Providing Adolescent Contraception in the Emergency Room: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Providing Adolescent Contraception in the Emergency Room (NCT02475980), a registered phase not stated study. The primary outcome is Length of Stay.

2. Clinical Question

The clinical question has two related parts in the study summary: whether comprehensive counseling can be delivered feasibly in a pediatric emergency department, and whether counseling is associated with initiation of contraception among sexually active adolescents attending that department. These are distinct questions. Feasibility concerns whether the intervention can be implemented in the care setting; an initiation outcome concerns what happened after counseling. The record identifies counseling as the intervention but does not provide an outcome result for either question.

The registered primary outcome is length of stay, rather than contraception initiation. Length of stay can describe the time spent in the emergency department and may be relevant when considering how an additional service fits into a busy clinical workflow. It does not by itself establish whether counseling was feasible or whether contraception was initiated. The stated outcome timeframe is chart review for patient follow-up approximately 4 weeks after enrollment. The record does not state a comparator or allocation method, so it does not support a controlled treatment-effect question.

3. Trial Design

The registry record identifies this as a completed pilot study sponsored by the University of New Mexico. It lists an enrollment of 13 and describes one behavioral intervention: comprehensive contraception counseling. The described participants were adolescent post-menarchal girls ages 13-18 with Medicaid insurance, presenting to a pediatric emergency department for a non-emergent complaint. The intervention description and the participant description indicate the setting and intended group, but the record does not report further details about how eligible participants were approached or how counseling was delivered.

The record does not state that participants were randomized, and the allocation method is not stated. It describes one group of adolescent girls receiving counseling and does not identify a like-for-like control group. Consequently, the registered information does not establish a comparative design, and any difference between groups cannot be interpreted from this record. The number of participants in any comparator group is not reported in the registry record.

The study dates listed are 2015-02 for study start and 2015-07 for primary completion. The status is COMPLETED. Completion status describes the registry status; it does not, on its own, mean that outcome results or statistical analyses were posted. The primary outcome is emergency department length of stay, measured in minutes, with a median and full range specified. Its timeframe is chart review for patient follow-up approximately 4 weeks after enrollment. The listed secondary outcomes are descriptive statistics of participants and follow-up adherence.

The record lists 6 outcome measures, while the detailed outcome information identifies the primary length-of-stay measure and two secondary outcome descriptions. The other outcome measures are not described in the registry record. No statistical analyses are listed. The registry record also does not report a protocol-level sample-size justification, detailed eligibility procedures, or the planned handling of missing observations. These omissions limit how fully the study procedures can be reconstructed from the registration alone.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

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 Length of Stay, measured over Measured at time of chart review for patient follow-up, approximately 4 weeks after enrollment..

The primary endpoint is emergency department length of stay, measured in minutes. The registry record specifies that it is to be summarized using the median and full range. It states that the measure is assessed at chart review for patient follow-up, approximately 4 weeks after enrollment. The record describes the endpoint as emergency department length of stay for participants.

Length of stay is a process measure: it describes time spent in the care setting, rather than a direct measure of contraception initiation or counseling quality. In a study of an intervention delivered during emergency care, this type of measure can be used to characterize how the service fits into the visit. That is a general reason to measure a care-process outcome; the registry does not state a specific rationale for selecting length of stay as its primary endpoint.

General statistical interpretation: the median is the central observation when measured values are ordered. It can be useful when a distribution is skewed or includes unusually long stays, because extreme values have less influence on the median than on the arithmetic mean. The full range describes the smallest and largest observed values, but it is sensitive to extreme observations and gives little information about how values are distributed between the endpoints. Reporting a median and range therefore offers a compact description, not a complete picture of the distribution.

The registry record does not report the observed median, range, participant-level values, or an uncertainty interval for this endpoint. It also does not report the result of a comparison with another group. The endpoint definition alone cannot establish how long participants stayed or whether counseling changed that duration.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record lists emergency department length of stay as the primary outcome and specifies a median and full range. It lists 0 analyses, so the record does not identify an inferential method used to analyze that outcome. No test, regression model, adjustment strategy, confidence interval procedure, or missing-data method is reported in the registry record. Statistical methods are general explanations, not descriptions of methods confirmed to have been used in this study.

What does a median describe?

General: the median is the middle value after observations are arranged from lowest to highest. Unlike the mean, it is not pulled as strongly by unusually large or small observations. That can make it a useful summary for time measures, which may have a long right tail when some visits take considerably longer than others. A median does not tell the reader how tightly observations cluster around the center, whether there are several subgroups, or how the distribution is shaped. The registry record does not report the observed median or the individual length-of-stay observations.

What does the full range add?

General: the range reports the minimum and maximum observed values. It makes the observed extremes visible, but those extremes can change substantially when a small number of observations are added or removed. The range does not show the frequency of values between its endpoints. A median with a range can therefore describe a center and extremes, while leaving considerable uncertainty about the overall distribution. The registry record does not state the observed range.

What would a confidence interval contribute?

