Coordinated Emergency Department Transitions: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Coordinated Emergency Department Transitions (NCT06933849), a na na study. The primary outcome is Percent of Eligible Emergency Department Visits With Completed Outreach.

2. Clinical Question

The clinical question concerns whether case managers can deliver structured information and discharge support to emergency department providers for eligible visits involving patients with Alzheimer disease or related disorders who are served in assisted-living settings. PartnerED’s stated goal is to reduce unnecessary hospital admissions, but the primary outcome measures whether outreach was completed, not whether admissions were avoided.

A secondary outcome asks about the percent of successful outreach conversations in which staff reported that an unnecessary hospitalization was avoided. That is a report of staff assessment following successful conversations, not a direct comparison of hospitalization rates between intervention and control groups. The registry record does not report results for this outcome either. Accordingly, the study description supports a question about implementation and acceptability of the outreach process, while it does not furnish a comparative estimate of the intervention’s effect on hospital admission.

3. Trial Design

The registry lists PartnerED Care as an observational study with a single-group model. It is marked completed, with Brown University as sponsor. The record lists the intervention as behavioral and names it structured case management. Phase is recorded as NA, allocation as NA, and masking as none. These entries are consistent with a service-delivery evaluation rather than a randomized, masked comparison, but the registry record does not give further detail on the study protocol.

The intervention was intended to transmit structured clinical and discharge support information to emergency department providers in real time. Chronic care managers employed by Bluestone Accountable Care Organization led the intervention. Eligible emergency department visits were identified using electronic admission, discharge, and transfer notifications. The primary outcome’s timeframe is within 1-3 hours of emergency department registration.

The registry record reports 1376 participants, whose visits totaled 1989 emergency department visits. The unit for the primary outcome is visits, rather than participants. This distinction matters because a participant could contribute more than one visit; the record does not describe how repeated visits were handled in any statistical analysis.

The recorded study dates are start 2024-10-04 and primary completion 2025-02-18. The record lists two outcome measures and zero analyses. It does not report a protocol-level sample-size justification, planned statistical methods, interim analyses, or a detailed analysis population. It also does not describe a concurrent control group or a before-and-after comparison. Without those details or outcome estimates, the record supports a description of the study’s intended implementation assessment, but not a conclusion about comparative effectiveness.

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

Analysis population for the primary outcome, as defined in the registry: 1376 study participants had a total of 1989 emergency department visits. The unit of measure for this outcome is emergency department visits.

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 Percent of Eligible Emergency Department Visits With Completed Outreach, measured over Within 1-3 hours of emergency department registration.

The primary endpoint is the percent of eligible emergency department visits with completed outreach. For each eligible visit, the intended event is that a case manager communicates structured clinical and discharge support information to an emergency department provider about a patient in their care. The specified timeframe is within 1-3 hours of emergency department registration.

This endpoint is used to assess whether the intervention’s central operational step occurred promptly: reaching emergency department providers with relevant information. In an implementation-focused study, the proportion of eligible visits with completed outreach can indicate how consistently the process was delivered across the visits under study. It does not, by itself, measure whether the information changed clinical decisions or whether a hospitalization was necessary.

The outcome is visit-based. The registry record reports 1376 participants and 1989 emergency department visits, but it does not report the number of visits with completed outreach or the resulting percentage. A percentage requires both a defined denominator and a count meeting the completion criterion. The denominator is described as eligible emergency department visits; the completed-outreach count is not reported in the registry record.

The secondary outcome concerns successful outreach conversations in which staff reported avoidance of an unnecessary hospitalization. That measure captures staff-reported assessment in a subset of conversations and is distinct from a verified admission outcome or a comparison of admission rates. Neither outcome’s results are reported in the registry record, so the magnitude and precision of any observed implementation outcome cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The outcome definitions and study design determine what statistical conclusions would be appropriate. The registry record identifies a visit-level percentage as the primary outcome, an observational single-group design, and zero listed analyses. It does not report the actual outcome values or statistical methods. The explanations below describe general statistical principles and should not be read as a claim that a particular method was used for this study.

