Communication Research, Emergency Medicine, Uncertainty
Conditions
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.
Interventions
OTHEREducational 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.
Sponsors
Northwestern University
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Standardized patients will score the residents upon completion of each simulation encounter, and they will be masked to the assignment of the participant.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Eligible participants include all emergency medicine residents at Thomas Jefferson University and Northwestern University.
Exclusion criteria
-None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % of Residents Who Pass the UCC at the T2 Assessment | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of DP Sessions | up to eleven months | Investigators will evaluate the association between number of Deliberate Practice (DP) sessions completed and achieving the Minimum Passing Standard (MPS) |
| Change in Pass Rates Within Groups From T2 to T3 | 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. | 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. |
Countries
United States
Participant flow
Pre-assignment details
Eligible participants included all emergency medicine resident physicians within the emergency medicine residency programs at Thomas Jefferson University and Northwestern University during the 2019-2020 academic year.
Participants by arm
| Arm | Count |
|---|---|
| Group A (Intervention Group) Participants had at least three study visits. The first visit (T1) consisted of a baseline test, during which participants completed a simulated encounter with a standardized patient (SP) to establish a baseline score. Participants in Group A were given access to the intervention. The second visit (T2) was scheduled on average 16-19 weeks after T1 and consisted of another simulated encounter with the SP. Group A returned 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.
Educational Curriculum Intervention: The intervention included: 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 allowed trainees to practice communication techniques presented within the online module and to receive feedback on their performance. These sessions were conducted with standardized patients via a video platform, during a scheduled appointment. | 55 |
| Group B (Control Group) Participants had at least three study visits. The first visit (T1) consisted of a baseline test, during which participants completed a simulated encounter with a standardized patient (SP) to establish a baseline score. The second visit (T2) was scheduled on average 16-19 weeks after T1 and consisted of another simulated encounter with the SP; following this session, participants in Group B were introduced to the intervention. The Group B returned for a third visit (T3) to provide information on how the curriculum impacts their score.
Educational Curriculum Intervention: The intervention included: 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 allowed trainees to practice communication techniques presented within the online module and to receive feedback on their performance. These sessions were conducted with standardized patients via a video platform, during a scheduled appointment. | 54 |
| Total | 109 |
Baseline characteristics
| Characteristic | Group A (Intervention Group) | Group B (Control Group) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 54 Participants | 109 Participants |
| Age, Continuous | 29.1 years STANDARD_DEVIATION 2.2 | 29.3 years STANDARD_DEVIATION 3.2 | 29.2 years STANDARD_DEVIATION 2.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 51 Participants | 99 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 8 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 36 Participants | 42 Participants | 78 Participants |
| Sex: Female, Male Female | 18 Participants | 22 Participants | 40 Participants |
| Sex: Female, Male Male | 37 Participants | 32 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A (Intervention Group) | % of Residents Who Pass the UCC at the T2 Assessment | 29 Participants |
| Group B (Control Group) | % of Residents Who Pass the UCC at the T2 Assessment | 2 Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A (Intervention Group) | Change in Pass Rates Within Groups From T2 to T3 | Achieved Mastery at T2 (UCC >= 19/21) | 29 participants |
| Group A (Intervention Group) | Change in Pass Rates Within Groups From T2 to T3 | Achieved Mastery at T3 (UCC >= 19/21) | 30 participants |
| Group B (Control Group) | Change in Pass Rates Within Groups From T2 to T3 | Achieved Mastery at T3 (UCC >= 19/21) | 31 participants |
| Group B (Control Group) | Change in Pass Rates Within Groups From T2 to T3 | Achieved Mastery at T2 (UCC >= 19/21) | 2 participants |
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)
Time frame: up to eleven months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Intervention Group) | Number of DP Sessions | number of deliberate practice sessions | 1.7 number of deliberate practice sessions | Standard Deviation 0.9 |
| Group A (Intervention Group) | Number of DP Sessions | 1st attempt: passed | 1.0 number of deliberate practice sessions | Standard Deviation 0 |
| Group A (Intervention Group) | Number of DP Sessions | 1st attempt: failed | 2.4 number of deliberate practice sessions | Standard Deviation 0.8 |
| Group B (Control Group) | Number of DP Sessions | number of deliberate practice sessions | 1.5 number of deliberate practice sessions | Standard Deviation 0.7 |
| Group B (Control Group) | Number of DP Sessions | 1st attempt: passed | 1.0 number of deliberate practice sessions | Standard Deviation 0 |
| Group B (Control Group) | Number of DP Sessions | 1st attempt: failed | 2.2 number of deliberate practice sessions | Standard Deviation 0.4 |