General: a confidence interval communicates the statistical uncertainty around an estimate, conditional on a specified analysis and its assumptions. It is not a guarantee that the true value lies within a particular interval, and it does not address bias caused by selection, missing observations, or an unsuitable comparison. The registry record does not report a confidence interval for length of stay or another outcome. Since no analysis is listed, there is no posted inferential estimate whose precision can be evaluated.

Why does allocation matter?

General: random allocation can help balance measured and unmeasured participant characteristics between groups on average, while a nonrandom comparison can be affected by differences in who receives each approach. A valid causal comparison also depends on clearly defined groups, outcome measurement, and appropriate analysis. In this record, allocation is not stated and a like-for-like control group is not described. This prevents a reader from treating the record as a randomized comparison or interpreting an unreported contrast as a treatment effect.

What does over-dispersion mean in general?

General: over-dispersion occurs when observed variation is greater than a statistical model assumes. If a model underestimates variation, standard errors may be too small and confidence intervals may be too narrow. The relevance depends on the outcome and model. The registry record does not report a model, a count outcome analysis, or a diagnostic assessment of dispersion, so over-dispersion cannot be assessed as a feature of this study's analysis.

How should planning illustrations be read?

The registry record describes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. For time-to-event tables, the described quantity is total events; for other cases, it is participants per arm. The numerical illustrations and the observed effect value are not reported in the registry record.

General: a sample-size illustration asks how much information a future study might need under stated assumptions. Such a calculation depends on the anticipated effect, variability, allocation, significance threshold, and analysis model. Changing an assumed effect changes the planning requirement. Planning values are not observed participant counts, and they are not evidence that the completed study had a particular probability of finding a result. They should not be described as observed power. The record does not report a protocol-based sample-size justification, and the planning illustration is not stated to be the study's own design calculation.

The two-arm assumptions in a planning illustration do not establish that the trial itself used two arms or equal allocation. The registered study description identifies adolescent girls receiving counseling, while allocation is not stated and no like-for-like control comparison is identified. The planning assumptions and the study design description therefore answer different questions. The former describes conditions used for an illustration; it cannot fill gaps in the registered design.

Because no analysis results are listed, there are no sponsor-reported statistical findings to compare with recalculated values. No recalculated results are reported in the registry record. If recalculated values were available and conflicted with a sponsor's own analysis, the sponsor's own analysis would take precedence for describing the posted analysis, while the recalculation would remain a separate, unadjusted calculation from summary statistics. That distinction does not arise from any numerical result reported in this record.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 6 outcome measures, but it does not provide detailed descriptions for all of them. It names emergency department length of stay as the primary outcome and lists descriptive statistics of participants and follow-up adherence as secondary outcomes. The record lists 0 analyses. It does not report a statistical plan for controlling multiplicity, such as a hierarchy of hypotheses, an adjustment method, or a distinction between confirmatory and exploratory tests.

General: when multiple outcomes or multiple statistical tests are examined, the chance of at least one apparently notable result can increase if each test is interpreted without accounting for the overall testing strategy. A prespecified primary outcome can help focus interpretation, while secondary outcomes can provide supporting or exploratory information. The number of registered outcomes alone does not reveal how many tests were conducted, whether outcomes overlap, or how results were selected for reporting. Those details are not reported in the registry record.

Missing-data procedures are also not reported. The record does not state how incomplete follow-up was handled, whether any outcome values were unavailable, or whether analyses used all enrolled participants or a defined subset. Follow-up adherence is named as a secondary outcome, but no adherence result or missingness summary is listed. Without those details, the completeness of outcome ascertainment cannot be evaluated.

The record does not define an analysis population, such as all enrolled participants or participants with available follow-up, and no participant flow is reported. These omissions matter because the set of people included in an analysis can affect what a result represents. No assumptions about missingness or analysis-population membership can be inferred from the COMPLETED status or the enrollment count.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

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 figures list 13 adolescent girls at risk for serious adverse events and 0 with serious adverse events. For the other adverse-event category, the figures also list 13 at risk and 0 affected. The registry record lists no serious-event terms. These are the posted counts for the groups described in the record; they should not be read as proof that no adverse event could occur.

The death field is null. That is not the same as a reported count of zero deaths: death information is not reported in the registry record. The distinction between a zero count and an unreported value is important when reading safety summaries. A zero reported event count describes what is recorded for the stated group, whereas a null entry leaves the death count unspecified.

General statistical interpretation: when no events are recorded in a limited group, the observation remains compatible with uncertainty about the underlying event frequency. The absence of a recorded event in this study group does not establish absence of risk in other participants or settings. The record does not report event definitions, collection procedures, severity grading beyond the serious-event category, or duration of safety surveillance. No broader safety conclusion can be drawn from these entries alone.

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

The registry record documents a completed pilot study of comprehensive contraception counseling in a pediatric emergency department. It identifies a population of adolescent post-menarchal girls ages 13-18 with Medicaid insurance who presented for a non-emergent complaint, and it lists enrollment of 13. The study summary states that the aims were to assess feasibility and the impact of counseling on contraception initiation. The primary outcome listed in the registry is emergency department length of stay.

