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Wadey RCT MSK Short Case Simulations With FMED

Primary Purpose

Musculoskeletal Diseases or Conditions

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational Tool
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Musculoskeletal Diseases or Conditions

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with an MSK condition included in the education tool of MSK Short Case Simulations 1-20 (Upper extremity; lower extremity; axial skeleton; trauma and MSK infections Patients) seen either in a family medicine clinic; emergency department; clinical ward in the hospital setting or sporting event at which FMRL were covering from a learners perspective Patients assessed by FMRLs between the months of July 2023 through to March 2024 Patient must be free of cognitive impairment and be able to complete an English survey or have a translator present to assist with the translation Electronic devices to accommodate QR codes Exclusion Criteria: non-English speaking participants an inability to complete QR codes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    FMRL CTL-PGY1 (Post Graduate Year 1) and FMRL CTL - PGY2 (Post Graduate Year 2)

    FMRL EXP - PGY1 and FMRL EXP - PGY2

    Arm Description

    This arm of participants reflects family medicine resident learners (FMRLs) who will not be exposed to the 1-20 MSK case simulations.

    This arm of participants reflects family medicine resident learners (FMRLs) who will be exposed to the 1-20 MSK case simulations.

    Outcomes

    Primary Outcome Measures

    Participant demographics
    Questionnaire (Qualitative analyses)
    Pre and Post-test questionnaires for each of the 20 MSK short case simulations - paired T-tests
    Knowledge questions
    Satisfaction questionnaire for EXP group on the educational experience of the MSK case simulations- qualitative analyses
    The participants completing the 20 MSK short case simulations will complete a satisfaction questionnaire of the case simulations
    Patient experience of their individual clinical encounter with the FMRL
    the patients will complete a link to a QR code (5 minutes) and indicate their level of satisfaction of their clinical encounter with the FMRL
    Educator evaluation of a FMRL
    An educator who would normally supervisor the FMRL with patients would complete a link to a QR code (2 minutes) and indicate the competency of the FMRL
    Focus group
    All participants will meet at the end of the study/academic year to review the process and their participation in the study

    Secondary Outcome Measures

    Full Information

    First Posted
    May 5, 2023
    Last Updated
    June 19, 2023
    Sponsor
    Sunnybrook Health Sciences Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05914922
    Brief Title
    Wadey RCT MSK Short Case Simulations With FMED
    Official Title
    Musculoskeletal (MSK) Educational Tool and Impact on Patients Randomized Control Trial - Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2024 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sunnybrook Health Sciences Centre

