Palliative Care Consultations in the Skilled Nursing Facility (SNF) Setting: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Palliative Care Consultations in the Skilled Nursing Facility (SNF) Setting (NCT03958552), a non-randomized na study. The primary outcome is Number of Participants Who Completed Patient Quality of Life Surveys.

2. Clinical Question

3. Trial Design

This was a completed pilot study with a parallel-group, nonrandomized design and no masking. Its registry title concerns palliative care consultations in the skilled nursing facility setting. The registry lists the sponsor as the University of Maryland, Baltimore, and the phase as not applicable. Enrollment is recorded as 45. The study started on 2019-10-01, reached primary completion on 2022-12-07, and has completed status.

Both groups received standard Medicare skilled nursing facility care; the consultation group also received a palliative care consultation with a trained provider. Because allocation was nonrandomized, differences between groups could reflect how participants entered each group, as well as any difference associated with the consultation. The registry explicitly cautions that the arms are not a like-for-like control comparison. The assignment process and baseline group characteristics are not reported in the registry record.

The primary outcome concerns the number of participants who completed Patient Outcome Survey questionnaires. The record describes baseline administration for both groups and follow-up after enrollment for the control group or after the intervention for the consultation group. Secondary outcomes concern completion of the Consult Satisfaction Survey and adherence to skilled nursing facility consultation recommendations. The registry lists three outcome measures, but does not report outcome values or analyses. A detailed statistical plan, including the planned approach to account for nonrandom allocation, is not reported in the registry 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

Analysis population for the primary outcome, as defined in the registry: Both intervention and control groups are administered a baseline POS and follow up POS.

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 Number of Participants Who Completed Patient Quality of Life Surveys, measured over Collected upon admission to the nursing home and enrollment and again 15-21 days after enrollment in the study (control group) or intervention received (intervention group)..

The registered primary endpoint is the number of participants who completed Patient Outcome Survey quality-of-life surveys. This is a count of completed surveys, not a direct measure of the survey score or a summary of how participants felt. The registry describes the Patient Outcome Survey as a ten-item instrument covering physical, emotional, psychological, and spiritual needs, as well as provision of information and support. Items use a five-point Likert scale from 0, not at all, to 4, overwhelmingly, and refer to symptoms or needs in the past week. The overall profile score is calculated by summing responses, ranges from 0 to 40, and higher values represent a worse outcome.

Survey completion can indicate whether participants were able to provide follow-up information, which is relevant when evaluating a pilot and the feasibility of collecting patient-reported outcomes in this setting. It is distinct from the survey score: completion counts alone do not show the level of reported need or any change in quality of life. The registry describes baseline and follow-up survey administration, with follow-up timing tied to enrollment for the control group and to receipt of the intervention for the consultation group. Actual completion counts, scores, and changes are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

General explanation. A parallel-group study follows participants in separate groups receiving different care strategies. A randomized study uses a chance-based assignment process to help make groups comparable at baseline. Here, the registry records nonrandomized allocation and explicitly warns that the groups are not a like-for-like control comparison. Without random assignment, measured and unmeasured differences between groups may complicate interpretation. The registry does not describe the allocation procedure, baseline balance, or methods intended to address confounding.

The study is identified as a pilot. In general, pilot studies can evaluate whether procedures and outcome collection are workable and can inform later research. A pilot’s outcomes should still be interpreted according to their definitions and the evidence actually reported. In this record, survey completion is the primary outcome, but no completion counts or other primary results are reported. A sample-size justification or a formal objective for precision is not reported in the registry record.

What does the primary outcome count?

The primary outcome counts participants who completed Patient Outcome Survey questionnaires. It is not the same as the questionnaire’s overall profile score. The score is described as a sum across ten items, with possible values from 0 to 40 and higher values representing a worse outcome. The registry does not report observed scores, score changes, or the number completing each assessment. A count of completed surveys can describe data collection, but cannot by itself establish the participants’ quality-of-life levels.

The stated schedule includes a baseline survey and a follow-up survey 15-21 days later. For the control group, the interval is described relative to enrollment; for the intervention group, it is described relative to receipt of the intervention. Such timing is relevant when interpreting changes, because the reference point for follow-up differs between groups. The record does not report whether all assessments occurred within the stated window or how timing variation was handled.

How should uncertainty be assessed?

