This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Testing the Effectiveness of a Falls Prevention System (NCT03678402), a na na study. The primary outcome is High Risk Fall Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03678402 |
| Phase | NA |
| Condition | High Risk for Falling |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 521 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Tammy Moore |
| Results posted | Yes |
2. Clinical Question
Population
Patients designated as high risk for falling at the OSU Wexner Center Brain and Spine Hospital. The primary endpoint describes the intended measurement during a hospital stay, which averaged 5 days.
Intervention
The intervention is identified as the PUP™ sock, also described as Patient is UP fall prevention technology. The study arm is named the Palarum Fall Prevention System.
Comparator
The planned reference is historical fall-rate data for the prior 12 months from the same nursing units, described in the registry as historical NDNQI data and as Benchmark Data. It is not a concurrent control group.
Primary question
Does the fall rate among patients designated high risk for falling decrease with use of the intervention, measured as falls per 1000 patient days and compared with the historical reference?
This is a question about a rate, not simply the number of falls. The denominator, patient days, accounts for the amount of time patients contribute to observation. That matters when the duration of hospital stays or the number of patients observed differs between periods. The registry identifies one primary outcome measure, High Risk Fall Rate, but does not report its observed value, the historical value, or an estimated contrast between them. As a result, the clinical question is clear, but the registry record does not contain the numerical result needed to quantify any change.
3. Trial Design
The registry identifies this as a completed, single-group intervention study with 521 participants enrolled. It lists the intervention as the PUP™ sock and names the study arm Palarum Fall Prevention System. The location described is the OSU Wexner Center Brain and Spine Hospital. The registry says the study concerns nursing units where the intervention was used, and its arm description refers to Pods on three contiguous floors, but the description is truncated and does not give a complete account of implementation.
The design is not randomized: allocation is listed as NA, masking is listed as NONE, and the study model is SINGLE GROUP. The comparator described in the study question is historical information from the prior 12 months, rather than a concurrently enrolled comparison group. The registry refers both to historical falls-rate data from the same nursing units and to historical NDNQI data. It does not report how those historical data were collected or whether their definitions and ascertainment matched those in the intervention period.
The study start date is 2019-06-24, and the primary completion date is 2020-06-30. The status is COMPLETED, and phase is listed as NA. These administrative details do not establish how many participants contributed usable data, how long each participant was observed, or whether every unit contributed to the outcome analysis. Those details are not reported in the registry record.
Because the comparison is historical, differences between periods could reflect changes other than the intervention. The design can describe the fall rate during the intervention period and compare it with an earlier benchmark, but the registry record does not establish that the periods were otherwise equivalent. A randomized, concurrent comparison is not part of the design described in the 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.
Overall Study
| Stage | Palarum Fall Prevention System |
|---|---|
| STARTED | 521 |
| COMPLETED | 521 |
| NOT COMPLETED | 0 |
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.
| Characteristic | Unit | Palarum Fall Prevention System |
|---|---|---|
| Participants analysed | 521 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 425 |
| Age, Categorical: >=65 years | Participants | 96 |
| Age, Continuous | years | 59.5 (18.1 to 92) |
| Sex: Female, Male: Female | Participants | NA |
| Sex: Female, Male: Male | Participants | NA |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | NA |
| Race (NIH/OMB): Asian | Participants | NA |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | NA |
| Race (NIH/OMB): Black or African American | Participants | NA |
| Race (NIH/OMB): White | Participants | NA |
| Race (NIH/OMB): More than one race | Participants | NA |
| Race (NIH/OMB): Unknown or Not Reported | Participants | NA |
| Region of Enrollment: United States | participants | 521 |
6. Primary Endpoint
The registry lists the primary outcome as High Risk Fall Rate, measured over hospital stay (on average 5 days).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | falls/1000 patient days |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is High Risk Fall Rate, expressed in falls per 1000 patient days. It is intended to measure the frequency of falls among patients designated high risk for falling, relative to the time those patients spent in the hospital. The registry gives the outcome timeframe as the hospital stay, with an average stay of 5 days.
