MISSION-Vet HUD-VASH Implementation Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for MISSION-Vet HUD-VASH Implementation Study (NCT01430741), a randomized na study. The primary outcome is MISSION Fidelity Index.

2. Clinical Question

This is an implementation question rather than a direct test of a clinical outcome. It asks whether an implementation support approach changes staff delivery of a behavioral program. The record describes MISSION-Vet as addressing mental health, substance use, and related issues among homeless Veterans through activities that include outreach, psychoeducation, and links to community resources, although the intervention description is incomplete. The primary endpoint is staff fidelity, not a measure of Veteran symptoms, housing stability, or substance use. Those outcomes should not be inferred from a fidelity measure. The record lists six outcome measures and seven analyses, but does not report the detailed results needed to understand the full set of questions tested.

3. Trial Design

The study is listed as randomized, open-label, and parallel, and its status is completed. An analysis note characterizes the design as cluster-randomized and cautions that a simple individual-level re-analysis would be misleading. The registry record does not describe the randomization unit, how clusters were formed, the method used to generate the allocation sequence, or how allocation was concealed. Those details are important to understanding how groups were constituted and how dependence among people in the same cluster was handled.

The study compares GTO-supported implementation with implementation as usual in the HUD-VASH setting. The arm descriptions distinguish case-management staff and Veterans. The primary measure was assessed in staff only, while the record lists separate groups for case management and Veterans under each implementation approach. Because the design is cluster-randomized, the apparent individual-level group counts should not be treated as independent observations without accounting for the cluster structure.

The registry reports enrollment of 227. It lists a start date of 2012-10-29 and a primary completion date of 2015-09-30. The listed sponsor is the VA Office of Research and Development. The phase is listed as NA, which does not characterize a drug-development phase for this behavioral and implementation study.

Masking is listed as none. The record does not explain whether outcome assessors or analysts were blinded, and those details are not reported in the registry record. It also does not describe the number or size of clusters, recruitment procedures, eligibility criteria, or participant flow. These omissions limit the ability to assess the balance of groups, the reach of the implementation strategy, and the precision of cluster-adjusted estimates.

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: All case managers were invited to participate and verbally consented before randomization into the IU or the GTO group. 10 refused to participate.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Clinician fidelity to MISSION-Vet using IU or GTO. Only assessed Staff population.

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: Limited baseline characteristics were collected for the Veteran population who received case management. Only age was collected for Veterans. No baseline characteristics were collected on the staff population.

6. Primary Endpoint

The registry lists the primary outcome as MISSION Fidelity Index, measured over 12-months.

The primary endpoint is the MISSION Fidelity Index at 12 months. It concerns the percentage of MISSION-Vet staff use and assesses whether activities were present in delivery to each participating Veteran. Listed activities include DRT, peer-led sessions, self-guided exercises, referrals made, and delivery of the workbook. The registry says fidelity was analyzed as the percent of adoption of MISSION-Vet.

The operational threshold described in the record is comparatively simple: fidelity is defined by whether the case manager conducted at least one session with a Veteran. The description also says the index has no composite score. These details matter because a measure that records any qualifying contact captures a different aspect of implementation than a measure that scores completeness, frequency, or quality across multiple activities. Although the index description lists several activities, the stated threshold is at least one session; the record does not explain how those elements are combined or reported beyond this definition.

The measure was embedded in the VA Electronic Medical Record System. An electronic record can provide a structured way to capture service delivery, but the registry record does not describe data validation, missing documentation, or how a recorded contact was verified. The endpoint is used to assess adoption and fidelity of MISSION-Vet implementation, not to establish whether Veterans experienced changes in health or housing. No group-specific percentage, contrast, confidence interval, or statistical test for this primary measure is reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Why does clustering affect the analysis?

The registry's analysis note describes the study as cluster-randomized and says a simple individual-level re-analysis would be misleading. In a cluster-randomized design, allocation occurs for groups rather than independently for every person. Outcomes from people in the same group can be correlated because they share staff, setting, or implementation conditions. General statistical principle: this correlation reduces the amount of independent information in the data compared with an analysis that assumes every observation is unrelated to every other observation.

Analyses of cluster-randomized studies therefore generally need to reflect clustering, for example through a model or variance calculation that accounts for the group structure. The exact method, the randomization unit, and the number and size of clusters are not reported in the registry record. Without those details, readers cannot verify whether the analysis reflected the design or how much clustering affected precision. The note says only the sponsor's own analysis is shown; its numerical results and methods are not reported in the registry record.

What does a confidence interval communicate?

General statistical principle: a confidence interval expresses uncertainty around an estimated effect. Its location indicates the range of effect values compatible with the data under the model, and its width conveys precision. A narrow interval indicates greater precision than a wide interval, but interpretation also depends on what effect sizes are meaningful for the question. The registry record does not report a confidence interval for the MISSION Fidelity Index comparison, so precision cannot be assessed.

