Developing a Deliberate Practice Intervention to Recalibrate Physician Heuristics in Trauma Triage: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Developing a Deliberate Practice Intervention to Recalibrate Physician Heuristics in Trauma Triage (NCT05168579), a randomized na study. The primary outcome is Percentage of Participants Who Signed up for the Intervention That Completed All 3 Coaching Sessions..

2. Clinical Question

The broader study aims are to assess fidelity of coaching delivery, the potential effect of the intervention on virtual-simulation performance compared with control, and acceptability to trainees. Under-triage and participants describing coaching as acceptable are listed as secondary outcomes. These aims address feasibility and potential performance effects in a laboratory setting; the record does not report results that answer whether performance differed between groups.

3. Trial Design

This is a randomized, single-masked, parallel-group study of a behavioral intervention. The registry lists the study as completed and gives an enrollment of 72. The brief summary describes recruitment of a national convenience sample, with trainees identified as n=30 and a control group of physicians identified as n=30. Those descriptions do not establish the final number assigned to or analyzed in each group; those counts are not reported in the registry record.

Participants assigned to deliberate practice were to meet with a coach once per week for thirty minutes over a three week period. The coach and trainee played a puzzle video game and discussed contextual cues that should inform triage decisions. The control group completed a virtual simulation. The intervention description ends after referring to the completion of the three weeks, so any additional procedures at that point are not reported in the registry record.

The stated primary outcome concerns completion of all 3 coaching sessions among people who signed up for the intervention, over the 3 week intervention period. Other aims concern coaching fidelity, performance on a validated virtual simulation, and acceptability measured using validated instruments and semi-structured debriefing interviews. Under-triage is also listed as a secondary outcome.

The registry lists the study start as 2021-12-15 and primary completion as 2022-03-11. It does not report who was masked, the randomization procedure, allocation concealment, or the final group-specific recruitment and follow-up details. The primary endpoint result and comparative performance results are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Board-certified emergency physicians who triage and treat adult patients in the emergency department of either a non-trauma center or a Level III/IV trauma center in the United States.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants Who Signed up for the Intervention That Completed All 3 Coaching Sessions., measured over 3 week intervention period.

The primary endpoint is described as the percentage of participants who signed up for the intervention and completed all 3 coaching sessions. Its timeframe is the 3 week intervention period. The operational description, however, defines the measure as a summary of the number of trainees who signed up for coaching and completed all sessions. The registry thus names a percentage but specifies a participant count. It does not report the completion count, the number who signed up, or a percentage.

Completion is a feasibility measure: it records whether participants carried out the planned coaching schedule. In an intervention study, such information can help readers distinguish difficulties with delivering or engaging in the program from its potential effect on a separate performance outcome. Completion alone does not measure triage accuracy, coaching fidelity, acceptability, or comparative performance. Those are addressed by separate study aims or outcomes.

For a percentage to be interpreted, its denominator must be clear. For example, the denominator might be everyone who signed up, but the registry does not provide the actual count or clarify how withdrawals or incomplete participation were handled. The title and description therefore do not allow the endpoint result to be reconstructed. No comparison of completion between groups is specified as the primary question.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes random allocation, single masking, and a parallel-group design. In general, random allocation aims to make treatment groups comparable at the start of a trial with respect to measured and unmeasured characteristics. It does not guarantee balance in every sample, and it does not itself establish that the outcome was measured or analyzed appropriately. Details of sequence generation and allocation concealment are not reported in the registry record.

What does a parallel-group design mean?

In general, a parallel-group trial assigns participants to different study conditions and follows each group under its assigned condition. Here, the conditions are deliberate practice and control. The record labels masking as single, but does not identify who was masked or describe how masking was maintained. It is therefore not possible to judge which participants, coaches, assessors, or analysts knew group assignment.

How should the primary outcome be understood?

The primary outcome concerns completing all 3 coaching sessions among those who signed up. It is a count-based measure according to the outcome description, although the outcome title calls it a percentage. A count answers how many people met the completion definition. A percentage also needs a clearly defined denominator. In general, the numerator is the number meeting the completion criterion and the denominator is the relevant group of participants. Neither the observed count nor the denominator is reported, so no completion rate can be interpreted or recalculated.