What a visit-level percentage represents

In general, a percentage for this outcome would be the number of eligible visits meeting the completed-outreach definition divided by the number of eligible visits assessed, expressed as a percent. The registry identifies eligible emergency department visits as the unit of measure and describes the outcome as completed outreach within 1-3 hours of registration. It reports 1989 total visits among 1376 participants, but it does not report the completed-outreach count or confirm the exact denominator used in an analysis. No percentage can therefore be recovered from the registry record.

A percentage is descriptive: it conveys how often a defined event occurred in a specified set of observations. Its interpretation depends on consistent definitions of eligibility, completion, and the time window. If some eligible visits were not assessable, it would also matter how those visits were handled. The registry record does not report operational rules for partial, delayed, or unsuccessful contact, nor does it describe missing outcome information.

Why the visit and participant units matter

General statistical reasoning distinguishes the number of people from the number of observations. Here, the primary endpoint is defined per emergency department visit, while participants may contribute visits more than once. Repeated observations from the same person can be more alike than observations from different people. If an analysis treats every visit as statistically independent, uncertainty may be understated when within-person dependence is present. Analyses can account for clustering or repeated measures, but the registry record does not report whether such methods were used. It also does not give the distribution of visits across participants, so that dependence cannot be characterized from the available information.

Over-dispersion is a general issue when observed variation in count or binary data exceeds what a simple probability model assumes. For a visit-level completion indicator, unmodeled differences among participants, providers, or settings could produce more variability than a basic model allows. Recognizing and modeling over-dispersion can affect estimated uncertainty. This is a general consideration, not a reported feature or analysis of PartnerED.

Estimation and uncertainty

In general, a point estimate summarizes the observed outcome, while a confidence interval describes statistical uncertainty around that estimate under specified modeling assumptions. A narrow interval would indicate greater precision than a wide interval, but neither interval width nor an estimate can be evaluated without the reported values. No confidence interval or other precision measure for the primary endpoint is reported in the registry record.

A hypothesis test asks whether data are compatible with a specified statistical null hypothesis under an analysis model. A p-value is not a measure of the size or practical importance of an effect, and it does not establish causation. No hypothesis test or p-value is reported in the registry record. More importantly, the single-group design does not supply a concurrent comparison from which to estimate a treatment contrast.

What a single-group observational design can support

In general, a single-group observational evaluation can describe how often an implementation activity occurred among the observed eligible cases. It can also document participants’ or staff members’ reports, when these are collected and reported. Such a design does not by itself show what would have happened to the same cases without the intervention. A comparison group, a defined pre-intervention period, or another credible design for estimating a counterfactual would be needed to support a comparative claim. The registry record does not describe such a comparison.

Observational results can also be affected by confounding: characteristics associated with both intervention exposure or delivery and the outcome can influence an apparent association. In a single-group study, confounding is not resolved merely by reporting an outcome percentage. Adjustment for measured factors may sometimes help, but it cannot ensure removal of unmeasured confounding. The record does not report covariate adjustment or a confounding-control plan.

Outcome hierarchy and interpretation

The primary outcome tracks completed outreach, while the secondary outcome captures staff reports of avoiding an unnecessary hospitalization in successful outreach conversations. They address related but different questions. Completion is a process measure; staff-reported avoidance is a reported judgment about a possible consequence. Neither is equivalent to an independently verified comparison of hospitalization outcomes. General interpretation should preserve those distinctions and avoid treating an implementation measure as a direct causal effect on admissions.

