DiabetesDKANCT02799563
A Computer-Based Simulation of DKA Management
A study testing Coach, Preselected number of cases, Coach, Self-selected number of cases and No coach, Preselected number of cases in people with Diabetes, run by Unity Health Toronto.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Coach, Preselected number of cases, Coach, Self-selected number of cases and No coach, Preselected number of cases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First-year internal Medicine trainees (PGY-1) in their first 6 months of training and third-year medical students (CC3) were recruited to participate in this study. Inclusion criteria were: either a CC3 or PGY-1 rotating through their General Internal Medicine (GIM) rotation at one of the 7 teaching sites in Toronto.
Who cannot join
- Excluded were those participants who participated in the DKA study during a previous block and participants who were not rotating through a GIM rotation.
About this study
Official title: Integration of a Computer-Based Simulation of DKA Management Into Medical Education: A 2 by 2 Factorial Cluster Randomized Controlled Trial
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).
Read the detailed description
Diabetic ketoacidosis (DKA) accounts for approximately 115,000 hospital discharges per year in the United States. Appropriate management of this life-threatening clinical presentation requires timely and meticulous intervention, including avoidance of hypokalemia, hypoglycemia and DKA recurrence. However, clinical management continues to be less than ideal; for example, in a recent retrospective chart audit of patients admitted to a large teaching hospital with the primary diagnosis of DKA, 75% of them were placed on an inappropriate insulin regimen. This evidence to practice gap may be bridged with the use of computer simulation training.
In a simulated training environment, the trainee has the opportunity to manage uncommon but important clinical presentations that they may otherwise not experience in their training, without the risk of patient harm. A recent systematic review by Cook et al. analyzed 405 studies that compared a simulation-based intervention to no intervention for health care professionals from various disciplines. The authors found that simulation improved knowledge [pooled effect sizes of 1.20 (95% confidence interval (CI), 1.04-1.35)] and skills [pooled effect sizes of 1.09 (95% CI,1.03-1.16)]. Another systematic review analyzed 50 studies that compared virtual patient simulation with no intervention and found large positive effects of virtual patient simulation compared to no intervention (pooled effect sizes 0.94 (95% CI 0.69-1.19) for knowledge outcomes, 0.80 (95% CI 0.52-1.08) for clinical reasoning and 0.90 (95% CI 0.61-1.19) for other skills).
Although there are many studies comparing simulation to no intervention, very few studies have directly compared different simulation-based interventions. Two systematic reviews of the effectiveness of simulation have demonstrated that repetitive practice is superior to a single-use instructional modality. Few studies included in these reviews reported how much practice is necessary to obtain long-term skill retention. These systematic reviews also demonstrated that training adapted to individualized performance is associated with better learning outcomes.
What remains unclear, however, is who should have the locus of control when defining the parameters of individualized learning. One randomized controlled trial compared self-regulated learning and instructor-regulated learning interventions for resident training using lumbar puncture simulation and revealed that self-regulated learning can lead to superior long-term skill retention at 3 months. As focused repetitive practice is one of the key elements of deliberate practice, one would postulate that self-regulated learners have a higher chance of achieving superior results given that they can optimize their amount of practice; however, this has yet to be assessed for the simulator learning environment.
The effectiveness of unsupervised versus supervised simulation curricula has yielded conflicting results. A systematic review comparing different simulation modalities revealed that group instruction was not associated with better outcomes (pooled effect size -0.22), whereas a previous systematic review of randomized trials comparing simulation to other educational modalities revealed that group instruction was associated with a positive learning effect (pooled effect size 0.72). One could assume that supervised learning is superior to unsupervised learning, as the former provides learners with the opportunity for continuous informative feedback, a key element of deliberate practice, in order to enhance their continued practice. However, this has not been formally tested for simulation-based education.
