Criminal Justice Coordinated Transitional Care: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Criminal Justice Coordinated Transitional Care (NCT05376371), a na na study. The primary outcome is Feasibility Outcome: Number of Participants Who Are Enrolled and Complete the Baseline Study Assessment.

2. Clinical Question

3. Trial Design

Criminal Justice Coordinated Transitional Care is a pilot implementation study of an adapted care-transition intervention for incarcerated people preparing for release. Its official title describes health systems innovations supporting transitions of care for people living with HIV, hepatitis C, and substance use disorder. The conditions listed in the record are HIV, Hepatitis C, and Substance Use Disorders.

The registry identifies the study model as single group and allocation as NA. It lists CJC-TraC as the intervention and does not list a comparator arm. Masking is recorded as NONE, and phase is recorded as NA. With no randomized control group, the study design is suited to describing feasibility and outcomes within the intervention group, but it cannot by itself establish a comparative treatment effect.

The registry lists enrollment of 219. The brief summary states that the project aimed to enroll 220 incarcerated individuals with HIV, HCV, or a history of substance misuse who were preparing for release. That summary says participants could expect to be on study for up to 6 months. The study status is COMPLETED, with a start date of 2022-11-29 and a primary completion date of 2024-12-03.

The stated primary outcome concerns enrollment and completion of a baseline assessment, rather than a comparison of clinical outcomes between groups. Secondary outcomes concern attendance at non-emergency outpatient care visits within 3-months following release and the number of participants with a first such visit within 60 days. Although 10 outcome measures are listed, the registry records 0 analyses. Outcome results beyond the overall enrollment figure are not reported in the registry record.

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:

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 Feasibility Outcome: Number of Participants Who Are Enrolled and Complete the Baseline Study Assessment, measured over at enrollment, up to 1 day.

The primary endpoint is the number of participants who both enroll and complete the baseline study assessment. Its stated timeframe is at enrollment, up to 1 day. The registry describes this count as a feasibility outcome: completing the assessment after enrollment is meant to demonstrate whether the target population can be engaged in the prison setting.

This endpoint is a count, not a treatment-effect estimate. In a single-group pilot, it can describe whether participants entered the study and completed the initial assessment, but it does not compare outcomes with usual care or another intervention. The overall registry enrollment is 219; that figure is not identified as the count completing the baseline assessment. The combined primary endpoint result is not reported in the registry record, so the enrollment figure alone cannot establish how many participants met both conditions.

Feasibility is an implementation question. A count of enrolled participants who complete baseline assessment can help characterize whether study procedures reached the intended population at the point of enrollment. It does not, on its own, show whether the intervention changed health-care use after release, whether participants continued to engage with care, or whether outcomes differed from what would have occurred without CJC-TraC. Those questions require outcome data and, for comparative effect claims, an appropriate comparison. The registry’s secondary outcomes concern outpatient care after release, but their numerical results are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the primary count measure?

In general, a count outcome records how many participants meet a stated event definition. Here, the definition requires both enrollment and completion of the baseline study assessment. The endpoint is recorded at enrollment, with a timeframe of up to 1 day. It is therefore a measure of initial study engagement, not a continuous clinical measurement or a comparison between treatment groups. The registry describes its purpose as demonstrating feasibility of engaging the target population in the prison setting.

A count needs a clear denominator and an unambiguous event definition for interpretation. The registry enrollment is 219, while the primary endpoint is a distinct combined measure. Since the endpoint result is not reported, the number of enrolled participants who completed baseline assessment cannot be determined from the record. It would be incorrect to treat total enrollment as though it were the endpoint result.

What can a single-group study estimate?

In general, a single-group study can describe characteristics and outcomes among its participants. If outcome measurements are available, it can report the number or proportion experiencing an event, or describe changes over time where the measurements and analysis support that description. However, without a comparator, the study does not directly estimate the difference between CJC-TraC and another care strategy. Changes observed within a group can reflect factors other than the intervention, so a within-group observation does not by itself establish a causal effect.

