Brief Educational Video for Patients Prescribed LTBI Treatment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Brief Educational Video for Patients Prescribed LTBI Treatment (NCT05412212), a randomized na study. The primary outcome is Treatment Completion.

2. Clinical Question

The investigators’ stated hypothesis is that the educational video intervention will improve treatment completion compared with standard care. That is the question motivating the trial, not a reported finding: the registry record does not report a treatment-completion result or a comparison between groups. It also does not report an estimate of the size or precision of any group difference.

The trial description includes other questions beyond completion. These concern whether patients initiate treatment, initiation and completion by treatment regimen if feasible, whether intervention-group participants watch the video, and the perceptions of those who watch it. The registry record describes the intended outcomes but does not report results for them. The recorded primary measure concerns completion within the specified follow-up period; it does not, by itself, answer whether patients watched the video or how they perceived it.

3. Trial Design

The registry record describes a randomized, parallel-group trial with no masking. It is marked completed, with a start date of 2022-06-03 and a primary completion date of 2024-12-29. The recorded enrollment is 1894. The record lists the phase as NA and identifies Kaiser Permanente as the sponsor.

At the time of prescription, eligible patients were to be randomized to the video intervention or standard care at a 2 to 1 ratio. People assigned to the intervention were to receive a secure text message or e-mail invitation with a link to the video. People assigned to standard care were not to receive messages or contact from the research team. The record does not describe masking, and its masking field says NONE.

The primary outcome is treatment completion, assessed in the year following the prescription order. Secondary outcomes are treatment initiation, defined as at least one dispensation in that year; initiation and completion by regimen if feasible; the proportion of intervention-group participants who watched the video; and perceptions reported by viewers. The record describes an invitation to viewers to respond to 4 short questions about accessibility and content.

These entries describe the planned comparison and intended measures, not the results. The registry record does not report the numbers randomized to each group, group-specific outcome counts, or a completed analysis. It also does not report the reasons for any differences between enrollment and the numbers included in outcome analyses.

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 Treatment Completion, measured over 1 year after treatment prescription.

The primary endpoint is treatment completion: the proportion of patients prescribed LTBI treatment who complete it within 1 year of the prescription. The description defines completion as dispensing the required number of doses. The unit is participants, and the outcome is recorded as a count of participants. The registry record does not specify the required number of doses for each regimen.

Completion is used to represent whether patients reach the end of the prescribed treatment course, rather than merely whether treatment is started. The record separately defines initiation as at least one dispensation, making initiation a distinct secondary outcome. Keeping these outcomes separate matters for interpretation: a patient may initiate treatment without meeting the recorded definition of completion, while an initiation result alone would not establish the completion outcome.

The endpoint is assessed within 1 year after the prescription order. This time window anchors the outcome to the prescription rather than to the date of video viewing. The registry record does not report the observed completion counts or proportions, a comparison estimate, or its uncertainty. Accordingly, the endpoint definition can be described, but the trial’s observed result cannot be interpreted from the registry information available.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies a randomized parallel-group design with no masking. Random allocation is intended to create groups that can be compared, while a parallel design assigns each participant to one group for the trial comparison. These are general descriptions of the design; the registry record does not report the randomization sequence, allocation concealment procedures, or implementation details.

What does the outcome measure?

The primary measure is a binary participant outcome: treatment completion within 1 year is the event, and the recorded outcome type is a count of participants. General statistical explanation: a binary outcome distinguishes whether each participant meets a defined condition or does not. Group counts can be used to describe the observed data, while proportions express those counts relative to the number of participants assessed. The registry record defines completion by dispensing the required number of doses, but does not report the observed counts, denominators, or proportions.

What comparison was planned?

The trial description specifies a 2 to 1 randomization ratio between the video invitation and standard care. A comparison of completion between randomized groups would address the primary question, provided the outcome and analysis population were defined and reported. The registry record does not report the group results, an effect estimate, or the statistical method used for a primary comparison. It therefore cannot establish whether the intended analysis compared proportions, adjusted for other variables, or used another approach.

