Fostering MAT Use in Justice Populations: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Fostering MAT Use in Justice Populations (NCT04363320), a randomized na study. The primary outcome is Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase.

2. Clinical Question

3. Trial Design

The registry describes a randomized, unmasked, factorial trial, with behavioral interventions and no applicable phase listed. The study was titled “Fostering MAT Use in Justice Populations.” Its stated purpose was to test NIATx Coaching and ECHO with jail- and community-based healthcare providers as strategies to increase medication-assisted treatment use among justice populations. The record lists an enrollment of 256 and a completed status. The start date is 2020-07-30, and the primary completion date is 2024-02-28.

The four intervention combinations varied NIATx Coaching intensity and whether ECHO was included. All combinations began with a virtual kick-off meeting split over two days. High-dose coaching included 12 monthly coaching calls; low-dose coaching included four calls scheduled at months 1, 4, 8, and 12. The ECHO combinations included 12 monthly scheduled prescriber video conferences, while the no-ECHO combinations did not list these conferences.

The primary outcome was measured during the intervention phase, with a timeframe described as baseline to 12 months. Site staff tracked counts of justice-involved people initiated on and engaged with MOUD. The registry record does not explain the randomization unit, allocation concealment, stratification, or the statistical model. It also does not report whether any outcomes were assessed by masked personnel. The stated masking is none.

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:

Analysis population for the primary outcome, as defined in the registry: The Overall Number of Participants Analyzed reported are justice involved individuals staff (who were not consented and enrolled). Staff (consented participants) collected counts of justice involved individuals with various MOUD from their sites. Not all sites provided all three forms of medication at all times. Due to lack of tracking systems in the jail, some sites were only able to provide one of the two monthly counts.

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 overall number analyzed includes the count of staff participants consented. The overall number of units analyzed is the number of sites that started the study.

6. Primary Endpoint

The registry lists the primary outcome as Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase, measured over baseline to 12 months.

The primary endpoint is the mean number of new eligible justice-involved people initiated with MOUD per month during the intervention phase. The registry defines included individuals as people initiated on buprenorphine, extended-release injectable naltrexone, or methadone and engaged with MOUD use. Counts came from organization monthly tracking sheets. The timeframe is baseline to 12 months.

This is a continuous measure of implementation reach: it describes how many people sites newly initiated, on average, over a month. It focuses on uptake of MOUD in the service settings targeted by the implementation strategies rather than on an individual clinical outcome. Site-level tracking can help assess whether implementation support coincides with changes in service reach, but the measure alone does not describe treatment quality, duration, individual outcomes, or why counts changed.

The registry record notes that not all sites provided data for all three forms of medication. It does not report the observed mean, standard deviation, number of contributing sites, or outcome results by intervention combination. The endpoint is therefore described, but its observed values and precision cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the trial as randomized and factorial. Randomization is a design method intended, in general, to reduce systematic differences between assigned groups. A factorial structure assigns combinations of intervention components—in this case, coaching intensity and ECHO participation. This can support estimates of the components' separate effects and their joint pattern, depending on the prespecified contrasts and analysis. The registry record does not report the randomization unit, the allocation procedure, the analysis model, or the planned contrasts, so those details cannot be evaluated.

What does the primary measure represent?

The primary measure is a mean of a continuous quantity: the monthly number of newly initiated, eligible justice-involved people receiving MOUD. A mean describes the average value across the analysis units used. The record calls the endpoint a mean and identifies standard deviation as its dispersion measure, but it does not report the observed means or standard deviations. It also does not specify in the registry record whether analysis units were sites, months, or another level, or how repeated monthly observations were handled.

In general, a standard deviation describes variation among measured values; it is not the same as the standard error, which describes uncertainty in an estimated mean. A mean and standard deviation can help characterize an outcome, but they do not by themselves provide an adjusted comparison or a confidence interval. The registry record does not report the model, standard errors, confidence intervals, or test statistics for the primary endpoint.

Why might count data need special care?

The endpoint is a count summarized as a mean. In general, count outcomes may be skewed, and their variability can exceed what a simple model assumes. Over-dispersion means that the observed variation is greater than a model's assumed variation; if ignored, uncertainty estimates and tests can be unreliable. Counts may also differ because sites serve different numbers of people or have different observation opportunities. Appropriate methods depend on the data structure and assumptions. The registry record does not report whether the outcome was modeled as count data, whether over-dispersion was assessed, or whether site size or observation time was incorporated.