General explanation. An estimate describes the value calculated from observed data. A confidence interval expresses uncertainty around an estimate under the assumptions of the analysis; a narrower interval generally indicates greater precision, while a wider interval indicates less precision. A p-value, when used, assesses compatibility between the data and a specified null hypothesis under the test’s assumptions. Neither a confidence interval nor a p-value can replace consideration of the design, measurement, missing data, or practical meaning of the outcome.

The registry record reports no outcome estimates, confidence intervals, or p-values, and lists zero analyses. Thus, the precision and statistical uncertainty of any treatment-group comparison are not reported in the registry record. No statistical test, model, covariate adjustment, or method for handling the nonrandomized design is described.

What does over-dispersion mean in general?

General explanation. For count outcomes, a statistical model may assume a particular relationship between the average count and its variability. Over-dispersion occurs when observed variability exceeds what a model assumes. If it is ignored, standard errors can be too small and confidence intervals can be too narrow. Whether over-dispersion is relevant depends on the outcome and analytic model. The registry does not report a count-data model or an assessment of over-dispersion; applying one cannot be inferred from the outcome being a count.

The registry record also describes planning illustrations based on an observed effect and specified assumptions. In general, such illustrations show the sample size that would be needed under stated conditions to detect a chosen fraction of an effect. They are planning scenarios, not observed trial results and not observed power. The record states assumptions of a two-sided significance level of 0.05, equal allocation, and a normal approximation. The effect values and resulting planning counts are not reported in the registry record, and no such illustration establishes that the pilot was designed or powered in that way.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and secondary outcomes concerning completion of the Consult Satisfaction Survey and adherence to skilled nursing facility consultation recommendations. It does not describe a prespecified strategy for controlling the chance of false-positive findings across multiple outcomes or analyses. A multiplicity plan is not reported in the registry record. Since the record lists zero analyses and does not provide outcome results, it is not possible to assess how multiple comparisons were handled in practice.

Missing data are particularly relevant to an outcome defined by survey completion. The registry does not report how many surveys were completed at each assessment, the reasons for noncompletion, or how incomplete questionnaires were treated. It does not describe imputation, sensitivity analyses, or another missing-data method. In general, missingness can affect both the number of observations available and how representative the observed responses are of all enrolled participants. Without information about missingness and its handling, the meaning of any survey-based comparison would be harder to assess.

The analysis population is also not described. The registry does not state whether analyses were intended to include all enrolled participants, only those who received the consultation, or another defined group. It does not report whether participants were analyzed according to their original group assignment, how crossovers or departures from care were handled, or whether exclusions were planned. These details are not reported in the registry record. The record’s enrollment figure alone does not establish the number included in any outcome analysis.

11. 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 adverse-event record lists the Standard Care group with 10 participants at risk and the Palliative Care Consult group with 35 participants at risk. For both groups, the listed number affected by serious adverse events is 0, the listed number affected by other adverse events is 0, and deaths are recorded as 0. No top serious adverse-event terms are listed.

These figures describe what the registry record reports for the groups and risk counts shown. They should not be read as proof that no adverse events occurred outside the recorded definitions, observation period, or reporting process. The record does not provide additional detail on event ascertainment, follow-up duration for safety, severity criteria, or the handling of events. The risk counts are not a substitute for the study’s enrollment figure, and they do not establish how many participants contributed to each efficacy outcome.

Because the study was nonrandomized and the safety group sizes differ, the zero counts alone do not support a comparative estimate of safety. The registry record does not report a statistical comparison or uncertainty interval for adverse events. The figures are best read as the recorded event counts, with the limitations of the registry’s reporting detail in mind.

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

The registry record establishes that this was a completed pilot evaluating a palliative care consultation in the skilled nursing facility setting, with standard care as the comparison. It defines the Patient Outcome Survey and identifies the number of participants completing surveys as the primary outcome. It also describes the timing of baseline and follow-up collection and names consultation satisfaction and adherence to recommendations as secondary outcomes.

Those design details do not amount to evidence of a measured difference. No primary or secondary outcome results are reported, and no statistical analyses are listed. There is no reported estimate of survey completion, survey scores, or contrast between groups, and no confidence interval or p-value to indicate precision or statistical compatibility. The registry record therefore does not show whether reported quality of life, survey completion, satisfaction, or recommendation adherence differed between the groups.