A rate is useful when the amount of observation differs across patients or periods. Counting falls alone would not account for differences in time spent at risk of having a fall. Patient days provide an exposure denominator, making it possible to express fall occurrence relative to observed inpatient time. This can help compare an intervention period with historical data even when the total amount of patient observation is not identical, provided the numerator and denominator are defined and collected comparably.
The registry describes the intended comparison as a decrease relative to historical falls-rate data for the prior 12 months. It does not report a numerical fall rate for either period, the number of falls contributing to a rate, or the patient-day totals. It also does not report an estimated change or its uncertainty. The endpoint definition therefore identifies what the study set out to measure, but does not by itself show the observed result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical limitation is that the registry record contains no numerical result for the primary endpoint. It lists one outcome measure and zero analyses, but gives neither the intervention-period fall rate nor the historical rate. There is no reported estimate of the difference between periods, confidence interval, or p-value. Consequently, the direction and magnitude of the observed comparison cannot be assessed from the registry record, and its precision cannot be evaluated.
The study question concerns a rate per 1000 patient days, so an interpretable comparison would require information about falls and patient-day exposure in both periods, along with a method for comparing those rates. The registry record does not report those underlying totals or the method used for an analysis. A reader therefore cannot determine whether the intervention-period rate was lower, higher, or similar to the historical rate from the posted registry information.
Even if a numerical before-and-after comparison were available, a historical benchmark would not provide the same basis for causal interpretation as a concurrent control group. Changes in patient mix, unit practice, staffing, fall recording, or other conditions across periods could contribute to a rate difference. These are general considerations for historical comparisons; the registry record does not establish whether any such changes occurred in this study. The absence of random allocation also means the record does not describe a mechanism for balancing differences between groups.
The enrollment count of 521 describes the number enrolled, not necessarily the number with complete outcome data or the denominator used in an analysis. The record does not report an analysis population, participant flow, missing outcome data, or follow-up completeness. It is therefore not possible to connect enrollment directly to the number of patient days or falls included in the primary endpoint.
The reported serious adverse event figures list 521 at risk and zero affected, but these figures do not supply the missing efficacy result. They also do not establish the completeness of safety follow-up or describe how events were collected. Overall, the registry record documents the study question, design, and enrollment, but not the numerical primary-endpoint findings needed to judge the size or precision of the historical comparison.
9. Statistical Methods Explained
The registry describes a count-based outcome expressed as a rate: falls per 1000 patient days. No analysis method or numerical result is reported. The explanations below describe general statistical considerations for this type of endpoint; they are not a description of a method confirmed as having been used in this study.
Why use a rate?
A count records how many events occurred, while a rate relates that count to an amount of exposure. For inpatient falls, patient days represent the time contributed by patients during their hospital stays. A rate can make comparisons more meaningful when the amount of observation differs between periods. It does not remove all comparability concerns: the events and exposure must be defined consistently, and the patients or units being compared may differ in other ways.
The registry gives the endpoint unit as falls per 1000 patient days and describes the timeframe as the hospital stay, averaging 5 days. The record does not report the fall counts or patient-day totals used to calculate a rate, nor does it state how repeat falls by the same patient were handled. It also does not report the rate calculation or comparison method.
What does variation in counts mean?
General count models often begin with an assumption about how much variation to expect in event counts. Over-dispersion means the observed variation is greater than that assumption would allow. If over-dispersion is present and not addressed, standard errors may be too small and confidence intervals may be too narrow. In plain terms, an analysis could appear more precise than the data justify. This is a general issue for count outcomes, not a finding about this study. The registry does not report whether over-dispersion was assessed or how variation was modeled.
Falls may also be grouped by nursing unit or occur repeatedly for an individual. When observations share a unit or person, they may not be statistically independent. General methods can account for such clustering, but the registry record does not report whether clustering was considered, what unit-level data were available, or whether repeated events were modeled.
What would an uncertainty estimate contribute?
A confidence interval is a range of values compatible with the data under the assumptions of the analysis. It communicates the uncertainty around an estimated rate or contrast; it does not guarantee that the true value lies within the interval. A p-value, when reported, describes how compatible the observed data are with a specified null model under the analysis assumptions. Neither measure substitutes for the estimated effect or resolves design limitations such as the use of a historical comparator.
