Improving Communication in the PICU: The Navigate Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Improving Communication in the PICU: The Navigate Study (NCT02333396), a randomized na study. The primary outcome is Satisfaction With Decision Making (Percentage of "Excellent" Scores in the Decision Making Domain of the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire).

2. Clinical Question

The central comparison concerns a parent-reported satisfaction outcome after discharge, rather than a clinical measure of the child's health. The registry describes a randomized, parallel-group study, but does not report enough detail to characterize the decision-making situations, families, or clinical circumstances beyond its broad description of patients facing life-changing decisions. The posted primary result therefore addresses the recorded satisfaction measure in the analyzed groups; it does not, by itself, describe every aspect of communication or family experience that motivated the study.

3. Trial Design

The Navigate Study is registered as a randomized, parallel-group trial with no masking. The registry lists an enrollment of 442 and a status of completed. The listed study dates are 2015-04-06 for the start and 2017-04-28 for primary completion. The registry does not report the method used to generate or conceal the random allocation sequence, or further details about the trial's organization.

Participants were assigned to PICU Supports or an educational brochure about the pediatric intensive care unit. PICU Supports is described as a navigator-based intervention, while the comparator is described as an educational brochure. The registry does not report detailed procedures for delivering either intervention, the amount or timing of contact, or whether other communication supports were used in either arm.

The primary outcome was measured 3-5 weeks following PICU discharge. The reported arm summaries include 124 participants for PICU Supports and 117 for the educational brochure. These outcome counts differ from the enrollment figure; the reasons and the participant flow from enrollment to outcome assessment are not reported in the registry record. The registry lists 14 outcome measures and 10 analyses, and identifies 13 secondary outcomes as posted. Several secondary outcomes concern parent satisfaction, decision regret, anxiety, depression, post-traumatic distress, and health-related quality of life. The brief description also identifies communication and team collaboration as study interests.

Randomization supports a comparison between assigned groups, but interpretation still depends on the outcome data available and the analysis used. Details of the original sample-size rationale, the planned analysis population, any interim analyses, and the full statistical analysis plan are not reported in the registry record. The registry does identify the primary outcome and its assessment period, allowing the main reported comparison to be read in that context.

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 Satisfaction With Decision Making (Percentage of "Excellent" Scores in the Decision Making Domain of the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire), measured over 3-5 weeks following PICU discharge.

The primary endpoint is the percentage of excellent scores in the decision-making domain of the Pediatric Family Satisfaction in the Intensive Care Unit questionnaire. It is recorded as a mean, with the outcome expressed as a percentage, and assessed 3-5 weeks following PICU discharge. The registry defines the measure's range as 0 to 100 and states that a higher score is better.

This measure is used to capture parents' satisfaction with decision making during a period when families may be engaging with consequential choices in the PICU. A questionnaire outcome can represent a dimension of experience that is not captured by clinical events alone. In this case, it focuses on whether parents rated decision-making experiences at the highest category, rather than on a general measure of satisfaction alone.

The endpoint should be interpreted according to its specific definition. It is not a direct measure of all communication between parents and clinicians, nor is it an assessment of the child's health. The registry does not report the questionnaire's scoring details beyond the stated range and direction, the precise denominator used to calculate the percentage, or how incomplete questionnaire responses were handled. Those details matter when judging how the reported percentages relate to all enrolled participants and how comparable the analyzed groups are.

7. Results Posted in the Registry

• Educational Brochure: mean 56.09 versus 60.35 on control; difference -4.26 (95% CI -99.34 to 90.82), standardized effect d = -0.01; z-test p = 0.930.

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.

Pediatric Family Decision Making Satisfaction in the Intensive Care Unit (pFS-ICU)

• 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:
  • Educational Brochure: mean 82.80 versus 86.63 on control; difference -3.83 (95% CI -7.78 to 0.12), standardized effect d = -0.25; z-test p = 0.058.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Educational Brochure and the control. The interval gives the range of effects that remain compatible with the data.

Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire)

• 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:
  • Educational Brochure: mean 82.94 versus 87.22 on control; difference -4.28 (95% CI -8.25 to -0.31), standardized effect d = -0.27; z-test p = 0.035.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Educational Brochure than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Parental Decision Regret (Decision Regret Scale)

• 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:
  • Educational Brochure: mean 12.87 versus 12.61 on control; difference 0.26 (95% CI -4.38 to 4.90), standardized effect d = 0.01; z-test p = 0.912.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Educational Brochure and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes extend the study's focus beyond the primary decision-making satisfaction measure to other aspects of parent experience. The registry identifies 13 secondary outcomes as posted, including measures of family decision-making satisfaction, overall PICU satisfaction, decision regret, anxiety, depression, post-traumatic distress, and health-related quality of life. The brief description also names communication and team collaboration as study interests.