A p-value addresses compatibility between observed data and a specified null hypothesis under a statistical model. It does not measure the size or importance of an effect. A p-value alone would not show whether an implementation difference was large, small, or estimated precisely; it should be read alongside the effect estimate and its uncertainty. The registry record does not report a primary-comparison p-value. No conclusion about statistical significance can therefore be drawn from the outcome information recorded.

How should the endpoint definition be read?

The MISSION Fidelity Index is described as a measure of adoption and fidelity, with a stated threshold of at least one session between a case manager and a participating Veteran. The description also lists activities such as DRT, peer-led sessions, self-guided exercises, referrals, and workbook delivery. These are not interchangeable measurement concepts: recording whether any contact occurred does not necessarily capture whether all program activities were delivered or how well they were delivered. The registry says there is no composite score, but does not further explain how the listed activities contribute to the reported percentage.

General measurement principle: interpretation depends on the operational definition and the way observations are recorded. Embedding the measure in the VA Electronic Medical Record System may support consistent documentation, but an electronic record entry is not by itself proof of complete or accurate capture. The registry record does not report validation procedures, the approach to incomplete records, or whether missing documentation was distinguished from no service delivery.

What do the planning assumptions mean?

The record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. General statistical principle: such calculations explore the sample size associated with a specified target effect and assumptions; they do not establish what effect was observed or what effect is clinically or operationally important.

The record also distinguishes planning illustrations from the trial's own design. They should not be read as observed power. Observed power is not a substitute for the estimate and its uncertainty, and a planning calculation cannot make a missing outcome result interpretable. The primary observed effect and the details of the trial's original sample-size justification are not reported in the registry record. The assumptions alone do not reveal whether the trial had adequate precision for its primary implementation question.

Why does the distinction between sponsor analysis and recalculation matter?

For cluster-randomized designs, a simple re-analysis from aggregate individual-level summaries can omit the dependence induced by clustering. General statistical principle: a recalculation that ignores the design may yield uncertainty estimates that are not appropriate for the randomized comparison. The analysis note explicitly rules out a simple individual-level re-analysis and says only the sponsor's own analysis is shown. Because no numerical sponsor result is present in the registry record, there is no estimate to interpret or compare with an unadjusted calculation.

Any assessment of the analysis would need the effect estimate, the model or test used, the cluster structure, and the treatment of missing observations. These details are not reported in the registry record. The study's randomized and parallel labels describe broad design features, but do not by themselves specify the statistical analysis plan.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures and seven analyses, but does not report the full analysis plan, which outcome was designated primary in the protocol, or whether the listed analyses were prespecified. It also does not describe a multiplicity strategy. When several outcomes or comparisons are examined, general statistical principle: the chance of at least one apparently notable result can increase if each is assessed separately without accounting for the set of analyses. Adjustment methods and their appropriateness depend on the study questions and analysis plan; the record does not say whether any were used.

The primary measure is identified as the MISSION Fidelity Index at 12 months, but the registry record does not give a result for it or explain how the other analyses relate to that primary question. Without the results and prespecification details, readers cannot assess selective reporting, the hierarchy of outcomes, or how uncertainty should be interpreted across multiple tests.

Missing-data methods are not reported in the registry record. The record does not describe whether missing outcome data occurred, how missing staff records were treated, or whether imputation or another method was used. It also does not report analysis populations, exclusions after randomization, adherence to assigned implementation approach, or participant flow. These omissions matter because incomplete outcome recording can affect both the estimated level of fidelity and the comparison between approaches.

The listed outcome population for the primary measure is staff only. The record does not specify whether the primary analysis included all staff assigned to a group, only staff with documented service activity, or another population. It does not report whether cluster-level participation or departures were considered. These details are not reported in the registry record and cannot be inferred from the randomized designation.

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 record lists serious and other events as zero affected in each of the four named groups. For the case-management groups, the at-risk figures are 22 for MISSION-Vet - IU Case Management and 37 for GTO Case Management. For the Veterans groups, the at-risk figures are 87 for MISSION-Vet - IU Veterans and 81 for GTO Veterans. The figures are reported separately by group and should not be combined into a new total.

These entries describe the adverse-event fields recorded in the registry; they do not establish that no adverse events of any kind occurred. The record does not provide event definitions, collection procedures, surveillance duration for adverse events, or details about how events were attributed. The top serious-event terms list is empty. Death counts are not reported in the registry record.

Zero affected in a registry field means no affected participants were recorded in that field for the listed group. It does not quantify how precisely the study could rule out uncommon events, and it is not a substitute for a detailed safety report. The primary endpoint is an implementation measure among staff, rather than a clinical safety outcome. The safety entries should therefore be read as limited registry reporting, not as a comprehensive assessment of clinical risk.

