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Musculoskeletal Diseases or ConditionsNCT05914922

Wadey RCT MSK Short Case Simulations With FMED

A study testing Educational Tool in people with Musculoskeletal Diseases or Conditions, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Musculoskeletal Diseases or Conditions
What is being tested?
Educational Tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteCanada
Study dates
2 Jul 2023to 30 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • non-English speaking participants
  • an inability to complete QR codes

Trial locations and contacts

1 site in 1 country.

Canada1 site, 1 recruiting
  • Sunnybrook Health Sciences Center

    Toronto, Ontario, ON M4N 3M5

    Himani Anand, PG, 4169678500 ext. 8616, himani.anand@sri.u.toronto.ca

    Veronica M Wadey, MD,MA,, (416) 967-8615, Veronica.Wadey@sunnybrook.ca

    Recruiting

Other trials in Canada

About this study

Official title: Musculoskeletal (MSK) Educational Tool and Impact on Patients Randomized Control Trial - Pilot Study

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

Read more
  1. Demographic questionnaire for the Learner;
  2. 100 MCQ (multiple-choice questionnaire) reflecting the same questions contained in the 20 MSK Short Case Simulations
  3. Pre/Post multiple choice question knowledge questionnaire
  4. Learner satisfaction questionnaire
  5. Patient experience and satisfaction questionnaire - QR Code
  6. Educator evaluation questionnaire - QR Code
  7. Focus group questionnaire

Primary Objectives

  1. 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.
  2. 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
  3. 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
Read the 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:

  1. 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.
  2. 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

  1. Demographic questionnaire for the Learner;
  2. 100 MCQ questionnaire reflecting the same questions contained in the 20 MSK Short Case Simulations
  3. Pre/Post multiple choice question knowledge questionnaire
  4. Learner satisfaction questionnaire
  5. Patient experience and satisfaction questionnaire - QR Code
  6. Educator evaluation questionnaire - QR Code
  7. 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
Being tested
Educational Tool
Medical subject headings
Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational ToolOther

    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.

Study groups in NCT05914922
Study groupRoleWhat they receive
FMRL CTL-PGY1 (Post Graduate Year 1) and FMRL CTL - PGY2 (Post Graduate Year 2)No interventionThis arm of participants reflects family medicine resident learners (FMRLs) who will not be exposed to the 1-20 MSK case simulations.
FMRL EXP - PGY1 and FMRL EXP - PGY2ExperimentalThis arm of participants reflects family medicine resident learners (FMRLs) who will be exposed to the 1-20 MSK case simulations.
Receives: Other: Educational Tool

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participant demographics

    Questionnaire (Qualitative analyses)

    Measured: up to 7 months

  2. Pre and Post-test questionnaires for each of the 20 MSK short case simulations - paired T-tests

    Knowledge questions

    Measured: up to 7 months

  3. 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

    Measured: up to 7 months

  4. 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

    Measured: up to 7 months

  5. 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

    Measured: up to 7 months

  6. Focus group

    All participants will meet at the end of the study/academic year to review the process and their participation in the study

    Measured: up to 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start2 Jul 2023
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05914922
Sponsor's protocol ID
5777
Status last verified
May 2024
First submitted
5 May 2023
Last updated
13 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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.

    PubMed 30211396
  • 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.

    PubMed 15102634
  • 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.

    PubMed 11140349
  • 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.

    PubMed 8882045
  • 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.

    PubMed 11940622
  • Watts SA, Zhang Z. Competency in musculoskeletal and sports medicine: evaluating a PGY-1 curriculum. Fam Med. 2011 Oct;43(9):659-63.

    PubMed 22002779
  • 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.

    PubMed 18636305
  • 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.

    PubMed 35317712
  • 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.

    PubMed 17183615
  • Rules of Thumb, Gerald van Belle, 2002, Wiley

  • Visit-Specific Satisfaction Instrument (VSQ-9) | RAND

Questions about this trial

What is this clinical trial studying?

A study testing Educational Tool in people with Musculoskeletal Diseases or Conditions, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Himani Anand, PG (416-967-8500 ext. 8616, himani.anand@sri.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant demographics (time frame: up to 7 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05914922, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.

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