These are general statistical considerations, not descriptions of methods confirmed for this trial. The record does not state whether an analysis used a count regression model, a transformation, a nonparametric method, or another approach. It would be inappropriate to assign a method to the trial without a reported analysis description.

How should uncertainty be read?

In general, an effect estimate describes the magnitude and direction of a comparison, while a confidence interval communicates its statistical uncertainty under the model and assumptions. A narrow interval is more precise than a wide interval, but precision is not the same as clinical or implementation importance. A p-value addresses compatibility of data with a specified null model; it does not measure the size or practical relevance of an effect. The registry record does not report these statistics for the primary endpoint, so the strength of evidence and precision cannot be assessed.

The record lists seven outcome measures and 16 analyses. When multiple outcomes or comparisons are examined, the chance of at least one apparently unusual result can increase. In general, multiplicity procedures can control specified error rates, but the appropriate approach depends on which comparisons were planned and which conclusions are intended. The registry record does not report whether any correction or hierarchical testing strategy was used.

What do planning calculations mean?

In general, a sample-size calculation is a planning exercise based on assumptions about an effect, variability, significance level, allocation, and analysis method. It is not observed power and does not establish that the trial detected an effect. The record describes a planning illustration based on a fraction of an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; non-time-to-event illustrations are expressed as participants per arm. These assumptions describe the illustration, not necessarily the trial's original design. The registry record does not report the trial's own sample-size justification or planning assumptions.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists seven outcome measures and 16 analyses, but does not describe how the analyses were prioritized or whether multiplicity was addressed. When many outcomes or comparisons are examined, interpreting an isolated statistical finding requires attention to the analysis plan and the possibility of chance findings. In general, an adjustment can change the threshold or interval interpretation used for a family of tests. The record does not report whether such an adjustment was made, which comparisons formed any testing family, or whether the primary endpoint had a prespecified contrast.

Missing-data methods are also not reported in the registry record. The primary outcome depended on monthly tracking sheets, and the record states that not all sites provided all three forms of medication. It does not say whether missing medication information or missing monthly site reports occurred, how much information was unavailable, or how missing values were handled. The degree to which incomplete reporting could affect estimates therefore cannot be assessed.

The primary population description distinguishes staff who collected the information from the justice-involved individuals represented in the counts. It says the individuals were not consented and enrolled, while staff were the consented participants. The registry record does not give the number of sites or staff contributing primary outcome data, the analysis population definition beyond this description, or whether all randomized sites were included in each analysis. It also does not report whether analyses followed assignment regardless of adherence or used another population definition.

These omissions limit assessment of both bias and statistical uncertainty. They do not establish that data were missing or that multiplicity affected the findings; they mean those issues are not reported in the registry record.

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 safety figures are reported across the four intervention combinations. For high-dose NIATx Coaching with ECHO, 78 were listed at risk for serious events and 78 for other events; zero were affected in either category, and deaths were 0. For low-dose coaching with ECHO, the corresponding at-risk figures were 65 and 65, with zero affected in both categories and deaths of 0. For high-dose coaching without ECHO, the figures were 60 and 60, zero affected in either event category, and deaths of 1. For low-dose coaching without ECHO, the figures were 53 and 53, zero affected in either category, and deaths of 0.

These are descriptive registry counts. The record does not report the nature or cause of the death, whether it was considered related to an intervention, or the timing of events. The figures do not establish that any intervention caused or prevented an event. The registry record also does not describe how event surveillance was conducted or whether the at-risk counts represent all people exposed to each implementation combination. Zero affected in a category means no affected events were recorded in that category in the posted figures; it is not proof that the underlying risk is zero.

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

The trial addresses an implementation question: whether coaching intensity and ECHO participation, alone or in combination, were associated with the monthly number of newly initiated justice-involved people receiving MOUD. The intervention descriptions and primary measure make the intended service-level focus clear. The registry record reports a completed randomized factorial study, but it does not report the primary outcome estimates needed to say what the study found.

