Trial to Evaluate the Efficacy of a Manualized Reflective Writing Program for Clinical Phase Physician Assistant (PA) Students.
Primary Purpose
Burn Out, Student Burnout, Physician Assistant Student Burnout
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reflective Writing Workshop Sessions
Sponsored by
About this trial
This is an interventional supportive care trial for Burn Out
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: -
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Reflective Writing Workshop Sessions (RWW)
Arm Description
No intervention
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06000488
Brief Title
Trial to Evaluate the Efficacy of a Manualized Reflective Writing Program for Clinical Phase Physician Assistant (PA) Students.
Official Title
Open-label Controlled Trial to Evaluate the Efficacy of a Manualized Reflective Writing Program for Clinical Phase PA Students.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Out, Student Burnout, Physician Assistant Student Burnout
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Reflective Writing Workshop Sessions (RWW)
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Reflective Writing Workshop Sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in total burnout score over time as measured by the Copenhagen Burnout Inventory (CBI)
Description
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.
Time Frame
baseline (week 0), and weeks 4,12, and 26
Secondary Outcome Measure Information:
Title
Attitudes and mediators of behavioral change assessed by self report
Description
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).
Time Frame
week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathew Chiang
Phone
203-785-3974
Email
mathew.chiang@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathew Chiang
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trial to Evaluate the Efficacy of a Manualized Reflective Writing Program for Clinical Phase Physician Assistant (PA) Students.
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