How should uncertainty be understood?

General statistical explanation: an effect estimate describes the observed contrast between groups, while a confidence interval describes the range of values compatible with the data and the specified method. A p-value addresses how unusual the observed data would be under a stated null model and assumptions; it does not measure the probability that the intervention works. The registry record reports no effect estimate, confidence interval, or p-value, so the magnitude and precision of a primary comparison cannot be assessed.

What do the planning assumptions mean?

The record includes a sample-size-assumptions statement describing a planning illustration based on the observed effect, not the trial’s own design. It specifies a two-sided significance level of 0.05, equal allocation between arms, a normal approximation, and an effect to detect expressed as a stated fraction of the observed effect. This generic illustration is distinct from the trial’s described 2 to 1 allocation. It is not evidence of the trial’s original sample-size justification, and it must not be interpreted as observed power. The registry record does not report the trial’s sample-size justification or the effect value used in any planning illustration.

General statistical explanation: a sample-size calculation depends on its assumptions, including the effect targeted, variability or event frequency, allocation, and chosen error criteria. A planning calculation answers a hypothetical design question; it does not describe what the completed trial found. The registry record does not provide enough detail to determine the original design calculation or whether it changed.

What can be concluded from the posted analysis entries?

The record reports 0 analyses and does not provide a statistical plan for the primary endpoint. The trial’s design and endpoint can be described, but there is no analysis output to interpret. Information about covariate adjustment, interim analyses, handling of missing data, subgroup methods, or analysis populations is not reported in the registry record. General statistical explanation: these choices affect how estimates are constructed and how readers assess whether an analysis answers the intended question. Without the methods and results, the registry entries do not support a claim about the direction, magnitude, or precision of an intervention effect.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary outcome measure, treatment completion, and describes several secondary outcomes. It does not report a multiplicity strategy, such as whether or how statistical testing across outcomes would be adjusted. No analysis entries or outcome-specific results are reported, so the record does not establish whether any statistical tests were performed. General statistical explanation: when several outcomes or subgroup comparisons are tested, multiplicity can increase the chance of at least one apparently notable result arising by chance. A prespecified approach helps readers interpret a collection of tests, but no such approach is reported.

Missing-data methods are also not reported in the registry record. There is no account of missing outcome status, loss to follow-up, exclusions, or how unknown completion status would be handled. The recorded enrollment of 1894 does not identify the number with an observed primary outcome. General statistical explanation: missing outcomes can affect an estimate if participants with unobserved outcomes differ from those whose outcomes are known. The extent and handling of missingness are therefore relevant to assessing a trial comparison.

The analysis population is not reported in the registry record. The entries do not say whether a primary analysis included all randomized participants, only those with available outcome data, or another defined group. The record also does not report whether participants were analyzed according to randomized assignment. These are important distinctions when interpreting a randomized comparison, but no approach can be inferred from the available record.

Interim analyses and stopping rules are not reported in the registry record. Their absence from the record does not establish whether they were or were not used; it means the registry information does not describe them.

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

The trial record describes a test of an invitation to watch a brief educational video, compared with standard care, among adults prescribed LTBI treatment. Its primary question concerns completion within 1 year of the prescription order. This is the scope of the recorded research question, not a conclusion about the intervention’s effect.

The record does not report outcome results. It therefore cannot show whether completion differed between groups, how large any difference was, or how uncertain an estimate might be. It also cannot establish whether the video was watched by participants assigned to the intervention, or what viewers thought about its accessibility and content. The stated hypothesis should not be mistaken for an observed finding.

Even if a group comparison were available, its interpretation would depend on the actual outcome data, analysis methods, missingness, and analysis population. General statistical explanation: a trial estimate applies most directly to the population and intervention as studied, and uncertainty around that estimate matters when assessing how compatible the data are with different effect sizes. The registry entries do not provide those estimates or the information needed to assess their precision.

