A Transition of Care Model From Hospital to Community for Hispanic/Latino Adult Patients With Diabetes.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Transition of Care Model From Hospital to Community for Hispanic/Latino Adult Patients With Diabetes. (NCT04864639), a na na study. The primary outcome is Emergency Department (ED) Visits Within 30 Days Post Discharge.

2. Clinical Question

The clinical question is therefore descriptive rather than comparative in the posted record. It concerns emergency department use after participants received the transition model, not whether that model changed use relative to usual care or another intervention. The registry also names unplanned hospital readmissions within 30 days post-discharge as a secondary outcome, but does not report its result.

The study’s stated overarching goal was to develop, test, and determine the feasibility of a transition-of-care model for Hispanic/Latino adults with diabetes. Feasibility is distinct from evidence of comparative effectiveness: the record would need to report the relevant feasibility measures and their results to support conclusions about implementation. Those measures and findings are not reported in the registry record. The primary endpoint alone, even if its summary were available, would describe emergency department use in the observed group; without a comparator, it would not establish what would have happened under another care approach.

3. Trial Design

The registry describes a completed pilot study sponsored by Duke University, with a start date of 2021-08-04 and a primary completion date of 2022-02-17. Its phase is listed as NA. The design is recorded as single-group, and allocation is NA; masking is recorded as NONE. These entries do not describe a randomized comparison.

The intervention is named Transition of Care Model and classified as OTHER. The brief summary frames the work as addressing a gap in the transition from hospital to community for Hispanic/Latino adults with diabetes. The arm description calls the group “Transition of Care” and states that 32 participants will be discharged to a newly developed discharge/transition-of-care model. The registry’s enrollment field, however, reports 12. The record does not explain the difference between these entries, so it is not possible to determine from the record whether they refer to different stages or populations.

The primary endpoint is emergency department visits within 30 days post-discharge, expressed as a mean with standard deviation. Unplanned readmissions to the hospital within 30 days post-discharge is listed as a secondary outcome. The registry records 2 outcome measures and 0 analyses. It does not report an outcome estimate for either measure.

Because there is no separate control group, this design can describe outcomes among participants receiving the model if results are reported, but it cannot isolate the model’s effect from other explanations for those outcomes. The record does not report details of recruitment, eligibility criteria, intervention delivery, adherence, follow-up completeness, or the statistical analysis plan. These details should not be inferred from the study title or its stated aim.

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:

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 Emergency Department (ED) Visits Within 30 Days Post Discharge, measured over 30 days post-discharge.

The primary endpoint is the number of times a participant revisited the emergency department after hospital discharge, measured over 30 days post-discharge. The registry specifies the endpoint as emergency department visits and identifies the summary measure as a mean with standard deviation. The reported timeframe makes the outcome a measure of short-term emergency department use following the transition from hospital to community care.

In general, counting visits can capture repeated use, rather than only whether a participant had any visit. A mean describes the average count in the group; a standard deviation describes variation in those counts around the mean. These summaries answer different questions: the mean characterizes the group average, while the standard deviation helps convey how dispersed individual counts are. For count outcomes, distributions may be skewed or include many zeros, so the mean and standard deviation may not fully describe the distribution. The registry does not report additional distributional summaries or a model for this endpoint.

Emergency department use is relevant to a transition-of-care pilot because the outcome occurs after discharge and concerns subsequent acute-care use. That relevance does not make it a direct measure of every aspect of care transition or feasibility. The registry does not report the observed mean, standard deviation, or participant-level distribution. Consequently, the endpoint’s result and its precision cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Interpreting a clinical-trial result starts by distinguishing the design, the outcome definition, the estimate, and the uncertainty around that estimate. In this record, the design and primary endpoint are described, but the outcome estimate and its uncertainty are not reported in the registry record. General statistical concepts can explain what those quantities would mean, but they cannot fill in the missing findings.

What does a single-group design estimate?

In general, a single-group study can summarize outcomes observed among the participants receiving the intervention. A group mean would describe the average outcome in that group, and an associated confidence interval would indicate the range of values reasonably compatible with the data and the method used to calculate the interval. A confidence interval is not a guarantee that the true value lies inside its limits, nor does it capture every source of uncertainty, such as bias from selection or incomplete follow-up.

A comparative treatment effect requires a contrast between intervention and comparator outcomes. The registry records a single-group model and no separate control group. Thus, the record does not define a concurrent comparison from which to estimate a difference between care approaches. A within-group summary, if reported, would not by itself answer what would have happened to the same population under another approach.

How should the primary endpoint be understood?

The endpoint is a count of emergency department visits within 30 days post-discharge. The registry says the measure is summarized as a mean and standard deviation. In general, a mean is useful for describing average event burden across a group, while the standard deviation indicates how varied the counts are. Those statistics do not show the full shape of a count distribution. For example, a group may contain many participants with no visits and a smaller number with repeated visits; a mean and standard deviation alone may not reveal that pattern.

