Nurse Coach-Led Early Palliative Care for Older Adults With COPD and Their Care Partners: The Project EPIC Pilot RCT: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Nurse Coach-Led Early Palliative Care for Older Adults With COPD and Their Care Partners: The Project EPIC Pilot RCT (NCT05040386), a randomized na study. The primary outcome is Survey Feasibility.

2. Clinical Question

The primary question is about feasibility of survey completion, not whether the intervention changes COPD symptoms, quality of life, or another clinical outcome. For patient participants, 12 of 15 in each arm completed all available survey sets. For caregiver participants, the count was 6 of 10 in the EPIC arm and 8 of 10 in usual care. The registry presents patient and caregiver counts separately, so the results should be read as distinct participant groups rather than combined into one estimate.

The trial also posted selected measures at 6 months, including life space, cognitive status, and activities of daily living. These measures provide additional descriptive information, but they do not replace the stated primary feasibility outcome. The registry record does not report a primary clinical effectiveness question or a formal analysis plan for assessing clinical benefit.

3. Trial Design

Project EPIC is a randomized, parallel-group pilot trial comparing EPIC with usual care for COPD. The registry lists the allocation as randomized and masking as single; it does not identify who was masked. The study is marked completed and lists an enrollment of 50. The recorded start date is 2022-05-19, and the primary completion date is 2024-10-25.

The trial includes patient participants and caregiver participants. The posted participant groups are 15 patient participants in the EPIC arm, 15 patient participants in usual care, 10 caregiver participants in the EPIC arm, and 10 caregiver participants in usual care. The arm descriptions state that caregivers, if available, were randomized to the same study arm as the patient participant. The record does not provide further detail about the randomization sequence or how allocation was implemented.

The intervention is described as a nurse coach-led early palliative care program delivered by telephone. The brief description says the study refines and pilot tests the intervention in older adults with COPD and care partners. Usual care is described as the standard of care for COPD. Detailed descriptions of the coaching content, frequency, duration, and adherence are not reported in the registry record.

The primary outcome is survey feasibility at 6 months. The record also lists secondary outcomes including the UAB Life Space Assessment, Chronic Respiratory Questionnaire, PROMIS Global Health 10, Montgomery Borgatta Caregiver Burden, Hospital Anxiety and Depression Scale, modified Telephone Interview for Cognitive Status, Katz Index of Activities of Daily Living, and Lawton Instrumental Activities of Daily Living. Results for 10 secondary outcomes are posted, while the record lists 14 outcome measures. Detailed results available for interpretation include only selected measures; the other outcome results are not reported in the registry record presented for this analysis.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: This sample represents the total patient and caregiver participants who started the EPIC intervention and completed at least the introductory session.

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 Survey Feasibility, measured over 6 months.

The primary endpoint is Survey Feasibility at 6 months. It is defined as the count of patient and caregiver participants who completed 100% of all available survey sets across the study. The registry presents patient and caregiver counts separately for each randomized arm. In the patient groups, 12 of 15 participants in the EPIC arm and 12 of 15 in usual care met the completion definition. Among caregivers, 6 of 10 in the EPIC arm and 8 of 10 in usual care did so.

This endpoint is useful in a pilot because it describes whether participants can complete the planned survey collection. Completion is relevant to the practicality of collecting outcome data in a larger study, particularly when both patients and care partners are involved. It does not measure clinical improvement, and a completed survey set should not be interpreted as evidence of a change in health status.

The endpoint uses a strict completion definition: participants must complete all available survey sets to be counted. The record does not provide details about how partial completion was handled beyond that definition, or whether survey burden, reasons for noncompletion, or completion at individual time points were separately analyzed. Those details are not reported in the registry record.

