NCT03240913CompletedNot Applicable
A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty: Development and a Pilot Randomized Controlled Trial.
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Calgary
- Enrollment
- 163
- Locations
- 1
- Primary Endpoint
- Decision quality
Study Overview
Brief Summary
The primary objectives of this study are to: 1) develop an educational tool known as the Patient Reported Outcome Measure informed Decision Aid (PROM-DA) that will describe the options for patients considering total knee arthroplasty (TKA) surgery, and help them imagine what to expect if they choose either option; 2) assess the extent that the PROM-DA improves patients decision quality; 3) determine the feasibility of a larger trial to test the PROM-DA in multiple sites and more patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult (age≥30) patients with knee osteoarthritis (OA)
- •Have an appointment with a surgeon for consultation about Total Knee Arthroplasty at the Edmonton Bone and Joint Centre
- •Understands, speaks and reads English; and
- •Able to provide informed consent.
Exclusion Criteria
- •Individuals who have had prior total knee arthroplasty
- •Physician-diagnosed Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Fibromyalgia, or Gout.
Arms & Interventions
Treatment Group
Experimental
Intervention: Baseline and Follow-up Surveys (Behavioral)
Treatment Group
Experimental
Intervention: Patient Reported Outcome Measure informed Decision Aid (Other)
Non Treatment Group
Placebo Comparator
Conventional information
Intervention: Baseline and Follow-up Surveys (Behavioral)
Non Treatment Group
Placebo Comparator
Conventional information
Intervention: Pamphlet (Other)
Outcomes
Primary Outcomes
Decision quality
Time Frame: 40 to 52 weeks after baseline
Hip and Knee Decision Quality Instrument (HK-DQI)
Secondary Outcomes
- Values(Baseline)
- Surgery(27 to 30 weeks after baseline)
- Decisional conflict(Baseline)
- Preference for involvement in decision making(Baseline)
- Treatment Preference(Baseline)
- Patient-reported shared decision-making(3 to 6 weeks after baseline)
- Depression(40 to 52 weeks after baseline)
- Decisional regret(40 to 52 weeks after baseline)
- Concordance(40 to 52 weeks after baseline)
- Quality of life (condition-specific)(40 to 52 weeks after baseline)
- Quality of life (generic)(40 to 52 weeks after baseline)
- Knowledge about total knee arthroplasty surgery(Baseline)
- Willingness to have surgery(Baseline)
- Expectations(40 to 52 weeks after baseline)
- Surgical consult(1 to 4 weeks after baseline)
- Satisfaction with knee replacement surgery(40 to 52 weeks after baseline)
Investigators
Study Sites (1)
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