Self-regulated learning and supervised versus unsupervised learning in simulation education require further exploration. The investigators conducted a 2-by-2 factorial cluster randomized controlled trial, comparing the impact of (1) coached versus non-coached administration, and (2) preselected number of practice cases versus self-selected number of practice cases, on medical student and resident scores on computer-based simulation of DKA management. By utilizing the theory of deliberate practice, the investigators hypothesized that participants who used the simulator in a supervised environment would score superiorly on the simulator. In addition, we hypothesized that participants who were randomized to self regulated learning would score superiorly on the simulator.
- Conditions
- Diabetes
- Being tested
- Coach, Preselected number of cases, Coach, Self-selected number of cases, No coach, Preselected number of cases, No coach, Self-selected number of cases
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coach, Preselected number of casesOther
Coach, Self-selected number of casesOther
No coach, Preselected number of casesOther
No coach, Self-selected number of casesOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Coach, Preselected number of cases | Experimental | Cohort 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). Receives: Other: Coach, Preselected number of cases |
| Cohort B: Coach, Self-selected number of cases | Experimental | Cohort 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. Receives: Other: Coach, Self-selected number of cases |
| Cohort C: No coach, Preselected number of cases | Experimental | Cohort 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). Receives: Other: No coach, Preselected number of cases |
| Cohort D: No coach, Self-selected number of cases | Experimental | Cohort 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. Receives: Other: No coach, Self-selected number of cases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test 1 scores
Difference in simulator scores between the 4 cohorts immediately post- intervention (Test 1)
Measured: Immediately after intervention
Secondary outcomes (5)
Test 2 and Test 3 scores
Difference in simulator scores between the four cohorts 3 and 6 months post- intervention (Tests 2 and 3).
Measured: 3 and 6 months after intervention
Self-reported comfort with DKA management (5-point Likert scale)
Differences in comfort level with DKA management between the 4 cohorts after the intervention and throughout the study.
Measured: Before, immediately after, 3 months after intervention
Correlation between simulator score and standardized exam score
CC3 participant scores on their standardized DKA-specific Objective Standardized Clinical Exam (OSCE) stations and DKA-specific written examination questions, as well as PGY-1 scores on their standardized DKA-specific OSCE stations were obtained and compared with their scores on Test 1 (primary outcome)
Measured: Immediately after intervention, end of rotation (up to 10 months after intervention)
Number of simulations conducted
The average number of simulations per cohort were compared throughout the study.
Measured: From intervention to 6 months after intervention
Scores on Standardized exams
Scores on the PGY-1 and CC3 standardized exams were compared in each cohort.
Measured: End of rotation (up to 10 months after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799563
- Sponsor's protocol ID
- 30043
- Acronym
- DKA
- Status last verified
- Jun 2016
- First submitted
- 24 May 2016
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of a Computer-Based Simulation of DKA Management Into Medical Education: A 2 by 2 Factorial Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02799563
- Acronym / sponsor ID
- DKA / 30043
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Diabetic ketoacidosis (DKA) accounts for approximately 115,000 hospital discharges per year in the United States. Appropriate management of this life-threatening clinical presentation requires timely and meticulous intervention, including avoidance of hypokalemia, hypoglycemia and DKA recurrence. However, clinical management continues to be less than ideal; for example, in a recent retrospective chart audit of patients admitted to a large teaching hospital with the primary diagnosis of DKA, 75% of them were placed on an inappropriate insulin regimen. This evidence to practice gap may be bridged with the use of computer simulation training.
In a simulated training environment, the trainee has the opportunity to manage uncommon but important clinical presentations that they may otherwise not experience in their training, without the risk of patient harm. A recent systematic review by Cook et al. analyzed 405 studies that compared a simulation-based intervention to no intervention for health care professionals from various disciplines. The authors found that simulation improved knowledge [pooled effect sizes of 1.20 (95% confidence interval (CI), 1.04-1.35)] and skills [pooled effect sizes of 1.09 (95% CI,1.03-1.16)]. Another systematic review analyzed 50 studies that compared virtual patient simulation with no intervention and found large positive effects of virtual patient simulation compared to no intervention (pooled effect sizes 0.94 (95% CI 0.69-1.19) for knowledge outcomes, 0.80 (95% CI 0.52-1.08) for clinical reasoning and 0.90 (95% CI 0.61-1.19) for other skills).