7. Results Posted in the Registry

• Intervention (EPIC): Patient Participants: 80.0% (12/15) versus 80.0% (12/15) on control; risk difference 0.0 percentage points (95% CI -28.6 to 28.6), risk ratio 1.00 (0.70–1.43); unadjusted two-proportion z-test p = 1.000.
• Intervention (EPIC): Caregiver Participants: 60.0% (6/10) versus 80.0% (12/15) on control; risk difference -20.0 percentage points (95% CI -56.5 to 16.5), risk ratio 0.75 (0.43–1.32); unadjusted two-proportion z-test p = 0.275.
• Control (Usual Care): Caregiver Participants: 80.0% (8/10) versus 80.0% (12/15) on control; risk difference 0.0 percentage points (95% CI -32.0 to 32.0), risk ratio 1.00 (0.67–1.49); unadjusted two-proportion z-test p = 1.000.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

UAB Life Space Assessment

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Control (Usual Care): Patient Participants: mean 52.10 versus 46.60 on control; difference 5.50 (95% CI -13.09 to 24.09), standardized effect d = 0.22; z-test p = 0.562.
  • Control (Usual Care): Caregiver Participants: mean 90.30 versus 46.60 on control; difference 43.70 (95% CI 28.47 to 58.93), standardized effect d = 2.27; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Control (Usual Care): Patient Participants and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Control (Usual Care): Caregiver Participants than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Modified Telephone Interview for Cognitive Status (mTICS)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Intervention (): Patient Participants: mean 28.60 versus 31.70 on control; difference -3.10 (95% CI -7.21 to 1.01), standardized effect d = -0.54; z-test p = 0.139.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention (): Patient Participants and the control. The interval gives the range of effects that remain compatible with the data.

Katz Index of Activities of Daily Living

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Intervention (): Patient Participants: mean 5.70 versus 5.30 on control; difference 0.40 (95% CI -0.49 to 1.29), standardized effect d = 0.32; z-test p = 0.378.
  • Control (Usual Care): Caregiver Participants: mean 6.00 versus 5.30 on control; difference 0.70 (95% CI -0.11 to 1.51), standardized effect d = 0.56; z-test p = 0.090.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention (): Patient Participants and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Control (Usual Care): Caregiver Participants and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes cover several domains, including life space, respiratory health, global health, caregiver burden, mood, cognitive status, and activities of daily living. They are distinct from the primary survey-feasibility endpoint: their purpose is to describe scale-based or other outcome measurements, whereas the primary outcome counts participants who completed all available survey sets. Consequently, secondary outcome results cannot be used as a substitute for the primary feasibility result.

The posted secondary findings do not form a single consistent pattern across all measures and participant groups. Available contrasts differ in direction, size, and precision. Some estimates are accompanied by intervals that include zero, while at least one posted comparison has an interval that does not include zero. This range of findings should be read as exploratory rather than as a coherent confirmatory signal. The registry lists 14 outcome measures and reports results for 10, while detailed results available for interpretation are limited to selected measures.

In general, testing many outcomes increases the chance that one or more comparisons will appear striking by chance, especially when results are interpreted without a multiplicity adjustment. The registry record does not report a correction strategy, a hierarchy for secondary outcomes, or reported analyses. The posted unadjusted comparisons therefore carry less inferential weight than a single prespecified primary analysis supported by a documented plan. The record also does not state whether the secondary outcomes were intended to be exploratory.

The primary endpoint and secondary outcomes answer different questions. Similar patient survey-completion counts do not imply that clinical scale outcomes were unchanged, and differences on a secondary scale do not establish that survey collection was feasible for all participants. The secondary findings may help describe what was measured in this pilot and inform further study, but their small groups, unadjusted status, and incomplete outcome reporting limit the strength of broader conclusions.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• UAB Life Space Assessment
• Chronic Respiratory Questionnaire (CRQ)
• PROMIS Global Health 10
• Montgomery Borgatta Caregiver Burden
• Hospital Anxiety and Depression Scale (HADS)
• Modified Telephone Interview for Cognitive Status (mTICS)
• Katz Index of Activities of Daily Living
• Lawton Instrumental Activities of Daily Living

9. Statistical Interpretation

10. Statistical Methods Explained

What is being compared? The primary endpoint is a binary participant-level outcome: whether a participant completed 100% of all available survey sets. The posted counts give the number meeting that definition and the group size. The risk difference expresses the contrast between the intervention and usual-care groups on this completion outcome. The reported patient risk difference is 0.0; the caregiver risk difference is -0.2. A value of zero represents no observed difference in the completion proportions, while a negative caregiver estimate indicates a lower observed completion proportion in the intervention group under the stated contrast.

