Prevalence of Chronic Inebriates to the Emergency Department and Suitability for Sobering House Services: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Prevalence of Chronic Inebriates to the Emergency Department and Suitability for Sobering House Services (NCT01783223), a registered phase not stated study. The primary outcome is Intoxicated Patients Eligible for a Sobering House.

2. Clinical Question

The clinical question is descriptive: it concerns the frequency of intoxication in an ED and the potential suitability of intoxicated patients for a setting where they could await sobriety. The study also planned to review prior alcohol-related visits to the hospital, both ever and in the last year. Those visit-history measures may characterize the population, but the registry record does not report their results.

The primary assessment was tied to the current ED admission. The record describes discharge from the ED as the end of study participation and gives an expected average time of 9 hours. This design can describe screening and clinician-assessed eligibility in the setting studied. It cannot, without a comparator and reported outcome results, establish whether a sobering house changes health outcomes, ED use, or subsequent visits.

3. Trial Design

NCT01783223 is listed as a completed study sponsored by Hennepin Healthcare Research Institute. The registry record gives a start date of 2012-11 and a primary completion date of 2018-06-26. Enrollment is listed as 668. The study concerns alcohol intoxication and the potential suitability of intoxicated ED patients for sobering house services.

The brief description says patients would be identified prospectively by screening all patients presenting to the ED 24/7 for one month. A running tally of ED patients would be kept, and patients noted to have alcohol intoxication would be identified. Their charts would then be reviewed for alcohol-use details, suitability for a sobering house, and previous alcohol-related visits to the hospital. The listed arm is “Intoxicated Patients,” described as patients in the ED who appear to be intoxicated with ethanol.

This is a screening and chart-review design, not a randomized comparison. The registry record does not describe treatment assignment, a control arm, or a like-for-like comparison group. Allocation is not stated. The primary endpoint is described as a count of participants, while the objective also refers to determining proportions. The record does not include a reported primary endpoint result or an analysis of that endpoint.

Eligibility for a sobering house was to be assessed during the current ED admission, at the treating physician’s discretion. The stated criteria include the ability to ambulate without assistance and no further acute need for medical treatments. The study period for an individual patient ends at ED discharge, with an expected average time of 9 hours. The registry record does not report the actual distribution of time in the ED, the number of patients screened, or the number meeting the eligibility criteria.

The enrollment figure should not be interpreted as the number of all ED attendees or as the number of intoxicated patients: the registry record does not specify which of these counts it represents. It also does not give enough information to determine how the prospective one-month screening description relates to the listed study dates.

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

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 Intoxicated Patients Eligible for a Sobering House, measured over Eligibility for a sobering house is assessed during the current ED admission. The study ends when patient is discharged from the ED, an expected average time of 9 hours..

The primary endpoint is titled “Intoxicated Patients Eligible for a Sobering House” and is measured in participants. Its stated purpose is to determine the proportion of ED patients who are intoxicated and how many of those patients would be eligible for a sobering house. The endpoint therefore combines a screening question—whether a patient is intoxicated—with a clinician-assessed suitability question.

The listed eligibility assessment is made during the current ED admission. The treating physician decides suitability, with the stated considerations of being able to ambulate without assistance and having no further acute need for medical treatments. This endpoint is relevant to the study’s service-planning question because it distinguishes intoxicated patients who might be considered for a sobering house from those who do not meet those clinical conditions.

As a general statistical point, a count describes how many people meet a definition, while a proportion relates that count to a specified denominator. For a prevalence question, the denominator matters: it could refer to all ED patients screened or to a subgroup, depending on the precise question. The registry record does not report the observed count, the denominator used for the primary result, or the resulting proportion. It also does not report how physicians applied the eligibility criteria in practice or whether assessments were standardized. Consequently, the endpoint’s purpose can be described, but its observed magnitude and precision cannot be interpreted from the registry record.

The stated follow-up ends at ED discharge, with an expected average time of 9 hours. This is an assessment of status during the current encounter, not a reported measure of later service use or longer-term outcomes.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods cannot be fully reconstructed because the registry record does not report a primary analysis. It lists one outcome measure and zero analyses. It does not report an analysis plan, a statistical model, an estimate, or a confidence interval. The discussion below explains general concepts that are relevant to a descriptive screening study; it does not claim that these methods were used for this study.