The registry record gives no analysis details for either outcome. Statistical model, interval method, handling of repeated visits, covariates, missing-data procedures, and decision thresholds are not reported in the registry record. As a result, the appropriate reading is limited to the endpoint definitions, population description, and design characteristics that are actually documented.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists two outcome measures: the primary endpoint is the percent of eligible emergency department visits with completed outreach, and the secondary endpoint concerns successful outreach conversations in which staff reported avoidance of an unnecessary hospitalization. Considering more than one outcome can raise a general multiplicity issue when multiple statistical tests are performed. Repeated testing can increase the chance of a false-positive finding across a family of tests. The record lists zero analyses and reports no tests, so there is no reported multiplicity adjustment or testing strategy to assess. Whether any adjustment was planned is not reported in the registry record.

Missing data can affect both the numerator and denominator of a visit-level percentage. For example, incomplete documentation of eligibility or outreach completion may make it unclear whether a visit should count as an event, a non-event, or an observation with unknown status. This is a general issue for process outcomes. The registry record does not report the amount or pattern of missing data, the number of visits excluded, or a method for handling missing outcome information.

The record reports 1376 participants and 1989 emergency department visits, but does not state which participants or visits were included in each outcome analysis. It does not describe an intention-to-treat population, a per-protocol population, or another analysis population. Since the study is observational and single-group, those labels may not map directly onto its analytic choices; the relevant inclusion and exclusion rules are not reported in the registry record.

The record also does not report whether repeated visits were clustered by participant, whether incomplete outreach was counted as unsuccessful, or whether the secondary outcome denominator included only successful conversations. The outcome wording indicates that the secondary measure applies to successful outreach conversations, but the detailed denominator and missing-data rules are not reported. These omissions limit reproducibility and make it difficult to know precisely which observations an eventual estimate would represent.

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 safety information lists one group, “All Patients With Eligible Emergency Department Visits,” with 1376 at risk. It records 0 serious adverse events, 0 other adverse events, and 3 deaths. These are the counts recorded for the group; the registry record does not provide event descriptions or further detail about how they were collected.

The counts should be read separately. The recorded death count is not an explanation of cause, timing, relationship to the intervention, or whether a death was included in an adverse-event category. Those details are not reported in the registry record. The record also does not provide definitions for serious versus other adverse events, a follow-up duration for safety monitoring, or a description of ascertainment procedures. It is therefore not possible to infer from these counts whether events were related to the intervention or to compare safety between intervention and control groups.

Because this is a single-group observational study, the registry does not present a concurrent safety comparator. A count of zero recorded events does not establish that no events occurred outside the registry’s reporting or ascertainment process, and it is not a comparative risk estimate. The safety entries are descriptive registry counts only. Their interpretation is limited by the absence of event-level context and by the lack of a reported comparison group.

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

The study’s stated purpose is to learn about the feasibility, acceptability, appropriateness, and adherence associated with a case-management intervention for eligible emergency department visits. Its primary endpoint focuses on whether a case manager completed outreach to an emergency department provider within the specified timeframe. That focus makes the measure relevant to the implementation process: it asks whether a central component of PartnerED was delivered as intended.

The endpoint does not directly measure whether a patient was admitted, whether an admission was unnecessary, or whether the intervention changed care. Although the intervention’s stated goal is to reduce unnecessary hospital admissions, a goal is not an outcome result. The secondary outcome records staff reports of avoided unnecessary hospitalization in successful conversations, but that is not the same as an independently verified admission outcome or a controlled estimate of admissions prevented.

The registry record reports 1376 participants and 1989 emergency department visits, and it marks the study completed. It does not report the completed-outreach count or percentage, results for the secondary outcome, an effect estimate, or uncertainty measures. Thus, the record cannot establish the level of implementation success or the precision of an observed result.

The observational, single-group design also limits causal interpretation. Without a comparison group, it is not possible to distinguish an intervention effect from other explanations for any outcome pattern. The record does not describe a statistical adjustment strategy that could address measured differences or other sources of bias.

