Home Safety Intervention: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Home Safety Intervention (NCT06216327), a na na study. The primary outcome is Feasibility: Number of Participants Recruited Within One Year.

2. Clinical Question

3. Trial Design

This is a completed pilot study of a behavioral household safety intervention. The registry record describes one intervention arm and no comparator. Allocation is listed as NA, masking as none, the study model as single group, and phase as NA. The record lists enrollment as 40. These design features mean the record does not describe a randomized comparison or a masked assessment of intervention versus control.

The study aim is to pilot test a lethal means safety intervention developed for Veterans with elevated suicide risk who seek care in VHA clinical settings. Its rationale, as described in the registry summary, is that access to lethal methods such as firearms and medications increases suicide risk, and that VA/DoD guidelines recommend clinician-delivered interventions to reduce access among patients at elevated risk. The summary also states that interventions had not been developed or tested among Veterans with elevated suicide risk.

The study start date is 2024-10-08, and the primary completion date is 2025-07-18. The registry status is completed. The sponsor is the VA Office of Research and Development. The primary endpoint concerns recruitment within one year, described as an average of one year through study completion. Details of recruitment procedures, intervention delivery, follow-up, and the protocol’s rationale for the enrollment target are not reported in the registry record.

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.

Before assignment: 40 veterans consented to participate in the study. 3 discontinued enrollment prior to their baseline visit (2 unable to contact after consent, 1 due to time).

Baseline Visit (Time Point 0)

Reasons for not completing this period:

30 Day Follow up (4 Weeks)

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: 40 veterans consented to participate in the study. 3 discontinued enrollment prior to their baseline visit (2 unable to contact after consent, 1 due to time). 37 participants attended their baseline (day 0) visit.

6. Primary Endpoint

The registry lists the primary outcome as Feasibility: Number of Participants Recruited Within One Year, measured over through study completion, an average of one year.

The primary endpoint is titled Feasibility: Number of Participants Recruited Within One Year. It measures a count: the number of participants recruited within the stated timeframe. The endpoint description sets a recruitment goal of 40 Veterans in one year, while the timeframe is described as through study completion, an average of one year.

Recruitment is a feasibility measure because it addresses whether a study can enroll the intended population at the pace needed to carry out the planned work. In general, feasibility endpoints can inform whether recruitment procedures and study settings are workable; they do not by themselves establish a clinical effect of an intervention. That distinction is particularly important in a single-group pilot without a comparator.

The registry record lists enrollment as 40, but it does not separately report the primary endpoint result as a count recruited within the specified timeframe. The overall enrollment figure therefore should not be treated as a separately reported endpoint result without that clarification. The record also does not report a target attainment analysis, an uncertainty interval, or an analysis method for this endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record describes a single-group pilot and identifies recruitment as the primary feasibility endpoint. It lists 28 outcome measures and 0 analyses. It does not report a statistical analysis plan, an estimation method, a model, a confidence interval, or hypothesis tests. The explanations below are general statistical concepts; they do not identify methods as having been used in this study.

What does a recruitment count measure?

In general, a count outcome records how many events or people meet a defined condition over a specified period. For this study, the stated endpoint is the number of participants recruited within one year, and the description gives a recruitment goal of 40 Veterans. Interpreting a count requires knowing the period over which it was collected and how recruitment was defined. The registry record gives a timeframe described as through study completion, an average of one year, but does not provide a separate endpoint count or further operational detail about when a participant qualifies as recruited.

A count alone does not show how consistently recruitment occurred over time, how many people were approached, or whether recruitment differed by site or participant characteristics. Those details can help explain feasibility, but they are not reported in the registry record. The listed enrollment is 40; the record does not explicitly equate that figure with the primary endpoint count within the timeframe.

Why does the single-group design matter?

In general, a single-group study can describe what happened among the participants who received an intervention, but it cannot create a concurrent counterfactual comparison. Without a comparator arm, observed changes in beliefs or readiness cannot be separated from changes that might occur over time for other reasons. This design is consistent with a pilot focused on feasibility, but it does not provide the same basis for estimating an intervention effect as a comparative design. The registry record does not report a plan for causal estimation.

Masking can reduce some forms of bias when participants, clinicians, or outcome assessors do not know the assigned group or treatment. The record lists masking as none, and it describes no comparator group. It does not report whether any particular outcome assessment used procedures intended to limit assessment bias.

What would an uncertainty interval convey?

