This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Maintaining Implementation Through Dynamic Adaptations (MIDAS) Suicide Prevention 2.0 Clinical Telehealth (NCT06011759), a na na study. The primary outcome is SP2Clin Metric.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06011759 |
| Phase | NA |
| Condition | Suicidal Self-directed Violence, Suicidal Preparatory Behavior |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 4 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned implementation at the VAMC level, not individual participant enrollment. The service was intended for Veterans with a history of suicidal self-directed violence or preparatory behaviors in the past 12 months. The registry lists suicidal self-directed violence and suicidal preparatory behavior as conditions.
Intervention
The implementation approach combined qualitative interviews and feedback with optional delivery of Academic Detailing and/or LEAP, a team-based quality improvement program. The broader aim was to help providers improve care and increase referrals to SP 2.0 Clinical Telehealth.
Comparator
The design is recorded as single-group, with allocation listed as NA. The registry does not describe a randomized comparator for the primary question. Control and Intervention labels appear in the adverse-event record, but that does not establish a like-for-like control comparison.
Primary question
The primary measure was the SP2Clin Metric: quarterly SP 2.0 suicide prevention telehealth consults submitted among those with a suicide behavior event. It was assessed from baseline to 12-months post-baseline, with the implementation focus on increasing referrals.
The central statistical question is whether the recorded consult metric changed during the stated period in the setting of the implementation work. The registry describes the intended direction of the implementation effort, but does not report the observed metric values or a numerical estimate of change. It also does not report a comparison that would isolate the effect of Academic Detailing, LEAP, or the broader implementation approach from other influences. The measure is at the VAMC level; the record says participants are not enrolled in the study.
3. Trial Design
This study is listed as completed, with a single-group model and allocation recorded as NA. Masking is listed as none, and phase is listed as NA. The sponsor is the VA Office of Research and Development. The registry dates are 2022-11-01 for study start and 2024-08-29 for primary completion.
The intervention is described as a multi-faceted implementation intervention involving qualitative interviews and feedback, with optional delivery of Academic Detailing and/or LEAP. Academic Detailing and LEAP are both classified as behavioral interventions. The project aimed to increase referrals to SP 2.0 Clinical Telehealth through these implementation activities. The summary describes SP 2.0 as providing accessible, evidence-based suicide prevention treatment to Veterans with a history of suicidal self-directed violence or preparatory behaviors in the past 12 months.
The primary outcome is a continuous measure reported as a mean with standard deviation. The measure is based on quarterly dashboard data and covers baseline to 12-months post-baseline. The registry describes a secondary outcome as change in the number of consults to the SP 2.0 Clinic. Five outcome measures and two analyses are listed, but the details of the additional measures and analyses are not reported in the registry record.
The registry enrollment is 4. That figure should be read alongside the record’s explicit statement that participants are not enrolled and enrollment and analysis were conducted at the VAMC level; it is not an individual patient enrollment count. The record does not describe random assignment, a protocol-specified control group, or the exact allocation of implementation activities among VAMCs. The displayed adverse-event record has Intervention and Control labels, but the study is not described as a randomized comparison, and those labels do not support a causal between-group interpretation.
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.
Before assignment: 13 sites within VISNs of interest were approached directly. Following introductory presentations, 4 sites agreed to participate in the intervention arm. Four non-enrolled control sites were matched to the intervention arm sites based on size and baseline referral rates.
Overall Study
| Stage | Intervention | Control |
|---|---|---|
| STARTED | NA | NA |
| COMPLETED | NA | NA |
| NOT COMPLETED | NA | NA |
Analysis population for the primary outcome, as defined in the registry: Participants are not enrolled in this study. All enrollment and analysis were conducted at the VAMC level.
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: The data came from a dashboard provided by an operational office and did not include demographics.
| Characteristic | Unit | Intervention | Control | Total |
|---|---|---|---|---|
| Participants analysed | NA | NA | NA | |
| Age, Categorical: <=18 years | — | — | — | |
| Age, Categorical: Between 18 and 65 years | — | — | — | |
| Age, Categorical: >=65 years | — | — | — | |
| Sex: Female, Male: Female | — | — | — | |
| Sex: Female, Male: Male | — | — | — |
6. Primary Endpoint
The registry lists the primary outcome as SP2Clin Metric, measured over Baseline to 12-months post-baseline.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | telehealth consults |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the SP2Clin Metric, expressed as telehealth consults. The registry defines it as the number of suicide prevention telehealth consults submitted among those with a suicide behavior event. Quarterly metric data are reported and available on a VA national dashboard, and the stated timeframe is baseline to 12-months post-baseline.
