Improving Patient Prioritization During Hospital-homecare Transition: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Improving Patient Prioritization During Hospital-homecare Transition (NCT04136951), a na na study. The primary outcome is Number of Rehospitalizations Within 60 Days After Hospital Discharge.

2. Clinical Question

The study title identifies a mixed-methods investigation of a clinical decision support tool, and the brief summary describes work to build and evaluate an evidence-based homecare tool. The record does not describe the qualitative methods, how they relate to the rehospitalization outcome, or which analyses were planned for either type of data. The central statistical constraint is that the stated question implies a change in rehospitalizations, but the registry record describes a single-group study rather than a controlled comparison. Without reported outcome values and an analysis, the direction and precision of any difference cannot be assessed.

3. Trial Design

The registry record identifies a completed, single-group study of the PREVENT clinical decision support tool. Its allocation is listed as not applicable, and masking is listed as none. The phase is also listed as not applicable. These entries describe a study without a reported randomized allocation or masking procedure; they do not establish a comparison group. The record explicitly cautions that its arms are not a like-for-like control comparison.

The intervention is categorized as “other.” In the experimental phase, the PREVENT recommendation about homecare priority was to be included in referral communication to homecare intake coordinators. Coordinators were instructed to prioritize patients considered high risk. The record does not state how coordinators otherwise made prioritization decisions, whether adherence to recommendations was measured, or whether the recommendation was followed in every referral.

Enrollment is listed as 1915. This is a study enrollment figure, not necessarily the number included in an analysis of the primary endpoint; analysis populations and outcome denominators are not reported. The sponsor is Columbia University. The recorded start date is 2023-08-01, primary completion date is 2024-04-01, and study status is completed.

The official title describes a mixed-methods study, but the registry record does not report the specific qualitative methods, their sample, or how qualitative findings were integrated with the quantitative outcome. Nor does it report a statistical analysis plan or a comparison design. The stated primary outcome is a count of rehospitalizations within 60 days after discharge. No numerical result for that outcome is recorded. The study design therefore supports describing an evaluation in which PREVENT recommendations were shared, but the record does not provide the information needed to estimate a controlled effect of the tool.

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.

Pre-intervention Phase (3 Months)

Intervention Phase (3 Months)

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 Number of Rehospitalizations Within 60 Days After Hospital Discharge, measured over Up to 60 days after hospital discharge.

The primary endpoint is the number of rehospitalizations within 60 days after hospital discharge. The registry defines rehospitalization as a recurrent hospital admission within 60 days from discharge. It is therefore focused on repeat admissions in the specified period, rather than simply whether a person was discharged or referred to homecare.

A count endpoint records how many events occurred. In this study, the outcome description connects that count to the stated aim of learning whether using PREVENT results in a decreased incidence of rehospitalization. A measure of repeat admissions is relevant to that aim because it directly represents the event named in the question. However, interpreting a count generally depends on knowing its denominator and how events were attributed and observed. The registry record does not report the analyzed population, the observed count, or the analysis used to compare counts.

The timeframe is up to 60 days after discharge. This defines the period covered by the endpoint; it does not, by itself, explain how incomplete follow-up was handled or whether every participant contributed the full period. Those details are not reported in the registry record. No numerical primary outcome result, effect estimate, confidence interval, or p-value is reported, so the endpoint's observed level and statistical precision cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The study is recorded as a single-group evaluation, not a randomized comparison. That design feature governs what can be inferred: the record describes sharing PREVENT recommendations with homecare intake coordinators, but does not report a separate control group or a controlled contrast. No statistical analysis is recorded. The registry record does not report a prespecified analysis method for the primary count outcome, covariate adjustment, or a statistical plan.

What does a count outcome represent?

The primary outcome is the number of recurrent hospital admissions within 60 days after discharge. General statistical explanation: count data represent event totals, and their distribution can differ from measurements such as blood pressure or elapsed time. A count model may be considered when the study has event totals and suitable information about the population and observation period. The choice depends on the data structure and assumptions. The registry record does not say that a count model was used, and it does not provide the event data needed to assess any model.

General statistical explanation: over-dispersion occurs when count outcomes vary more than a chosen model expects. If present, it can make uncertainty estimates from a model that assumes less variation too narrow. Assessing it requires outcome data and a specified model. Neither an assessment nor a model is reported in the registry record, so over-dispersion cannot be evaluated for this study. Similarly, repeated admissions may require attention to the fact that events can cluster within a person; the record does not report how events were attributed or modeled.

What can an estimate and confidence interval tell readers?

General statistical explanation: an effect estimate summarizes the contrast or association targeted by an analysis. Its interpretation depends on the comparison being made, the outcome definition, and the analysis population. A confidence interval describes uncertainty around an estimate under the method's assumptions. It is not a guarantee that the true effect lies within the interval, and it does not resolve limitations in design or measurement. Here, no primary outcome estimate or confidence interval is reported, so neither direction nor precision can be evaluated.