How should the confidence intervals be read? A confidence interval describes the range of values reasonably compatible with the estimate under the calculation method. For the patient comparison, the interval runs from -0.286 to 0.286. For caregivers, it runs from -0.565 to 0.165. Both include zero, so the estimates are compatible with no difference as well as with differences in either direction. The intervals are wide, reflecting the limited precision of the small groups. A confidence interval is not a guarantee that the true value lies within its bounds, nor does it describe the probability that a particular hypothesis is true.

What does the p-value contribute? The unadjusted p-value measures how unusual the data would be under a specified no-difference model, according to the calculation used. The patient comparison has an unadjusted p-value of 1.0, and the caregiver comparison has an unadjusted p-value of 0.275. These values do not measure the size or importance of an effect. They also do not establish that the groups are equivalent. The registry does not list reported analyses, so the comparisons should be understood as unadjusted re-calculations from the posted summary counts rather than as a documented sponsor analysis.

What do the secondary comparisons represent? For continuous outcomes, the posted comparisons use group means and standard deviations to estimate a mean difference and its uncertainty. The life-space and other available continuous-outcome summaries are therefore contrasts in average scale scores at the stated assessment, not changes from baseline unless a change outcome is specifically described. Baseline-adjusted models and repeated-measures analyses are not reported in the registry record. The available comparisons are unadjusted, and the record does not describe a multiplicity correction or a hierarchy for interpreting secondary outcomes.

In general, a standard deviation describes variation among participant scores, whereas a confidence interval around a mean difference describes uncertainty in the estimated contrast. These are different quantities. In general, larger variability or smaller groups make an estimate less precise. When group sizes are small, a few observations can have substantial influence on a group mean or on the apparent difference between groups.

How should the planning illustrations be understood? The posted planning illustrations use an observed effect as a reference and show participants per arm for 80% or 90% power under stated assumptions. The assumptions are a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is the stated fraction of the observed effect. For the caregiver survey-completion contrast, the illustrations include planning for 100%, 75%, and 50% of the observed effect. Other selected comparisons also have planning illustrations. These are hypothetical planning calculations, not outcomes observed in the trial and not observed power. They should not be interpreted as the trial’s original sample-size justification; that justification is not reported in the registry record.

In general, planning from an observed pilot effect can be unstable because the estimate may be imprecise, particularly when participant groups are small. A smaller assumed effect leads to a larger planning requirement under otherwise unchanged assumptions. The illustrations are conditional on their assumptions and do not establish the sample size required for every future design. The registry does not report whether any separate design calculation, interim analysis, or other statistical procedure was used.

What is not specified? The registry does not report the identity of the masked party, details of sequence generation or allocation concealment, an analysis population definition, handling of missing data, or adjusted statistical models. It also does not report a multiplicity strategy for the secondary outcomes. These omissions limit how fully the posted estimates can be evaluated as a complete statistical analysis. In general, prespecified methods and transparent reporting help distinguish planned comparisons from exploratory ones and clarify how incomplete observations are treated.

11. Confidence Intervals and Precision

Precision is limited by the small groups contributing to the primary outcome: 15 patient participants in each arm and 10 caregiver participants in each arm. The patient risk-difference estimate is 0.0, but its 95% confidence interval extends from -0.286 to 0.286. The caregiver estimate is -0.2, with an interval from -0.565 to 0.165. Both intervals include zero and encompass effects in either direction. The estimates therefore do not pin down a narrow range of possible between-arm differences.

In general, a confidence interval gives a range of values compatible with the observed data and the statistical method. A narrow interval indicates greater precision; a wide interval indicates greater uncertainty. It is not a range containing all possible participant outcomes, and it does not by itself establish whether an effect is important. For this pilot, the primary intervals allow substantial uncertainty about the size and direction of any difference in survey completion.

