- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05979090
Mastery Learning in Communication Skills
November 15, 2024 updated by: Ann & Robert H Lurie Children's Hospital of Chicago
Mastery Learning in Communication Skills to Improve Milestone Performance and Burnout
The goal of this study is to determine whether mastery learning in communication skills can improve skills in a simulated environment and have translational improvements in outcomes.
The main questions it aims to answer are: 1.
Does mastery learning improve skills in the simulation laboratory? 2. Does mastery learning improve clinical skills as seen by milestone performance?
and 3 Does mastery learning improve burnout levels?
The study is a multi-institutional randomized controlled trial of anesthesiology residents from five different residency programs.
Participants will be randomized to mastery training in communication skills and standard of care, which is vicarious learning.
Researchers will compare these two groups to see if mastery learning improves skills and translational outcomes.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
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
- Name: Heather Ballard, MD
- Phone Number: 3122275170
- Email: hballard@luriechildrens.org
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University Simulation Center
-
Contact:
- Jeff Barsuk, MD
- Phone Number: 312-503-7700
- Email: jbarsuk@nm.org
-
Contact:
- Daniel Cronin, BS
- Phone Number: 312-503-7700
- Email: dcronin@northwestern.edu
-
Principal Investigator:
- Heather Ballard, MD
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Anesthesiology residents rotating at Ann and Robert H. Lurie Children's Hospital of Chicago
Exclusion Criteria:
- Participant refusal
- Study participants who have already undergone the mastery learning in difficult conversations course.
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard of Care Group
|
|
|
Experimental: Mastery Learning Group
|
Participants will undergo simulation-based mastery learning curriculum in difficult conversations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Communication skills
Time Frame: one year
|
Post test checklist skills scores, a 16-item checklist was developed using the modified Delphi technique with possible scores of 0 (lowest) to 16 (highest).
All items in the checklist are graded dichotomously and (1 if done correctly and 0 if not done or done incorrectly.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Milestones Performance
Time Frame: two years
|
The ACGME interpersonal and communication core competency is subdivided into three Anesthesiology Milestones: Patient and Family-centered communication, Interprofessional and Team Communication, and Communication within Health Care Systems.
Each milestone is graded on a score of 1 (novice) to 5 (expert) by each residency program's Clinical Competency Committee (CCC).
|
two years
|
|
Burnout levels
Time Frame: 1.5 years
|
The Maslach Burnout Inventory Scale (MBI-9) will be used to estimate the levels of burnout prior to participation in the intervention, immediately after course completion, and at 2 and 6 months after training.
The MBI is a measure of job burnout defined by three subscales: emotional exhaustion (EE) (9 items), depersonalization (DP) (5 items), and professional accomplishment (PA) (8 items), each with 7-point Likert-type, frequency response scale (0 = never, 1 = a few times a year or less, 2 = once a month or less, 3 = a few times a month, 4 = once a week, 5 = a few times a week, 6 = every day) [1, 2].
Scales are scored such that higher scores indicate more of each construct.
Higher scores on the EE and DP subscales indicate a higher burnout symptom burden; lower scores on the PA subscale indicate a higher burnout symptom burden.
|
1.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Heather Ballard, MD, Ann and Robert H. Lurie Children's Hospital of Chicago
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 (Actual)
January 18, 2023
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
January 1, 2028
Study Registration Dates
First Submitted
July 19, 2023
First Submitted That Met QC Criteria
July 27, 2023
First Posted (Actual)
August 7, 2023
Study Record Updates
Last Update Posted (Estimated)
November 18, 2024
Last Update Submitted That Met QC Criteria
November 15, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20235952
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
de-identified study data will be available upon request when study is completed and published
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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