Accordingly, the available registry information supports a description of who and what the study was designed to evaluate, the intervention’s intended process, and the outcome definitions. It does not support a conclusion that the intervention did or did not reduce hospital admissions, nor does it permit a quantitative judgment about completed outreach. Those conclusions would require outcome results and, for causal comparisons, a design and analysis capable of supporting them.

13. Why This Trial Matters Statistically

This study is statistically notable for the distinction between an implementation endpoint and a clinical service outcome. The primary measure is the percent of eligible visits with completed outreach, which can describe delivery of a case-management process. The intervention’s stated goal concerns unnecessary hospital admissions, but the primary endpoint does not measure admissions. Keeping process measures separate from downstream outcomes prevents a successful communication process from being mistaken for evidence of a change in hospitalization.

The visit-level unit also matters. The registry reports 1376 participants and 1989 emergency department visits, meaning the outcome is framed around visits rather than a single observation per participant. General statistical methods must account for the possibility that multiple visits from one participant are related. The registry record does not report how that issue was addressed, if at all. This affects how precisely an estimate could be interpreted.

The single-group observational design makes the descriptive and causal questions different. A descriptive completion percentage could characterize observed implementation if the numerator, denominator, and missing-data rules were reported. A causal claim about whether the intervention reduced admissions requires a comparison that estimates what might have occurred without the intervention. The registry record describes no such comparator and lists zero analyses.

Finally, transparency about results is essential for statistical interpretation. The record gives outcome definitions and population counts but does not report outcome values, effect estimates, or uncertainty. Without those elements, readers cannot assess the observed level of outreach, its precision, or whether the secondary staff-reported outcome occurred. The study’s documented design is informative, but its registry record does not supply the quantitative findings needed to evaluate performance or impact.

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.

Several limitations specific to the registry record constrain interpretation. The primary endpoint is defined, but its observed count and percentage are not reported. The same is true of the secondary outcome. Thus, the central implementation questions cannot be answered quantitatively from the recorded results.

The study is listed as observational and single-group, and no comparator is described. This prevents a direct estimate of how outcomes would differ under another care approach. The stated aim of reducing unnecessary hospital admissions is not itself evidence of a reduction, and the primary endpoint measures outreach completion rather than admissions. The staff-reported secondary endpoint is also narrower than an objectively measured change in hospitalization.

The outcome unit is emergency department visits, while participants may contribute multiple visits. Although the record reports 1376 participants and 1989 visits, it does not report the distribution of visits by participant or whether statistical methods accounted for repeated observations. Eligibility rules are described in broad terms through electronic admission, discharge, and transfer notifications, but detailed exclusions and denominator rules are not reported.

Statistical analysis methods, confidence intervals, hypothesis tests, covariate adjustments, missing-data handling, and analysis populations are not reported in the registry record. The registry lists zero analyses. The safety record reports event counts but not definitions, timing, attribution, or ascertainment details. These limitations are specific to what is documented; additional protocol or outcome information is not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Coordinated Emergency Department Transitions — NCT06933849.
• Registry record last updated 2026-05-27; status last verified 2026-05.
• Results first posted 2026-03-03.
• 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

PartnerED Care is listed as a completed observational study sponsored by Brown University. It evaluates structured case management for eligible emergency department visits involving patients with Alzheimer disease or associated disorders in an assisted-living care context. Chronic care managers employed by Bluestone Accountable Care Organization delivered clinical and discharge support information to emergency department providers by phone and fax. Eligible visits were identified through electronic admission, discharge, and transfer notifications.

The registry reports 1376 participants and 1989 emergency department visits. The primary outcome is the percent of eligible visits with completed outreach within 1-3 hours of emergency department registration. A secondary outcome concerns staff reports of avoided unnecessary hospitalization in successful outreach conversations. The record lists two outcome measures and zero analyses, but does not report outcome values or statistical estimates. It describes a single-group study, with no comparator group reported. Safety entries list 0 serious adverse events, 0 other adverse events, and 3 deaths; further event context is not reported in the registry record.