A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty

University of Calgary

Status: Completed

Conditions: Knee Osteoarthritis; Total Knee Arthroplasty

Treatments: Other: Pamphlet; Other: Patient Reported Outcome Measure informed Decision Aid; Behavioral: Baseline and Follow-up Surveys

Study type: Interventional

Funder types: Other

Identifiers

NCT03240913

REB16-0869

Details and patient eligibility

About

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.

Enrollment: 163 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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163 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Treatment:

Behavioral: Baseline and Follow-up Surveys

Other: Patient Reported Outcome Measure informed Decision Aid

Non Treatment Group

Placebo Comparator group

Description:

Conventional information

Treatment:

Behavioral: Baseline and Follow-up Surveys

Other: Pamphlet