Trial of Simulation-based Mastery Learning to Communicate Diagnostic Uncertainty

Emergency Medicine Clinical Trial

Official title:

Simulation-based Mastery Learning to Improve Communication in Times of Diagnostic Uncertainty: Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04021771
• Other study ID #: 19G.356
• Status: Completed
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: August 16, 2020

Study information

• Verified date: May 2021
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to teach emergency medicine resident physicians to communicate more effectively with patients at the time of emergency department discharge in the setting of diagnostic uncertainty (i.e. no definitive cause identified for the patient's symptoms). All residents will complete baseline and follow up assessments by completing in-person simulated patient discharged. After the baseline assessment, they will complete an online educational curriculum that has been developed by the study team, and will participate in video-based simulation deliberate practice (DP) and feedback sessions using a simulation-based mastery learning (SBML) approach. They will be assessed with the Uncertainty Communication Checklist (UCC), a tool already developed by the study team, that has a minimum passing standard (MPS) that was established through engagement of both patients and physicians. The investigators will perform a 2-arm wait-list randomized control trial with resident physicians to test the efficacy of the SBML curriculum in training residents to have a discharge discussion with patients discharged from the emergency department with diagnostic uncertainty.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: August 16, 2020
• Est. primary completion date: February 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-Eligible participants include all emergency medicine residents at Thomas Jefferson University and Northwestern University. Exclusion Criteria: -None

Related Conditions & MeSH terms

• Communication Research
• Emergencies
• Emergency Medicine
• Uncertainty

Intervention

Other:
• Educational Curriculum Intervention
The intervention includes: 1) Online web-based education module created with the Rise 360 platform that has ten lessons, providing the learner with an introduction, background, and a map of how to navigate a discharge conversation for patients with diagnostic uncertainty. Core content are presented with multiple interactive components such as flip-cards, multiple-choice, drag-and-drop, sketch videos, and narrated clips. 2) Mobile application game designed to facilitate practice of the content learned in the online curriculum 3) Deliberate practice sessions allow trainees to practice communication techniques presented within the online module and to receive feedback on their performance. These sessions will be conducted with standardized patients via a video platform, during a scheduled appointment.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of Residents Who Pass the UCC at the T2 Assessment	Investigators will measure the percentage of residents who meet or exceed the Minimum Passing Standard (MPS) on the Uncertainty Communication Checklist (UCC) in the intervention group versus the control group at the second assessment (T2). At T2, resident physicians completed a simulation encounter with a standardized patient (SP) and the SP assessed the physician's performance using a checklist using the UCC. Our team developed the UCC in prior work with extensive patient input. The UCC includes 21 checklist items; items were assessed as either performed correctly (1 point) or incorrectly (0 points) and all items were added into a total score, which can range from 0-21 points. Since 1 = achieved and 0 = did not achieve, 1 is always better for each individual item and the higher the total score the better. Physicians achieved mastery when they met or exceeded the MPS, i.e. when they correctly performed at least 19 of the 21 items.	Although we originally planned for T2 to occur 4-8 weeks after the baseline assessment, T2 ended up taking place 16-19 weeks after baseline assessment due to the residency schedule.
Secondary	Number of DP Sessions	Investigators will evaluate the association between number of Deliberate Practice (DP) sessions completed and achieving the Minimum Passing Standard (MPS)	up to eleven months
Secondary	Change in Pass Rates Within Groups From T2 to T3	This will assess the change within groups on the percentage pass rate on the Uncertainty Communication Checklist (UCC) from the second assessment (T2) to the third assessment (T3), which will assess retention of mastery in the intervention group and will be a supplemental assessment of the interventions' efficacy in the delayed intervention (control) group.	Thus this outcome measure was assessed at T2 (16-19 weeks after baseline assessment) and T3; although we originally planned for T3 to occur 4-8 weeks after T2, T3 ended up taking place 11-15 weeks after T2 due to the residency schedule.