Rural Home Hospital: Proof of Concept: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Rural Home Hospital: Proof of Concept (NCT04531280), a na na study. The primary outcome is Number of Patients That Completed Their Rural Home Hospitalization.

2. Clinical Question

The study is titled Rural Home Hospital: Proof of Concept. Its stated purpose is to examine the implications of providing hospital-level care in rural homes. The primary endpoint counts patients who were hospitalized in the rural home hospital for treatment of an acute condition and discharged from that setting after treatment was complete. The registry reports that three patients completed a rural home hospitalization.

This design can describe what happened within the home-care group, but it cannot by itself estimate how outcomes would have differed under traditional hospital care. The registry record does not report a comparison group, a treatment-effect estimate, or a statistical test of a comparative question. The results therefore address completion in this group, rather than comparative effectiveness.

3. Trial Design

This is a completed, single-group proof-of-concept study of home hospital care for acutely ill adults in rural and ultra-rural settings. The sponsor is Brigham and Women's Hospital. The registry lists the phase as NA, allocation as NA, and masking as none. Enrollment was 7. The recorded start date is 2021-02-18, and the primary completion date is 2021-05-07.

The intervention is described as hospital-level care delivered in a patient's home in place of traditional hospital care. The registry does not list a randomized allocation or a like-for-like control group. Consequently, the study design supports a descriptive account of the participants receiving home hospital care, but not a direct estimate of the difference between home care and hospital care.

The primary outcome is the number of patients who completed their rural home hospitalization. Its timeframe is described as the day of admission to the day of discharge, estimated 10 days later. The endpoint description reports that three patients completed a rural home hospitalization. The registry also lists secondary outcomes concerning care transitions, patient experience, satisfaction, acceptability, perceived safety and quality, caregiver burden, escalation to hospital care, adverse events, and unplanned mortality.

The registry record does not report a protocol-level sample-size justification, detailed statistical analysis plan, or planned interim analyses. It lists 13 outcome measures and zero analyses. The record does not describe the status or endpoint outcomes of participants who are not included in the reported completion count, so the difference between enrollment and the reported count should not be interpreted as a specific disposition without further information.

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: No significant event occurred after participant enrollment

Overall Study

Analysis population for the primary outcome, as defined in the registry: Three patients completed a rural home hospitalization. Rural home hospitalized patients were treated for their acute condition in rural home hospital.

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 baseline analysis population only includes patients. Baseline characteristics were not collected for clinicians

6. Primary Endpoint

The registry lists the primary outcome as Number of Patients That Completed Their Rural Home Hospitalization, measured over Day of admission to day of discharge, estimated 10 days later.

The primary endpoint is a count: the number of patients who completed their rural home hospitalization. The registry defines completion as receiving treatment for an acute condition in the rural home hospital and being discharged from that setting after treatment was complete. The reported count is three participants. The stated timeframe runs from the day of admission to the day of discharge, estimated 10 days later.

A completion count is useful for describing whether participants reached the study's defined endpoint in the care model being examined. In a proof-of-concept study, such a measure can document the occurrence of the operational outcome without requiring a comparison between groups. It does not, on its own, quantify a treatment effect or establish why participants did or did not complete hospitalization.

Because the result is reported as a count rather than a rate with a stated denominator, the endpoint result should be read as the number reported, not as a proportion of all enrolled participants. Although enrollment was 7, the registry does not explain how the completion count relates to the disposition of every enrolled participant. It also does not report a confidence interval or other measure of uncertainty for the count. The endpoint therefore gives a direct descriptive result, while leaving uncertainty and participant disposition insufficiently characterized.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a participant count. Counts answer how many people met a defined condition; they do not automatically describe the chance of that condition in a wider population. Here, the defined condition is completion of rural home hospitalization after treatment for an acute condition, and the reported count is three.

What a count can tell us

A count is directly interpretable when the event definition and the number of people assessed are clear. The registry describes what qualifies as completion, but does not explain how the reported count relates to all 7 enrolled participants or give a disposition for those not included in the completion count. Without that information, the result should remain a count rather than being converted to a proportion. No new percentage or rate can be inferred from the record without making assumptions about the denominator and participant status.

General statistical explanation: an estimate is more informative when accompanied by an uncertainty measure, such as a confidence interval. The interval describes the range of values compatible with the observed data under specified assumptions. It does not guarantee that the true value lies in that range, and it does not account for sources of bias that the analysis has not addressed. No confidence interval for the primary endpoint is reported in the registry record.

Why the design matters

The study is recorded as single-group, with no masking and no randomized allocation. A single-group description can document outcomes among those receiving an intervention. It does not provide a direct contrast with a separate group receiving another approach. Comparative estimates require a defined comparison and an analysis that accounts for the design. Neither a comparator arm nor a comparative analysis is listed in this record.

