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

Primary Purpose

Osteoarthritis, Knee, Arthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Receives interdisciplinary sessions
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring arthroplasty, rehabilitation, interdisciplinary

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 19 years of age or older Expecting to undergo knee arthroplasty surgery within 12 months Pain or functional limitation due to the musculoskeletal condition Able to walk 10 meters without physical assistance Able to tolerate 50 minutes of activity (including rest breaks, as needed) Have adequate cognitive-communicative ability to participate (based on clinical judgment of the research team) Able to provide informed consent Exclusion Criteria: Are living in long-term care Have significant neurological conditions Are medically unstable Have medical condition(s) significantly impacting lower extremity function

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Receives interdisciplinary sessions

    Arm Description

    Interdisciplinary care by a team that includes: orthopedic surgeon, physiotherapist, a patient navigator, and the patient

    Outcomes

    Primary Outcome Measures

    Change in Oxford Knee Score Questionnaire
    Subjectively measures functional ability. Minimum score: 0. Maximum score: 48. Higher score indicates better outcome.

    Secondary Outcome Measures

    Change in Pain Visual Analogue Scale
    Subjective measurement of pain. Minimum score: 0cm. Maximum score: 10cm. Lower score indicates better outcome.
    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.
    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.
    Change in Timed Up and Go Test
    Objectively measures mobility. Minimum score: 0s. Maximum score: unlimited s. A lower score indicates a better outcome.
    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.
    Semi-structured interview
    Open-ended questions regarding participants' attitudes and satisfaction with the program and areas for improvement

    Full Information

    First Posted
    December 1, 2022
    Last Updated
    December 21, 2022
    Sponsor
    University of British Columbia
    Collaborators
    Interior Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05664724
    Brief Title
    Simultaneous Physiotherapy and Orthopedic Surgeon Interdisciplinary Care (SPOSIC)
    Acronym
    SPOSIC
    Official Title
    Simultaneous Physiotherapy and Orthopedic Surgeon Interdisciplinary Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of British Columbia
    Collaborators
    Interior Health

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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: 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 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: The protocol will establish proof-of-concept, and demonstrate sufficient feasibility to support a future full-scale multi-site RCT. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee, Arthritis
    Keywords
    arthroplasty, rehabilitation, interdisciplinary

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Receives interdisciplinary sessions
    Arm Type
    Experimental
    Arm Description
    Interdisciplinary care by a team that includes: orthopedic surgeon, physiotherapist, a patient navigator, and the patient
    Intervention Type
    Behavioral
    Intervention Name(s)
    Receives interdisciplinary sessions
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Oxford Knee Score Questionnaire
    Description
    Subjectively measures functional ability. Minimum score: 0. Maximum score: 48. Higher score indicates better outcome.
    Time Frame
    Baseline, Post-intervention (immediately after 6 month post-op intervention)
    Secondary Outcome Measure Information:
    Title
    Change in Pain Visual Analogue Scale
    Description
    Subjective measurement of pain. Minimum score: 0cm. Maximum score: 10cm. Lower score indicates better outcome.
    Time Frame
    Baseline, Post-intervention (immediately after 6 month post-op intervention)
    Title
    Change in Keele Assessment of Participation Questionnaire
    Description
    Subjective measurement of social role participation restrictions. Minimum score: 0. Maximum score: 44. Higher score indicates better outcome.
    Time Frame
    Baseline, Post-intervention (immediately after 6 month post-op intervention)
    Title
    Change in EuroQol 5D3L Questionnaire
    Description
    Subjective measurement of health-related quality of life. Minimum score: 0.0. Maximum score: 1.0. Higher score indicates better outcome.
    Time Frame
    Baseline, Post-intervention (immediately after 6 month post-op intervention)
    Title
    Change in Timed Up and Go Test
    Description
    Objectively measures mobility. Minimum score: 0s. Maximum score: unlimited s. A lower score indicates a better outcome.
    Time Frame
    Baseline, Post-intervention (immediately after 6 month post-op intervention)
    Title
    Satisfaction Survey
    Description
    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.
    Time Frame
    Post-intervention (immediately after 6 month post-op intervention)
    Title
    Semi-structured interview
    Description
    Open-ended questions regarding participants' attitudes and satisfaction with the program and areas for improvement
    Time Frame
    Post-intervention (immediately after 6 month post-op intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 19 years of age or older Expecting to undergo knee arthroplasty surgery within 12 months Pain or functional limitation due to the musculoskeletal condition Able to walk 10 meters without physical assistance Able to tolerate 50 minutes of activity (including rest breaks, as needed) Have adequate cognitive-communicative ability to participate (based on clinical judgment of the research team) Able to provide informed consent Exclusion Criteria: Are living in long-term care Have significant neurological conditions Are medically unstable Have medical condition(s) significantly impacting lower extremity function
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Holly Wise
    Phone
    250.558-9140
    Email
    holly.wise@interiorhealth.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Brodie Sakakibara, PhD
    Email
    brodie.sakakibara@ubc.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brodie Sakakibara, PhD
    Organizational Affiliation
    The University of British Columbia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Simultaneous Physiotherapy and Orthopedic Surgeon Interdisciplinary Care (SPOSIC)

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