In general, a confidence interval describes the statistical uncertainty around an estimate under a specified method and its assumptions. A narrower interval indicates greater precision under those assumptions, while a wider interval indicates less precision. An interval for a recruitment rate or count would answer a different question from an interval for a treatment contrast. No confidence interval or other uncertainty interval is reported for the primary endpoint or the listed secondary outcomes.

For counts, statistical methods sometimes account for over-dispersion, which occurs when count variability exceeds what a simple model assumes. In general, ignoring over-dispersion can make uncertainty appear too small. Whether over-dispersion is relevant depends on the outcome distribution and analysis model. The registry record does not report a count model, a dispersion assessment, or model assumptions, so no specific count-model interpretation can be made for this study.

How should statistical significance be understood?

In general, a p-value quantifies how compatible observed data are with a specified null model under the assumptions of a statistical test. It is not a measure of the size or importance of an effect, and it does not establish that an intervention caused an outcome. A p-value also does not replace an estimate and its uncertainty. No p-values or tests are reported in the registry record, so statistical significance cannot be assessed from the posted information.

Likewise, sample-size calculations are planning tools whose results depend on assumptions about the endpoint, effect, variability, allocation, and analysis. They are not observed evidence and do not substitute for outcome results. The registry record does not report the protocol’s sample-size justification or the assumptions used to set the recruitment target. The stated goal of 40 is part of the feasibility endpoint description; it should not be interpreted as a reported statistical power calculation.

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("Intervention Arm")
n      <- c(40)
events <- c(40)
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  Intervention Arm  40  40  100.0  91.2  100.0  91.2  100.0  91.4  99.9

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 28 outcome measures, including a primary recruitment feasibility measure and secondary outcomes concerning participant trust, beliefs about secure medication and firearm storage, and readiness to store medications and firearms securely. It lists 0 analyses. Numerical estimates for these outcomes and details about which outcomes were analyzed are not reported in the registry record.

Multiplicity arises in general when several outcomes or statistical tests are considered. If many tests are conducted, the chance of at least one result appearing statistically notable can increase, depending on the testing strategy and the outcomes’ relationships. Common approaches include identifying a primary outcome in advance, using a hierarchy for testing, or adjusting inference across a family of tests. The registry record does not report whether any multiplicity strategy was planned or used. With no posted tests or results, the impact of multiplicity cannot be evaluated.

Missing-data methods and the amount or pattern of missing outcome data are not reported in the registry record. The record also does not describe analysis populations, such as whether outcome summaries would include all enrolled participants or only participants with observed measurements. In general, these choices matter because incomplete responses can affect estimates, especially if missingness is related to participant characteristics or outcomes. No assumptions or sensitivity analyses addressing missing data are reported.

The registry record does not report an analysis plan, interim analyses, or a statistical explanation for the enrollment target. The listed enrollment of 40 and the stated recruitment goal of 40 are descriptive details; neither supplies the missing details about outcome analysis, multiplicity, or analysis populations.

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 0% reporting threshold.

The registry record reports 0 serious adverse events among 40 participants at risk in the intervention arm. It also reports 0 other adverse events among 40 participants at risk and 0 deaths. These are recorded event counts for the single intervention group; the study has no comparator arm for a comparative safety assessment.

A zero count means no events of that category are recorded in the registry for the stated group. In general, it does not establish that the underlying risk is zero. The interpretation of safety counts depends on how events were defined and collected, the length of observation, and whether all relevant events were captured. Event definitions, participant-level observation time, and further safety-monitoring details are not reported in the registry record.

The reported counts should therefore be read as descriptive registry figures, not as proof that the intervention is free of risk or as evidence that its safety is equivalent to another approach. The record does not provide a comparative safety estimate or an uncertainty interval.

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

The study addresses a practical feasibility question: whether a Veteran-centered household safety intervention could be piloted among Veterans with elevated suicide risk seeking care in VHA clinical settings. The primary endpoint is defined around recruiting 40 Veterans within one year. The registry record lists overall enrollment as 40 and marks the study completed, but it does not separately report the endpoint count within the specified timeframe. The posted information therefore does not establish, in an endpoint result, whether the recruitment goal was reached within that period.

The record also identifies participant trust and beliefs or readiness related to secure storage of medications and firearms as secondary outcome topics. These outcomes are relevant to the intervention’s focus, but their numerical results are not reported in the registry record. No change estimates, uncertainty measures, or results comparing participants over time are reported. The listed outcome topics alone do not demonstrate that beliefs or storage practices changed.

