Underutilization of Hospice in Older African Americans: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Underutilization of Hospice in Older African Americans (NCT04458090), a randomized na study. The primary outcome is Hospice Knowledge Scale.

2. Clinical Question

The registry’s background describes hospice use disparities and possible barriers, including limited knowledge, mistrust, perceived discrimination, and health literacy. These are presented as context and potential reasons for studying a decision aid; the posted primary result does not measure each barrier or establish that any one of them explains hospice use.

The trial therefore addresses a focused knowledge question rather than hospice enrollment, time in hospice, or satisfaction with end-of-life care. Those outcomes are not reported as primary results. The record also does not say whether the decision aid was intended to change any of them, or how knowledge scores were expected to relate to later decisions.

3. Trial Design

The registry describes a randomized, single-masked, parallel-group trial. Participants were assigned to an intervention arm that received a hospice patient decision aid or a control arm that did not receive the aid. The posted primary outcome lists 72 participants in each arm, and the trial enrollment is 144. The record does not explain the randomization procedure, the unit of randomization, or who was masked.

The trial is marked completed. Its recorded start date is 2019-03-01, and its primary completion date is 2021-04-30. The phase is listed as NA, and the study type is categorized as other rather than as a drug phase trial. The sponsor is University of Colorado, Denver. These administrative details describe the registry entry; they do not provide information about how the intervention was delivered or how the study was conducted at individual sites.

The primary outcome is the Hospice Knowledge Scale, assessed at 1 month. The record lists three outcome measures, but only the primary measure is described in the registry entries; the other outcome details are not reported in the registry record. No secondary results are posted. Eligibility criteria, recruitment procedures, locations, participant demographics, baseline scores, adherence, and follow-up completion are also not reported in the registry record.

The record does not include a sample-size justification or enough detail to reconstruct the trial’s planned statistical analysis. In particular, it does not report the randomization method, masking roles, prespecified analysis population, handling of missing observations, or any interim analyses. Those omissions limit how fully the design and conduct can be assessed from the registry entry alone.

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 Hospice Knowledge Scale, measured over 1 month.

The primary endpoint is the Hospice Knowledge Scale score at 1 month. The registry describes the scale as 23 true/false items, with each correct answer worth 1 point. The stated possible score range is 0 to 23, and higher scores indicate more hospice knowledge. A score therefore summarizes responses across questions about hospice knowledge rather than reporting a separate result for each question.

The scale is used to assess whether knowledge differs between the decision-aid and control arms after assignment. Knowledge is relevant to the study’s stated context because the registry background identifies lack of accurate hospice information as a possible barrier to hospice use. However, this endpoint measures knowledge, not whether a participant later enrolls in hospice, how long they receive hospice care, or their satisfaction with care.

The posted arm values are means of 17 for the intervention and control groups. The registry lists a full range from 0 to 23 for each arm, while no separate spread value is posted. The record does not give baseline scores, item-level results, or an estimate of the between-arm difference with uncertainty. Consequently, the reported means alone cannot show how individual scores were distributed or how precisely any group contrast was estimated.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the posted endpoint summarize?

The primary measure is a mean score on the Hospice Knowledge Scale at 1 month. In general, a mean summarizes the average score in a group. It is useful for describing the group’s overall score level, but it does not show the range of individual responses, the shape of the score distribution, or whether a small number of high or low values influenced the average. The posted means are 17 for both arms.

The scale has 23 true/false items, with each question worth 1 point. The registry says scores can range from 0 to 23 and that higher scores indicate more hospice knowledge. These details help interpret the direction and scale of the outcome. They do not reveal which items participants answered correctly or whether the scale performs equally well across participants. Those measurement details are not reported in the registry record.

What does a comparison of arm means usually require?

In general, a two-arm comparison asks whether the observed outcome differs between the assigned groups, while accounting for the variability in individual outcomes. A test statistic or estimated contrast is commonly accompanied by an uncertainty measure, such as a confidence interval. The interval helps distinguish a point estimate from the precision with which the comparison is known. Here, the record posts arm means but no contrast estimate or uncertainty measure.

The equality of the two displayed means does not establish that the underlying group outcomes are identical. Individual scores may vary around each mean, and the record does not provide a standard deviation or another separate measure of spread. The arm entries include a full range of 0 to 23, but the record does not make clear whether those bounds describe observed scores or simply the scale’s possible range. Without more distributional detail, the posted means cannot describe how similar participants’ scores were within or between arms.

