RN-Led Palliative and Supportive Care Intervention: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for RN-Led Palliative and Supportive Care Intervention (NCT04570709), a non-randomized na study. The primary outcome is Retention Rate.

2. Clinical Question

The registered primary outcome is called “Retention Rate,” but its parameter is a count of participants. Its description focuses on participants who consented and completed the intervention, while its population description refers to subjects who started the study and completed the intervention. These descriptions point to completion and retention as the central feasibility question; the registry record does not clarify how the count was converted into a rate or define a denominator.

The intervention is intended to address activity needs during an acute leukemia hospital stay. The registry record frames the study as examining feasibility and acceptability, rather than as a randomized test of clinical effectiveness. It does not report a treatment-effect comparison, an outcome estimate, or results that establish whether the intervention met a feasibility or acceptability target. Accordingly, the primary question that can be described is whether participants completed the intervention, not whether the intervention changed health outcomes relative to standard care.

3. Trial Design

This was a single-institution feasibility and acceptability study with non-randomized allocation, no masking, and a sequential model. The registry record lists 67 participants enrolled and marks the study as completed. The listed condition is acute myeloid leukemia; the brief summary describes the study population more broadly as patients with acute leukemia and emphasizes the activity needs of older adults. Further eligibility criteria and the number of participants in each arm are not reported in the registry record.

The intervention was Palliative And supportive Care inTervention (PACT), categorized as “OTHER” in the record. Participants in the intervention arm were to receive PACT from a multidisciplinary team of registered nurses, occupational therapists, and physical therapists. Participants in the control arm were to receive standard of care and no intervention. The study began on 2020-09-14, and primary completion is recorded as 2023-04-04.

Because allocation was non-randomized, differences between arms may reflect differences in the participants or circumstances assigned to each arm, as well as any intervention-related differences. The registry record itself cautions that the arms are not a like-for-like control comparison. Sequential allocation describes the model, but the specific sequence, assignment process, and timing of any changes are not reported in the registry record. The record also does not describe masking beyond stating that none was used.

The registered outcome set contains eight measures, while the record lists zero analyses. The primary outcome concerns participant retention or completion, assessed at baseline and up to 30 days during the first and second cycles. The registry record does not report the arm-specific enrollment, the number completing the intervention, or a numerical primary outcome result. Thus, the design and intended feasibility question can be characterized, but observed retention cannot be assessed from the posted registry results.

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: A total of seventy-two participants consented to the study, but five of them withdrew their consent during screening and therefore were not enrolled in the study.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Potential research participants screened.

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: Subjects who were joined to the study. Care Partner -Control" and "Care Partner- Interventional" Arms were not assessed for this Baseline Measure support person and miles traveled to the clinic.

6. Primary Endpoint

The registry lists the primary outcome as Retention Rate, measured over Baseline and up to 30 days (first and second cycles).

The primary endpoint is “Retention Rate,” with the parameter recorded as a count of participants. Its description defines the intended event as a participant who consented to the study completing the study intervention at the assessment time point. The listed timeframe is baseline and up to 30 days, spanning the first and second cycles. The population description refers to subjects who started the study and completed the intervention.

Retention is used in feasibility work to describe whether participants remain engaged through the intervention or study procedures. As a general statistical concept, a count can show how many participants completed, while a rate also requires a clearly defined denominator. The registry record does not report a numerator, denominator, completion count, or the rule used to calculate a rate. Nor does it clarify the difference between the endpoint description’s consent-based population and the population description’s reference to subjects who started the study.

The outcome is relevant to the study’s stated feasibility and acceptability purpose: completion is one observable aspect of whether an intervention can be delivered and participants can remain involved. But a retention measure alone does not establish acceptability, explain why participants did or did not complete, or measure clinical benefit. The registry record does not report a threshold for success or an observed endpoint value. The endpoint’s purpose can therefore be described, but its result and interpretation against any target cannot be determined from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies the primary measure as a count of participants and labels it “Retention Rate.” These are related but not interchangeable summaries. A count is the number of participants meeting a stated condition. A rate expresses that count relative to a defined group or period and therefore needs a denominator and a clear rule for who is included. The record describes completion among participants who consented, but its population description refers to subjects who started the study and completed the intervention. It does not provide the observed count, the denominator, or a calculation rule. As a result, the reported measure cannot be reconstructed or interpreted as a rate.

What does a confidence interval add?