    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
    Study Agent/ Intervention/ Procedure The educational tool consisted of 20 short (MSK) case simulations of 15 minutes duration reflecting conditions of the upper extremity; lower extremity; spine; trauma and MSK infections were developed, reviewed and integrated into links that also contained demographic questionnaires; pre and post simulation knowledge questions and learner satisfaction surveys. Outcome Measures Demographic questionnaire for the Learner; 100 MCQ (multiple-choice questionnaire) reflecting the same questions contained in the 20 MSK Short Case Simulations Pre/Post multiple choice question knowledge questionnaire Learner satisfaction questionnaire Patient experience and satisfaction questionnaire - QR Code Educator evaluation questionnaire - QR Code Focus group questionnaire Primary Objectives To determine if learners working through the 20 MSK Short Case Simulations delivered through on-line links would improve their knowledge, skills and satisfaction in learning how to identify and initially manage patients with various MSK conditions when compared to learners not exposed to the same educational tool. To determine patients' experience undergoing one of the 20 MSK assessments and initial management of their various MSK conditions by the learners and their satisfaction in receiving their initial care management in both groups To determine if the assessment and initial management of the 20 MSK conditions by the learners on the patients was deemed to be competent by the educators in both groups
    Detailed Description
    This study is an educational study and the intervention is the 20 Short Case Simulations. The educational tool consists of 20 short (MSK) case simulations of 15 minutes duration reflecting conditions of the upper extremity; lower extremity; spine; trauma and MSK infections. They've been developed, reviewed and integrated into links that also contain demographic questionnaires; pre and post simulation knowledge questions and learner satisfaction surveys. MSK complaints comprise up to 30% to 40% of primary care visits. Despite this, MSK curriculum vary widely among institutions, and there is little consistency in how physicians in training are prepared to treat MSK disorders. To address this need, these modules were developed specifically for frontline healthcare providers and a full content review was completed to generate an educational tool. The review and refinement process indicated the presence of a statistical difference when comparing post to pre-test knowledge scores; high internal consistency (Chronbach Alpha) and strong satisfaction scores among all participant learners. Primary Hypothesis: 1. The study hypotheses that the family medicine resident learners being exposed at the start of an academic year to the MSK short case simulations will benefit their assessment and initial management of patients with 20 MSK conditions and that patient experiences will be enhanced when compared to family resident learners not exposed to the same educational tool. Secondary Hypotheses: The study hypothesize that the confounding variable of self-initiated learning of MSK content by family medicine residents not exposed to the 20 MSK case simulations may result in an increase in knowledge and skills and patient satisfaction. The study further hypothesize that self-directed learning on the part of both CTL (Control) and EXP (Experimental) groups may lead to increase in knowledge and skills that may be a confounding variable reflected in the retention T3 scores. The study is a Randomized Control Trial. Learners from the SBHSC Family Medicine Residency Training Program (FMRLs) will be recruited into this educational study from July 2nd, 2023 through to May 2024. Patients undergoing assessment and initial management of one of the 20 MSK Short Case Simulations will be recruited during the same study time period of June 2023 through to March 1 2024. Educators providing supervision of the FMRLs (Family Medicine Residents) and management of patients' MSK conditions will be recruited to participate during the same time period of July 2, 2023 through to March 1, 2024. Study Agent/ Intervention/ Procedure The educational tool consisted of 20 short (MSK) case simulations of 15 minutes duration reflecting conditions of the upper extremity; lower extremity; spine; trauma and MSK infections were developed, reviewed and integrated into links that also contained demographic questionnaires; pre and post simulation knowledge questions and learner satisfaction surveys. Outcome Measures Demographic questionnaire for the Learner; 100 MCQ questionnaire reflecting the same questions contained in the 20 MSK Short Case Simulations Pre/Post multiple choice question knowledge questionnaire Learner satisfaction questionnaire Patient experience and satisfaction questionnaire - QR Code Educator evaluation questionnaire - QR Code Focus group questionnaire Sample Size Calculation: N=24 Data Analysis Survey Monkey will be used to collect and analyze the data and SAS ( Statistical Analysis System) Version 9.4 or later will be used for statistical analyses QR Code will be utilized to collect the information from the patients in the learning environments where MSK conditions are being assessed and initially managed QR codes will be provided to the education supervisors after each clinical encounter of the FMRL to be assessed for competence Qualitative analysis will be done assessing for knowledge and skills resulting from the MSK Short Case Simulations Qualitative analysis will be completed on the focus group data that will determine information pertaining to the overall learning experience

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Musculoskeletal Diseases or Conditions