What does a prevalence estimate require?

General: A prevalence estimate is a count of people meeting a definition divided by the number of people assessed in the population of interest. The choice of denominator must match the question. To estimate the proportion of all ED patients who were intoxicated, the denominator would need to correspond to the patients screened for intoxication. To estimate eligibility among intoxicated patients, the denominator would need to correspond to intoxicated patients whose eligibility was assessed. Those are different questions, and their denominators are not interchangeable.

The registry describes screening all ED patients 24/7 for one month and keeping a running tally, but it does not report the tally, the number screened, the number identified as intoxicated, or the number assessed for eligibility. Although enrollment is listed as 668, the record does not identify that figure as the denominator for either prevalence question. No prevalence estimate can be recovered from the enrollment figure alone.

How should a count be distinguished from a proportion?

General: A count reports the number of observed participants meeting a definition. A proportion places that count in relation to a denominator, which makes the scale of the result interpretable for the population being described. A count without a corresponding denominator does not show how common the outcome was in the group of interest. Conversely, a proportion without a clear definition of who was eligible for inclusion can be difficult to interpret or reproduce.

The primary outcome is described as a count of participants, while its objective also refers to proportions. The record does not resolve how the primary outcome was summarized, which denominator was used, or whether the intoxication and eligibility questions were reported separately. These details are not reported in the registry record.

Why does precision matter?

General: An estimate based on a sample is subject to uncertainty. A confidence interval expresses that uncertainty under a stated statistical procedure. A narrower interval indicates greater precision, while a wider interval indicates less precision. A confidence interval is not a guarantee that the true value lies within its endpoints, and its interpretation depends on the method and assumptions used.

No estimate or confidence interval for the primary endpoint is reported. The precision of the prevalence and eligibility findings therefore cannot be assessed. The registry record also does not report a statistical method for handling missing or uncertain eligibility assessments. A numerical precision statement cannot be inferred from the enrollment figure alone.

What can a single-group design establish?

General: A descriptive study can characterize who was screened and how often specified conditions or classifications were observed, provided its definitions, denominators, and results are reported. A single-group screening design does not, by itself, estimate a causal effect of a service. A causal comparison ordinarily requires a suitable basis for comparing outcomes under different conditions, with attention to how people entered each condition and to other factors that may affect outcomes.

This registry record does not describe randomized assignment or a comparator. It describes a group of intoxicated patients and an assessment of potential eligibility. The analysis cannot therefore be interpreted as a comparison of sobering-house care with another service, nor as evidence that such a service changed an outcome. No comparative analysis is listed.

Why can physician discretion affect classification?

General: When an outcome depends on clinical judgment, the observed classification can depend on how consistently the criteria are understood and applied. Clear operational definitions, common assessment procedures, and documentation of disagreements can help readers assess reliability. This is particularly important when the endpoint is a judgment about suitability rather than a measurement made by an instrument.

The registry states that the treating physician determines eligibility and names the ability to ambulate without assistance and the absence of further acute treatment needs as criteria. It does not report how those criteria were operationalized, whether clinicians received common instructions, whether a second assessment was performed, or how missing chart information was treated. These elements cannot be assumed.

What is the role of the planning illustration?

The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not evidence that the present study assigned participants to two arms or tested a treatment comparison. The registry record does not report a primary effect estimate or an analysis that would allow the underlying observed effect to be checked. The listed illustration cannot replace an observed endpoint result.

General: A sample-size calculation asks how many participants might be needed under stated assumptions for a future or planned analysis. It is not an observed result and should not be described as observed power. The record’s planning language should be read as an illustration, not as a description of an analysis performed in this single-group screening study. The actual method, if any, for analyzing the primary endpoint is not reported in the registry record.

