Hearing Impairment, Strategies, and Outcomes in Emergency Departments: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Hearing Impairment, Strategies, and Outcomes in Emergency Departments (NCT03594500), a randomized na study. The primary outcome is Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay.

2. Clinical Question

3. Trial Design

The registry record describes a randomized, parallel-group trial with no masking. Consenting participants receiving emergency-department care were assigned to PockeTalker or no PockeTalker. The trial is recorded as completed, and its phase is listed as NA. The sponsor is the VA Office of Research and Development.

Enrollment is recorded as 133. This is the registry enrollment figure, not a reported primary-outcome analysis population. The group-level adverse-event figures separately list 66 participants at risk in the intervention group and 67 in the control group. The registry record does not explain whether every enrolled participant contributed data to each outcome, how exclusions or withdrawals were handled, or whether outcome denominators differed across measures.

The recorded study start date is 2019-03-18, and the primary completion date is 2019-11-26. The planned primary-outcome timeframe is the duration of the emergency-department stay, described as an average of 1-2 days. The intervention descriptions state that participants were randomly assigned while receiving emergency-department care; further details of allocation procedures, concealment, and implementation are not reported in the registry record.

The registry record lists eight outcome measures and zero analyses. It names education level, primary language, living arrangements, whether a participant was alone in the emergency department, and hospital readmission among the secondary outcomes. The record’s stated aims include assessing screening feasibility and acceptability, deriving a preliminary estimate of the effect on primary outcomes, and identifying evidence relevant to decision makers in Veteran Affair Medical Centers, emergency departments, and audiology services. These aims describe the intended work; they do not establish that a particular result was obtained.

Because no outcome analysis is posted in the registry record, the randomized design alone cannot establish the size or precision of a group difference. The design describes how assignment was intended to occur, while the posted record does not provide the primary-outcome data needed to evaluate the comparison.

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: Those randomized to receive the hearing assistance device, how many used the hearing assistance device in the ED

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.

Population: The first phase of intervention, the Hearing Impairment, Strategies and Outcomes in VA Emergency Departments (HearVA-ED) was conducted in the Emergency Departments of the Manhattan and Brooklyn VAs of the New York Harbor Healthcare System and recruited hearing impaired ED patients who are 60 years and older and were admitted to the ED with a low acuity triage score indicating a high likelihood of discharge home.

6. Primary Endpoint

The registry lists the primary outcome as Patient-Rated Quality of Hearing, Understanding, and Communication With Providers During ED Stay, measured over Duration of ED stay, average of 1-2 days.

The primary outcome is patient-rated quality of hearing, understanding, and communication with providers during the emergency-department stay. Participants were to answer a six item questionnaire using a 10-point Likert scale, with 1 meaning do not agree at all and 10 meaning completely agree. The items address whether providers’ voices were clear, whether participants could hear sounds they wanted to hear, whether noise caused a problem, whether listening was tiring, whether they understood what was said, and whether they understood without effort. Higher scores are described as indicating better communication and understanding with providers.

Patient ratings capture the experience of communication from the participant’s perspective, rather than relying only on a clinician’s assessment of hearing or communication. In general, that makes a self-reported measure relevant when the question concerns whether participants felt able to hear and understand providers during care. A questionnaire can also distinguish aspects of the experience, such as hearing clarity and effortful listening, that a single global question might not capture.

There is an important measurement detail in this record: the outcome is described as a percentage of participants, while its questionnaire description gives six item-level ratings. The registry record does not report a scoring rule, a threshold defining a favorable response, how item responses would be combined, or which response categories would contribute to the percentage. It also does not report a posted outcome value. Consequently, the intended construct is clear, but the precise percentage-based endpoint and its result cannot be reconstructed from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods can help distinguish a trial’s design, its measurements, and the strength of the evidence produced by its analysis. In this case, the registry record gives some design details and the planned primary measure, but lists zero analyses and does not report a single primary-outcome comparison. The explanations below describe general statistical principles and clarify what the record does and does not establish; they do not imply that a particular analysis was performed.

What does random allocation contribute?

In general, random allocation assigns participants to study groups using a chance-based process. When implemented properly, it helps reduce systematic differences between groups at the point of assignment, including differences that investigators may not have measured. A parallel-group design means participants are assigned to one group for the comparison rather than serving as their own comparison across treatment periods. These design features can support causal interpretation when the analysis, outcome measurement, follow-up, and handling of missing data are also appropriate.

The registry record identifies allocation as randomized and the model as parallel. It does not report the sequence-generation method, allocation concealment, or a statistical analysis plan. Those omissions prevent a reader from assessing the details of how randomization was carried out or how the primary comparison was intended to be analyzed.

What does the primary outcome measure?

The planned measure is based on participants’ ratings of hearing, understanding, and communication during emergency-department care. In general, a Likert response records an ordered level of agreement. Treating such responses as a single score, grouping responses into categories, or defining the fraction of participants meeting a threshold are different analytical choices. Each choice can answer a different question and may produce a different summary.