The secondary estimates also vary in precision. For example, the patient life-space mean-difference interval runs from -13.09 to 24.09, while the caregiver life-space interval runs from 28.47 to 58.93. These intervals describe different participant groups and should not be combined into a single conclusion. Small groups can produce imprecise estimates even when the observed contrast appears large. Conversely, an estimate with a narrow interval still requires attention to the outcome definition, analysis method, and multiplicity of comparisons.

The registry does not report a formal precision target or a sample-size justification for the trial. The planning illustrations based on observed effects are conditional calculations, not evidence that the trial was designed to achieve a particular level of precision. A pilot’s estimates can help inform future planning, but their uncertainty should remain central to interpretation.

12. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary feasibility outcome and multiple secondary measures. It does not report a multiplicity strategy, such as an adjustment to account for testing several outcomes, or a hierarchy that would identify which secondary comparisons should be treated as confirmatory. Without such information, unadjusted secondary p-values should be interpreted cautiously. In general, making many comparisons creates more opportunities for apparently unusual results to occur by chance. This does not invalidate individual estimates, but it reduces the weight that should be placed on isolated findings.

The registry record lists no reported analyses. The available arm summaries and unadjusted re-calculations describe contrasts based on posted values, but the record does not document a full statistical analysis plan or explain whether these comparisons were prespecified. Details about covariate adjustment, analysis populations, and model selection are not reported in the registry record.

Missing-data handling is also not reported in the registry record. The primary outcome counts participants who completed 100% of all available survey sets, but the record does not explain how partial responses, unavailable assessments, or other incomplete observations were treated beyond that definition. It does not report imputation methods or reasons for noncompletion. The completion count is informative for the stated endpoint, but it does not describe all patterns of missing or partial data.

Randomization is listed, but the record does not provide details about sequence generation or allocation concealment. Masking is listed as single, without identifying who was masked. Interim analyses are not reported in the registry record. These are reporting gaps rather than evidence that a particular method was or was not used. In general, complete reporting of these methods helps readers assess whether the analysis reflects the randomized groups, how incomplete observations may affect results, and how multiple outcomes were handled.

13. 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 records zero serious adverse events, zero other adverse events, and zero deaths in each of the four participant groups. The groups at risk were 15 patient participants in the EPIC arm, 15 patient participants in usual care, 10 caregiver participants in the EPIC arm, and 10 caregiver participants in usual care. No serious-event terms are listed.

These figures describe the adverse-event information recorded in the registry for the listed groups. They should not be interpreted as proof that the intervention has no risks or that no event could occur. In general, a pilot with small participant groups provides limited information about uncommon events, and a zero count cannot establish that the underlying risk is zero. The registry record does not provide further details about event definitions, collection methods, follow-up duration for safety, or the relationship of any event to study participation. The counts are therefore a limited description of reported events, not a comprehensive safety assessment.

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

The primary result describes survey feasibility in this pilot. Patient completion counts were 12 of 15 in both arms. Caregiver completion counts were 6 of 10 in EPIC and 8 of 10 in usual care. The unadjusted estimates and their confidence intervals indicate substantial uncertainty, particularly for caregiver completion. These findings can inform discussion of survey collection in a study involving patients and care partners, but they do not establish a precise difference between arms.

The result does not show whether EPIC improves or worsens COPD symptoms, quality of life, mood, function, or other clinical outcomes. The primary endpoint is completion of survey sets, not a clinical response. Selected secondary outcomes provide descriptive comparisons, but the registry does not report a full analysis plan, multiplicity approach, or reported analyses. Those results should not be treated as definitive evidence of clinical effectiveness.

The trial’s pilot status and small participant groups matter to interpretation. In general, estimates from small studies can be unstable, and confidence intervals can include a broad range of possible effects. A p-value alone cannot establish equivalence, benefit, or lack of benefit. The posted caregiver p-value of 0.275, for example, does not show that the arms are the same; the interval also includes differences in either direction.

The adverse-event counts are also limited: zero events are recorded in each group, but these data cannot rule out uncommon harms or establish safety across settings and populations. The findings apply to the participants and measures recorded for this trial. Eligibility criteria beyond the general description, detailed intervention delivery, and broader applicability are not fully described in the registry record. Future interpretation would require fuller reporting and evidence from studies designed to assess clinical outcomes with adequate precision.