The registry record identifies treatment initiation and treatment completion by regimen as secondary questions, with regimen-stratified analyses described as conditional on feasibility. It does not report whether those analyses were feasible or what they found. Nor does the record report viewer-response results or detail the extent of video viewing.

The adverse-event fields contain zeros for the listed categories in both groups, but the registry provides no accompanying explanation or event analysis. Those entries alone do not support a broader conclusion about safety. In short, the available record documents the trial’s design and outcome definitions, but does not report evidence that answers the efficacy or safety questions.

12. Why This Trial Matters Statistically

This trial raises a practical statistical question: how to evaluate a brief educational intervention using an outcome defined by treatment completion rather than by video engagement alone. The registry distinguishes completion from initiation and also identifies viewing and viewer perceptions as secondary outcomes. That separation is useful because these measures describe different steps and experiences in the intervention pathway.

The randomized design is relevant to the intended comparison of the video invitation with standard care. At the same time, the described 2 to 1 allocation and the equal-allocation assumption in the generic planning statement serve different purposes. The latter is identified as an illustration rather than the trial’s own design. Keeping design details separate from planning assumptions prevents a sample-size illustration from being read as a description of how participants were allocated or as evidence of achieved power.

The record also illustrates why outcome definitions and follow-up windows matter. Completion is tied to dispensing the required number of doses within 1 year after prescription, while initiation has its own definition. These definitions identify what would count as an event, but an event definition is not an outcome result. Without group counts and an analysis, neither the direction nor precision of a comparison can be assessed.

Finally, a completed-trial status does not itself communicate findings. The record contains design and outcome information but reports no analyses or results. For statistical interpretation, this distinction is central: a clear research question and a defined endpoint are prerequisites for evaluating evidence, but they do not replace the observed data and analysis needed to answer the question.

13. 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 principal limitation for interpretation is that the registry record does not report the primary outcome results or any analysis. There are no group-specific counts, denominators, effect estimates, confidence intervals, or p-values. Consequently, the central comparison cannot be quantified or assessed for precision.

The recorded enrollment of 1894 does not establish the number randomized to each arm or the number with outcome data. The registry record does not report participant flow, eligibility exclusions, adherence to assignment, missing outcome information, or the analysis population. These omissions limit assessment of how the planned randomized comparison was carried out and analyzed.

The intervention is described as an invitation to watch the video, not as confirmed viewing by every participant assigned to the intervention. The registry record does not report the proportion who watched it or the results of the 4 short questions for viewers. It therefore does not permit assessment of intervention reach or viewer perceptions.

The completion definition refers to the required number of doses but does not specify that number or describe how completion was determined across regimens. Regimen-specific analyses are described as conditional on feasibility, but their conduct and results are not reported. The record also does not report a multiplicity strategy, missing-data procedures, interim analyses, or detailed statistical methods.

Finally, the adverse-event fields list zeros but provide no further explanation or analysis. This limits what can be concluded from those entries. These are limitations of the information reported in the registry record; they do not establish that the unreported procedures or data were absent from the trial itself.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Brief Educational Video for Patients Prescribed LTBI Treatment — NCT05412212.
• Registry record last updated 2026-07-09; status last verified 2026-03.
• Results first posted 2026-07-09.
• 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.

17. Record Summary

The registry record describes a completed randomized, parallel-group trial with no masking, sponsored by Kaiser Permanente. It lists 1894 participants enrolled, a start date of 2022-06-03, and a primary completion date of 2024-12-29. Adults prescribed LTBI treatment were to be assigned at a 2 to 1 ratio to a brief-video invitation or standard care.

The primary outcome is completion within 1 year after the prescription, defined by dispensing the required number of doses. Secondary outcomes concern initiation, outcomes by regimen if feasible, video viewing, and viewer perceptions. The registry record reports 0 analyses and does not report outcome results, group comparisons, or precision estimates. It records zeros in the listed adverse-event fields for both groups, with no serious terms listed.