Trial of Simulation-based Mastery Learning to Communicate Diagnostic Uncertainty

NCT ID: NCT04021771

Last Updated: 2021-05-25

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-04

Study Completion Date

2020-08-16

Brief Summary

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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.

Detailed Description

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Conditions

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Uncertainty Communication Research Emergency Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Standardized patients will score the residents upon completion of each simulation encounter, and they will be masked to the assignment of the participant.

Study Groups

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Group A (Intervention Group)

Participants will have at least three study visits. The first visit (T1) will consist of a baseline test, during which participants will complete a simulated encounter with a standardized patient (SP) to establish a baseline score. Participants in Group A will be given access to the online interactive module and will have the opportunity to have video-based DP sessions with the SPs. The second visit (T2) will be scheduled 4-8 weeks after T1 and will consist of another simulated encounter with the SP. Group A will return for a third visit (T3) to provide information about the decay of learned skills and if performance on the task is maintained by a single intervention.

Group Type OTHER

Educational Curriculum Intervention

Intervention Type OTHER

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.

Group B (Control Group)

Participants will have at least three study visits. The first visit (T1) will consist of a baseline test, during which participants will complete a simulated encounter with a standardized patient (SP) to establish a baseline score. The second visit (T2) will be scheduled 4-8 weeks after T1 and will consist of another simulated encounter with the SP; following this session, participants in Group B will be introduced to the intervention. Group B will return for a third visit (T3) to provide information on how the curriculum impacts their score.

Group Type OTHER

Educational Curriculum Intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

-None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristin L Rising, MD MS

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Rising KL, Cameron KA, Salzman DH, Papanagnou D, Doty AMB, Piserchia K, Leiby BE, Shimada A, McGaghie WC, Powell RE, Klein MR, Zhang XC, Vozenilek J, McCarthy DM. Communicating Diagnostic Uncertainty at Emergency Department Discharge: A Simulation-Based Mastery Learning Randomized Trial. Acad Med. 2023 Mar 1;98(3):384-393. doi: 10.1097/ACM.0000000000004993. Epub 2022 Oct 4.

Reference Type DERIVED
PMID: 36205492 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32070353 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Northwestern University Version

View Document

Document Type: Informed Consent Form: Thomas Jefferson University Version

View Document

Other Identifiers

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19G.356

Identifier Type: -

Identifier Source: org_study_id

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