The registry lists a single-group model and allocation as NA, with no masking. It does not list a control arm. The record therefore does not describe a randomized allocation process or a like-for-like treatment comparison. A statistical method cannot create a control group that the study design did not include.

How should estimates and uncertainty be read?

In general, an estimate describes the data observed in a study, while a confidence interval expresses uncertainty around an estimate under the assumptions of the analysis. A narrower interval indicates greater precision within those assumptions; a wider interval indicates less precision. A confidence interval does not correct for selection bias, missing outcomes, or the lack of a comparator. No confidence intervals or effect estimates are listed among the registry analyses, and the registry records 0 analyses.

A p-value, in general, assesses how compatible data are with a specified statistical model or null hypothesis. It does not quantify the size or practical importance of an effect, and it does not establish causation. No p-values or inferential results are reported in the registry record. Because there is no comparator group, a conventional between-group treatment-effect test is not documented in the record.

What do the secondary outcomes imply for analysis?

The secondary outcomes concern outpatient care after release: attendance at non-emergency visits within 3-months and participants with a first non-emergency outpatient visit within 60 days. These describe event occurrence and timing. In general, an event count or proportion summarizes whether an event occurred over a defined period, while a time-to-event analysis also uses information about when it occurred and may need to account for participants whose event was not observed during follow-up. The record does not report the numerical outcomes or an analysis method, so it is not possible to determine how follow-up, censoring, or incomplete observation were handled.

How should planning calculations be distinguished from study results?

In general, sample-size calculations are planning illustrations based on assumptions about the effect to detect, statistical significance level, allocation, and analysis method. They do not report observed outcomes and are not observed power. The stated assumptions for the planning illustrations describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. Time-to-event planning uses a total event count, while other planning results use participants per arm. These are planning assumptions, not the design of this single-group study, and the record does not report a sample-size justification for the trial itself.

In general, over-dispersion matters when variability in count data is greater than a statistical model expects. If ignored, uncertainty can be understated and inferential conclusions can be misleading. The primary endpoint is a participant count, but no model, dispersion estimate, or analysis is reported. It would therefore be speculative to say that any particular count model or adjustment was used.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("CJC-TraC Intervention")
n      <- c(219)
events <- c(219)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  CJC-TraC Intervention  219  219  100.0  98.3  100.0  98.3  100.0  98.3  100.0

11. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study evaluates multiple outcomes, time points, or statistical tests. In general, conducting many tests can increase the chance of at least one apparently notable result by chance. Researchers may address this through a prespecified hierarchy, adjustment procedure, or a clear distinction between primary and exploratory outcomes. The registry lists 10 outcome measures, but it records 0 analyses. A multiplicity strategy is not reported in the registry record, so it is not possible to determine whether any adjustment or testing hierarchy was planned or used.

The primary outcome is the count of participants who enroll and complete the baseline assessment. Secondary outcomes address post-release outpatient care, including attendance within 3-months and first visits within 60 days. The registry does not report numerical results for these outcomes or statistical tests. There is therefore no reported set of outcome estimates from which to assess how multiplicity was handled.

Missing-data handling is also not reported in the registry record. This matters in general because participants may have incomplete assessments or follow-up, and the analysis can depend on whether missingness is excluded, modeled, or addressed through another approach. For post-release outcomes, the record does not describe how participants without an observed visit, or without complete follow-up, were treated. No assumptions about those cases should be inferred.

The analysis populations are not reported in the registry record. The available record does not define whether outcome analyses included all enrolled participants, only those completing baseline assessment, or another set. With no listed analyses, there is no basis to assess exclusions, protocol deviations, or the handling of participants who did not complete follow-up.