Because the primary analysis, denominators, and outcome estimates are absent, there is no basis for evaluating statistical significance, effect size, or precision for the main clinical question. Those quantities are not reported in the registry record.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Intoxicated Patients")
n      <- c(668)
events <- c(163)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Intoxicated Patients  668  163  24.4  21.2  27.8  21.3  27.8  21.3  27.8

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary outcome measure and zero analyses. It does not report a statistical analysis plan, the use of secondary endpoints, or a procedure for controlling multiplicity. Multiplicity arises when multiple outcomes, comparisons, or analyses are considered; repeated testing can increase the chance that at least one result appears noteworthy by chance. General methods for addressing multiplicity include prespecifying a primary comparison or adjusting inference across a defined family of tests. The record does not say whether such methods were planned or used.

The absence of reported analyses means there is no set of primary or secondary statistical tests to assess for multiplicity. It would be inappropriate to infer that multiplicity was controlled, or that it was not a concern in the investigators’ work, from the registry entry alone. The analysis plan and any procedures for selecting among outcomes are not reported in the registry record.

Missing data are also not described. The record does not report whether any patients lacked chart information, were not fully assessed for intoxication, or had an indeterminate eligibility assessment. It does not explain how incomplete screening records or unavailable documentation were handled. General: Missingness can affect a descriptive estimate if the people with missing assessments differ from those with complete assessments. Reporting the number and reasons for missing assessments, as well as how they were handled, helps readers judge whether the reported denominator represents the intended population.

Analysis populations are not defined. The record does not specify whether all screened patients, all patients identified as intoxicated, or only those with complete chart review would be included in each analysis. It also does not give a flow of patients from screening through eligibility assessment. These details are not reported in the registry record, so the relationship between enrollment and the intended endpoint population remains unclear.

12. 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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: hospital admission (6.6%), endotracheal intubation (0.9%).

The registry lists 50 participants with serious adverse events among 668 at risk, 505 participants with other adverse events among 668 at risk, and 0 deaths in the “Intoxicated Patients” group. These are counts recorded for the group; they should not be treated as results of a comparison between treatment arms. The record does not describe a comparator group or randomized allocation.

The top serious-event terms are hospital admission at 6.6% and endotracheal intubation at 0.9%. These entries identify terms listed in the safety record. The registry does not specify in this entry whether the listed terms overlap, how events were adjudicated, or the precise relationship of these terms to the participant-level serious-event count. They should not be added together or assumed to represent mutually exclusive categories.

General: Safety counts describe recorded events under the registry’s reporting definitions; they do not alone establish that a study procedure caused an event. Interpretation depends on the event definitions, observation period, ascertainment, and clinical context. The record does not report attribution, event timing, or a detailed safety-analysis method. The listed figures therefore describe what the registry records, not a causal estimate or a comparison of risk.

The safety figures are distinct from the primary question about intoxication prevalence and sobering-house eligibility. They do not supply the missing primary endpoint counts or denominators.

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

The registry record establishes the study’s descriptive aim: to identify intoxicated patients in the ED and assess how many might be eligible for a sobering house. It describes prospective screening, chart review, and eligibility criteria involving ambulation and acute medical needs. It also records enrollment of 668 and lists safety-event counts. These details explain what the investigators intended to examine and what categories the record contains.

The record does not report the observed number of ED patients screened, the number identified as intoxicated, the number considered eligible, or a denominator for either prevalence question. It therefore does not provide a reported estimate of how common intoxication was in the ED or what proportion of intoxicated patients met the eligibility criteria. The enrollment figure cannot fill that gap because the record does not identify it as either endpoint denominator.

Nor does the registry record establish whether a sobering house service affected patient outcomes. There is no comparator group described, no treatment allocation, and no reported analysis of a service effect. A physician’s assessment of potential eligibility is not the same as evidence about the consequences of receiving that service.

General: Descriptive findings can help characterize a local service question when the population, screening process, definitions, counts, and denominators are clear. Their relevance beyond the setting studied depends on how similar other settings and populations are. The record does not report enough about the screened population or the endpoint results to judge how broadly any prevalence estimate would apply.

The completed status indicates that the study is recorded as completed, but completion does not itself establish that the primary result was analyzed or posted. The registry lists zero analyses. The appropriate conclusion is therefore limited: the study addressed an important ED screening and suitability question, but the primary numerical findings needed to answer that question are not reported in the registry record.