This measure was selected to represent referral activity to SP 2.0 Clinical Telehealth, consistent with the project’s implementation focus on increasing referrals. It is an implementation measure at the VAMC level, rather than a patient-level measure of symptoms, clinical response, or safety. A change in consult counts would describe change in recorded service activity; by itself, it would not establish why the count changed or whether care improved.
The registry identifies the endpoint’s mean and standard deviation as the summary statistics. However, the numerical values at baseline and follow-up, the estimated change, and the uncertainty around that change are not reported in the registry record. The endpoint definition also does not provide a denominator for interpreting the consult count as a rate. Consequently, the measure can be described from its definition and timeframe, but the magnitude and precision of any observed change cannot be evaluated from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes an implementation initiative intended to increase referrals to SP 2.0 Clinical Telehealth. Its primary outcome is the quarterly SP2Clin Metric, which counts consults among those with a suicide behavior event. The measure is assessed from baseline to 12-months post-baseline and is reported as a mean with standard deviation. Numerical endpoint results are not reported in the registry record. Therefore, the direction, magnitude, and precision of any change cannot be stated.
In general, an estimate of change describes the size and direction of a difference over time, while an uncertainty interval describes the range of values compatible with the data and analysis. Neither a numerical change estimate nor a confidence interval is reported in the registry record. A p-value for the primary outcome is also not reported in the registry record. Without those results, it is not possible to assess whether the observed metric changed, how variable the measurements were, or how compatible the data are with different possible changes.
The single-group design limits causal interpretation. Even if a change in the consult metric were reported, the registry record does not describe a randomized comparison that would distinguish the intervention’s contribution from other changes occurring over the same period. The implementation activities were multi-faceted and optional, so the record also does not establish which components were delivered at each VAMC or permit component-specific effects to be separated. The Control label in the adverse-event record does not change the stated single-group design or establish a valid comparison for the primary endpoint.
The registry lists an enrollment of 4, while also stating that participants are not enrolled and that enrollment and analysis were conducted at the VAMC level. Interpretation should therefore stay at the level identified by the record and should not treat this as an individual patient sample size. Details about the number of VAMCs contributing to each time point, completeness of dashboard observations, or variation between VAMCs are not reported in the registry record.
The registry lists five outcome measures and two analyses, but does not report the numerical findings or a full account of the analyses. The displayed adverse-event entries record zero for each listed event category and deaths in both labeled groups; denominators and further details are not reported in the registry record. These entries do not provide evidence about the primary consult outcome. Overall, the record describes the study’s purpose, design, and outcome definition, but does not provide results sufficient to quantify the implementation change or its uncertainty.
9. Statistical Methods Explained
The primary outcome is continuous and is summarized using a mean and standard deviation. In general, a mean describes the average value of a measure, while a standard deviation describes how spread out measurements are around that average. The endpoint is defined as quarterly consult activity at the VAMC level, so those summaries describe the metric as recorded across the relevant units and time points. The numerical summaries themselves are not reported in the registry record.
What does the timeframe define?
The stated timeframe is baseline to 12-months post-baseline. This identifies the period over which the registry intended to assess the primary metric. It does not specify, in the registry record, the exact quarterly observations used, how the baseline value was defined, or how missing quarterly observations were handled. Those details matter because measurements collected at multiple time points can have different patterns of variation and different degrees of completeness.
In general, repeated observations from the same unit are related rather than independent. Analyses that account for this relationship can estimate changes and uncertainty more appropriately than methods that treat every observation as unrelated. The registry identifies two analyses, but the methods used, their targets, and their assumptions are not reported in the registry record. It is therefore not possible to say whether the analyses modeled repeated measurements, summarized changes directly, or used another approach.
What does the single-group design permit?
The registry identifies a single-group model and allocation as NA. In general, observing a measure before and after an implementation activity can describe temporal change, but a before-and-after pattern alone does not identify the cause of that change. Other influences over time may also affect the metric. A randomized or otherwise suitable comparison can help address some alternative explanations, but the registry does not describe such a comparison for the primary endpoint. The Intervention and Control labels in the adverse-event listing are not enough to establish a comparative analysis of consult activity.