Why does randomization matter, and what remains unknown?

In general, random assignment is intended to make the comparison between groups less vulnerable to systematic differences in participant characteristics at the time of assignment. The registry identifies the study as randomized, but does not describe how the random sequence was generated or concealed. It also does not report baseline characteristics or baseline knowledge scores. The design label is informative, but it is not a substitute for details about allocation procedures and the resulting groups.

The study is identified as single-masked, but the record does not say who was masked or what masking involved. That distinction matters when evaluating how expectations might affect intervention delivery, participant responses, or outcome assessment. No conclusion about those possibilities can be drawn from the masking label alone.

What can be learned from the sample-size information?

In general, a sample-size calculation uses assumptions about the outcome, the effect to detect, the significance level, allocation, and the planned analysis. The sample-size section accompanying this page is a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The stated effect to detect is a fraction of the observed effect. Such illustrations are planning aids; they are not observed power and do not show what the trial was designed to detect.

The registry record does not report the trial’s own sample-size justification or assumptions. The posted primary result has equal arm means, and no recalculated comparison is available in the record. A planning illustration based on an observed effect cannot replace the trial’s original design rationale. It also cannot supply missing information about the analysis or the precision of the reported result.

What do the posted analysis fields tell us?

The record lists zero analyses and does not provide a two-arm comparison. It does not state whether the means were calculated for all randomized participants, only participants with an observed one-month score, or another analysis population. It also does not identify a statistical model, adjustment variables, or a strategy for missing data. These are not minor details: analysis choices can affect which participants contribute to a result and how uncertainty is quantified.

In general, over-dispersion means that observed variability is greater than a model’s assumptions allow. It can make standard errors and tests unreliable if the model does not account for that extra variability. Nothing in the posted results establishes that over-dispersion occurred here, and no model is described to evaluate it. It is therefore a general methodological consideration, not a finding about this trial.

Likewise, a confidence interval would not by itself resolve every design or measurement limitation, but it would show the precision of a specified estimate under the analysis assumptions. Because no interval or analysis estimate is posted, the record supports descriptive interpretation of the arm means only. Readers should not infer an unreported test, model, or adjustment from the randomized design label.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures, but the primary measure is the only outcome described in detail. No secondary results are posted, and the record lists zero analyses. The record does not state how many outcomes were prespecified for formal testing, which outcome was intended to be primary in the analysis plan, or whether any multiplicity adjustment was planned. It is therefore not possible to assess how the possibility of multiple statistical comparisons was handled.

In general, multiplicity concerns arise when several outcomes or comparisons are tested, because the chance of at least one apparently notable result can increase as more tests are considered. Statistical approaches can address this issue, but the choice depends on the planned comparisons and analysis. No particular approach is reported for this trial. The absence of posted secondary results should not be interpreted as evidence that the other outcomes were not collected or analyzed.

Missing-data handling is also not reported in the registry record. The primary outcome lists 72 participants in each arm, but the record does not state how many were assigned, assessed at 1 month, or included in the reported means. It gives no information about withdrawals, incomplete scales, or the reasons data might be unavailable. Without participant flow and missingness details, the completeness and representativeness of the reported outcome data cannot be assessed.

The analysis population is not specified. In general, an intention-to-treat analysis retains participants in their randomized groups, while other analysis populations may apply different inclusion rules. The record does not say which approach, if any, was used. It also does not describe imputation or other methods for handling missing outcomes. These omissions prevent a full assessment of the reported means and any potential comparison.

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

The posted primary outcome shows a mean Hospice Knowledge Scale score of 17 in each arm at 1 month. This is a descriptive account of the values in the registry. Because there is no reported between-arm estimate, confidence interval, or test, the results do not establish whether the arms differed beyond the equality of their displayed means or how precisely a group difference was estimated.

Equal reported means do not prove equivalence. Equivalence requires a prespecified margin and an analysis designed to assess whether plausible differences fall within that margin; neither is reported in the registry record. The same means also do not establish that the decision aid had no effect. Without baseline scores, individual-level data, and a comparison analysis, readers cannot determine how scores changed or what differences remain compatible with the posted results.