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

The study addresses whether an implementation support model can facilitate adoption and fidelity of MISSION-Vet in HUD-VASH. Its primary measure is defined around staff delivery, with fidelity described as at least one case-manager session with a participating Veteran. This makes the outcome relevant to implementation activity, but it does not directly measure Veteran health, housing, or substance-use outcomes.

The registry record does not report a primary outcome estimate or a comparison between GTO and implementation as usual. It therefore does not establish whether the approaches differed, how large any difference was, or how precise an estimate might be. The absence of a reported result is not evidence that the approaches were equivalent, and it is not evidence that one approach was better. Such conclusions require results and uncertainty estimates.

Even if staff adoption differed, that would answer an implementation question rather than demonstrate a downstream change in Veterans' circumstances. General principle: implementation outcomes and clinical or social outcomes are related but distinct questions. A change in service delivery does not by itself establish a change in symptoms, housing stability, or other outcomes. The registry description identifies the rationale for addressing mental health and substance use in HUD-VASH, but it does not report findings on those consequences.

The design is described as cluster-randomized, so interpretation also depends on analysis that accounts for clusters. The registry note cautions against simple individual-level re-analysis. The underlying cluster details and statistical methods are not reported in the registry record, limiting independent assessment of the reported analysis. The completed status and enrollment figure describe the study record, not its outcome.

13. Why This Trial Matters Statistically

This trial is statistically notable because the research question concerns implementation in a service-delivery setting, while its primary endpoint is measured among staff. The outcome definition focuses on adoption and fidelity of MISSION-Vet, with a threshold based on whether a case manager conducted at least one session with a participating Veteran. That operational definition is central to interpreting what a result would mean: it concerns recorded delivery, not necessarily the completeness or quality of every program component.

The cluster-randomized design also makes the unit of analysis important. Observations within a shared cluster may be correlated, so the design must be reflected in uncertainty estimates. The registry note explicitly warns that individual-level re-analysis would be misleading. This is a useful reminder that randomized allocation does not automatically make every person an independent statistical unit.

The record illustrates the limits of interpreting a trial from design and endpoint descriptions alone. It reports the primary question, the groups, and the endpoint definition, but not the numerical primary result. Without an estimate and an uncertainty interval, readers cannot determine the direction, size, or precision of the comparison. The listed outcome and analysis counts also make the absence of a reported analysis plan relevant to interpreting potential multiplicity.

For implementation research, clear reporting of the cluster structure, outcome capture, analysis population, missing data, and effect estimates is necessary to judge both statistical evidence and practical meaning. Those details are not reported in the registry record. The study's topic and design remain identifiable, but the comparative evidence cannot be evaluated from the recorded results.

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 registry record provides a truncated brief summary and truncated descriptions of MISSION-Vet in the arm descriptions. It therefore does not fully specify the intervention content or implementation-as-usual procedures. The detailed protocol, eligibility criteria, setting characteristics, recruitment process, and participant flow are not reported in the registry record.

Although an analysis note calls the study cluster-randomized, the randomization unit, number and size of clusters, and allocation procedures are not reported. The record does not provide the sponsor's analysis methods or numerical outcome estimates. It also does not report confidence intervals, p-values, or the primary effect estimate. This prevents assessment of effect magnitude, precision, or the analysis of clustering.

The primary endpoint description names several activities but defines fidelity using at least one session. The registry does not explain how the activity list relates to the percentage of adoption, how records were validated, or how missing documentation was handled. The analysis population for the primary outcome and the handling of missing staff records are not reported in the registry record.

The record lists six outcome measures and seven analyses, but does not provide a full statistical plan or multiplicity approach. The adverse-event entries are limited to recorded counts; definitions, collection methods, and death counts are not reported in the registry record. These reporting gaps constrain interpretation and should not be filled by assumptions about the protocol or analysis.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: MISSION-Vet HUD-VASH Implementation Study — NCT01430741.
• Registry record last updated 2018-06-29; status last verified 2018-05.
• Results first posted 2017-05-30.
• 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

NCT01430741, the MISSION-Vet HUD-VASH Implementation Study, is listed as completed and randomized, with an open-label parallel design. An analysis note identifies it as cluster-randomized. The registry reports enrollment of 227, a start date of 2012-10-29, and primary completion on 2015-09-30. The sponsor is the VA Office of Research and Development.

The study compares GTO-supported implementation with implementation as usual. The primary outcome is the MISSION Fidelity Index at 12 months, assessed in staff and defined around adoption and delivery of MISSION-Vet. The registry record does not report the primary outcome estimate, comparative effect, confidence interval, or p-value. It lists six outcome measures and seven analyses, but detailed methods and analysis populations are not reported in the registry record.

Adverse-event fields record zero affected for serious and other events in each listed group. Death counts are not reported in the registry record. The cluster structure and missing-data methods are insufficiently described for independent statistical evaluation.