The intervention itself includes qualitative interviews and feedback and optional Academic Detailing and/or LEAP. In general, a multi-component implementation strategy may vary in delivery and uptake across sites. To interpret its association with an outcome, information about which components were delivered, when they were delivered, and how consistently they were used can be important. Those implementation details are not reported in the registry record. The record therefore supports describing the intervention’s planned components, not assigning the outcome to a particular component.
What do the planning assumptions mean?
The sample-size planning description specifies a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not evidence that the study used a two-arm randomized design. The study is described as single-group, and the record does not provide the numerical observed effect or the numerical planning outputs. The planning illustrations are hypothetical requirements for future sample sizes, not observed power and not findings about this study.
In general, a significance level sets a threshold used in a specified hypothesis-testing procedure, and a normal approximation uses properties of the normal distribution to estimate a sampling distribution. Equal allocation is an assumption about how participants or units would be divided between arms for planning. Because the registry describes the analysis at the VAMC level and does not provide details of a two-arm primary comparison, these assumptions should not be read as the actual study design or analysis plan. The record does not report the protocol’s sample-size justification.
Why can over-dispersion matter for counts?
General statistical context: count outcomes can vary more than a simple model assumes, a property often called over-dispersion. If present, this can make uncertainty estimates from a model that assumes less variability too narrow. The SP2Clin Metric is a consult count, but the registry does not report a count-model specification, an assessment of over-dispersion, or a variance structure. No claim about whether over-dispersion occurred in this study can be made from the registry record.
A further general consideration is the distinction between a count and a rate. A count records the number of events, whereas a rate relates that count to an exposure or population denominator. The endpoint definition gives the number of consults among those with a suicide behavior event, but a denominator for a rate is not reported in the registry record. Interpretation should therefore remain tied to the recorded consult metric rather than treating it as a rate or an individual-level risk.
The registry identifies five outcome measures and two analyses. It does not report which analysis corresponds to which outcome, the statistical models, covariate adjustments, confidence intervals, p-values, or handling of clustering and repeated measurements. These omissions prevent a detailed assessment of model fit and assumptions. General explanations of means, variability, repeated observations, and count modeling do not establish which methods were used in this study.
10. Confidence Intervals for Each Arm
No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.
| Arm | Participants | Mean | Standard deviation | 95% CI for the mean |
|---|---|---|---|---|
| Intervention | 4 | 22.600 | 4.100 | 16.076 to 29.124 |
| Control | 4 | 20.000 | 3.800 | 13.953 to 26.047 |
R code and output
arm <- c("Intervention", "Control")
n <- c(4, 4)
m <- c(22.6, 20)
sp <- c(4.1, 3.8)
sd <- sp # posted standard deviations
for (i in seq_along(n)) {
se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}
CARM Intervention 4 22.600 4.100 16.076 29.124
CARM Control 4 20.000 3.800 13.953 26.04711. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures and two analyses. It names the primary SP2Clin Metric and identifies a secondary outcome as change in the number of consults to the SP 2.0 Clinic. The remaining outcome details and the mapping between outcomes and analyses are not reported in the registry record. A multiplicity strategy, such as a prespecified hierarchy or adjustment for testing multiple outcomes, is not reported in the registry record. Without that information, the family of statistical tests and any control of false-positive findings cannot be assessed.
Missing-data methods are not reported in the registry record. In particular, the record does not state whether all quarterly dashboard observations were available, how missing time points were treated, or whether any imputation or sensitivity analysis was used. Completeness matters because a mean based on available observations may represent a different set of VAMCs or periods from one based on a complete series. The record does not provide enough detail to determine whether missingness could affect the interpretation.
The analysis population is described as VAMC-level: participants are not enrolled, and enrollment and analysis were conducted at the VAMC level. The registry enrollment is 4, but it should not be interpreted as an individual participant count. The number of units contributing data to each analysis and the handling of any units without complete data are not reported in the registry record. The analysis methods and any interim analyses are also not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry supports a description of the implementation goal, the primary metric, and the study design. The goal was to increase referrals to SP 2.0 Clinical Telehealth through a multi-faceted approach that included qualitative interviews and feedback and optional Academic Detailing and/or LEAP. The primary outcome was quarterly consult activity from baseline to 12-months post-baseline. Numerical findings for that outcome are not reported in the registry record.
As a result, the record does not establish whether consult activity increased, decreased, or remained similar. It does not provide an estimated change, confidence interval, or p-value for the primary outcome. The absence of these numerical results means that neither the size of a possible change nor its statistical precision can be evaluated. The intended direction of the implementation effort is not itself evidence that the measured outcome changed in that direction.
