Simultaneous Physiotherapy and Orthopedic Surgeon Interdisciplinary Care (SPOSIC) (SPOSIC)

Simultaneous Physiotherapy and Orthopedic Surgeon Interdisciplinary Care

This study will test a protocol to implement simultaneous physiotherapy and orthopedic surgeon interdisciplinary care for patients undergoing knee replacement surgery. These interdisciplinary sessions will help tailor personalized goals, involving the patient as a key member of the team.

Study Overview

• Status: Not yet recruiting
• Conditions: Arthritis; Osteoarthritis, Knee
• Intervention / Treatment: Behavioral: Receives interdisciplinary sessions

Detailed Description

The purpose of this project is to test a quality improvement protocol to improve outcomes following knee arthroplasty surgery utilizing simultaneous physiotherapy and orthopedic surgeon interdisciplinary care. In an era of increasing demands on health care budgets, it is vital to improve quality of care without substantially increasing its cost. This study will focus on a quality improvement strategy that aims to redeploy existing resources to achieve higher quality care without substantially altering costs. This interdisciplinary approach involves establishing a high functioning team that includes the patient as a pivotal member and builds collaboration in the pre-operative period that can be leveraged in the post-operative period to achieve optimal outcomes. This differs from traditional, siloed care for knee arthroplasty.

Participants will be involved in usual care surrounding knee arthroplasty which includes education sessions and pre-habilitation pre-operatively and rehabilitation post-operatively. Participants will also attend two interdisciplinary sessions at 2 months and 1 month prior to surgery to outline expectations, explore patients' questions and concerns, set expectations for the next interdisciplinary session, and ensure goal congruence between all members of the team. At each of these sessions a physical assessment will also be completed by the orthopedic surgeon and physiotherapist. Following surgery, participants will attend four more interdisciplinary sessions at 2 weeks, 6 weeks, 3 months, and 6 months post-operatively. These sessions will address safety and medical issues, revisit patient expectations, reinforce care team expectations, focus on a personalized rehabilitation plan, and ensure goal congruence between the various team members. The physical assessment will also be repeated.

The objectives of the study are as follows:

1. Evaluate the feasibility (e.g., recruitment and retention, administrative and participant burden, lived experiences) of treating knee arthroplasty patients through a novel interdisciplinary program aimed to optimize recovery among patients; and
2. Estimate the size of the program's effect on biopsychosocial outcomes among community-dwelling individuals undergoing knee arthroplasty and rehabilitation.

The hypotheses of the study are as follows:

1. The protocol will establish proof-of-concept, and demonstrate sufficient feasibility to support a future full-scale multi-site RCT.
2. Simultaneous physiotherapy and orthopedic surgery interdisciplinary care (SPOSIC) will improve the primary outcome of functional disability, as measured by the 12-item Oxford Knee score (OKS), and improvements will also be shown in the secondary outcomes of pain, participation in social roles, health-related quality of life, and mobility.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Holly Wise; Phone Number: 250.558-9140; Email: holly.wise@interiorhealth.ca
• Study Contact Backup: Name: Brodie Sakakibara, PhD; Email: brodie.sakakibara@ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 19 years of age or older
2. Expecting to undergo knee arthroplasty surgery within 12 months
3. Pain or functional limitation due to the musculoskeletal condition
4. Able to walk 10 meters without physical assistance
5. Able to tolerate 50 minutes of activity (including rest breaks, as needed)
6. Have adequate cognitive-communicative ability to participate (based on clinical judgment of the research team)
7. Able to provide informed consent

Exclusion Criteria:

1. Are living in long-term care
2. Have significant neurological conditions
3. Are medically unstable
4. Have medical condition(s) significantly impacting lower extremity function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Receives interdisciplinary sessions; Interdisciplinary care by a team that includes: orthopedic surgeon, physiotherapist, a patient navigator, and the patient

Behavioral: Receives interdisciplinary sessions; Along with usual care, participants receive six interdisciplinary sessions at 2 months and 1 month pre-operatively and 2 weeks, 6 weeks, 3 months, and 6 months post-operatively attended by an orthopedic surgeon, a physiotherapist, a patient navigator, and the patient. The pre-operative interdisciplinary sessions will outline expectations, explore patients' questions and concerns, set expectations for the next interdisciplinary session, and ensure goal congruence between all members of the team. Along with usual care during the post-operative period, participants will receive interdisciplinary sessions that address safety and medical issues, revisit patient expectations, reinforce care team expectations, focus on a personalized rehabilitation plan, and ensure goal congruence between the various team members.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Oxford Knee Score Questionnaire	Subjectively measures functional ability. Minimum score: 0. Maximum score: 48. Higher score indicates better outcome.	Baseline, Post-intervention (immediately after 6 month post-op intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Visual Analogue Scale	Subjective measurement of pain. Minimum score: 0cm. Maximum score: 10cm. Lower score indicates better outcome.	Baseline, Post-intervention (immediately after 6 month post-op intervention)
Change in Keele Assessment of Participation Questionnaire	Subjective measurement of social role participation restrictions. Minimum score: 0. Maximum score: 44. Higher score indicates better outcome.	Baseline, Post-intervention (immediately after 6 month post-op intervention)
Change in EuroQol 5D3L Questionnaire	Subjective measurement of health-related quality of life. Minimum score: 0.0. Maximum score: 1.0. Higher score indicates better outcome.	Baseline, Post-intervention (immediately after 6 month post-op intervention)
Change in Timed Up and Go Test	Objectively measures mobility. Minimum score: 0s. Maximum score: unlimited s. A lower score indicates a better outcome.	Baseline, Post-intervention (immediately after 6 month post-op intervention)
Satisfaction Survey	Measures participants' satisfaction or dissatisfaction with the intervention. Scores ranked from strongly disagree to strongly agree. Strongly agree indicates a participant was more satisfied with the intervention.	Post-intervention (immediately after 6 month post-op intervention)
Semi-structured interview	Open-ended questions regarding participants' attitudes and satisfaction with the program and areas for improvement	Post-intervention (immediately after 6 month post-op intervention)

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Interior Health
• Investigators: Principal Investigator: Brodie Sakakibara, PhD, The University of British Columbia

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Estimate): December 26, 2022

Study Record Updates

• Last Update Posted (Estimate): December 26, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: rehabilitation; arthroplasty; interdisciplinary
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: SPOSIC

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