A Computer-Based Simulation of DKA Management
DKA
Integration of a Computer-Based Simulation of DKA Management Into Medical Education: A 2 by 2 Factorial Cluster Randomized Controlled Trial
1 other identifier
interventional
124
0 countries
N/A
Brief Summary
A 2-by-2 factorial cluster randomized controlled trial was performed to: 1) Compare the effects of supervised (coached) versus unsupervised (no coach) administration of the DKA simulator on trainees' knowledge of DKA management immediately after (primary outcome) using the simulation and 3 and 6 months post-intervention (secondary outcome); 2) Determine whether a preselected number of DKA simulator practice cases or a self-selected number (self-regulated learning) of DKA simulator practice cases will result in superior trainee knowledge with respect to DKA management immediately after (primary outcome) and 3 and 6 months post-intervention (secondary outcome).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Jul 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 24, 2016
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedJune 15, 2016
June 1, 2016
11 months
May 24, 2016
June 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Test 1 scores
Difference in simulator scores between the 4 cohorts immediately post- intervention (Test 1)
Immediately after intervention
Secondary Outcomes (5)
Test 2 and Test 3 scores
3 and 6 months after intervention
Self-reported comfort with DKA management (5-point Likert scale)
Before, immediately after, 3 months after intervention
Correlation between simulator score and standardized exam score
Immediately after intervention, end of rotation (up to 10 months after intervention)
Number of simulations conducted
From intervention to 6 months after intervention
Scores on Standardized exams
End of rotation (up to 10 months after intervention)
Study Arms (4)
Cohort A: Coach, Preselected number of cases
EXPERIMENTALCohort A completed the DKA simulator cases during two one-hour coached sessions. They were assigned a pre-selected number of DKA simulator cases (2 cases with 2 reps each, for 4 reps in total).
Cohort B: Coach, Self-selected number of cases
EXPERIMENTALCohort B completed the DKA simulator cases during two one-hour coached sessions. They were assigned a self-selected number of DKA simulator cases and were instructed to complete as many cases until they felt comfortable with DKA management.
Cohort C: No coach, Preselected number of cases
EXPERIMENTALCohort C completed the DKA simulator cases in a non-coached setting, on their own time. They were assigned a pre-selected number of DKA simulator cases (2 cases with 2 reps each, for 4 reps in total).
Cohort D: No coach, Self-selected number of cases
EXPERIMENTALCohort D completed the DKA simulator cases in a non-coached setting, on their own time. They were assigned a self-selected number of DKA simulator cases and were instructed to complete as many cases until they felt comfortable with DKA management.
Interventions
Eligibility Criteria
You may not qualify if:
- Excluded were those participants who participated in the DKA study during a previous block and participants who were not rotating through a GIM rotation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2016
First Posted
June 15, 2016
Study Start
July 1, 2014
Primary Completion
June 1, 2015
Study Completion
October 1, 2015
Last Updated
June 15, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share