Patient-Centered Reproductive Decision Support Tool for Women Veterans: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Patient-Centered Reproductive Decision Support Tool for Women Veterans (NCT04584294), a randomized na study. The primary outcome is Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM).

2. Clinical Question

The central comparison is between participants whose providers were randomized to the MyPath arm and participants whose providers were randomized to usual care. The intervention was delivery of access to a decision tool before the visit; it was not described as a change to the clinical services themselves. The study hypothesis also concerned communication confidence, reproductive health knowledge, and contraceptive choices, which are listed among the secondary outcomes.

The registry record describes the question and intended endpoint, but does not report the primary outcome counts or a comparison estimate. It therefore does not establish from the posted results whether the arms differed in reported shared decision making, or how precisely any difference was estimated. The interpretation must remain focused on the design and measurement rather than a conclusion about the intervention's effect.

3. Trial Design

This was a randomized, parallel-arm study with single masking. The registry lists an enrollment of 465 and a completed status. The study began on 2021-03-01, with primary completion on 2024-08-30. Phase is listed as NA. The sponsor was the VA Office of Research and Development.

Providers were randomized to intervention or usual care. Patients scheduled to see providers assigned to the intervention arm received a text message containing the MyPath link after study enrollment and before the appointment. Patients scheduled to see providers assigned to usual care received no study intervention and usual primary care. This provider-level assignment is important context: patient outcomes may be grouped by provider, so the statistical analysis may need to account for that structure. Whether the analysis did so is not reported in the registry record.

Single masking is recorded, but the identity of the masked group and the procedures used to maintain masking are not reported in the registry record. The record also does not report the allocation sequence method, concealment procedures, or detailed implementation of randomization. Those details should not be inferred from the randomized designation alone.

The primary endpoint was assessed within one month after the visit and concerned participants' reports of a reproductive-needs discussion that included shared decision making. The record lists 18 outcome measures and 14 analyses. Several secondary outcomes address discussion occurrence, communication self-efficacy, reproductive health knowledge, contraceptive decision conflict, confidence in a contraceptive method, and contraceptive method choice or use. The registry record does not provide the outcome results needed to describe the observed contrast between randomized arms.

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.

Enrollment to Post-Visit - PATIENTS

Reasons for not completing this period:

3-month Follow-up - PATIENTS

Reasons for not completing this period:

6-month Follow-up - PATIENTS

Reasons for not completing this period:

Enrollment to Post-Visit - PROVIDERS

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Enrolled Veterans were excluded from the analytic sample if they were withdrawn from the study prior to any outcomes assessment due to non-attendance at their scheduled primary care visit, pregnancy diagnosed at the scheduled primary care visit, or self-withdrawal prior to outcomes assessment.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Per the study protocol, enrolled Veterans were excluded from the analytic sample if they were withdrawn from the study prior to any outcomes assessment due to non-attendance at their scheduled primary care visit, pregnancy diagnosed at the scheduled primary care visit, or self-withdrawal prior to outcomes assessment.

6. Primary Endpoint

The registry lists the primary outcome as Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM), measured over Within one month post-visit.

The primary endpoint concerns whether a participant reported a discussion during the scheduled primary care visit about pregnancy goals, prepregnancy health, or contraception that included shared decision making. Assessment was within one month after the visit. This outcome focuses on a communication process: whether reproductive needs were discussed in a way the participant experienced as shared decision making, rather than on a clinical event or a specific reproductive choice.

The registry describes CollaboRATE as three 5-point Likert scale questions, combined into a score from 0-12, with higher scores indicating more shared decision making. The primary outcome uses a top-box score to define shared decision making. The exact threshold or rule used to assign the top-box category is not reported in the registry record. The endpoint is listed as a count of participants, consistent with reporting how many met the defined outcome, but the registry does not provide those counts in the record details available for this analysis.

This type of endpoint is used to assess whether the encounter addressed a patient's reproductive goals through a participatory discussion. It is distinct from the secondary outcomes concerning knowledge, confidence, decision conflict, or contraceptive method choice and use. A self-reported endpoint captures the participant's account of the encounter; it does not independently verify what was said or establish that a discussion changed subsequent decisions. Without arm-specific outcome counts and an effect estimate, the result and its precision cannot be interpreted.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does randomization establish?

Randomization assigns study units to arms using a chance-based process, with the aim of making groups comparable on average at the start of a study. This trial is listed as randomized and parallel. The description says providers were randomized, while the outcome is measured for participants scheduled to see those providers. This distinction matters because the assignment unit and the measurement unit are not necessarily the same. Participants connected to the same provider may have more similar experiences than participants connected to different providers. In general, an analysis should reflect such grouping when it is relevant. Whether the trial's analysis accounted for provider-level grouping is not reported in the registry record.

The record does not describe how the random sequence was generated, how assignment was concealed, or which people were masked. Randomized allocation and single masking are the reported design labels; more detailed procedures cannot be inferred from those labels.