The absence of a comparator means that the study cannot provide a randomized or concurrent-control contrast. The single-group pilot can be understood as an early feasibility effort, but it does not establish that the intervention caused any change or improved a clinical outcome. The posted information also does not establish that the intervention reduces suicide, firearm injury, overdose, or access to lethal methods.

The registry records no serious adverse events, other adverse events, or deaths in the intervention group. Those figures are descriptive and should not be read as proof of zero risk. In general, safety interpretation also depends on ascertainment and follow-up details, which are not reported in the registry record. The most defensible reading is therefore limited: the record describes the planned feasibility focus, the single-group design, the listed enrollment, and event counts, while leaving outcome effectiveness and precision unresolved.

14. Why This Trial Matters Statistically

Feasibility is a meaningful statistical question in pilot research because a larger evaluation depends on being able to identify and recruit the intended participants. This study targets Veterans with elevated suicide risk in VHA clinical settings and tests a household safety intervention developed for that population. Its recruitment endpoint makes the practical ability to enroll participants central to the stated purpose.

The design also matters for interpreting what can be learned. A single-group pilot can describe the intervention context and support evaluation of recruitment and other feasibility questions. It does not, on its own, provide a controlled estimate of what would have happened without the intervention. Naming that distinction helps keep feasibility evidence separate from evidence of clinical effect.

The intervention’s subject matter is reflected in its secondary outcome topics: trust in the VA healthcare system, beliefs about secure medication and firearm storage, and readiness to store these items securely. These are distinct from the primary recruitment endpoint. Their presence in the registry indicates what the study planned to assess, not what the assessments found. The registry record does not report the numerical results needed to characterize those outcomes.

Statistically, the record illustrates why enrollment, endpoint results, and inferential evidence should not be conflated. Enrollment is listed as 40, while the primary endpoint is recruitment within one year; a separate count for that endpoint is not reported. The record lists 0 analyses and does not report estimates or uncertainty. Keeping these distinctions visible prevents unsupported claims about recruitment success, participant response, or effectiveness.

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 principal limitation for interpreting the registry record is that it does not report numerical results for the primary feasibility endpoint or the secondary outcomes. Although enrollment is listed as 40 and the recruitment goal is 40 within one year, the record does not separately give the endpoint count within that timeframe. The study is marked completed, but completion status is not a substitute for a posted outcome estimate.

The single-group design has no comparator, so it does not support a direct comparison with usual care or another intervention. The record also lists no masking. Any changes that may have occurred among participants cannot be attributed to the intervention from the design information reported. The intervention description is broad, and details about its components, delivery, adherence, and fidelity are not reported in the registry record.

Participant eligibility beyond the stated focus on Veterans with elevated suicide risk seeking care in VHA settings is not reported. The record does not describe recruitment flow, the number approached or screened, participant characteristics, or follow-up completeness. Those omissions limit interpretation of who enrolled and how representative the enrolled group may be of the intended population.

The statistical analysis plan, sample-size justification, handling of missing data, analysis populations, and multiplicity approach are not reported in the registry record. Nor are estimates, uncertainty intervals, or outcome-specific analyses listed. Safety counts are available, but event definitions and observation details are not. These limitations restrict interpretation to the study’s registry-described design, goals, enrollment, and recorded event counts.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Home Safety Intervention — NCT06216327.
• Registry record last updated 2026-08-28; status last verified 2026-08.
• Results first posted 2026-08-28.
• 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

The registry record describes NCT06216327, titled Home Safety Intervention, with the official title Veteran-Centered Lethal Means Safety Suicide Prevention Intervention (CDA 19-076). It is a completed, single-group behavioral pilot sponsored by the VA Office of Research and Development. The intervention is described as a household safety intervention, with no comparator arm and no masking.

The primary endpoint concerns the number of participants recruited within one year, with a stated goal of 40 Veterans. Enrollment is listed as 40, but a separate numerical result for recruitment within the endpoint timeframe is not reported in the registry record. The record lists 28 outcome measures and 0 analyses. Numerical results for the listed secondary outcomes are not reported.

The study start date is 2024-10-08, and the primary completion date is 2025-07-18. The registry records 0 serious adverse events, 0 other adverse events, and 0 deaths among 40 participants at risk in the intervention arm. These counts are descriptive and are not comparative safety estimates.