In general, count outcomes can be over-dispersed when their variability exceeds what a simple Poisson model would anticipate. Over-dispersion matters because a model that assumes too little variability can produce confidence intervals that are too narrow and tests that are too optimistic. Other approaches may account for extra variation or focus on different features of the distribution. The registry record does not report a model choice, distributional assessment, or analysis method for the primary endpoint, so none should be attributed to the investigators.

What can be said about statistical testing?

The registry records 0 analyses. It does not report a p-value, a confidence interval, a hypothesis test, or an adjusted estimate for the primary endpoint. Without an observed estimate and its uncertainty, statistical significance and precision cannot be evaluated. Even where a p-value is available, general statistical interpretation treats it as a measure of compatibility between data and a specified null model, not as the probability that a treatment is effective or that the null hypothesis is true. No such test result is posted for this endpoint.

The record also does not report whether analyses were prespecified, whether covariates were used, or how repeated visits were handled. The planned summary as a mean and standard deviation does not answer those questions. It should not be taken as proof that a particular inferential method was used.

How do planning calculations differ from trial findings?

General sample-size calculations depend on assumptions about the effect to detect, variability, significance level, allocation, and analysis method. The planning assumptions described for the illustration use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is defined as a stated fraction of the observed effect. The record does not report the trial’s own sample-size justification, and the illustration is not the trial’s design rationale.

A planning illustration is not observed power. Observed power is not a substitute for reporting the estimate and its confidence interval, and a planning calculation cannot supply missing trial results. The registry does not report the primary outcome estimate from which readers could assess the observed effect. It also does not report details needed to determine whether the illustrative assumptions match this single-group study. Accordingly, the illustration should not be interpreted as evidence that the study had a particular ability to detect a clinical effect.

Why does the absence of a comparator matter?

Randomization and a suitable comparison group can help separate intervention effects from background differences, although design and conduct still matter. Here, allocation is NA and the study is single-group. General explanations of randomized trials or comparative models therefore should not be mistaken for a description of this study. The record supports a descriptive framing, and any causal interpretation would require evidence not present in the registry record.

These methods concepts clarify what information is needed for a statistical assessment: a clearly defined analysis population, observed outcome summaries, an uncertainty measure, and enough detail about the analysis to understand its assumptions. Those items are not reported in the registry record for the primary endpoint.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 2 outcome measures: emergency department visits within 30 days post-discharge as the primary outcome, and unplanned readmissions to the hospital within 30 days post-discharge as a secondary outcome. It records 0 analyses, and no results for either outcome are reported in the registry record.

In general, multiplicity arises when investigators examine several outcomes, time points, subgroups, or statistical tests. If many tests are conducted, the chance of at least one apparently unusual result can increase unless the analysis plan accounts for that testing. A prespecified primary endpoint helps identify the principal question, but it does not reveal whether other analyses were planned or how multiplicity was handled. The registry does not report a multiplicity strategy or a statistical analysis plan, so no adjustment or hierarchy should be assumed.

The record does not report missing-data counts, reasons for missingness, imputation methods, or sensitivity analyses. It also does not define an analysis population, such as all enrolled participants or participants with complete follow-up. The enrollment field reports 12, while the arm description states 32 participants; the record does not explain how those entries relate to the population included in any analysis. Since no analyses are listed, the results cannot be checked against a defined analysis set.

In general, missing outcomes can affect both the estimated group summary and its uncertainty, especially if missingness is related to health status or care use. Complete-case results, if used, may not represent all enrolled participants. Those are general considerations, not claims about how missingness occurred in this study. The registry record does not report the information required to assess that issue.

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 safety record lists 0 serious adverse events affected among 12 at risk and 0 other adverse events affected among 12 at risk. It also records 1 death. No serious adverse event terms are listed. These are separate entries, and the record does not explain how the death relates, if at all, to the adverse-event entries.

In general, an “at risk” count identifies the population denominator used for a safety category, while an affected count records participants with an event as entered in that category. Such counts do not describe event timing, duration, severity beyond the category, or causal relationship to an intervention unless those details are reported. The record does not provide those details for the death or describe its cause or timing. It also does not report the method or completeness of safety-event ascertainment.

Zero recorded affected participants for the adverse-event categories should be read as a registry count, not as proof that no safety concerns could occur. With no further safety narrative, the clinical meaning of the death cannot be determined from the registry record. These entries also do not establish whether an event was judged related or unrelated to the model.

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

The record establishes that a completed pilot was registered to examine a transition-of-care model for Hispanic/Latino adults with diabetes moving from hospital to community care. It identifies emergency department visits within 30 days post-discharge as the primary endpoint and unplanned readmissions within 30 days post-discharge as a secondary outcome. It also gives the study’s single-group design and the safety counts recorded in the registry.