No confidence interval, p-value, or numerical estimate for the primary outcome appears in the registry record. The registry also does not report the statistical model, adjustment variables, significance threshold for the primary analysis, or whether any interim analyses were planned or conducted. These items are not reported in the registry record, so no particular modeling or testing procedure should be attributed to the study.
How should planning illustrations be read?
Any sample-size illustrations associated with this study are planning illustrations, not observed power and not a record of the study's original design justification. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. For time-to-event examples, the stated quantity is a total event count; other examples are participants per arm. These hypothetical assumptions do not match the registry's single-group design with a historical comparator, and they should not be read as the study's actual allocation or as evidence that a target power was achieved. The registry does not report the study's own sample-size justification.
Because no primary outcome analysis is reported, there is no observed effect estimate from the registry record to interpret alongside such planning assumptions. A planning calculation cannot supply the missing rate, uncertainty interval, or comparison result, and it cannot establish what the study found.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies one primary outcome measure, High Risk Fall Rate, and records zero analyses. It does not report a multiplicity plan, including whether additional outcomes or comparisons were tested, whether adjustments were intended, or how any analysis would prioritize primary and secondary questions. The count of listed outcome measures alone does not establish the full set of analyses that may have been considered. These details are not reported in the registry record.
Missing-data handling is also not described. The registry does not give the number of participants with observed outcome data, the number with incomplete records, reasons for missingness, or any imputation or exclusion procedures. The enrollment count of 521 should not be assumed to equal the analysis population. The record does not describe a participant flow or specify how patient days were handled for incomplete stays.
Analysis populations are not reported in the registry record. It is not stated whether analyses included all enrolled participants, only those who used the intervention, or another group. The registry also does not report whether the historical data were complete for the same units and outcome definitions as the intervention period.
No interim-analysis plan, stopping rule, or statistical analysis plan is reported in the registry record. The absence of these details does not establish that such procedures were or were not used; it means their status cannot be determined from the record. With no analysis results and no account of missing data or analysis populations, it is not possible to assess how those choices might affect the primary comparison.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Palarum Fall Prevention System | 0 | 521 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Palarum Fall Prevention System | 0 of 521 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Palarum Fall Prevention System | 0 of 521 |
The registry's adverse-event figures list the Palarum Fall Prevention System group with 521 participants at risk, zero affected by serious adverse events, zero affected by other events, and zero deaths. These are the figures recorded for the group; they should be read as registry counts rather than as proof that no event occurred outside the record's ascertainment or reporting process.
The registry does not provide serious adverse event terms, so no particular event type can be described. It also does not report definitions, collection procedures, the duration or completeness of safety follow-up, or whether events were assessed as related to the intervention. The 521 at-risk figure should not be treated as evidence that all 521 had identical observation time or complete follow-up.
These safety counts are separate from the primary fall-rate endpoint. The adverse-event listing does not report the number of falls or patient days and cannot be used to infer the intervention-period fall rate. The record's zero counts describe what was entered in the adverse-event fields; they do not establish the absence of risk or provide a complete safety profile.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was designed to examine a fall rate among patients designated high risk for falling, using the PUP™ system and a historical benchmark from the prior 12 months. It also records 521 enrolled participants and a completed study status. Those details describe the question and setting, not the numerical answer to the question.
No primary-endpoint rate, historical benchmark rate, estimated contrast, confidence interval, or p-value is reported. Therefore, the posted registry results do not establish whether the fall rate changed, how large any change was, or how precisely it was estimated. A lower rate cannot be inferred from the stated purpose of determining whether the rate decreases.
The design also limits what a hypothetical rate difference could establish. A comparison with an earlier period can be affected by differences between periods apart from the intervention. Without a concurrent control group, a numerical contrast would describe the observed periods but would not, on its own, isolate the intervention as the cause of a difference. This is a general interpretation of historical comparisons, not a claim that a particular alternative explanation occurred in this study.
