Clinical trial NCT05914922: 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
Overall status: RECRUITING
Phase: NA
Conditions: Musculoskeletal Diseases or Conditions
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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

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

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

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

Primary outcomes:
measure: Participant demographics
timeFrame: up to 7 months
measure: Pre and Post-test questionnaires for each of the 20 MSK short case simulations - paired T-tests
timeFrame: up to 7 months
measure: Satisfaction questionnaire for EXP group on the educational experience of the MSK case simulations- qualitative analyses
timeFrame: up to 7 months
measure: Patient experience of their individual clinical encounter with the FMRL
timeFrame: up to 7 months
measure: Educator evaluation of a FMRL
timeFrame: up to 7 months
measure: Focus group
timeFrame: up to 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Veronica M Wadey, MD,MA
role: PRINCIPAL_INVESTIGATOR
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