It does not report the primary endpoint result, the secondary outcome result, or any statistical analyses. As a result, the posted information cannot show the observed frequency of emergency department use or readmission, the variability in outcomes, or the precision of an estimate. No comparative effect can be inferred because a separate control group is not reported. The fact that the study is marked completed does not itself establish that results were posted or that the model achieved its stated goals.

The pilot aim includes feasibility, but the registry record does not report feasibility measures or their findings. Without those results, it is not possible to judge feasibility from the record. Likewise, the safety counts do not explain the recorded death, and they do not establish a causal relationship or rule one out.

These limitations are about what can be concluded from this registry record, not a judgment that the study was uninformative. A pilot may be intended to develop procedures and generate preliminary observations. To interpret such work, readers need outcome summaries, information about who was analyzed and followed, and an account of missing data and analysis methods. Those details are not reported in the registry record. The appropriate conclusion is therefore narrow: the record describes a single-group pilot and its planned outcomes, but does not provide results that permit assessment of outcome magnitude, precision, or comparative effect.

13. Why This Trial Matters Statistically

This study’s statistical importance lies in the distinction between a feasibility-oriented pilot and a comparative evaluation. The stated aim is to develop, test, and determine feasibility of a transition-of-care model for Hispanic/Latino adults with diabetes. That is a meaningful research question, but it requires outcomes that match the aim. A clinical-use endpoint such as emergency department visits can describe what happened after discharge; implementation or feasibility questions require their own defined measures and results.

The single-group design is central to interpreting any eventual outcome summary. Without a separate comparator in the registry record, an observed count would describe the participants’ experience under the model, but it would not identify a causal effect relative to another care approach. This is a design limitation for causal comparison, not a reason to dismiss descriptive or developmental work. It simply defines which statistical claims the design can support.

The record also illustrates why registration details and results must be considered separately. It specifies an endpoint, unit, summary measure, and timeframe, yet does not report the observed endpoint value or an analysis. A prespecified outcome definition is valuable for clarity, but readers still need results and uncertainty to assess what the study observed. The reported enrollment and arm-description figures also differ, and the record does not explain their relationship. Clarifying participant flow and analysis populations would help readers understand the basis for any future estimate.

Finally, the safety entries require context. Counts alone do not communicate event timing, attribution, or completeness of follow-up. Statistical interpretation depends not only on arithmetic summaries but also on design, outcome ascertainment, and transparent reporting. In this case, the registry supports a careful description of the study framework while leaving the clinical outcomes and feasibility findings unresolved.

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 key limitation for interpreting this specific trial is that the registry record does not report outcome results or analyses. The primary endpoint is defined, but its mean and standard deviation are absent. The secondary readmission outcome is named without a result. Therefore, the study’s observed outcomes and their precision cannot be assessed from this record.

The single-group design and absence of a separate control comparison limit causal interpretation. The record does not describe randomization or a comparator, so any group outcome would be descriptive rather than a direct estimate of the model’s effect relative to another approach. In addition, the stated pilot goal includes feasibility, but the registry record does not report feasibility measures or results.

Participant information is not fully reconciled: the enrollment field reports 12, while the arm description states that 32 participants will be discharged to the model. The record does not explain this difference or identify an analysis population. It also does not report eligibility details, recruitment, participant flow, follow-up completeness, or missing-data handling. Without those details, the population represented by any analysis cannot be established.

The record does not report the statistical analysis plan, distributional checks, covariate adjustment, or a multiplicity strategy. The primary outcome is a count summarized by a mean and standard deviation, but no additional distributional information is available. Safety reporting records 1 death but gives no cause, timing, or relationship to the intervention, and describes no serious adverse event terms. These gaps constrain both statistical and clinical interpretation; they should not be filled by assumptions.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Transition of Care Model From Hospital to Community for Hispanic/Latino Adult Patients With Diabetes. — NCT04864639.
• Registry record last updated 2023-03-17; status last verified 2023-03.
• Results first posted 2023-03-17.
• 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

NCT04864639 is a completed, single-group pilot sponsored by Duke University, with a start date of 2021-08-04 and primary completion on 2022-02-17. It concerns a Transition of Care Model for Hispanic/Latino adults with diabetes moving from hospital to community care. The registry records phase NA, allocation NA, and masking NONE.

The primary endpoint is emergency department visits within 30 days post-discharge, summarized as a mean with standard deviation. Unplanned readmissions within 30 days post-discharge is listed as a secondary outcome. The registry reports 12 enrolled, while the arm description states 32 participants; the record does not explain the difference. It lists 0 analyses and does not report outcome results.

The safety entries record 0 serious adverse events affected, 0 other adverse events affected, and 1 death. The record does not describe the death’s cause, timing, or relationship to the model. Overall, the registry describes the design and intended outcomes but does not provide findings with which to assess the clinical outcomes or feasibility.