The posted secondary results do not form a uniformly conclusive pattern. Some questionnaire score estimates are higher in the PICU Supports group, while other comparisons are close to no difference. This broad pattern is compatible with the primary result's uncertainty: the secondary analyses do not resolve the wide uncertainty in the primary unadjusted estimate, nor do they establish a consistent difference across all measured experiences. Each outcome has its own scale and interpretation, so findings should not be treated as interchangeable.

Secondary results carry less weight than the designated primary outcome for assessing the central trial question, especially when many outcomes are examined. A collection of unadjusted tests increases the opportunity for some apparently notable results to arise by chance. The registry does not report whether a multiplicity adjustment was prespecified or applied, nor does it describe a hierarchy for interpreting the secondary outcomes. The secondary p-values should therefore be treated as exploratory signals rather than as independent confirmation of a single overall effect.

There are also differences between the unadjusted comparisons and the registry's reported mixed-model analyses for secondary measures. The record does not provide the model details needed to explain those differences. Outcome counts vary across measures, and the reasons are not reported. Taken together, the secondary findings add context about the range of parent-reported outcomes examined, but they do not replace a clear, precise result for the primary endpoint.

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

• Pediatric Family Decision Making Satisfaction in the Intensive Care Unit (pFS-ICU)
• Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire)
• Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire)
• Parental Decision Regret (Decision Regret Scale)
• Parental Anxiety (Anxiety SF8a)
• Parental Depression (Depression SF8a)
• Parental Impact of Event/Post-Traumatic Distress (Impact of Event Scale-revised)
• Parental Health-related Quality of Life (Global Health Scale) Physical

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous in the registry's statistical classification: it is a mean of a measure expressed as a percentage. A mean summarizes the central level of the recorded outcome in each arm. It does not describe how every participant responded, so it is useful to consider the arm summaries together with the uncertainty around the comparison.

What the unadjusted comparison represents

The recalculated comparison uses the posted group summaries to estimate an unadjusted mean difference. In plain terms, it contrasts the average outcome in the educational brochure group with the average in PICU Supports, without accounting for other variables through a model. The reported estimate is -4.26. The sign depends on the order of the groups in that calculation; it should not be read as an independent indication of which group did better without noting that order. The primary outcome definition says higher is better, and the posted arm means are 60.35 for PICU Supports and 56.09 for the educational brochure.

An unadjusted calculation is a useful check on the posted summaries, but it may not match an analysis that uses a statistical model or handles repeated observations, covariates, or other features differently. The registry labels its reported analysis as a mixed models analysis. Further details needed to reproduce that model, including its specification and treatment of missing observations, are not reported in the registry record.

How to read a confidence interval and p-value

A confidence interval describes uncertainty in an estimated effect under the assumptions of the analysis. A wider interval indicates that the data are compatible with a broader range of values. For a difference, an interval containing zero is compatible with no difference as well as with differences in either direction. The primary unadjusted interval, -99.34 to 90.82, includes zero and is extremely broad relative to the outcome's defined range. It therefore gives little precision about the size or direction of any difference.

A p-value measures how unusual the data, or results more extreme, would be under a specified null model. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. The unadjusted primary p-value is 0.93, while the registry's mixed-model analysis reports p=0.44. Both are read alongside their estimates and intervals, not in isolation. Neither p-value establishes equivalence or proves that the groups had identical outcomes.

Why model and recalculated estimates may differ

The posted mixed-model result is a Beta Estimate of 3.57 with a 95% confidence interval from -5.77 to 12.9. A model-based coefficient can differ from a simple difference calculated from arm means because the method and assumptions differ. However, the registry record does not report enough detail to identify the specific reason for the difference or to reconstruct the mixed model. The recalculation is an unadjusted check based on posted summaries, not a replacement for the sponsor's own analysis.

The primary arm summaries list dispersion as standard error. Standard error describes the uncertainty in an estimated mean, whereas standard deviation describes the variation among individual observations. Keeping these concepts distinct matters: a mean and its standard error characterize an estimate, while the standard deviation characterizes participant-level spread. The registry does not provide arm-level confidence intervals for the primary means. The recalculation and reported model result should therefore be understood in the context of the summary information and methods actually posted.