The registry description gives six question topics and a 10-point response scale with its endpoints, and states that higher scores indicate better communication and understanding. It also describes the primary outcome in percentage terms. However, the registry record does not state how responses were combined, whether any items had to meet a criterion, which categories counted toward the percentage, or how incomplete questionnaires would be handled. Therefore, neither the exact endpoint calculation nor a participant-level classification rule is reported.

Why is a single comparison needed?

A group comparison requires a clearly defined outcome and a summary that corresponds to the scientific question. For a percentage outcome, an analysis might compare the fraction meeting a prespecified definition in each group; for a scale score, it might compare score distributions or group summaries. These are general examples, not methods reported for this trial. A confidence interval, in general, describes uncertainty around an estimated effect under the assumptions of the analysis. A significance test addresses compatibility between data and a specified null hypothesis under its model. Neither can be interpreted without an actual estimate and the analysis definition.

The registry record notes that the primary outcome has several categories or time points and was not reduced to one comparison. It reports no primary-outcome estimate, confidence interval, or test result. Thus there is no posted statistical contrast whose magnitude or precision can be explained.

What does the planning illustration mean?

The record describes a sample-size planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It describes planning for a stated fraction of the observed effect. In general, a sample-size calculation asks what enrollment would be needed to detect a chosen effect under specified assumptions. Such an illustration is not an observed power calculation and is not evidence that the trial was designed using those assumptions. The registry record does not report the trial’s own sample-size justification or statistical plan.

A planning exercise based on an observed effect is especially dependent on the effect estimate used and the outcome definition. Here, a single primary-outcome comparison is not reported, so the record does not provide a numerical basis for interpreting the illustration as a trial result. Planning estimates are not observed outcomes, and they do not substitute for a confidence interval around a reported comparison.

What can the analysis status establish?

The registry record lists zero analyses. This establishes that no analyses are listed in that record; it does not establish that no analysis was ever conducted outside the registry. Conversely, readers cannot treat an unposted analysis as evidence. Statistical conclusions should be grounded in reported estimates, methods, denominators, and uncertainty measures. For this trial, the design and intended measure can be described, but the primary outcome’s effect and precision are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists eight outcome measures, including the patient-rated primary outcome and secondary measures such as education level, primary language, living arrangements, being alone or with others in the emergency department, and hospital readmission. When a study examines multiple outcomes, questionnaire items, categories, or time points, the chance of finding an apparently notable result can depend on how many comparisons are made and how they are selected. In general, a prespecified multiplicity strategy can clarify which comparisons are confirmatory and how interpretation accounts for multiple testing.

A multiplicity strategy, including any hierarchy among outcomes or adjustment for multiple comparisons, is not reported in the registry record. The record’s note that the primary outcome has several categories or time points and was not reduced to one comparison reinforces that a single inferential result is unavailable. There are zero analyses listed, so no posted testing strategy or multiplicity-adjusted results can be assessed.

The registry record does not report the amount or pattern of missing primary-outcome data, reasons for missingness, or a method for addressing incomplete questionnaires or follow-up. In general, missingness matters because participants with observed responses may differ from those without responses; the direction and size of any resulting bias depend on the missing-data process and analysis assumptions. No such assumptions or sensitivity analyses are reported.

The analysis population is also not reported. The record does not state whether the primary comparison was intended to include all randomized participants, participants who received the assigned approach, or another defined group. It does not give primary-outcome denominators by arm. The enrollment entry and the adverse-event risk counts do not establish the analysis population for the questionnaire outcome. These omissions limit assessment of both the completeness and the statistical handling of the trial data.

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 record reports zero serious adverse events among 66 participants at risk in the intervention group and zero among 67 participants at risk in the control group. It also reports zero other adverse events in each group and zero deaths in each group. These are event counts as recorded, not a comparison showing that the risk was identical between groups.

Zero recorded events do not establish that the true event risk is zero. In general, when no events are observed, uncertainty remains about the underlying event rate, and the amount of information depends on the number followed and the completeness and duration of surveillance. The registry record does not report an adverse-event collection timeframe, detailed ascertainment procedures, or a confidence interval for the event counts. It also lists no top serious adverse-event terms.

The group counts should therefore be read narrowly: the record contains no reported serious or other adverse events and no deaths for the listed at-risk participants. They do not provide evidence about unrecorded events, events outside the unspecified collection period, or the primary communication outcome. They should not be interpreted as proof of safety or as a quantified comparative safety estimate.

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

The record establishes that a randomized, parallel-group study was registered to compare PockeTalker with no PockeTalker during emergency-department care. It identifies a patient-rated outcome intended to assess hearing, understanding, and communication with providers, and it records the trial as completed. These details tell readers what question the trial was designed to address and how assignment was characterized.