How is the primary outcome defined?

The endpoint is a participant-level report of a reproductive-needs discussion with shared decision making, assessed within one month post-visit. The record describes three CollaboRATE questions on 5-point Likert scales and a combined score from 0-12, with higher scores representing more shared decision making. The primary outcome uses a top-box score. The exact cutoff for the top-box classification is not reported in the registry record.

The endpoint is listed as a count of participants. For a binary outcome, a count indicates how many participants met a specified definition; interpretation also needs the relevant denominator. Comparing counts alone can be misleading if group sizes differ. A proportion or an appropriate model can account for denominators, but the registry record does not report which analysis was used for the primary comparison. These are general principles rather than a description of the trial's unreported analysis.

What would an effect estimate convey?

A contrast between arms would describe how the endpoint differed under the chosen statistical scale and analysis. A confidence interval would convey the uncertainty around that estimate: narrower intervals indicate greater precision, while wider intervals indicate less precision. The interval's interpretation depends on the model and assumptions. A p-value, if reported, would describe how compatible the data are with a specified null hypothesis under the test assumptions; it is not a measure of clinical importance and is not the probability that the null hypothesis is true.

No primary effect estimate, confidence interval, or test result is reported in the registry record details summarized for this analysis. Consequently, it is not possible to explain a numerical estimate, assess its precision, or compare statistical and practical importance for this trial.

How should multiple outcomes be understood?

The record lists 18 outcome measures and 14 analyses, including the primary measure and secondary outcomes concerning reproductive discussion, provider communication, knowledge, decision conflict, confidence in a contraceptive method, and method choice or use. When several outcomes or analyses are considered, the chance of at least one apparently notable result can increase if each is assessed independently without adjustment. Multiplicity procedures can address this issue, but the registry record does not report whether such procedures were planned or used, or which outcomes were treated as confirmatory.

What do planning illustrations mean?

Any sample-size values based on observed effects are planning illustrations, not observed power. The stated assumptions for such illustrations are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect set as a stated fraction of the observed effect. For time-to-event outcomes, the illustration is expressed as a total number of events; for other outcomes, it is expressed as participants per arm. These are general planning calculations, not a report of the trial's original design justification. The trial's own sample-size justification is not reported in the registry record.

Planning calculations can help show how a target effect and analysis assumptions relate to a possible sample size. They do not tell whether the study actually detected an effect, and they should not be described as observed power. The registry record does not report an interim-analysis plan, the original power assumptions, or a justification for the enrollment target.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 18 outcome measures and 14 analyses. That breadth makes it important to distinguish a prespecified primary question from additional outcomes and analyses. Testing many outcomes can increase the chance of finding a result that appears notable by chance alone when no adjustment or hierarchy is used. Possible approaches include defining a primary endpoint, specifying an ordered testing strategy, or adjusting for multiple comparisons. The registry record does not report a multiplicity strategy, an outcome hierarchy beyond the designation of the primary measure, or which analyses were confirmatory.

Some secondary outcomes concern reproductive discussions and communication, while others concern reproductive health knowledge, contraceptive decision conflict, confidence, choice, or use. These outcomes may measure different aspects of the intervention's intended aims and should not be treated as interchangeable. Their results are not reported in the registry record details summarized for this analysis, so no outcome-by-outcome conclusion is possible.

The analytic population excludes enrollees who withdrew before outcome assessment because they did not attend the scheduled visit, had pregnancy diagnosed at the visit, or withdrew themselves. The number excluded for each reason is not reported in the registry record. The record does not report the handling of other missing responses, the amount of missing outcome data, or whether the primary analysis followed an intention-to-treat principle. It also does not report sensitivity analyses addressing missingness.

These gaps affect how confidently a reader could assess representativeness and robustness if an estimate were available. Excluding people before assessment can change the analyzed group relative to the enrolled group, while missing outcome responses can create additional uncertainty. The record's description alone does not establish the direction or size of any such influence.

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 registry record lists four safety groups: intervention patients, usual care patients, intervention providers, and usual care providers. It reports 209 intervention patients at risk and 182 usual care patients at risk; each group had 0 serious events, 0 other events, and 0 deaths. It reports 37 intervention providers at risk and 37 usual care providers at risk; each provider group had 0 serious events, 0 other events, and 0 deaths.

These figures describe the safety entries recorded for the listed groups. Zero recorded events is not proof that an event is impossible, and the figures do not by themselves compare risks under a statistical model. They should be interpreted in light of the groups and event categories recorded, rather than as evidence about every possible harm or every period after the study. The registry record does not give further event descriptions or a detailed safety-analysis method.

The absence of serious or other events and deaths in these entries is separate from the primary endpoint of self-reported shared decision making. Safety counts do not answer whether participants experienced a reproductive-needs discussion or whether the arms differed on the primary outcome. No medical conclusion about the intervention follows from these safety entries alone.