What randomization and no masking imply

Random assignment is intended to make the groups comparable on average, including characteristics not directly measured. It does not guarantee that the groups will be balanced in a particular trial, and it does not resolve issues caused by missing outcome data or differences in how outcomes are measured. The registry says the study was randomized and unmasked. In an unmasked study, participants and study personnel are not described as blinded to group assignment. For a parent satisfaction questionnaire, knowledge of the intervention could potentially influence reported experience; the registry does not report whether or how this possibility was assessed.

Randomization details beyond the allocation label, including sequence generation and concealment, are not reported. The planned analysis population, handling of missing data, prespecified covariates, and interim analyses are also not reported in the registry record. These gaps limit a full assessment of how closely the reported analyses follow the study's original statistical plan. They do not change the numerical results, but they constrain how much can be inferred from them.

Why variability matters

When observations vary considerably within groups relative to the group difference, estimates become less precise. Wider uncertainty makes it harder to distinguish a small difference from random variation. In general, over-dispersion means that the variability is greater than a statistical model expects; this can make standard errors too small if the model does not account for it. The registry does not report an over-dispersion assessment for this outcome, so that issue cannot be evaluated from the record. More generally, precision depends on the amount of information available, the variability of responses, and the assumptions of the analysis.

11. Confidence Intervals and Precision

The primary unadjusted mean difference is -4.26, with a 95% confidence interval from -99.34 to 90.82. The interval includes zero and is wide relative to the outcome's stated 0 to 100 range. Its breadth means the unadjusted estimate is not precise enough to pin down a narrow range of plausible differences. Because the interval also reaches beyond the outcome's defined limits, it should be read as a consequence of the calculation and its assumptions, not as a set of attainable outcome values.

The registry's mixed-model estimate is 3.57, with a 95% confidence interval from -5.77 to 12.9. This interval also includes zero, but it is much narrower than the unadjusted interval. The registry does not provide enough methodological detail to explain fully why the intervals differ, so they should not be combined or treated as though they came from the same analysis. The registry's model-based result and the unadjusted recalculation each have uncertainty that should be interpreted within their own methods.

Confidence intervals do not assign a probability that the true effect lies within a particular realized interval. They are a way to express the uncertainty associated with an estimate under the analysis assumptions. Here, both primary intervals include values consistent with no difference, and the unadjusted interval is especially broad. The posted results consequently leave substantial uncertainty about the size of any group difference. A non-significant result is not proof of equivalence, and a point estimate alone should not be treated as a precise description of the effect.

Precision is also limited by incomplete reporting about outcome availability and missing-data methods. The arm counts for the primary measure are 124 and 117, while the registry enrollment is 442. The record does not state why the analysis counts are smaller or whether missingness differed between groups. Without that information, the intervals describe sampling uncertainty under the analyses used, but do not account for every possible source of uncertainty about selection into the analyzed data.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning estimates are expressed as participants per arm, not total events. They are illustrations based on the observed effect rather than the trial's original design calculation. The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is the stated fraction of the observed effect. The original sample-size justification and the trial's own design assumptions are not reported in the registry record.

The 80% power column describes the number of participants per arm that the planning calculation estimates would be needed to have an 80% chance of detecting the selected effect under the stated assumptions. The 90% power column gives the corresponding planning estimate for a 90% chance. These are conditional planning targets, not guarantees: actual performance depends on whether the assumptions and target effect are appropriate.

The rows use different fractions of the observed effect. Planning for a smaller effect requires more participants per arm, because a smaller separation between group means is harder to distinguish from variation. For the primary outcome, the planning figures rise substantially as the target moves from the full observed effect to smaller fractions. The values are especially large because the observed unadjusted effect is very small relative to the variability reflected in the calculation. A small observed effect can therefore yield very large planning estimates, without establishing that the true effect is that small.

These figures are not observed power. They are planning illustrations derived from the observed effect, and they should not be read as a retrospective measure of whether the completed trial was adequately powered. The registry does not report the trial's original sample-size rationale, so the posted illustrations cannot substitute for it. The planning estimates also do not resolve the uncertainty in the primary result or account for unreported design and analysis details.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -4.260; pooled standard deviation σ = 376.109.
2. n = 2 × (1.96 + 0.842)² × 376.109² / -4.260² = 122,362.1, rounded up to 122,363 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -4.26                      # observed difference in means
sigma <- 376.10948691253                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2333396)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 122,363 (80% power), 163,809 (90% power)
 75% of observed effect: n per arm = 217,533 (80% power), 291,215 (90% power)
 50% of observed effect: n per arm = 489,449 (80% power), 655,233 (90% power)
power.t.test: 122363.1 
Simulated power at n = 122,363 per arm: 0.793 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry's own primary analysis is labeled a mixed models analysis. It reports a Beta Estimate of 3.57, a 95% confidence interval from -5.77 to 12.9, and p=0.44. The unadjusted recalculation from the posted arm summaries estimates a mean difference of -4.26 for the educational brochure relative to PICU Supports, with a 95% confidence interval from -99.34 to 90.82 and p=0.93.