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Phase I pertained to the development of authentic MSK case presentations. These cases were formulated into case presentations and a full content review was completed for each of the 20 MSK conditions. Phase II will now assess the impact of the case simulations on learning and patient care.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    FMRL CTL-PGY1 (Post Graduate Year 1) and FMRL CTL - PGY2 (Post Graduate Year 2)
    Arm Type
    No Intervention
    Arm Description
    This arm of participants reflects family medicine resident learners (FMRLs) who will not be exposed to the 1-20 MSK case simulations.
    Arm Title
    FMRL EXP - PGY1 and FMRL EXP - PGY2
    Arm Type
    Experimental
    Arm Description
    This arm of participants reflects family medicine resident learners (FMRLs) who will be exposed to the 1-20 MSK case simulations.
    Intervention Type
    Other
    Intervention Name(s)
    Educational Tool
    Intervention Description
    20 MSK short case simulations were developed based on authentic patient experiences. Strategies to optimize learning of MSK conditions to prepare learners for real-world clinical encounters would be important for family medicine resident learners. To address this need, 20 case simulations of 15 minute duration were developed. This study will determine if an online educational tool may be impactful for determining competency of family medicine resident learners in developing skills and knowledge of 20 MSK conditions while also determining if the tool impacts patient care and satisfaction.
    Primary Outcome Measure Information:
    Title
    Participant demographics
    Description
    Questionnaire (Qualitative analyses)
    Time Frame
    up to 7 months
    Title
    Pre and Post-test questionnaires for each of the 20 MSK short case simulations - paired T-tests
    Description
    Knowledge questions
    Time Frame
    up to 7 months
    Title
    Satisfaction questionnaire for EXP group on the educational experience of the MSK case simulations- qualitative analyses
    Description
    The participants completing the 20 MSK short case simulations will complete a satisfaction questionnaire of the case simulations
    Time Frame
    up to 7 months
    Title
    Patient experience of their individual clinical encounter with the FMRL
    Description
    the patients will complete a link to a QR code (5 minutes) and indicate their level of satisfaction of their clinical encounter with the FMRL
    Time Frame
    up to 7 months
    Title
    Educator evaluation of a FMRL
    Description
    An educator who would normally supervisor the FMRL with patients would complete a link to a QR code (2 minutes) and indicate the competency of the FMRL
    Time Frame
    up to 7 months
    Title
    Focus group
    Description
    All participants will meet at the end of the study/academic year to review the process and their participation in the study
    Time Frame
    up to 7 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with an MSK condition included in the education tool of MSK Short Case Simulations 1-20 (Upper extremity; lower extremity; axial skeleton; trauma and MSK infections Patients) seen either in a family medicine clinic; emergency department; clinical ward in the hospital setting or sporting event at which FMRL were covering from a learners perspective Patients assessed by FMRLs between the months of July 2023 through to March 2024 Patient must be free of cognitive impairment and be able to complete an English survey or have a translator present to assist with the translation Electronic devices to accommodate QR codes Exclusion Criteria: non-English speaking participants an inability to complete QR codes
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Himani Anand, PG
    Phone
    416-967-8500
    Ext
    8616
    Email
    himani.anand@sri.utoronto.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Veronica M Wadey, MD,MA
    Organizational Affiliation
    Sunnybrook Health Sciences Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    Wu V, Goto K, Carek S, et al. Family Medicine Musculoskeletal Medicine Education: A CERA Study. http://journals.stfm.org/familymedicine/2022/may/wu-2021-0414
    Results Reference
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    PubMed Identifier
    30211396
    Citation
    Sabesan VJ, Schrotenboer A, Habeck J, Lombardo D, Stine S, Jildeh TR, Meiyappan A. Musculoskeletal Education in Medical Schools: A Survey of Allopathic and Osteopathic Medical Students. J Am Acad Orthop Surg Glob Res Rev. 2018 Jun 28;2(6):e019. doi: 10.5435/JAAOSGlobal-D-18-00019. eCollection 2018 Jun.
    Results Reference
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    PubMed Identifier
    15102634
    Citation
    De Inocencio J. Epidemiology of musculoskeletal pain in primary care. Arch Dis Child. 2004 May;89(5):431-4. doi: 10.1136/adc.2003.028860.
    Results Reference
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    PubMed Identifier
    11140349
    Citation
    Matheny JM, Brinker MR, Elliott MN, Blake R, Rowane MP. Confidence of graduating family practice residents in their management of musculoskeletal conditions. Am J Orthop (Belle Mead NJ). 2000 Dec;29(12):945-52.
    Results Reference
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    PubMed Identifier
    8882045
    Citation
    Glazier RH, Dalby DM, Badley EM, Hawker GA, Bell MJ, Buchbinder R. Determinants of physician confidence in the primary care management of musculoskeletal disorders. J Rheumatol. 1996 Feb;23(2):351-6.
    Results Reference
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    PubMed Identifier
    11940622
    Citation
    Freedman KB, Bernstein J. Educational deficiencies in musculoskeletal medicine. J Bone Joint Surg Am. 2002 Apr;84(4):604-8. doi: 10.2106/00004623-200204000-00015.
    Results Reference
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    PubMed Identifier
    22002779
    Citation
    Watts SA, Zhang Z. Competency in musculoskeletal and sports medicine: evaluating a PGY-1 curriculum. Fam Med. 2011 Oct;43(9):659-63.
    Results Reference
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    PubMed Identifier
    18636305
    Citation
    Day CS, Yeh AC. Evidence of educational inadequacies in region-specific musculoskeletal medicine. Clin Orthop Relat Res. 2008 Oct;466(10):2542-7. doi: 10.1007/s11999-008-0379-0. Epub 2008 Jul 18.
    Results Reference
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    PubMed Identifier
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    Citation
    Connolly N, Abdalla ME. Impact of COVID-19 on medical education in different income countries: a scoping review of the literature. Med Educ Online. 2022 Dec;27(1):2040192. doi: 10.1080/10872981.2022.2040192.
    Results Reference
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    PubMed Identifier
    17183615
    Citation
    Wadey VM, Tang ET, Abelseth G, Dev P, Olshen RA, Walker D. Canadian multidisciplinary core curriculum for musculoskeletal health. J Rheumatol. 2007 Mar;34(3):567-80. Epub 2006 Dec 15.
    Results Reference
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    Citation
    Rules of Thumb, Gerald van Belle, 2002, Wiley
    Results Reference
    background
    Citation
    Visit-Specific Satisfaction Instrument (VSQ-9) | RAND
    Results Reference
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    Wadey RCT MSK Short Case Simulations With FMED

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