In general, a confidence interval describes the statistical uncertainty around an estimate under the assumptions of the method used. A narrow interval indicates greater precision, while a wide interval indicates less precision. An interval does not fix a poorly defined endpoint, remove bias from non-random allocation, or show that a result is clinically important. No confidence interval is reported for the primary outcome in the registry record, and there is no posted estimate around which to assess precision.

What can a non-randomized comparison show?

In general, a comparison between groups can describe how their observed outcomes differ, but the interpretation depends on how participants entered each group and on other factors related to both group assignment and outcome. Randomization is one way to reduce systematic baseline differences. Here, allocation is recorded as non-randomized, and the registry record cautions that the arms are not a like-for-like control comparison. The record does not provide an allocation procedure, baseline characteristics, or an analysis adjusting for group differences. No adjusted or unadjusted arm comparison is reported. A causal interpretation of any hypothetical group contrast would therefore be unwarranted.

Why are analyses and uncertainty measures important?

An outcome estimate communicates the observed data in a form tied to the endpoint. An uncertainty measure helps readers judge how compatible the data are with a range of underlying values. A statistical test, when used, answers a narrower question under specified assumptions; a p-value does not measure the size or importance of an effect. The registry record lists zero analyses, and no estimate, confidence interval, or p-value is reported for retention. Thus, neither the magnitude nor the precision of a primary outcome result can be evaluated from the posted results.

How should sample-size illustrations be read?

The described planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a stated fraction of the observed effect. The record characterizes these as planning illustrations computed from the observed effect, not as the trial’s own design. Such illustrations are hypothetical planning calculations: they are not the number enrolled, not evidence about what the study observed, and not observed power. A sample-size calculation for a chosen target effect cannot substitute for an outcome estimate or its uncertainty. The record does not report the study’s own sample-size justification, and the listed enrollment of 67 should not be confused with an arm-specific sample size or a result.

What does the adverse-event listing establish?

The record lists zero at risk and zero affected for serious and other adverse events in each of the four named groups, and zero deaths in each group. A count of affected participants can only be interpreted in relation to a population at risk and the completeness of event reporting. Since the listed at-risk counts are zero, the entries do not support a rate calculation or a conclusion about event frequency among enrolled participants. The registry record does not report further details that explain these entries.

These statistical distinctions matter because the study’s registered purpose is feasibility and acceptability, while its primary endpoint is completion-focused. A precise, clearly defined retention estimate could describe one aspect of feasibility, but it would not by itself establish acceptability or clinical effectiveness. In the absence of a posted outcome estimate and analysis, statistical methods can clarify what the intended measure means, but cannot supply a result that the registry record does not report.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists eight outcome measures and zero analyses. It does not report a multiplicity plan, such as whether one outcome was designated as the sole confirmatory endpoint or how testing across multiple outcomes would be handled. In general, examining multiple outcomes can increase the chance of finding at least one apparently unusual result by chance if each is tested separately. Methods for addressing that issue depend on the analysis plan and the role of each outcome. Neither that plan nor analyses are reported in the registry record, so the effect of multiplicity cannot be assessed.

The registry record does not describe missing-data methods, reasons for non-completion, or how missing outcome assessments were handled. These details are especially relevant to a retention endpoint: participants with unobserved completion status cannot simply be assumed to have completed or not completed without a stated rule. The record also does not state how withdrawals, missed assessments, or participants who did not start the intervention were classified.

Analysis populations are not reported in the registry record. The endpoint description refers to participants who consented and completed the intervention, while the population description refers to subjects who started and completed it. The record does not define an analysis set or clarify which participants were included in the intended denominator. Therefore, neither a complete-case interpretation nor another missing-data approach can be attributed to the study.

These omissions prevent assessment of whether missingness or outcome selection could affect the reported results. They do not establish that missing data occurred or that any particular method was used; those details are not reported in the registry record.

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

The record establishes that the study was designed to examine the feasibility and acceptability of a multidisciplinary, nurse-led palliative and supportive care intervention for adults with acute leukemia. It identifies retention or intervention completion as the primary outcome, reports enrollment of 67 participants, and marks the study as completed. These details describe the research question and conduct recorded in the registry, not the observed answer to the primary question.

The registry record does not report the number of participants who completed the intervention, a retention rate, or an endpoint-specific denominator. It also lists zero analyses. Therefore, the posted results do not show how often completion occurred, how precise any estimate might be, or whether completion differed between the intervention and control arms. A conclusion that the intervention succeeded or failed on feasibility grounds cannot be drawn from the listed information.