In particular, no comparison means, effect estimates, confidence intervals, or primary-outcome tests are reported in the record. As a result, the magnitude and direction of any difference, and how precisely it was estimated, cannot be determined. The record cannot support a conclusion that one combination increased or decreased reach relative to another. It also cannot establish equivalence or no difference; absence of a reported estimate is not evidence of no effect.

The endpoint concerns newly initiated individuals counted through site tracking. It does not, by itself, show whether people continued treatment, experienced improved health outcomes, or had other individual-level benefits or harms. The listed secondary outcome concerns MOUD sustainability, but its results are not reported in the registry record. Generalization beyond the participating settings would also depend on site characteristics and implementation context, details not reported.

The safety counts should be read separately from the primary endpoint. They describe recorded affected events and deaths by intervention combination, but attribution and event circumstances are not reported. They cannot be interpreted as evidence that a strategy caused a safety outcome.

Overall, the record defines the study question, intervention combinations, and main measurement approach. Without posted primary results and their uncertainty, its findings on implementation reach remain unreported.

13. Why This Trial Matters Statistically

Implementation studies ask whether evidence-based practices can be adopted and used in service settings, not only whether an intervention has an effect under tightly controlled conditions. This trial focused on providers in jail- and community-based healthcare settings and on MOUD uptake among justice-involved populations. Its primary endpoint was a service-reach measure, using monthly site tracking rather than an individual-level clinical outcome.

The factorial arrangement is statistically relevant because it distinguishes two implementation components: coaching intensity and ECHO participation. Such designs can potentially use data to assess component effects and whether the components work differently in combination. The value of that structure depends on clear definitions of the target contrasts and appropriate analysis; those details are not reported in the registry record.

The measure also illustrates challenges common to implementation data. Monthly counts may reflect both implementation activity and the amount or completeness of information collected by sites. The registry notes that not all sites reported all three forms of medication. That makes transparent reporting of data coverage, analysis units, variability, and uncertainty important for interpreting a reach estimate.

The registry record identifies the primary outcome and reports that the trial is completed, but does not report its primary results. This distinction matters: a well-defined question and design do not substitute for outcome estimates. Without those estimates, readers cannot assess whether the strategies were associated with differences in reach or how precise any comparison was.

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.

A central limitation of the registry record is that it does not report the primary outcome results. The mean monthly counts, standard deviations, between-combination estimates, confidence intervals, and statistical tests are not reported in the registry record. This prevents assessment of both effect direction and precision, regardless of the trial's completed status.

The primary endpoint relies on organization monthly tracking sheets. The record notes that not all sites provided data for all three medication types but does not describe data completeness, the handling of unavailable information, or how site-level differences were addressed. It also does not report the number of contributing sites or the analysis unit for the primary measure. These omissions make it difficult to assess representativeness and the potential influence of incomplete reporting.

The factorial design is described through four intervention combinations, but the record does not state the planned contrasts, statistical model, treatment of interaction, or randomization unit. It does not report allocation concealment or the analysis population. The record also lists multiple outcomes and analyses without describing any multiplicity strategy, and it does not provide the statistical analysis plan or sample-size justification.

Finally, safety figures are limited to counts by arm. Event descriptions, timing, and attribution are not reported. These are limitations of the information in the registry record and do not demonstrate that the trial itself lacked procedures or analyses that are not described there.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Fostering MAT Use in Justice Populations — NCT04363320.
• Registry record last updated 2025-05-28; status last verified 2025-05.
• Results first posted 2025-05-28.
• 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

NCT04363320, “Fostering MAT Use in Justice Populations,” is registered as a completed randomized, unmasked factorial trial with behavioral interventions. The trial evaluated high- versus low-dose NIATx Coaching with or without ECHO among jail- and community-based healthcare providers. The primary endpoint was the mean monthly number of new eligible justice-involved people initiated with and engaged in MOUD, tracked from baseline to 12 months.

The record lists an enrollment of 256, seven outcome measures, and 16 analyses. It describes MOUD sustainability as a secondary outcome and provides safety counts across the four intervention combinations. However, primary outcome estimates and their uncertainty are not reported in the registry record. The available description therefore establishes the question and measurement approach, but not the results of the primary comparison.