These results differ in both the estimate and its uncertainty. A model-based analysis and a simple unadjusted calculation need not agree, because they may use different statistical structures or information. The registry does not report sufficient detail about the mixed model, its coding, or its handling of missing outcomes to explain the discrepancy or reproduce the sponsor's calculation. The sign of the model coefficient should not be assigned a group direction without that coding information.

The unadjusted recalculation is a check based on the posted summaries; it is not a correction to the registry analysis. Both analyses have intervals that include zero, and neither yields a precise primary estimate. The model-based result should be described as the registry's reported analysis, while the recalculation should be described as an unadjusted comparison with its own assumptions. The registry record does not identify a discrepancy requiring one estimate to supersede the other.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists 14 outcome measures and 10 analyses, with 13 secondary outcomes posted. Examining multiple endpoints creates a multiplicity issue: the more statistical comparisons considered, the greater the chance that at least one result appears notable by chance alone. This general concern does not establish that any particular result is spurious, but it affects how much weight should be placed on isolated secondary findings.

A prespecified strategy might identify a primary endpoint, specify how secondary outcomes will be interpreted, or adjust significance thresholds for multiple testing. The registry identifies the primary endpoint, but whether a formal multiplicity procedure was planned or used is not reported in the registry record. The record also does not report a testing hierarchy or explain how the number of analyses relates to the listed outcomes. Secondary p-values should consequently be interpreted cautiously and in the context of the full set of outcomes rather than as separate definitive tests.

Missing-data handling is another important uncertainty. The primary outcome counts are 124 for PICU Supports and 117 for the educational brochure, compared with enrollment of 442. Counts also vary across secondary outcomes. The registry does not report the reasons for unavailable outcomes, the amount or pattern of missingness over time, or the method used to handle missing data. It is therefore not possible to determine from the record whether missingness was related to group assignment or outcome values.

The analysis population is not reported in enough detail to establish whether analyses followed an intention-to-treat approach, included all randomized participants, or used another population definition. The registry also does not provide the original statistical analysis plan, interim-analysis information, or model details. These omissions constrain assessment of prespecification and the potential influence of analysis choices. They do not prove that the analyses were inappropriate; they mean that those features cannot be evaluated from the registry record.

16. 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 reports zero serious adverse events among 124 participants at risk in the PICU Supports group and zero among 117 at risk in the educational brochure group. It also reports zero other adverse events in each group and zero deaths in each group. These are the posted counts for the populations at risk listed in the record.

Zero events in the registry means that no events in the reported categories were recorded for these groups in the posted results. It does not establish that the chance of an event is zero, nor does it prove that the interventions have no safety concerns. The record does not report further details about adverse-event definitions, ascertainment procedures, follow-up completeness, or the duration over which events were collected. Those reporting details affect how the counts can be interpreted.

The safety figures should also be kept separate from the primary satisfaction analysis. They do not measure communication quality or parent satisfaction, and they do not explain the differences in outcome counts for the questionnaire analyses. The registry reports no serious-event terms among the listed groups. The available information supports describing the observed counts, but not drawing broader conclusions about safety beyond those recorded figures.

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

The posted results describe a randomized comparison of PICU Supports and an educational brochure, with parent satisfaction with decision making as the primary outcome. The arm means were 60.35 and 56.09, respectively, and the registry's mixed-model analysis reported a Beta Estimate of 3.57 with a 95% confidence interval from -5.77 to 12.9. The unadjusted recalculation was imprecise, with a 95% confidence interval from -99.34 to 90.82. Both primary intervals include zero.

These results do not provide a precise estimate of the difference in decision-making satisfaction. They also do not demonstrate that the groups are equivalent. A wide interval can be compatible with a range of underlying effects, including no difference, and a non-significant p-value does not prove that the interventions had the same effect. The registry's model-based and unadjusted estimates arise from different analyses and should not be collapsed into one conclusion.

