider
TJA.However, patients' preferences for hip or knee replacements are strongly associated with
their misperceptions of the indications for, and the risks and benefits of, these
procedures. These misperceptions can be corrected with the use of patient decision aids.
Therefore, patient decision aids may have a role in ensuring that wait list reforms address
under-use of surgical procedures that informed patients need and want, while preventing the
over-use of procedures that informed patients do not value. If they were used in combination
with screening for surgical eligibility, they might also prevent inappropriate referrals for
surgery (i.e., patients who are not clinically eligible or who would not want surgery even
if they were clinically eligible).
Objective:
To pilot test the feasibility of a trial evaluating the incremental effects of patient
decision aids on reducing unnecessary surgical referrals for TJA, when used in combination
with a general practitioner intake clinic that screens patients for surgical eligibility.
Participants & Setting:
Patients referred for surgical consultation for hip or knee osteoarthritis at The Ottawa
Hospital will be recruited. Excluded are those with inflammatory arthritis, previous TJA, or
those unable to understand video/DVD decision aids due to deafness, blindness, cognitive
impairment, or language barrier.
Design:
In this pilot study, patients will be screened for surgical eligibility by a trained general
practitioner using a standardized examination of the hip/knee and questionnaire assessing
joint symptoms and disability. Eligible patients will be stratified by affected joint
(hip/knee) and randomly allocated to either: a) usual education; or b) a patient decision
aid which presents balanced evidence-based information on the treatment options, including
the risks and benefits. Automated reports will be sent to the surgeon for all patients.
Primary Outcomes:
- Feasibility of participant recruitment, intervention provision, and data collection;
sample size needed to detect differences in the rates of unnecessary referral
Secondary Outcomes
- Proportion of unnecessary surgical referrals.
- Decision quality, the extent to which patients' decisions are informed and
values-based.
- Perception of Preparation for Decision Making.
Timeline and Deliverables:
By the end of this one year study, we will prepare a report and policy brief on the evidence
of feasibility to support a larger scale multi-centre trial and a fully implementable set of
interventions, with standardized training, to facilitate replication elsewhere.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
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