A p-value, when reported, addresses how compatible the observed data are with a specified null hypothesis under an analysis model. It does not quantify the size or practical importance of an effect. The registry record does not report a p-value or identify a hypothesis test. It would therefore be inappropriate to infer a positive or negative finding from the study's stated objective or completed status.

How should planning illustrations be understood?

The stated planning assumptions describe illustrations using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They also say that the effect to detect is a stated fraction of the observed effect. The record distinguishes total events for time-to-event illustrations from participants per arm for other illustrations. These are planning assumptions, not a description of the study's single-group design. They do not establish that the actual study randomized participants equally between arms, and they are not observed power.

General statistical explanation: a sample-size calculation estimates the amount of information that a planned design might need to detect a specified effect under stated assumptions. Its output is sensitive to assumptions about the effect, variability, allocation, and analysis. A planning calculation cannot supply missing outcome results or turn an uncontrolled design into a controlled comparison. The registry record does not report the study's own sample-size justification, and the planning assumptions do not establish that such a calculation governed enrollment.

The stated assumptions refer to an observed effect, but the registry record does not report a numerical primary outcome effect or an analysis from which to assess one. Thus the illustrations cannot be checked against a posted result. No planning values are interpreted as trial findings. More generally, a sample-size target is not proof that a study had adequate precision, and a completed enrollment figure is not evidence that a particular effect was detected.

The record also does not explain whether any statistical analyses adjusted for differences in patient characteristics, whether there were subgroup analyses, or how the two listed outcome measures were analyzed. Those details matter because they define which question an estimate answers and how uncertainty should be interpreted. In their absence, the defensible statistical reading is limited to the recorded design, intervention, outcome definition, and missing numerical results.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists two outcome measures, but only the primary rehospitalization measure is described in the available study details. The other measure's definition and analysis are not reported. The record lists zero analyses, and it does not describe a multiplicity plan, such as how inference across more than one outcome or across multiple tests would be handled.

General statistical explanation: when several outcomes or hypotheses are tested, the chance of at least one apparently unusual result can increase if each is assessed separately. A prespecified multiplicity approach can define how to interpret a family of tests. Because no analysis results or multiplicity plan are reported, it is not possible to assess whether multiplicity was relevant to the analyses actually performed or how it was addressed.

Missing-data procedures are also not reported. The registry record does not state whether primary outcome data were complete for all enrolled participants, how incomplete follow-up was handled, or whether any imputation or sensitivity analysis was used. General statistical explanation: missing outcomes can affect estimates when the likelihood of missingness is related to outcome values or participant characteristics. The direction and size of any effect depend on the underlying data and assumptions; they cannot be inferred from the enrollment figure alone.

The analysis population is not reported. In particular, the record does not say how many participants contributed to the primary endpoint or whether any eligibility, follow-up, or data-quality criteria were applied after enrollment. The enrollment figure of 1915 should therefore not be interpreted as the endpoint denominator. The registry record also does not report a protocol-defined analysis population, an intention-to-treat approach, or another named population. Without these details and the endpoint results, neither missing-data bias nor the applicability of analyses can be evaluated.

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 1915 participants at risk for serious adverse events and 0 affected. It also lists 1915 at risk for other adverse events and 0 affected, with 0 deaths. These are the registry's recorded figures for the PREVENT group. They are counts, not estimates of comparative risk: the record does not describe a separate safety control group.

Zero recorded events means that no events are entered in these registry fields; it does not establish that no adverse events occurred outside the recorded information or that all events were captured. The record does not describe the safety collection method, event definitions beyond the serious/other categories, duration of safety follow-up, or how missing safety information was handled. The 60-day period specified for the primary rehospitalization outcome should not be assumed to define safety follow-up.

General statistical explanation: when no events are recorded, the data do not provide evidence of a comparative difference without an appropriate comparison and analysis. A zero count also does not, on its own, quantify the range of event rates compatible with the data. The figures should therefore be read as the adverse-event entries reported for this group, not as proof of absence of risk or as a treatment-effect finding.

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

The study record documents an evaluation of the PREVENT clinical decision support tool in the hospital-to-homecare transition. It describes how the tool's recommendation was to be communicated to homecare intake coordinators and states that coordinators would be instructed to prioritize patients considered high risk. The primary question concerns rehospitalizations within 60 days after discharge.

What the registry record does not establish is whether rehospitalizations decreased. It reports no numerical primary outcome result, effect estimate, confidence interval, or p-value, and lists zero analyses. A study objective describes what researchers intended to learn; it cannot be read as a result. Likewise, a completed status and an enrollment figure do not establish the direction or precision of an outcome.

The design further limits interpretation. The study is recorded as single-group, and no like-for-like control comparison is described. Without a reported comparator and analysis, the record does not show what rehospitalization outcomes would have been under another approach to prioritization. An observed outcome in a single group, even if it were reported, would not by itself isolate the contribution of PREVENT from other explanations.