The outcome is knowledge, not hospice use. The record does not report whether participants enrolled in hospice, how long they received hospice care, or how satisfied they were with care. The registry background discusses these topics and possible barriers, but those contextual statements are not outcomes of the posted primary analysis. The knowledge result cannot establish that any difference in knowledge led to a change in hospice decisions or care.

The results also do not establish whether the decision aid was received or used as intended, or whether the measure captured the information most relevant to participants. Details about intervention delivery, adherence, scale performance, and participants’ experiences are not reported. These omissions limit interpretation of what a score represents in practice.

In general, randomized assignment can support a causal comparison when the conduct and analysis preserve the randomized groups and other assumptions are met. The registry identifies randomized allocation, but the information needed to assess the analysis and missing data is not posted. The most defensible reading is therefore limited: the registry reports equal primary-outcome means, while the statistical comparison and its uncertainty are not reported.

12. Why This Trial Matters Statistically

This trial is statistically interesting because its primary outcome is a knowledge scale intended to represent a potential barrier described in the registry background. The study frames hospice knowledge as relevant to decision making, while the posted endpoint measures knowledge directly rather than a later care decision. Keeping that distinction clear helps readers match the statistical result to the question the outcome can answer.

The registry’s randomized, parallel-group design sets up a comparison between a decision-aid arm and a control arm. Yet design labels alone do not provide the inferential result. Here, the means are both 17, but no between-arm estimate or uncertainty is posted. This illustrates why a descriptive table and an analysis answer different questions: the former summarizes observed values, while the latter quantifies a specified contrast and its precision.

The record also illustrates the value of transparent reporting. Information about masking roles, baseline scores, outcome completeness, analysis populations, missing data, and statistical methods would help readers evaluate how the result was produced. The record lists three outcome measures but does not post secondary results, and it lists zero analyses. That leaves important questions unanswered even though the primary arm values are visible.

Finally, the reported scale has a defined score range and direction, which makes the endpoint’s basic interpretation clear. However, a mean without a separate measure of variability or a comparison interval gives only a partial picture. For biostatisticians and clinical researchers, the central lesson is to distinguish the posted descriptive result from an unreported inferential conclusion, and to treat planning illustrations as design aids rather than evidence about observed power or treatment effects.

13. 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 registry entry gives limited detail about who could participate and who was enrolled. The study title and background concern older African Americans, but eligibility criteria, participant characteristics, recruitment methods, and study locations are not reported in the registry record. The extent to which the enrolled group represents the population described by the study question therefore cannot be assessed from this entry.

The intervention is named as a hospice patient decision aid, but its content, format, language, delivery, and use are not described. The control arm is said not to receive the aid, but other care or information in either arm is not reported. The record also does not identify who was masked, so the practical implications of the single-masked designation are unclear.

The primary outcome is reported as a mean for each arm, with no separate spread estimate and no statistical comparison. Baseline scores, individual score distributions, and changes from baseline are not reported. The registry lists 72 participants per arm, but does not describe participant flow, the number assessed at 1 month, missing observations, or the analysis population. These gaps make it difficult to assess outcome completeness and precision.

The record lists three outcome measures but provides no secondary results, and it does not describe the statistical analysis plan. Sample-size justification, model choice, covariate adjustment, multiplicity procedures, and missing-data methods are not reported. The record also does not provide information on intervention fidelity or whether participants used the decision aid as intended. These limitations are specific to what is available in this registry entry; they do not establish that such information was absent from other study materials.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Underutilization of Hospice in Older African Americans — NCT04458090.
• Registry record last updated 2026-07-17; status last verified 2026-06.
• Results first posted 2022-08-30.
• 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.

17. Record Summary

This completed, randomized, single-masked, parallel-group trial is titled Underutilization of Hospice in Older African Americans and is sponsored by University of Colorado, Denver. The registry records a start date of 2019-03-01, a primary completion date of 2021-04-30, and enrollment of 144. The intervention arm received a hospice patient decision aid; the control arm did not.

The primary outcome is the Hospice Knowledge Scale at 1 month. It is described as a 23-item true/false scale, with scores from 0 to 23 and higher scores indicating more hospice knowledge. The posted mean is 17 in each arm, with 72 participants listed per arm. No two-arm analysis, confidence interval, or p-value is reported. The record lists three outcome measures and zero analyses; secondary results are not posted. The registry does not report the analysis plan, missing-data approach, participant flow, or sample-size justification.