UncertaintyNCT04021771
Trial of Simulation-based Mastery Learning to Communicate Diagnostic Uncertainty
A study testing Educational Curriculum Intervention in people with Uncertainty and Communication Research, run by Thomas Jefferson University at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncertainty, Communication Research, Emergency Medicine
- What is being tested?
- Educational Curriculum Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Sep 2019to 16 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Eligible participants include all emergency medicine residents at Thomas Jefferson University and Northwestern University.
Who cannot join
- -None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
Thomas Jefferson University
Philadelphia, Pennsylvania, 19128
About this study
Official title: Simulation-based Mastery Learning to Improve Communication in Times of Diagnostic Uncertainty: Randomized Control Trial
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.
- Conditions
- Uncertainty, Communication Research, Emergency Medicine
- Being tested
- Educational Curriculum Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Curriculum InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Intervention Group) | Other | 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. Receives: Other: Educational Curriculum Intervention |
| Group B (Control Group) | Other | 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. Receives: Other: Educational Curriculum Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
% 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.
Measured: 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 (2)
Number of DP Sessions
Investigators will evaluate the association between number of Deliberate Practice (DP) sessions completed and achieving the Minimum Passing Standard (MPS)
Measured: up to eleven months
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start4 Sep 2019
- Primary completion18 Feb 2020
- Study completion16 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for UncertaintyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Sponsor
- Investigators
- Kristin L Rising, MD MS, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021771
- Sponsor's protocol ID
- 19G.356
- Status last verified
- May 2021
- First submitted
- 25 Jun 2019
- Last updated
- 25 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36205492McCarthy 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.
PubMed 32070353
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-based Mastery Learning to Improve Communication in Times of Diagnostic Uncertainty: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04021771
- Acronym / sponsor ID
- 19G.356
- Conditions
- Uncertainty, Communication Research, Emergency Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 16 Aug 2020 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Posted 25 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A (Intervention Group) | Other | Other: Educational Curriculum InterventionParticipants 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 B (Control Group) | Other | Other: Educational Curriculum InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Eligible participants include all emergency medicine residents at Thomas Jefferson University and Northwestern University.
Key exclusion criteria (1 listed)
- -None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Curriculum InterventionThe 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. | Other | Group A (Intervention Group), Group B (Control Group) |
Primary outcome
% of Residents Who Pass the UCC at the T2 Assessment
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.
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.
2 secondary outcomes
Number of DP Sessions
Time frame: up to eleven months
Change in Pass Rates Within Groups From T2 to T3
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36205492Rising 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.
- Derived from this study: PubMed 32070353McCarthy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin L Rising, MD MS principal investigator
Thomas Jefferson University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Curriculum Intervention in people with Uncertainty and Communication Research, run by Thomas Jefferson University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of Residents Who Pass the UCC at the T2 Assessment (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04021771, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021; AzTrials last refreshed its copy on 30 Oct 2026.