Even with a reported change, a single-group design would describe change over time rather than establish that the implementation activities caused it. The registry does not describe random allocation or a like-for-like control comparison for the primary measure. It also does not report which optional implementation components were delivered at each VAMC, so a distinct effect of Academic Detailing, LEAP, or their combination cannot be identified from the record.
The endpoint is a measure of service activity, not a direct measure of patient-level clinical outcomes. A consult count does not by itself establish treatment receipt, clinical benefit, or safety. The adverse-event record lists zero counts for each listed category and deaths in both its Intervention and Control groups, but denominators and further event details are not reported in the registry record. Those entries should not be used to infer comparative safety or to substitute for the missing primary outcome results.
13. Why This Trial Matters Statistically
This study raises a useful statistical distinction between measuring implementation activity and measuring patient outcomes. The SP2Clin Metric counts consults submitted among those with a suicide behavior event, matching the project’s focus on referrals to a clinical telehealth service. It is therefore an implementation-relevant measure, but not a direct patient-level measure of symptoms, treatment response, or safety.
The VAMC-level unit of analysis is also important. The registry enrollment is 4, while the record explicitly says that participants are not enrolled and that enrollment and analysis were conducted at the VAMC level. Interpreting the study as a patient-level trial would misstate its unit of analysis. In general, analyses of site-level data must account for the structure and number of contributing sites, but the registry does not report the detailed analysis methods needed to assess that issue.
The study also illustrates how a multi-faceted implementation strategy complicates attribution. Qualitative interviews and feedback, Academic Detailing, and LEAP are described as parts of the approach, with some activities optional. Without details about delivery and uptake, an overall change cannot be separated into component-specific contributions. Without a suitable comparison, temporal change cannot be attributed to the intervention alone.
Finally, the record’s outcome definition and design are more informative than its unreported results. The metric, timeframe, and implementation purpose are clear, but no numerical primary outcome findings or uncertainty estimates are reported in the registry record. Statistical interpretation depends on both a well-defined measure and transparent results; a clear measure cannot replace the missing estimate and its precision.
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 most consequential limitation for interpretation is that numerical primary outcome results are not reported in the registry record. There is no reported baseline mean, follow-up mean, change estimate, standard deviation value, confidence interval, or p-value. The record therefore does not permit a quantitative assessment of the direction, size, or precision of change in consult activity.
The single-group design does not provide a randomized comparison for the primary endpoint. The registry lists allocation as NA and describes the model as single-group. Although Intervention and Control labels appear in the adverse-event record, the study is specifically identified as not being a randomized comparison, and the record cautions that the arms are not a like-for-like control comparison. Those labels should not be treated as a control design for evaluating consult outcomes.
The registry describes analysis at the VAMC level and states that participants are not enrolled. Its enrollment entry is 4, but details about the units contributing observations to each analysis are not reported in the registry record. The record also does not report the completeness of quarterly dashboard observations, the treatment of missing data, the statistical methods, or the handling of repeated measures and clustering.
The implementation strategy includes optional activities, and component delivery or uptake by VAMC is not reported in the registry record. Five outcome measures and two analyses are listed, but the remaining outcome definitions and any multiplicity approach are not reported. The endpoint is a consult count without a reported denominator for rate interpretation. These limitations constrain causal, component-specific, and precision-based conclusions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Maintaining Implementation Through Dynamic Adaptations (MIDAS) Suicide Prevention 2.0 Clinical Telehealth — NCT06011759.
- Registry record last updated 2025-12-29; status last verified 2025-12.
- Results first posted 2025-12-29.
- 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.
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18. Record Summary
The completed study, NCT06011759, examined a multi-faceted implementation approach intended to increase referrals to SP 2.0 Clinical Telehealth. The approach included qualitative interviews and feedback and optional Academic Detailing and/or LEAP. The registry identifies the model as single-group, allocation as NA, and masking as none. The sponsor is the VA Office of Research and Development.
The primary outcome was the quarterly SP2Clin Metric, defined as telehealth consults submitted among those with a suicide behavior event, assessed from baseline to 12-months post-baseline. The record lists five outcome measures and two analyses. It states that participants are not enrolled and that enrollment and analysis were conducted at the VAMC level; the registry enrollment is 4.
Numerical results for the primary outcome, methods details, missing-data handling, and multiplicity procedures are not reported in the registry record. The stated design does not support treating the study as a randomized comparison.