The enrollment count does not show how many participants contributed to the primary analysis, and the record does not report participant flow, missing outcome information, or the patient-day denominator. The safety figures list zero affected by serious events, zero affected by other events, and zero deaths among 521 at risk; they do not fill the gap in primary outcome reporting or establish complete safety ascertainment.
In short, the registry record supports a description of the planned historical comparison and study design, but it does not provide the numerical evidence needed to estimate the observed fall rate or its uncertainty. Any conclusion about the size, direction, or causal meaning of an effect would go beyond the reported results.
13. Why This Trial Matters Statistically
This study raises a practical statistical question: how to compare an event rate during an intervention period with a historical rate when the outcome depends on both event counts and time at risk. Expressing falls relative to patient days recognizes that patients may contribute different amounts of observation. That makes the denominator central to interpretation, not a technical detail.
The design also illustrates the distinction between measuring a change and attributing a change. A historical comparison can be informative about what happened across periods, but it cannot ensure that the periods were otherwise comparable. Changes in care, patient characteristics, documentation, or other conditions are general sources of uncertainty in before-and-after comparisons. The registry record does not report whether they were assessed.
Reporting the count, exposure denominator, estimated rate, and uncertainty would allow readers to understand both the scale of the outcome and the precision of the comparison. Reporting the analysis population and missing data would clarify who and what contributed to that estimate. These details are absent from the registry record, so the stated study question is more fully specified than the available statistical result.
The record also distinguishes study enrollment from analysis. Although 521 participants were enrolled, it does not report how many contributed complete outcome data or the total patient days. That distinction matters whenever rates are used, because an enrollment count alone does not reconstruct the exposure used to calculate them.
Statistically, the study is notable for the combination of a clinically interpretable rate endpoint and a nonconcurrent historical reference. The endpoint definition points to the kind of comparison that would be useful, while the missing numerical analysis and uncertainty estimates prevent that comparison from being evaluated in the registry record.
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 most direct limitation of the registry record is the absence of numerical primary-endpoint results. It identifies High Risk Fall Rate as the primary measure but does not report either period's rate, underlying falls, patient days, or a contrast. No confidence interval or p-value is listed, and the record lists zero analyses. The direction, magnitude, and precision of the primary comparison therefore cannot be evaluated.
The comparison is historical rather than concurrent. The registry describes prior-12-month data from the same nursing units, but does not report how historical events were ascertained, whether the definitions matched, or whether the units and patient populations were comparable across periods. General changes over time could influence a historical comparison; the record does not provide information to assess them.
The registry does not report participant flow, analysis populations, follow-up completeness, missing-data handling, or patient-day totals. Enrollment of 521 does not establish the number contributing to the outcome analysis. The arm description is truncated, and further implementation details are not reported in the registry record.
The statistical analysis plan, model, handling of repeated falls or unit clustering, assessment of over-dispersion, and adjustment strategy are not reported in the registry record. Multiplicity procedures and interim-analysis details are also not reported. These omissions prevent readers from judging how the primary comparison was conducted or how robust it might be to analytic choices.
Finally, the adverse-event listing has no event terms and does not describe ascertainment or follow-up. The zero counts should be interpreted in that reporting context. These limitations concern what can be concluded from the registry record; they do not establish that the study team did or did not conduct analyses or procedures that are not described there.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Testing the Effectiveness of a Falls Prevention System — NCT03678402.
- Registry record last updated 2024-07-12; status last verified 2024-07.
- Results first posted 2022-01-04.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed, single-group study of the PUP™ falls prevention system among patients designated high risk for falling. It lists 521 participants enrolled, allocation as NA, masking as NONE, and a historical comparison using falls-rate data from the prior 12 months. The primary endpoint is High Risk Fall Rate, expressed in falls per 1000 patient days during the hospital stay, which averaged 5 days.
The record lists one outcome measure but no analyses and does not report a numerical primary-endpoint result, historical rate, confidence interval, or p-value. It does not describe the analysis population, missing-data handling, or statistical analysis plan. Adverse-event figures list zero serious events, zero other events, and zero deaths among 521 at risk, with no event terms reported. The registry therefore documents the study question and design but does not provide the numerical outcome analysis needed to assess the historical rate comparison.