The study’s nonrandomized allocation is another limit on interpretation. The registry warns that the arms are not a like-for-like control comparison. In general, an observed difference in a nonrandomized study can reflect the characteristics or circumstances that shaped group assignment, as well as any association with the intervention. The record does not report enough information about allocation, baseline group characteristics, or adjustment to separate these possibilities.

The stated rationale concerns the potential role of palliative care consultation for older adults with advanced illness in skilled nursing facilities. That rationale explains why the topic was studied; it is not a result. The record does not establish that the consultation improved care, changed quality of life, or caused harm or benefit. It documents a study design and outcome definitions, while leaving its outcome findings and their uncertainty unreported.

13. Why This Trial Matters Statistically

This study addresses a setting identified in its registry summary as one where palliative care consultation is not widely available to Medicare patients: skilled nursing facilities. The summary describes concerns about potentially burdensome treatment and unrecognized or undertreated symptoms, and presents consultation as an approach to patient- and family-centered care. The statistical importance of the pilot is that evaluation in this setting depends not only on defining a care strategy, but also on collecting meaningful outcome information from participants.

The primary outcome focuses on completion of patient-reported quality-of-life surveys. That is distinct from a direct comparison of survey scores. Separating these endpoints matters: feasibility of obtaining responses and the content of those responses answer different questions. The registry describes a multidimensional instrument and follow-up timing, but reports neither completion results nor scores. Readers therefore cannot assess how well outcome collection worked or what participants reported.

The nonrandomized parallel design makes transparent reporting of group assignment and baseline characteristics especially important. Without those details and a reported analysis, the record cannot establish how comparable the groups were or whether a measured difference could be attributed to the consultation. The registry’s caution that the arms are not a like-for-like comparison is central to statistical interpretation, not a minor qualification.

For clinical researchers and biostatisticians, the record illustrates the distinction between a study’s rationale, its registered outcomes, and its results. A clear outcome definition helps specify what should be measured, but results and analytic methods are needed to judge magnitude and precision. Here, the registered design and measures are identifiable, while outcome estimates and analyses are not reported 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.

Several trial-specific limitations constrain interpretation. Allocation was nonrandomized, and the registry explicitly states that the arms are not a like-for-like control comparison. The process used to assign participants and information about baseline group characteristics are not reported in the registry record. This limits assessment of comparability and of potential confounding.

The registry identifies the primary outcome as the number of participants completing surveys, but reports no completion counts or Patient Outcome Survey scores. It also reports no results for the secondary outcomes of consultation satisfaction and adherence to recommendations. The record lists zero analyses, so no statistical estimates, uncertainty intervals, or tests are available for evaluation.

Details needed to assess outcome collection are not reported in the registry record, including reasons for noncompletion, treatment of partially completed questionnaires, and methods for handling missing data. The record does not describe the analysis population, exclusions, or whether participants were analyzed according to group assignment. The detailed statistical plan, including any adjustment for nonrandom allocation, is also not reported.

The registry describes a pilot and the intervention as a consultation with a trained provider, but does not report detailed information about intervention delivery or fidelity. The record does not provide enough detail to assess how consistently the consultation was delivered across participants. The safety summary records no affected participants or deaths in the listed groups, but additional information about safety ascertainment and follow-up is not reported. These limitations concern the scope of what can be learned from the registry record; they do not establish that procedures or analyses were absent outside it.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Palliative Care Consultations in the Skilled Nursing Facility (SNF) Setting — NCT03958552.
• Registry record last updated 2024-07-11; status last verified 2024-06.
• Results first posted 2024-07-11.
• 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.

18. Record Summary

The registry record describes a completed, parallel-group pilot of palliative care consultation in the Medicare skilled nursing facility setting. Allocation was nonrandomized and masking was absent. Standard care was compared with standard care plus a consultation from a trained provider. Enrollment is recorded as 45, and the sponsor is the University of Maryland, Baltimore.

The primary outcome is the number of participants who completed Patient Outcome Survey quality-of-life questionnaires. Secondary outcomes concern consultation satisfaction survey completion and adherence to consultation recommendations. The record describes the survey instrument and assessment timing, but does not report outcome values or statistical analyses. It lists zero analyses and cautions that the nonrandomized groups are not a like-for-like comparison. The registry records zero serious adverse events, other adverse events, and deaths in each listed group, with the stated risk counts. Outcome estimates, their precision, missing-data methods, and the detailed statistical plan are not reported in the registry record.