For a binary outcome, such as whether a participant completed the sessions, an analysis could compare the proportion meeting the criterion between groups or estimate the proportion within the intervention group. Those are general approaches, not methods reported for this study. The registry record does not specify the primary analysis, the treatment of missing observations, or whether the outcome was analyzed as a count or converted to a proportion.

What do uncertainty and significance measures contribute?

In general, an effect estimate describes the size and direction of a difference or association, while a confidence interval describes uncertainty around that estimate under the chosen method. A p-value summarizes how compatible the observed data are with a specified null model; it does not measure clinical importance or the probability that a hypothesis is true. Neither an effect estimate, a confidence interval, nor a p-value for the primary endpoint or a group comparison is reported in the registry record.

The registry gives planning assumptions for a sample-size illustration: a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. It also states that such calculations are planning illustrations based on an observed effect, not the trial's own design. The record does not report a numerical planning result in the information available for this analysis. Such illustrations are not observed power and do not establish the power of this completed study. The trial's own sample-size justification is not reported in the registry record.

What analytical details are not available?

Details of the statistical analysis plan, outcome models, adjustment variables, handling of repeated or clustered observations, and any interim analyses are not reported in the registry record. The coaching intervention involves coach-trainee pairings, but the record does not describe an analysis accounting for that structure; no such method should be assumed. The same applies to the validated simulation outcome and acceptability measures: their scoring, analysis populations, and comparison procedures are not reported.

In general, over-dispersion occurs when observed variability in count data is greater than a model assumes, which can make standard errors too small if the model is not appropriate. This concept is relevant only when an analysis uses a count model with such assumptions; the registry does not report that a count model was used. Similarly, assumptions about normal approximations matter for planning calculations, but do not reveal what method was used to analyze the observed trial outcomes.

The record lists a primary outcome and secondary outcomes, but does not describe adjustment for multiple comparisons. It also does not specify whether analyses followed randomized assignment, included only participants who completed treatment, or used another analysis population. These omissions limit assessment of the methods and prevent independent reproduction of the intended analyses.

10. Multiplicity, Missing Data and Analysis Populations

The registry describes several objectives: intervention-delivery fidelity, potential performance effects, and acceptability. It lists 3 outcome measures, including the primary completion outcome and secondary outcomes concerning under-triage and participants describing coaching as acceptable. The multiplicity plan, including whether any outcome was designated as the main basis for confirmatory inference and whether comparisons were adjusted, is not reported in the registry record.

In general, testing multiple outcomes or comparisons can increase the chance of observing an apparently notable result by chance. A prespecified hierarchy or adjustment method can help readers understand how that issue was handled. No hierarchy or adjustment method is reported, and no outcome results are available to assess.

Missing-data procedures are not reported. The record does not describe how incomplete coaching, missing simulation assessments, or absent interview responses were handled. It does not report how many participants had outcome data available or whether missingness differed by group. These details matter because the observed results could be difficult to interpret if outcome availability depended on participation or performance.

Analysis populations are also not reported. The record does not say whether the performance comparison included everyone randomized, only those completing the intervention, or another defined group. The relationship between the enrollment entry of 72 and the trainee and control counts described in the study summary is not explained. No final analyzed group counts are reported.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry's adverse-event entries list 0 serious events and 0 other events in the deliberate-practice group, with 0 deaths. The control entries likewise list 0 serious events, 0 other events, and 0 deaths. Each group is recorded as having 36 participants at risk for the serious-event and other-event figures.

These entries mean that the registry records no events in those categories for the listed groups. They do not establish that no event could occur, nor do they give information about event definitions, surveillance procedures, duration of follow-up, or completeness of reporting. No serious-event terms are listed. The record does not provide event-level descriptions or uncertainty estimates.

In general, zero recorded events is a descriptive finding, not proof that risk is absent. Interpretation depends on how events were defined, collected, and reported, as well as the amount of observed follow-up. Those details are not reported in the registry record. The at-risk entries should not be assumed to represent the final analysis population or used to infer unreported outcomes.

12. What the Result Does, and Does Not, Mean

The record establishes that a randomized, parallel-group study evaluated a deliberate-practice coaching intervention for emergency physicians. It describes a coaching schedule, a virtual-simulation control condition, and aims concerning feasibility, fidelity, performance, and acceptability. It also records completion of the study and enrollment of 72.

