Trial to Evaluate the Efficacy of a Manualized Reflective Writing Program for Clinical Phase Physician Assistant (PA) Students.

Study Overview
=================
Brief Summary
-----------------
The following will be an open label controlled efficacy trial of the effects of longitudinal participation in an existing reflective writing program for medical students on burnout in physician assistant students.

Detailed Description
-----------------
The pilot of the reflective writing workshop for PA students will follow the existing curriculum used for the MD program. The workshops will run for 75 minutes with additional time at the end of the session to complete a post-intervention assessment survey. Planning and adaptation of the program materials will be conducted by a group of PA students and the current MD-student leaders of the reflective writing program under the guidance of Dr. Anna Reisman. All PA student participants will be split up into 1-2 groups of 6-10 students based on the number of participants. Sessions are expected to be held in-person pending COVID-19 guidance and will be held in reserved classroom space in the PA program building (100 Church Street South) or in reserved conference rooms at the Cushing-Whitney Medical Library. Trained PA and/or MD student facilitators will then use prepared materials to guide each group through a series of prompts, each eliciting written reflections of varying lengths. While all participants are encouraged to reflect, write, and share their responses, participation at all levels remains optional. Facilitators will not solicit any participants for a response. All program participants will be asked to complete a brief post-assessment survey consisting of short-answer and Likert scale questions about their attitudes towards program participation. Responses collected will be used to assess the feasibility and acceptability of the program for PA students and as feedback to guide potential future implementation of the program.

Official Title
-----------------
Open-label Controlled Trial to Evaluate the Efficacy of a Manualized Reflective Writing Program for Clinical Phase PA Students.

Conditions
-----------------
Burn Out, Student Burnout, Physician Assistant Student Burnout

Intervention / Treatment
-----------------
* Behavioral: Reflective Writing Workshop Sessions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: able to offer consent able to speak and read English. must be a student in Yale Physician Associate Program Class of 2024 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study sample will consist of clinical-phase PA students enrolled in the Yale Physician Associate Program Class of 2024.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No intervention | |
| Experimental: Reflective Writing Workshop Sessions (RWW)<br>Participants will participate in three 75-minute RWW sessions scheduled to take place after students finish their 1st, 3rd, and 5th clinical rotations during the study period. reflective writing workshops | Behavioral: Reflective Writing Workshop Sessions<br>* Three workshops of 75 minutes. Trained PA and/or MD student facilitators will then use prepared materials to guide each group through a series of prompts, each eliciting written reflections of varying lengths. While all participants are encouraged to reflect, write, and share their responses, participation at all levels remains optional.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total burnout score over time as measured by the Copenhagen Burnout Inventory (CBI) | The Copenhagen Burnout Inventory (CBI) is a well-validated 19-item questionnaire used to measure burnout in different groups (e.g. employees, medical trainees, students) across three domains (personal, work, and client/customer). Total scores range from 0 to 100. Higher scores are associated with greater levels of burnout. | baseline (week 0), and weeks 4,12, and 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attitudes and mediators of behavioral change assessed by self report | Attitudes and potential mediators of behavioral change will be assessed using a post-assessment survey consisting of short-answer and Likert-scale questions to be answered only by individuals who complete the active intervention. The survey will be distributed and completed at the end of each reflective writing workshop session. Analysis of the short response questions will use a rapid qualitative analysis method to identify patterns and themes. Likert-scale data will be analyzed by calculating the percentage of responses selecting each of the 5 dichotomous answer choices. A mean total score will be calculated through summation of all Likert scale categories as a numeric variable from 1-5, with higher scores indicating more positive responses for each question (e.g. Completely agree = 5 pts). | week 26 |