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

The registry record identifies a randomized comparison of a web-based decision support tool with usual care, and it defines a patient-reported primary endpoint concerning shared decision making during a reproductive-health discussion. It also describes the intervention's intended role: to help women Veterans obtain information and care relevant to their reproductive goals before a primary care visit. These details clarify the research question and the type of outcome the study was designed to assess.

They do not establish whether MyPath changed the occurrence of shared decision making, communication confidence, reproductive health knowledge, decision conflict, contraceptive confidence, or contraceptive choices. No primary comparison estimate is reported in the registry record details summarized for this analysis. A hypothesis, a stated aim, or a planned endpoint is not a trial result. Neither an effect's direction nor its size or precision can be inferred from the intervention description.

The endpoint is based on participant self-report and a top-box definition using CollaboRATE. It therefore represents the participant's reported experience under the registry's measurement approach, not an independent audit of the visit. The exact top-box rule is not reported in the registry record. Also, the stated exclusions before outcome assessment mean that the analytic population may differ from all enrolled Veterans; the number excluded is not reported.

The safety entries report zero serious events, zero other events, and zero deaths in the listed patient and provider groups. Those entries are useful to describe what was recorded, but they are not a substitute for the primary outcome results and do not prove that no risk exists. Overall, the record supports conclusions about study design, measurement, and recorded safety counts, but not a conclusion about the intervention's effect.

13. Why This Trial Matters Statistically

This trial raises a statistical question about an intervention delivered before a clinical encounter and an outcome centered on the patient's experience of communication. That makes the measurement target important: the primary endpoint is not simply whether a reproductive topic arose, but whether the participant reported a discussion that included shared decision making. Clear definitions are essential when translating a multi-item rating scale into a participant-level outcome.

The assignment structure is also statistically relevant. Providers were randomized, while outcomes were collected from patients scheduled to see them. When observations are grouped under shared providers, statistical analyses may need to account for dependence among participants. Treating all participant outcomes as independent when they are not can affect uncertainty estimates. The registry record does not report how this issue was handled, making it an important point for readers assessing a complete analysis.

The study lists multiple outcome measures spanning communication, knowledge, and contraceptive decisions. These are related but distinct questions, and a clear analysis plan helps readers understand which findings are primary and how other comparisons should be interpreted. The multiplicity plan is not reported in the registry record. Likewise, exclusions before outcome assessment are described, but their counts and the handling of other missing data are not reported.

These features illustrate why a trial record's design description and outcome estimates both matter. The design tells readers what comparison was intended; outcome counts and uncertainty estimates are needed to assess what the data show. Here, the record permits a careful account of the question and methods, but does not report a single primary-outcome comparison from which to judge the magnitude or precision of an observed effect.

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.

The primary limitation for interpreting results is that the registry record does not report a single primary-outcome comparison, including arm-specific counts or an effect estimate. The primary outcome has several categories or time points and is not reduced to one comparison in the record details summarized for this analysis. Without a numerical contrast and uncertainty estimate, the observed direction, magnitude, and precision cannot be assessed.

The endpoint is based on participant self-report within one month after the visit. Self-report is directly relevant to perceived shared decision making, but it may not be identical to an observer's account of the encounter. The registry description gives the CollaboRATE score range and the use of a top-box definition, but not the precise classification threshold.

Providers were randomized and patients scheduled with those providers were assessed. The record does not report whether the statistical analysis accounted for potential similarities among patients treated by the same provider. It also does not describe the randomization procedure or the identity of the group masked under the single-masking designation.

The record identifies exclusions before outcomes assessment for non-attendance, pregnancy diagnosed at the visit, and self-withdrawal, but gives no counts for these reasons. It does not report the extent or handling of other missing data, the analytic population definition beyond these exclusions, or sensitivity analyses. The number of outcome measures and analyses is recorded, but the multiplicity approach is not reported. The trial's original sample-size justification and interim-analysis plan are also not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Patient-Centered Reproductive Decision Support Tool for Women Veterans — NCT04584294.
• Registry record last updated 2025-11-06; status last verified 2025-10.
• Results first posted 2025-11-06.
• 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

NCT04584294, titled Patient-Centered Reproductive Decision Support Tool for Women Veterans, evaluated the MyPath web-based informational and decision support tool. The official title describes a web-based intervention intended to improve reproductive planning for women Veterans. The study was randomized, parallel, and single-masked, with providers assigned to intervention or usual care. Enrollment was 465, and the registry status is completed.

The primary endpoint was participant-reported occurrence of a reproductive-needs discussion with shared decision making within one month post-visit, measured using CollaboRATE and a top-box definition. The record lists 18 outcome measures and 14 analyses. It describes exclusions before outcome assessment but does not quantify them. The primary-outcome result is not reported as a single comparison in the registry record, and the record details summarized for this analysis do not include an effect estimate or its precision.

Safety entries list 0 serious events, 0 other events, and 0 deaths in each of the patient and provider groups. The record does not report the multiplicity plan, detailed missing-data methods, or the trial's own sample-size justification.