14. Why This Trial Matters Statistically

This study matters statistically because its central question depends on defining the population and denominator clearly. “How many ED patients were intoxicated?” and “How many intoxicated patients were eligible for a sobering house?” are related but different descriptive questions. The first concerns all patients screened; the second concerns the subset identified as intoxicated and assessed for eligibility. Reporting both counts and their respective denominators would allow readers to distinguish these questions.

The study also illustrates how a clinical classification can shape a statistical endpoint. Eligibility was determined at the treating physician’s discretion, using stated considerations about ambulation and acute medical needs. General: When clinical judgment defines an outcome, transparent criteria and consistent application help make estimates interpretable and reproducible. If practice differs across assessors, observed eligibility can reflect both patient status and assessment variation.

A count alone is not enough to establish prevalence, and an enrollment figure is not automatically the relevant denominator. Statistical interpretation depends on knowing which people were screened, which had complete assessments, and how the endpoint was calculated. Here, the registry record does not report those elements or the primary result. That absence prevents readers from evaluating the magnitude and precision of the descriptive findings.

The non-comparative design is also important. The study’s stated aim is service suitability and prevalence, not a randomized test of a sobering house. Keeping descriptive evidence separate from causal evidence prevents a clinician-assessed eligibility classification from being mistaken for proof of a service effect.

Finally, the record includes safety-event counts but no reported primary analysis. This highlights the need to interpret each type of result according to the question it addresses. Safety reporting does not substitute for the missing prevalence and eligibility estimates. The statistical importance of this study lies in the questions it was designed to describe and in the information needed to answer them clearly.

15. 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 of interpretation is that the primary outcome result is not reported in the registry record. There is no observed count of intoxicated patients, no reported count eligible for a sobering house, and no endpoint denominator. The listed enrollment of 668 does not resolve which participants were screened or assessed for the primary question.

The record describes screening all ED patients 24/7 for one month, but does not report the resulting tally or clarify how that screening period relates to the study start and primary completion dates. It does not provide a participant flow from ED screening to intoxication identification, chart review, and eligibility assessment. The screening rate, completeness, and reasons for any unavailable assessments are not reported in the registry record.

Eligibility depended on the treating physician’s discretion. Although the record names the ability to ambulate without assistance and no further acute need for medical treatments, it does not report how those criteria were operationalized or applied consistently. It does not describe assessment reliability, clinician training, or the handling of uncertain cases. These features may affect the classification but cannot be evaluated from the record.

The registry does not describe a comparator or random allocation. Therefore, the design cannot support a treatment-effect interpretation from the information recorded. It is also not possible to assess how representative the screened patients were of other EDs or time periods, because detailed characteristics and the screening results are not reported.

Finally, the analysis plan and handling of missing data are not reported. The record lists zero analyses, so estimates, confidence intervals, and model assumptions for the primary outcome cannot be reviewed. The safety entries lack reported attribution and detailed event context. These limitations do not negate the stated study question; they constrain what can be concluded from the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Prevalence of Chronic Inebriates to the Emergency Department and Suitability for Sobering House Services — NCT01783223.
• Registry record last updated 2022-09-15; status last verified 2022-08.
• Results first posted 2022-09-15.
• 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.

19. Record Summary

NCT01783223 is listed as a completed study sponsored by Hennepin Healthcare Research Institute, with enrollment of 668. The registry gives a start date of 2012-11 and a primary completion date of 2018-06-26. The study concerns alcohol intoxication and potential eligibility for sobering house services.

The record describes prospective ED screening, chart review, and physician assessment during the current admission. Eligibility includes the ability to ambulate without assistance and no further acute need for medical treatments. The expected average time to ED discharge is 9 hours.

The primary endpoint concerns intoxicated patients considered eligible for a sobering house. The registry record does not report the primary endpoint counts, denominators, estimates, or analysis. It lists zero analyses. Safety entries include 50 participants with serious adverse events among 668 at risk, 505 with other adverse events among 668 at risk, and 0 deaths. The primary descriptive findings are not reported in the registry record.