Clinical trial NCT03240913: A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty
Official title: A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty: Development and a Pilot Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Total Knee Arthroplasty
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of British Columbia
First posted: 2017-08-07
Enrollment: 163
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Decision quality
timeFrame: 40 to 52 weeks after baseline
Secondary outcomes:
measure: Quality of life (generic)
timeFrame: 40 to 52 weeks after baseline
measure: Quality of life (condition-specific)
timeFrame: 40 to 52 weeks after baseline
measure: Depression
timeFrame: 40 to 52 weeks after baseline
measure: Knowledge about total knee arthroplasty surgery
timeFrame: Baseline
measure: Values
timeFrame: Baseline
measure: Decisional conflict
timeFrame: Baseline
measure: Treatment Preference
timeFrame: Baseline
measure: Preference for involvement in decision making
timeFrame: Baseline
measure: Willingness to have surgery
timeFrame: Baseline
measure: Patient-reported shared decision-making
timeFrame: 3 to 6 weeks after baseline
measure: Decisional regret
timeFrame: 40 to 52 weeks after baseline
measure: Satisfaction with knee replacement surgery
timeFrame: 40 to 52 weeks after baseline
measure: Expectations
timeFrame: 40 to 52 weeks after baseline
measure: Surgical consult
timeFrame: 1 to 4 weeks after baseline
measure: Surgery
timeFrame: 27 to 30 weeks after baseline
measure: Concordance
timeFrame: 40 to 52 weeks after baseline
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Edmonton Bone and Joint Centre
state: Alberta
Study officials:
References:
citation: Bansback N, Trenaman L, MacDonald KV, Hawker G, Johnson JA, Stacey D, Marshall DA. An individualized patient-reported outcome measure (PROM) based patient decision aid and surgeon report for patients considering total knee arthroplasty: protocol for a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2019 Feb 23;20(1):89. doi: 10.1186/s12891-019-2434-2.