Clinical trial NCT04021771: Trial of Simulation-based Mastery Learning to Communicate Diagnostic Uncertainty
Official title: Simulation-based Mastery Learning to Improve Communication in Times of Diagnostic Uncertainty: Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uncertainty
Communication Research
Emergency Medicine
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2019-07-16
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study will employ a 2-arm wait-list control trial. Participants will be evenly randomly assigned to Group A or Group B. Investigators will use a control arm (Group B) to compare the impact of exposure to the educational curriculum to the impact of the baseline testing (T1) alone on subsequent test scores. However, to maintain the goal of mastery learning curriculum of allowing all learners to achieve mastery, following the second test (T2), the Group B participants will also be exposed to the intervention. All participants will return for a third test (T3). For participants in Group A, T3 will provide information about the decay of learned skills and if performance on the task is maintained by a single intervention or would require further follow-up education.
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

-Eligible participants include all emergency medicine residents at Thomas Jefferson University and Northwestern University.

Exclusion Criteria:

-None

Primary outcomes:
measure: % of Residents Who Pass the UCC at the T2 Assessment
timeFrame: 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 outcomes:
measure: Number of DP Sessions
timeFrame: up to eleven months
measure: Change in Pass Rates Within Groups From T2 to T3
timeFrame: 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.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Kristin L Rising, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCarthy DM, Powell RE, Cameron KA, Salzman DH, Papanagnou D, Doty AM, Leiby BE, Piserchia K, Klein MR, Zhang XC, McGaghie WC, Rising KL. Simulation-based mastery learning compared to standard education for discussing diagnostic uncertainty with patients in the emergency department: a randomized controlled trial. BMC Med Educ. 2020 Feb 19;20(1):49. doi: 10.1186/s12909-020-1926-y.