Although there are many studies comparing simulation to no intervention, very few studies have directly compared different simulation-based interventions. Two systematic reviews of the effectiveness of simulation have demonstrated that repetitive practice is superior to a single-use instructional modality. Few studies included in these reviews reported how much practice is necessary to obtain long-term skill retention. These systematic reviews also demonstrated that training adapted to individualized performance is associated with better learning outcomes.
What remains unclear, however, is who should have the locus of control when defining the parameters of individualized learning. One randomized controlled trial compared self-regulated learning and instructor-regulated learning interventions for resident training using lumbar puncture simulation and revealed that self-regulated learning can lead to superior long-term skill retention at 3 months. As focused repetitive practice is one of the key elements of deliberate practice, one would postulate that self-regulated learners have a higher chance of achieving superior results given that they can optimize their amount of practice; however, this has yet to be assessed for the simulator learning environment.
The effectiveness of unsupervised versus supervised simulation curricula has yielded conflicting results. A systematic review comparing different simulation modalities revealed that group instruction was not associated with better outcomes (pooled effect size -0.22), whereas a previous systematic review of randomized trials comparing simulation to other educational modalities revealed that group instruction was associated with a positive learning effect (pooled effect size 0.72). One could assume that supervised learning is superior to unsupervised learning, as the former provides learners with the opportunity for continuous informative feedback, a key element of deliberate practice, in order to enhance their continued practice. However, this has not been formally tested for simulation-based education.
Self-regulated learning and supervised versus unsupervised learning in simulation education require further exploration. The investigators conducted a 2-by-2 factorial cluster randomized controlled trial, comparing the impact of (1) coached versus non-coached administration, and (2) preselected number of practice cases versus self-selected number of practice cases, on medical student and resident scores on computer-based simulation of DKA management. By utilizing the theory of deliberate practice, the investigators hypothesized that participants who used the simulator in a supervised environment would score superiorly on the simulator. In addition, we hypothesized that participants who were randomized to self regulated learning would score superiorly on the simulator.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Coach, Preselected number of cases | Experimental | Other: Coach, Preselected number of casesCohort 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 | Experimental | Other: Coach, Self-selected number of casesCohort 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 | Experimental | Other: No coach, Preselected number of casesCohort 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 | Experimental | Other: No coach, Self-selected number of casesCohort 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First-year internal Medicine trainees (PGY-1) in their first 6 months of training and third-year medical students (CC3) were recruited to participate in this study. Inclusion criteria were: either a CC3 or PGY-1 rotating through their General Internal Medicine (GIM) rotation at one of the 7 teaching sites in Toronto.
Key exclusion criteria (1 listed)
- Excluded were those participants who participated in the DKA study during a previous block and participants who were not rotating through a GIM rotation.
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 |
|---|---|---|
| Coach, Preselected number of cases | Other | Cohort A: Coach, Preselected number of cases |
| Coach, Self-selected number of cases | Other | Cohort B: Coach, Self-selected number of cases |
| No coach, Preselected number of cases | Other | Cohort C: No coach, Preselected number of cases |
| No coach, Self-selected number of cases | Other | Cohort D: No coach, Self-selected number of cases |
Primary outcome
Test 1 scores
Time frame: Immediately after intervention
Difference in simulator scores between the 4 cohorts immediately post- intervention (Test 1)
5 secondary outcomes
Test 2 and Test 3 scores
Time frame: 3 and 6 months after intervention
Self-reported comfort with DKA management (5-point Likert scale)
Time frame: Before, immediately after, 3 months after intervention
Correlation between simulator score and standardized exam score
Time frame: Immediately after intervention, end of rotation (up to 10 months after intervention)
Number of simulations conducted
Time frame: From intervention to 6 months after intervention
Scores on Standardized exams
Time frame: End of rotation (up to 10 months after intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Coach, Preselected number of cases, Coach, Self-selected number of cases and No coach, Preselected number of cases in people with Diabetes, run by Unity Health Toronto.
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 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Test 1 scores (time frame: Immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2016.