General statistical explanation: random allocation, when used, can help balance known and unknown characteristics between groups on average. It does not guarantee balance in every study, and it cannot be assumed when allocation is listed as NA. Masking can reduce some forms of assessment or reporting influence, depending on the design and outcome. This study is recorded as having no masking, but the registry record does not give further detail about outcome assessment procedures.

Analyses and interpretation

The registry lists 13 outcome measures and zero analyses. This means the record does not present inferential analysis results for the listed outcomes. It does not report a statistical plan describing model choice, adjustment, hypothesis tests, or handling of missing observations. Those details are not reported in the registry record and should not be reconstructed by assumption.

General statistical explanation: a statistical test evaluates data against a specified null hypothesis and depends on a prespecified or otherwise clearly described analysis. A p-value, if reported, would not measure the size or clinical importance of an effect. Since no analyses are listed, there is no registry-reported p-value or test result to interpret for the primary endpoint.

Multiple outcomes can raise multiplicity concerns when several hypotheses are tested. Testing many hypotheses can increase the chance that at least one result appears notable by chance, depending on the testing approach. A plan might address this through a hierarchy, adjustment, or a clearly exploratory interpretation. The registry record does not report such a plan, and it lists zero analyses, so no multiplicity-adjusted or unadjusted inferential result is available to assess.

Planning calculations are not observed power

General statistical explanation: sample-size planning asks how many participants a future study might need under specified assumptions. Such calculations are not a measure of the power actually achieved after a study is complete. The registry's planning description refers to a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect set as a stated fraction of the observed effect. It also distinguishes participants per arm from total events for time-to-event calculations. These are planning assumptions, not evidence that this single-group study had a comparator or was designed with those operating characteristics.

Any planning illustration based on an observed effect should be read cautiously, especially when the underlying study has no comparative analysis listed. It cannot repair limitations in design, create an observed comparison, or be interpreted as observed power. No numeric sample-size planning results are stated in the registry record described for this study.

General statistical explanation: over-dispersion matters for count outcomes when the variability in counts exceeds what a chosen count model assumes. A model that ignores this can produce uncertainty estimates that are too narrow or otherwise poorly calibrated. The primary endpoint is reported as a participant count, but no count model or dispersion estimate is reported. There is therefore no basis to claim that over-dispersion was assessed or that a particular model was used.

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("Patients")
n      <- c(3)
events <- c(3)
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  Patients  3  3  100.0  29.2  100.0  43.9  100.0  39.8  99.4

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 13 outcome measures, including the completion endpoint and secondary outcomes for care transitions, patient experience, satisfaction, acceptability, perceived safety and quality, caregiver burden, escalation to hospital care, adverse events, and unplanned mortality. It lists zero analyses. No hypothesis-testing plan, outcome hierarchy, multiplicity adjustment, or distinction between confirmatory and exploratory analyses is reported in the registry record.

General statistical explanation: when investigators conduct tests across multiple outcomes, the chance of obtaining at least one apparently unusual result can depend on how many tests are considered and how the tests are related. A prespecified strategy can help readers interpret that risk. In the absence of reported analyses, there are no test results to adjust or interpret as confirmatory findings.

The record does not describe missing-data handling, imputation, or rules for including participants in an analysis population. It also does not report whether every enrolled participant contributed to each outcome. For the primary endpoint, enrollment was 7 and the count of patients completing rural home hospitalization was three, but the disposition of the remaining participants is not reported in the registry record. No analysis-population definition is reported.

General statistical explanation: missingness can affect interpretation when the availability of an outcome is related to participant characteristics or outcomes. Without information about why data are absent and how analyses handled them, the direction and magnitude of any resulting bias cannot be established. The reported completion count remains interpretable as a count, but should not be expanded into a population estimate or a complete account of participant outcomes.

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.

For patients, the registry lists 3 participants at risk for serious adverse events and 0 affected by serious adverse events. It also lists 3 patients at risk for other adverse events and 0 affected. Deaths are listed as 0. These are the safety figures recorded for the patient group; the at-risk count is 3, not the enrollment count of 7.

The clinician group is listed with 0 at risk and 0 affected for serious adverse events and other adverse events, with 0 deaths. With no clinicians listed as at risk, those figures should not be read as an estimate of clinician safety experience.

General statistical explanation: a recorded zero means no event was counted in the group and period represented by the registry entry. It does not prove that the underlying event risk is zero, and the precision of a zero count depends in part on how many people were observed and how completely events were ascertained. The registry record does not report further detail on safety surveillance, event definitions beyond the categories, or why the listed at-risk count differs from enrollment.

The safety figures should therefore be read as reported counts, not as comparative evidence. There is no control group or comparative safety analysis listed, and no serious adverse event terms are listed among the top serious terms.