It does not report the primary completion result. The outcome title refers to a percentage, while its description specifies a participant count, and neither the count nor its denominator is available. The record therefore cannot establish how often participants completed the coaching sessions. It also does not report the findings for the performance comparison, under-triage, or acceptability.

In general, an intervention's feasibility and its effect on performance are separate questions. Completing sessions can indicate whether participants engaged with the planned activity, but it does not by itself show that triage performance changed. Likewise, a performance comparison would need an estimate and information about uncertainty to support interpretation; those results are not reported in the registry record.

The absence of recorded adverse events is also descriptive and should not be interpreted as proof of no risk. The safety entries list no serious events, other events, or deaths in either group, but details on event monitoring and reporting are not available.

Accordingly, this record describes the trial's purpose, design, outcomes, and recorded safety figures, but does not provide enough outcome information to estimate the intervention's effect or the precision of any effect. It does not support a conclusion about whether coaching changes triage performance or is acceptable to participants.

13. Why This Trial Matters Statistically

This study raises several statistical questions common to behavioral and educational trials. The intervention is a coaching process, while the primary outcome concerns whether participants complete the planned sessions. Completion is informative about feasibility, but it is conceptually distinct from the performance outcome the intervention is intended to influence. Keeping those outcomes separate helps avoid treating participation as evidence of effectiveness.

The endpoint's wording also illustrates why an operational definition matters. A title describing a percentage and a measure defined as a count do not communicate the same information unless the denominator is clear. A count can describe the number completing sessions; a percentage also expresses that count relative to a defined group. Without both the observed count and denominator, readers cannot assess completion or its precision.

The design pairs trainees with coaches and uses a simulation outcome. In general, those features can raise questions about how dependence among observations, coaching delivery, and outcome assessment are handled. The registry does not report analytical details that answer those questions. Nor does it identify who was masked, explain the allocation procedure, or describe the analysis population.

Finally, the study has several aims and outcomes, but its multiplicity and missing-data plans are not reported. These omissions matter when evaluating how results would be interpreted and whether an analysis can be reproduced. Because outcome estimates are not reported, the record cannot answer the statistical questions about effect size, uncertainty, or group differences that the study was designed to explore.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The principal limitation for interpretation is that the registry record does not report results for the primary endpoint or the comparative performance outcome. It therefore provides no completion estimate, group effect estimate, or uncertainty measure. Results for the listed secondary outcomes are also not reported.

The primary endpoint is not fully clear as written: its title describes a percentage, whereas its measure description specifies a number of participants. The count, denominator, and rules for handling people who signed up but did not complete are not reported. This prevents reconstruction or interpretation of a completion rate.

The enrollment entry is 72, while the study summary identifies n=30 trainees and n=30 control physicians. The registry record does not explain the relationship between these figures, give final group assignments, or state the analyzed populations. No inference about final participant flow should be drawn from these entries.

Important design and analysis details are not reported, including who was masked, the randomization method, the statistical analysis plan, missing-data procedures, outcome-specific analysis populations, and any multiplicity approach. The record also does not provide detailed procedures for the virtual simulation, event monitoring, or intervention fidelity assessment. These gaps limit assessment of bias, reproducibility, and precision.

Safety entries record no events in the listed categories, but definitions and follow-up details are not reported. The record's sample-size assumptions describe a planning illustration rather than the trial's own design, and no numerical illustration result is reported. Together, these limitations mean that the posted record can describe study intent and structure but cannot establish the size, direction, or precision of outcome effects.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Developing a Deliberate Practice Intervention to Recalibrate Physician Heuristics in Trauma Triage — NCT05168579.
• Registry record last updated 2023-04-05; status last verified 2023-03.
• Results first posted 2023-04-05.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT05168579 is a completed randomized, single-masked, parallel-group study of deliberate-practice coaching for emergency physicians. The registry lists enrollment of 72 and describes a coaching intervention using three 30-minute sessions over a three-week period, compared with a control condition involving virtual simulation.

The primary outcome concerns completion of all 3 coaching sessions among participants who signed up. Its title refers to a percentage, but its description defines a participant count. Neither the count nor the denominator is reported. The record also does not report comparative performance, under-triage, or acceptability results.

The adverse-event entries record 0 serious events, 0 other events, and 0 deaths in each group, with 36 at risk in each group for the event entries. Analysis methods, missing-data procedures, and analysis populations are not reported in the registry record. The available information describes the study design and intended questions but does not provide outcome estimates or their precision.