The record does not establish the size or direction of any primary-outcome effect. It provides no single primary-outcome comparison, no outcome estimate, and no measure of its precision. The registry note says the outcome included several categories or time points and was not reduced to one comparison. The scoring and percentage rule are also not reported. Therefore, the posted record cannot show whether ratings differed between groups, how large any difference may have been, or how uncertain it was.

Likewise, the trial’s stated aims concerning feasibility, acceptability, preliminary effect estimation, and decision-maker evidence are not results. Secondary outcomes are named, but no analyses are listed. The record’s zero adverse-event entries are limited to the reported event counts and do not establish a zero underlying risk or resolve the primary question.

In general, a completed randomized study can contribute useful evidence only when its results, methods, and uncertainties are reported in enough detail to evaluate. This record contributes information about the intended comparison and questionnaire, but not a numerical estimate that can be interpreted as evidence for or against a group difference. The absence of a posted analysis should be understood as a limitation of what the registry record reports, not as a finding of no effect.

13. Why This Trial Matters Statistically

This trial is statistically notable because it pairs a randomized comparison with a patient-reported communication outcome in the emergency-department setting. The outcome description recognizes that communication is not only whether speech is audible: it also includes clarity, interference from noise, listening effort, and understanding. Capturing these aspects can be important when the research question concerns participants’ experience of communication during care.

The record also illustrates why outcome definitions must be sufficiently explicit for analysis and interpretation. A six item questionnaire using a 10-point Likert scale can be summarized in more than one way. A percentage endpoint requires a rule that defines what counts in its numerator and denominator, while a scale-based analysis requires a stated scoring approach. The registry record gives the question content and scale anchors but does not report the conversion to a percentage. Without that operational detail and a posted comparison, readers cannot identify the precise estimand or quantify its uncertainty.

Randomization is a useful design feature, but it is not a substitute for reporting. A complete statistical account would allow readers to connect assignment, outcome collection, analysis population, missing data, and the effect estimate. The registry record lists no analyses, so this connection cannot be evaluated for the primary outcome.

The trial’s stated aims include feasibility and acceptability as well as a preliminary effect-size estimate. Those aims can be relevant in early work, but the record does not report results that establish whether they were achieved. Statistically, the key lesson is that design intent and outcome evidence are distinct: the former can be described from the registry, while the latter requires reported data and analysis. This record leaves the central comparative outcome unanswered.

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 primary limitation for interpreting the trial is that the registry record does not report a single primary-outcome comparison. It lists zero analyses and notes that the primary outcome has several categories or time points, rather than one reduced comparison. There is consequently no effect estimate, confidence interval, or statistical test to evaluate.

The measurement definition is also incomplete for quantitative interpretation. The record describes a six item questionnaire with a 10-point Likert scale and says higher scores indicate better communication and understanding. It describes the endpoint as a percentage of participants, but does not report how the six responses become that percentage, what qualifies as a favorable outcome, or how missing item responses are handled. This prevents a reader from reconstructing the primary endpoint from the description.

Important analysis details are not reported in the registry record, including an analysis population, primary-outcome denominators, the handling of missing data, and a multiplicity strategy. The record does not describe the randomization procedure in detail, allocation concealment, or the statistical analysis plan. It also does not explain whether care beyond the named intervention differed between groups. These are reporting limitations; their absence from the record does not establish what procedures were or were not used.

The trial is recorded as completed, but the registry information does not provide results for its stated feasibility, acceptability, or preliminary effect-estimation aims. The adverse-event collection timeframe and ascertainment procedures are not reported, which limits interpretation of zero recorded events. The planned primary-outcome timeframe is the emergency-department stay, described as an average of 1-2 days, but participant-level follow-up completeness is not reported.

Finally, the record’s stated sample-size illustration is a planning exercise based on an observed effect, not evidence of observed power or of the trial’s original design justification. The trial’s own sample-size rationale is not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Hearing Impairment, Strategies, and Outcomes in Emergency Departments — NCT03594500.
• Registry record last updated 2025-11-05; status last verified 2025-10.
• Results first posted 2021-06-18.
• 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

NCT03594500 is a completed randomized, parallel-group trial with no masking, sponsored by the VA Office of Research and Development. It compares PockeTalker with no PockeTalker for consenting participants receiving emergency-department care. Enrollment is recorded as 133; the study start date is 2019-03-18, and the primary completion date is 2019-11-26.

The planned primary outcome is patient-rated hearing, understanding, and communication with providers during the emergency-department stay. Its description includes a six item questionnaire using a 10-point Likert scale, while the endpoint is characterized as a percentage of participants. The registry record does not report the scoring rule or a single primary-outcome comparison. It lists eight outcome measures and zero analyses.

The registry record lists zero serious adverse events, zero other adverse events, and zero deaths in each group. These counts do not replace a primary-outcome analysis or establish the underlying event risk. The record describes the study design and intended question but does not report a numerical primary-outcome result or its precision.