Wadey RCT MSK Short Case Simulations With FMED

June 19, 2023 updated by: Dr. Veronica Wadey, Sunnybrook Health Sciences Centre

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

  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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: FMRL CTL-PGY1 (Post Graduate Year 1) and FMRL CTL - PGY2 (Post Graduate Year 2)
This arm of participants reflects family medicine resident learners (FMRLs) who will not be exposed to the 1-20 MSK case simulations.
Experimental: FMRL EXP - PGY1 and FMRL EXP - PGY2
This arm of participants reflects family medicine resident learners (FMRLs) who will be exposed to the 1-20 MSK case simulations.
Other: Educational Tool
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant demographics
Time Frame: up to 7 months
Questionnaire (Qualitative analyses)
up to 7 months
Pre and Post-test questionnaires for each of the 20 MSK short case simulations - paired T-tests
Time Frame: up to 7 months
Knowledge questions
up to 7 months
Satisfaction questionnaire for EXP group on the educational experience of the MSK case simulations- qualitative analyses
Time Frame: up to 7 months
The participants completing the 20 MSK short case simulations will complete a satisfaction questionnaire of the case simulations
up to 7 months
Patient experience of their individual clinical encounter with the FMRL
Time Frame: up to 7 months
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
up to 7 months
Educator evaluation of a FMRL
Time Frame: up to 7 months
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
up to 7 months
Focus group
Time Frame: up to 7 months
All participants will meet at the end of the study/academic year to review the process and their participation in the study
up to 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Veronica M Wadey, MD,MA, SunnyBrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 2, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

May 5, 2023

First Submitted That Met QC Criteria

June 19, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5777

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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