The non-randomized design further limits what an arm comparison could mean. Even if arm-specific results were available, the registry record’s warning that the groups are not a like-for-like control comparison would need to shape interpretation. Differences could not automatically be attributed to the intervention. The record does not report an analysis that addresses this concern.

The adverse-event entries should not be read as evidence that there were no events among participants: the record lists zero participants at risk as well as zero affected in each listed group. The entries do not provide a denominator for an event rate.

In general, a feasibility study can inform whether an intervention and its study procedures appear workable, while a clinical-effectiveness conclusion requires relevant outcome data and an appropriate comparison. The record identifies a feasibility-oriented question but does not report the outcome information needed to answer it. The absence of posted analyses is not evidence of either benefit or lack of benefit; it means the registered results do not establish either conclusion.

12. Why This Trial Matters Statistically

This trial is statistically notable because its primary outcome is closely tied to feasibility: whether participants who consented completed the intervention. Such an endpoint can be useful when the research question concerns delivery and participation, rather than a clinical outcome. But the label “Retention Rate,” the count-based parameter, and the two slightly different descriptions of the endpoint population make the denominator important. Without a clearly specified denominator and a posted count, readers cannot tell what the intended rate represents or judge its precision.

The non-randomized, sequential design also makes the distinction between description and causal comparison important. A control arm is present, but the registry record explicitly cautions that the arms are not a like-for-like comparison. In general, a control group does not by itself remove selection differences. Statistical adjustment can sometimes address measured differences, but it cannot guarantee removal of unmeasured differences. The registry record lists no analyses, so it does not show whether any comparison or adjustment was made.

The record reports 67 participants enrolled and marks the study completed, but it does not report the primary outcome result. This illustrates a basic reporting distinction: a completed study and a registered endpoint do not supply an estimate. A reader needs the observed outcome, a well-defined analysis population, and uncertainty information to evaluate a quantitative result. Those details are not reported in the registry record.

Finally, the adverse-event listing shows why denominators matter beyond the primary endpoint. Zero affected participants alongside zero at risk is not an event rate and cannot be taken as proof of zero events among enrolled participants. Clear reporting of populations, counts, and analytic decisions is necessary for even a feasibility study to support a reliable statistical interpretation.

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 most direct limitation for interpreting this trial is that no primary outcome result is reported in the registry record. Although retention is identified as the primary endpoint and the study is marked completed, the record gives no completion count, rate, denominator, or uncertainty estimate. The intended endpoint population is also not fully clear: the description refers to participants who consented, while the population statement refers to subjects who started the study. The record does not explain how that distinction was handled.

Non-randomized allocation limits the comparability of the intervention and control arms. The registry record itself states that the arms are not a like-for-like control comparison. Arm-specific enrollment and baseline characteristics are not reported in the registry record, nor are any analyses that might describe or adjust for group differences. Consequently, the record cannot support a reliable comparative or causal interpretation.

The single-institution setting limits how broadly results might apply, even if outcome estimates were available. The brief summary describes an intervention for activity needs among older adults with acute leukemia during hospitalization, but further eligibility details and the characteristics of enrolled participants are not reported in the registry record. The listed condition is acute myeloid leukemia, while the brief summary uses the broader term acute leukemia; the record does not explain the relationship between these descriptions.

Other trial-specific details needed to assess interpretation are also not reported in the registry record, including the allocation process, missing-data handling, analysis populations, and a sample-size justification. The adverse-event listing contains zero at-risk counts in every group, which prevents interpreting the entries as rates among participants. These limitations concern what the record reports; they do not establish what occurred outside the reported information.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: RN-Led Palliative and Supportive Care Intervention — NCT04570709.
• Registry record last updated 2024-09-25; status last verified 2024-09.
• Results first posted 2024-06-11.
• 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

The registry record describes NCT04570709, “RN-Led Palliative and Supportive Care Intervention,” as a completed, single-institution feasibility and acceptability study. It lists non-randomized allocation, no masking, a sequential model, and enrollment of 67 participants. The study began on 2020-09-14, with primary completion recorded as 2023-04-04.

The intervention was PACT, delivered by registered nurses, occupational therapists, and physical therapists; the control arm was described as receiving standard of care without the intervention. The primary outcome, “Retention Rate,” concerns participants completing the study intervention at baseline and up to 30 days, spanning the first and second cycles.

The record lists eight outcome measures and zero analyses. It does not report the primary outcome value, denominator, or an inferential comparison. Its adverse-event entries list zero at risk and zero affected in each of four groups, with zero deaths; these entries do not establish event rates among enrolled participants.