15. Why This Trial Matters Statistically

This trial is statistically informative because its primary outcome focuses on whether a study involving older adults with COPD and care partners can collect complete survey data. Feasibility questions are important in pilot work: an intervention study depends not only on randomization and delivery, but also on the ability to obtain usable outcome information from the intended participant groups. Reporting patient and caregiver completion separately makes those groups’ data-collection experience visible rather than masking it in a combined count.

The results also illustrate why estimates and uncertainty should be considered together. The patient risk difference is centered at zero, while the caregiver estimate favors usual care in the observed counts; both confidence intervals include zero and remain wide. A point estimate alone would obscure the range of differences compatible with these small groups. Likewise, unadjusted secondary findings across several outcomes need to be separated from the primary feasibility result.

The registry’s selected planning illustrations demonstrate how observed pilot effects may be translated into conditional sample-size scenarios. They are useful only as planning illustrations under their stated assumptions, not as observed power or the trial’s own sample-size justification. Because observed effects in small studies may be imprecise, such calculations should be treated as provisional inputs rather than firm design requirements.

The record also highlights the value of transparent methods reporting. Details about missing data, analysis populations, multiplicity, masking, and the analysis plan would help readers understand how to interpret both primary and secondary results. The central statistical lesson is not a claim about clinical benefit, but the importance of treating feasibility counts, exploratory contrasts, and uncertainty as distinct parts of a pilot trial’s evidence.

16. 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 are specific to the available record. The primary outcome counts participants meeting a strict all-surveys completion definition, but reasons for incomplete completion and patterns of partial responses are not reported. Without those details, the counts cannot identify whether noncompletion reflected participant burden, logistics, health status, or another cause.

The participant groups are small, so estimates for both the primary and secondary outcomes have limited precision. The caregiver comparisons include 10 participants per arm, and the patient comparisons include 15 per arm for the primary endpoint. Secondary outcome group sizes vary, and the registry does not explain the differing numbers contributing to each measure. These group sizes constrain interpretation of contrasts and make estimates vulnerable to individual observations.

The registry identifies single masking but does not state who was masked. It does not report details about randomization implementation, allocation concealment, analysis populations, missing-data methods, or a multiplicity plan. The intervention description is also incomplete in the available record: it identifies telephone nurse coaching and early palliative care but does not report the full content, delivery schedule, or adherence results.

The record lists 14 outcome measures and reports results for 10, while detailed results available for interpretation cover selected measures. It does not report a sample-size justification, interim analyses, or a complete analysis plan. Accordingly, the posted re-calculations should be treated as unadjusted descriptive comparisons rather than as evidence of a fully specified confirmatory analysis. These limitations restrict the conclusions that can be drawn about clinical outcomes, feasibility mechanisms, and generalizability.

17. Related Tutorials

18. Related Statistical Calculators

19. Sources

• ClinicalTrials.gov: Nurse Coach-Led Early Palliative Care for Older Adults With COPD and Their Care Partners: The Project EPIC Pilot RCT — NCT05040386.
• Registry record last updated 2026-10-13; status last verified 2026-10.
• Results first posted 2025-11-10.
• 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.

20. Record Summary

Project EPIC is a completed randomized, parallel-group pilot trial comparing telephonic nurse coach-led early palliative care with usual care for older adults with COPD and their care partners. The registry lists single masking, an enrollment of 50, a start date of 2022-05-19, and a primary completion date of 2024-10-25. Caregivers, if available, were assigned to the same arm as the patient participant.

The primary outcome was completion of 100% of available survey sets at 6 months. The posted counts were 12 of 15 patient participants in each arm, 6 of 10 caregivers in EPIC, and 8 of 10 caregivers in usual care. The unadjusted comparisons are imprecise, with confidence intervals including no difference. Selected secondary outcomes and zero recorded adverse-event counts are also posted. The registry does not report a sample-size justification, analysis plan, missing-data methods, or multiplicity strategy.