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

The primary result establishes that the registry reports three patients as having completed a rural home hospitalization under the stated endpoint definition. It is a descriptive observation from a single-group proof-of-concept study. The result does not estimate the difference between home hospital care and traditional hospital care, because no concurrent comparator is listed.

The result also does not establish a completion rate for all enrolled participants. Enrollment was 7, while the primary endpoint count is three. The registry record does not report the status or endpoint disposition of the other participants, and no denominator for a completion proportion is stated. A percentage or reason for non-completion should not be inferred.

General statistical explanation: an observed result and an estimate for a broader population are not the same thing. An estimate's precision depends on the amount and structure of the data and on the method used to analyze them. The registry provides no confidence interval or other uncertainty measure for the completion count. The small reported group and absent comparative analysis limit how far the result can be generalized or used to make a causal claim.

The result does not determine whether home hospital care is preferable to traditional hospital care, nor does it establish effects on safety, satisfaction, caregiver burden, or other listed secondary outcomes. Those outcomes appear in the registry, but analyses and outcome-specific results are not reported in the registry record. The adverse-event entry records zero affected patients among 3 listed at risk, but this is not a comparative safety estimate and does not establish zero risk.

The appropriate interpretation is narrow: the registry documents completion for three patients in this rural home hospital study. It gives a concrete account of an endpoint, while leaving important questions about participant disposition, precision, comparative outcomes, and the statistical analysis unanswered.

14. Why This Trial Matters Statistically

Statistically, this study illustrates the role and limits of a proof-of-concept design. A single-group study can document whether a defined outcome occurred among participants receiving a care model. Here, the registry records three completed rural home hospitalizations. Such a result can be informative as a description of the study experience without being a comparative estimate.

The distinction matters because a count is not a treatment effect. Without a concurrent comparator, the observed completion count cannot show what would have happened to similar participants under traditional hospital care. The record also does not state how the reported count relates to the full enrollment of 7, which limits interpretation of the endpoint as a study-wide completion frequency.

General statistical explanation: small descriptive studies can help identify practical questions for subsequent evaluation, but their results are usually imprecise and sensitive to the experiences of individual participants. Reporting a clear endpoint definition is valuable; reporting participant disposition, uncertainty, and analysis methods is also important for judging how much the result can support.

The registry lists a range of secondary outcomes spanning experience, safety, escalation, and mortality, but lists zero analyses. This distinction is useful for readers: outcomes named in a record are not equivalent to measured findings or statistical evidence. The safety counts also illustrate why denominators matter. The patient safety group is reported with 3 at risk, while enrollment is 7, and the record does not explain that relationship.

The statistical value of the record is therefore primarily descriptive. It identifies a specific outcome and records that it occurred for three patients, while making visible the limits of inference that follow from a single group, no listed analyses, and incomplete reporting of outcome disposition and uncertainty.

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.

Several limitations specific to this record constrain interpretation. The study is single-group, with no concurrent comparator and no randomized allocation listed. The endpoint can therefore describe completion in the home hospital group but cannot provide a direct comparison with traditional hospital care.

Enrollment was 7, while the primary endpoint reports three completed home hospitalizations. The registry record does not report the disposition of the other participants or explain how the endpoint count relates to all enrolled participants. It also does not give a confidence interval or another measure of precision for the primary count.

The record lists 13 outcome measures but zero analyses. Results for the secondary outcomes are not reported in the registry record, and the statistical analysis plan, multiplicity strategy, analysis populations, missing-data methods, and interim analyses are not reported in the registry record. The phase and allocation are listed as NA, and masking is listed as none; further design details are not reported in the registry record.

The patient safety figures use 3 as the at-risk count, while total enrollment is 7. The registry does not explain this difference or give further information about safety ascertainment. The clinician group lists zero at risk, so it does not provide an informative clinician safety denominator.

These are reporting and design limitations, not evidence that a particular unreported outcome occurred. They mean the posted results support a narrow descriptive reading and do not establish comparative effects, population-level precision, or the status of every enrolled participant.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Rural Home Hospital: Proof of Concept — NCT04531280.
• Registry record last updated 2025-01-30; status last verified 2024-12.
• Results first posted 2025-01-30.
• 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

Rural Home Hospital: Proof of Concept is a completed, single-group study sponsored by Brigham and Women's Hospital. The intervention is hospital-level care at home for acutely ill adults in rural and ultra-rural settings. Enrollment was 7; masking is listed as none, and allocation and phase are listed as NA.

The primary endpoint counts patients completing rural home hospitalization from admission to discharge, estimated 10 days later. The registry reports three completions. It lists 13 outcome measures and zero analyses. The patient safety entry lists 3 at risk and 0 affected for serious adverse events, with 0 deaths. The record does not report a comparator, comparative estimates, uncertainty intervals, the disposition of all enrolled participants, or statistical analysis details.