Those details define what the study set out to examine, but the registry record does not report numerical results for length of stay, feasibility, follow-up adherence, or contraception initiation. It lists 0 analyses. As a result, the posted record does not establish the magnitude or precision of an outcome, nor does it provide evidence of a difference between groups. The listed serious adverse-event and other adverse-event counts are 0 among 13 at risk in each category; the death field is not reported in the registry record.

The allocation method is not stated and no like-for-like comparator is described. Therefore, the record cannot support a causal claim that counseling changed an outcome. Even a complete descriptive account of participants receiving an intervention would not, by itself, separate an intervention effect from other influences on outcomes. The registry entry also does not provide enough information to judge whether follow-up was complete or how missing information was handled.

General: a pilot study can be useful for describing implementation questions and informing later research, but the value of a pilot depends on the information actually reported. A pilot enrollment count is not an estimate of treatment benefit, and planning illustrations are not observed power or outcome findings. Here, the registry record gives design and outcome definitions but no numerical result with which to quantify feasibility or an intervention effect.

The cautious conclusion is about the record rather than the intervention: a completed pilot study is registered, with counseling as the intervention and length of stay as the primary outcome, but efficacy and feasibility findings are not reported in the registry record. This absence of posted results should not be turned into a claim that the intervention did or did not affect outcomes.

13. Why This Trial Matters Statistically

This study is statistically notable for the gap between its stated clinical aims and the outcome information available in the registry record. The summary describes feasibility and contraception initiation, while the listed primary endpoint is emergency department length of stay. These outcomes address different dimensions of a service: implementation, patient behavior, and time spent in care. Keeping them distinct prevents a process measure from being mistaken for evidence about initiation or feasibility.

The record also illustrates why design details matter when interpreting a clinical question. A comparator and allocation method are not identified, so the registered information does not define a controlled contrast. Without a clear comparison, a causal effect cannot be separated from other explanations for an outcome. The absence of listed analyses further limits statistical interpretation: there is no estimate, uncertainty interval, or test result to evaluate.

Enrollment of 13 makes careful descriptive reporting particularly relevant. General: in a small study, individual observations can have a visible influence on summaries, and uncertainty around estimates may be substantial. A median and full range can describe central tendency and extremes, but neither substitutes for the underlying distribution or an uncertainty assessment. The registry record does not report these endpoint values, so even that descriptive interpretation is unavailable.

The entry also demonstrates that registry status and statistical evidence are not interchangeable. COMPLETED indicates the recorded study status, while posted outcome results and analyses are separate information. The presence of planning assumptions does not replace a design rationale or an observed result. Reading these distinctions carefully is useful for clinical researchers assessing what a registry can and cannot support.

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 limitations specific to this study's registry record constrain interpretation. The listed enrollment is 13, and the record describes adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint. The record does not report how many people were screened, eligible, approached, or declined participation. It therefore does not allow assessment of recruitment or representativeness beyond the stated participant description.

The intervention is described as comprehensive contraception counseling, but operational details are not reported. The record does not state the counseling content, duration, delivery procedures, or how consistency of delivery was assessed. It also does not report a comparator or allocation method. Consequently, the study description does not establish a controlled comparison, and the effects of counseling cannot be isolated from other influences using the registered information.

The primary endpoint is defined as emergency department length of stay, summarized by median and full range, with chart review for follow-up approximately 4 weeks after enrollment. However, the observed values are not reported. The registry record does not explain how length of stay was defined or which timestamps were used. Numerical findings for the stated feasibility and initiation aims are also not reported. The remaining outcome measures among the 6 listed measures are not detailed in the record.

No analyses are listed, and statistical methods, missing-data handling, analysis populations, and multiplicity procedures are not reported. The record does not provide a protocol-level sample-size justification. These omissions prevent evaluation of precision, potential bias from incomplete follow-up, and the relationship between the planned questions and reported analyses. The study's completion status does not resolve these information gaps.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Providing Adolescent Contraception in the Emergency Room — NCT02475980.
• Registry record last updated 2016-07-11; status last verified 2016-05.
• Results first posted 2016-07-11.
• 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 identifies NCT02475980, titled “Providing Adolescent Contraception in the Emergency Room,” with the official title “Providing Adolescent Contraception in the Emergency Room (PACER).” The sponsor is the University of New Mexico. The study is marked COMPLETED, with a start date of 2015-02, primary completion in 2015-07, and enrollment of 13.

The intervention is comprehensive contraception counseling, classified as behavioral. The described group is adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint. The study summary states aims concerning feasibility and contraception initiation. The primary outcome is emergency department length of stay in minutes, summarized by median and full range, with chart review for patient follow-up approximately 4 weeks after enrollment. Listed secondary outcomes are descriptive statistics of participants and follow-up adherence.

The record lists 6 outcome measures and 0 analyses. It does not report numerical primary or secondary outcome results. Serious adverse events and other adverse events are each recorded as 0 among 13 at risk; death information is not reported in the registry record. Allocation is not stated, and no like-for-like control comparison is identified.