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

A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty: Development and a Pilot Randomized Controlled Trial.

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 Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Total Knee Arthroplasty
• Intervention / Treatment: Behavioral: Baseline and Follow-up Surveys; Other: Patient Reported Outcome Measure informed Decision Aid; Other: Pamphlet

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5E 5R8
      • Edmonton Bone and Joint Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group	Behavioral: Baseline and Follow-up Surveys; (completed online); Other: Patient Reported Outcome Measure informed Decision Aid; (PROM-DA)
Placebo Comparator: Non Treatment Group; Conventional information	Behavioral: Baseline and Follow-up Surveys; (completed online); Other: Pamphlet; (usual care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision quality	Hip and Knee Decision Quality Instrument (HK-DQI)	40 to 52 weeks after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (generic)	Euroqol Five Dimensions Questionnaire (EQ-5D-5L)	40 to 52 weeks after baseline
Quality of life (condition-specific)	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	40 to 52 weeks after baseline
Depression	The Patient Health Questionnaire (PHQ-9)	40 to 52 weeks after baseline
Knowledge about total knee arthroplasty surgery	HK-DQI	Baseline
Values	HK-DQI	Baseline
Decisional conflict	Decisional Conflict Scale (SURE)	Baseline
Treatment Preference	Single item question: Do you feel the potential benefits of knee replacement surgery outweigh the potential surgical risks? Yes No Unsure	Baseline
Preference for involvement in decision making	Control Preferences Scale (CPS)	Baseline
Willingness to have surgery	Single item question: Based on your current understanding of the risks and benefits of knee replacement surgery of your knee arthritis, what is your current preference between having joint replacement surgery or non-surgical treatments? I would definitely consider having knee joint replacement surgery now. I would probably consider having knee joint replacement surgery now. I am not sure. I would probably not consider having knee joint replacement surgery now. I would definitely not consider having knee joint replacement surgery now.	Baseline
Patient-reported shared decision-making	CollaboRATE	3 to 6 weeks after baseline
Decisional regret	Decision Regret Scale	40 to 52 weeks after baseline
Satisfaction with knee replacement surgery	Three item questionnaire: Overall, how satisfied are you with the results of your knee replacement surgery?; How satisfied are you with your knee replacement surgery for reducing your pain when walking on a flat surface? Going up or down stairs? Sitting or lying down?; How satisfied are you with your most recent knee replacement surgery for improving your ability to perform five functions: Going up stairs? Getting in/out of a car or on/off a bus? Rising from bed? Lying in bed? Performing light domestic duties? Responses from 'very dissatisfied' to ' very satisfied'	40 to 52 weeks after baseline
Expectations	Single item question from Bourne et al. 2010. Clin Orthop Relat Res. related to whether expectations were met; not met; or whether they had no expectations.	40 to 52 weeks after baseline
Surgical consult	Electronic Medical Records (EMR)	1 to 4 weeks after baseline
Surgery	EMR	27 to 30 weeks after baseline
Concordance	HK-DQI	40 to 52 weeks after baseline

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: University of British Columbia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Actual): October 18, 2018
• Study Completion (Actual): March 3, 2020

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: REB16-0869

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No