General statistical explanation: an estimate is most informative when readers can identify the population analyzed, the comparison, the outcome definition, and the uncertainty around the estimate. Here, the outcome definition and timeframe are stated, but the analyzed population, numerical result, and statistical uncertainty are not reported. The primary outcome's direction, magnitude, and precision therefore remain unknown from this registry information.

The record supports a description of the intervention and intended evaluation, not a conclusion about clinical benefit or lack of benefit. It also does not establish how the tool was used in practice beyond the stated communication and prioritization instructions, or whether recommendations were followed. The safety entries report zero events in the listed categories, but without a comparator or additional safety-method details those entries do not demonstrate that the tool is free of risk. The appropriate conclusion is that the registry record leaves the principal outcome question unanswered.

13. Why This Trial Matters Statistically

This study raises a useful statistical question about evaluation of decision support during care transitions: how to assess an intervention intended to influence prioritization when the registry describes a single group and a count of subsequent admissions. The outcome is clearly linked to a defined period after hospital discharge, and the intervention description identifies a practical point of use: referral communication to homecare intake coordinators.

Statistically, the distinction between a study aim and a comparison is important. A question about whether rehospitalizations decrease needs an interpretable contrast. The registry record does not describe a like-for-like control group or report an analysis, so it does not provide a controlled estimate of the tool's effect. That gap matters because a numerical outcome without a suitable comparison would not, by itself, answer whether the tool caused any observed change.

The record also illustrates why enrollment and completion status should not be confused with analytical evidence. Enrollment is listed as 1915, while the primary endpoint denominator and numerical result are not reported. Without those details, readers cannot assess completeness, event frequency, or precision. The planning assumptions describe illustrative calculations, but those assumptions are distinct from the actual single-group study design and do not substitute for outcome results.

The safety entries also need context. Zero serious adverse events, other adverse events, and deaths are recorded for the group, but the registry does not report comparative safety data or the collection and follow-up methods. These figures are meaningful as recorded counts, not as a general guarantee about risk.

The main statistical lesson is to separate what the record establishes from what it leaves unknown. It establishes the intervention's intended workflow, the primary outcome definition, and key design labels. It does not provide the analysis needed to estimate an effect or its uncertainty. That distinction is important when readers evaluate evidence for clinical decision support in settings where implementation and outcome measurement may be closely connected.

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 main limitation specific to interpreting this study is its single-group design, with no like-for-like control comparison reported. The stated aim concerns a decrease in rehospitalization, but the registry record does not identify a comparator against which a decrease could be estimated. Its allocation entry is not applicable, and no controlled analysis is reported.

The primary endpoint is defined as the number of rehospitalizations within 60 days after discharge, but no count or other numerical result is posted. The record does not report the endpoint denominator, the number of participants with complete follow-up, or the analysis population. Enrollment of 1915 therefore cannot be assumed to be the number contributing to the primary outcome.

Implementation details are limited. The record states that PREVENT recommendations were to be shared with intake coordinators and that coordinators were instructed to prioritize high-risk patients. It does not report whether recommendations were followed, how prioritization was otherwise conducted, or how use of the tool was measured. These omissions limit interpretation of what exposure to the intervention meant in practice.

The official title identifies a mixed-methods study, but specific qualitative methods and their relationship to the quantitative outcome are not reported. The statistical plan, analysis method, treatment of missing data, multiplicity approach, and sample-size justification are also not reported in the registry record. Although planning assumptions are described, they are not a substitute for those study-specific details.

Finally, the safety entries contain zero events in the listed categories but do not describe event ascertainment or follow-up. Taken together, these limitations mean that the registry record provides a description of the intervention and intended outcome, but insufficient numerical and methodological detail to assess the magnitude, precision, or causal interpretation of the primary result.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Improving Patient Prioritization During Hospital-homecare Transition — NCT04136951.
• Registry record last updated 2025-10-08; status last verified 2025-09.
• Results first posted 2025-10-08.
• 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

The registry record describes a completed, single-group study of the PREVENT clinical decision support tool for prioritizing patients during the hospital-to-homecare transition. PREVENT recommendations about homecare priority were to be shared with intake coordinators, who were instructed to prioritize high-risk patients. Enrollment is listed as 1915, and the sponsor is Columbia University.

The primary endpoint is the number of rehospitalizations within 60 days after discharge, defined as recurrent hospital admission during that period. The record does not report a numerical primary outcome result or an analysis; it lists zero analyses. No like-for-like control comparison is described. The registry lists zero serious adverse events, zero other adverse events, and zero deaths among the recorded group, without comparative safety information.

The record identifies a mixed-methods study, but does not report the specific qualitative methods, statistical plan, missing-data procedures, or analysis population. It documents the intervention and outcome question but does not provide the findings needed to estimate an effect or its precision.