The trial addresses a specific parent-reported outcome at 3-5 weeks following PICU discharge. It does not, by itself, answer whether communication improved across every interaction, whether team collaboration changed, or whether any effect persisted beyond the reported assessment period. The brief study description names additional parent outcomes and team assessments, but the posted primary measure alone cannot stand in for all of them.

The registry record also leaves important interpretive details unresolved, including the original sample-size rationale, missing-data methods, analysis population, and mixed-model specification. The available results can be described accurately, but they do not justify medical advice or a broad claim about the practical value of either approach. A careful reading keeps the measured outcome, assessment time, uncertainty, and reporting limitations together.

18. Why This Trial Matters Statistically

This trial illustrates why a randomized design does not make every result self-interpreting. Randomization supports a fair comparison in principle, but readers still need to understand which participants contributed outcome data, how the endpoint was measured, and what analysis generated the reported estimate. Here, the registry provides a defined primary outcome and a mixed-model result, but does not report enough model detail to reproduce that analysis or explain its relationship to the unadjusted comparison.

The primary measure is a parent experience outcome rather than a clinical event. Statistical interpretation must respect that distinction. A questionnaire score can be meaningful for the experience it records, but its interpretation depends on the scoring definition, the population answering it, and the timing of assessment. The registry defines higher primary scores as better and gives the assessment period, while several further scoring and missing-data details are not reported.

The contrast between the model-based and unadjusted intervals also demonstrates why precision matters. A point estimate, a p-value, and a confidence interval answer different questions. The primary intervals both include zero, while the unadjusted interval is especially broad relative to the outcome range. Reporting only a p-value would conceal much of the uncertainty in the estimated difference.

Finally, the multiple secondary outcomes show the importance of distinguishing a designated primary question from a wider set of exploratory measures. When many outcomes are considered, isolated results should not be treated as conclusive without knowing the prespecified multiplicity strategy. The registry record makes the central question identifiable, but leaves several design and analysis details unreported. This makes transparent reporting of estimates, intervals, and limitations essential to a statistically responsible reading.

19. 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's description of the study population is broad. It identifies parents associated with PICU patients facing life-changing decisions, but detailed eligibility criteria and participant characteristics are not reported in the registry record. The record therefore does not support a detailed assessment of how well the analyzed participants represent other PICU families or settings.

The study is listed as unmasked. For a parent satisfaction endpoint, awareness of assignment may be relevant to how participants experience or report care. The registry does not describe whether outcome collection was standardized across groups or whether any steps were taken to reduce the influence of assignment awareness. This is a limitation in interpreting a subjective questionnaire outcome, not evidence that reported scores were biased.

Enrollment was 442, while the primary outcome counts were 124 for PICU Supports and 117 for the educational brochure. The record does not explain this difference, describe participant flow, or report missing-data methods. It also does not state the analysis population. Those omissions prevent assessment of how unavailable outcomes may affect the estimates.

The primary unadjusted interval is very wide and extends beyond the outcome's stated 0 to 100 range. The registry's mixed-model estimate has a narrower interval, but the model specification and coefficient coding are not reported. The trial's original sample-size rationale, the planned analysis details, interim analyses, and any multiplicity procedure are also not reported. These limitations make it difficult to evaluate the precision and prespecification of the reported comparisons beyond the information explicitly recorded.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Improving Communication in the PICU: The Navigate Study — NCT02333396.
• Registry record last updated 2025-03-26; status last verified 2025-03.
• Results first posted 2025-03-26.
• 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.

23. Record Summary

The Navigate Study, NCT02333396, is a completed randomized, parallel-group, unmasked study with enrollment of 442. It compared the navigator-based PICU Supports intervention with an educational brochure about the pediatric intensive care unit.

The primary outcome was the percentage of excellent scores in the decision-making domain of the Pediatric Family Satisfaction in the Intensive Care Unit questionnaire, assessed 3-5 weeks following PICU discharge. The registry's mixed-model analysis reported a Beta Estimate of 3.57, a 95% confidence interval from -5.77 to 12.9, and p=0.44. An unadjusted recalculation from the posted arm summaries was imprecise, with a 95% confidence interval from -99.34 to 90.82 and p=0.93.

The primary results leave substantial uncertainty about the size of any group difference. Secondary outcomes broaden the study's focus, but multiplicity, missing-data handling, and several analysis details are not reported in the registry record. The posted findings should be understood in light of the specific outcome, assessment period, and limitations of the available statistical reporting.