12. 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 lists one CJC-TRAC Intervention group for adverse-event reporting. For serious adverse events, 209 participants are listed as at risk and 0 as affected. For other adverse events, 209 are listed as at risk and 0 as affected. The record also lists 2 deaths. No serious adverse-event terms are listed.

These figures describe the registry entries and should not be read as a comparison between intervention and control groups: no control group is listed. The record does not provide details about event types, timing, severity beyond the serious-event category, or whether any event or death was considered related to CJC-TraC. In particular, the 2 deaths should not be presumed to be intervention-related or unrelated based on the information recorded.

In general, an “at risk” denominator identifies the group used for the event count, and an “affected” count records participants with the event as represented in the registry. Here, the serious and other adverse-event counts are both 0 among 209 at risk. That does not establish that no events occurred outside the registry’s reporting definitions or observation period. The record does not report further safety-analysis details or a comparative safety estimate.

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

The registry establishes that this completed study enrolled 219 participants and evaluated an adapted Coordinated Transitional Care intervention in a single-group pilot. The intervention was intended to help incarcerated people preparing for release transition their health care. The target population described in the record includes people living with HIV, hepatitis C, or a history of substance misuse, with substance use disorder also listed in the intervention description.

The central primary outcome was a feasibility count: participants who enrolled and completed the baseline assessment. That result is not reported in the registry record. The enrollment figure of 219 cannot stand in for the combined endpoint because the record does not say how many enrollees completed the assessment. The registry also lists post-release outpatient-care outcomes, but their results are not reported.

The design does not establish what would have happened to comparable participants without CJC-TraC. The single-group model and absence of a comparator mean that the registry cannot provide a randomized between-group estimate of intervention effect. Even a reported outcome among participants in the intervention group would describe that group, not the difference attributable to the intervention.

The record lists 0 participants affected by serious adverse events and 0 affected by other adverse events among 209 at risk, alongside 2 deaths. It does not provide details sufficient to interpret the deaths’ relationship to the intervention. These safety entries are descriptive and are not comparative findings.

In general, a pilot implementation study can inform whether an intervention and its procedures merit further evaluation, but that judgment depends on clearly reported feasibility and acceptability results. The registry describes feasibility and acceptability as aims, yet does not report the primary feasibility result or a numerical acceptability result. Thus, the record supports describing the study’s purpose, design, enrollment, and listed safety counts, but not a conclusion that CJC-TraC improved care, changed health outcomes, or was feasible or acceptable according to a particular threshold.

14. Why This Trial Matters Statistically

This trial is statistically important because it separates an implementation question from a treatment-effect question. CJC-TraC was studied as a pilot implementation intervention for health-care transitions after incarceration. Its primary outcome focused on enrollment and baseline assessment completion, an early indicator of whether study procedures could engage the intended population. That kind of outcome can be relevant when considering how to evaluate an intervention in a criminal justice setting.

The design also sets a clear boundary on interpretation. A single-group study can describe participation and outcomes in its enrolled group, but without a comparator it cannot establish a comparative effect. This distinction matters when reading any outcome reported from a pilot: feasibility, acceptability, and clinical effectiveness are different questions and require different evidence.

The registry records enrollment of 219 and identifies a primary feasibility outcome, but does not report the result for that outcome. It also lists secondary outcomes related to post-release outpatient care without numerical results. As a result, readers cannot assess the degree to which the study met its feasibility aim or what the post-release outcomes were. The record lists 10 outcome measures and 0 analyses, limiting assessment of statistical uncertainty, analysis choices, and multiplicity.

The safety record similarly calls for careful description rather than extrapolation. It lists 0 participants affected by serious adverse events and 0 affected by other adverse events among 209 at risk, as well as 2 deaths, with no further attribution details. These are registry counts, not comparative estimates.

For biostatisticians and clinical researchers, the study highlights why precise endpoint reporting matters. An overall enrollment figure is not interchangeable with a composite feasibility endpoint that also requires baseline completion. Likewise, reporting design and enrollment without outcome analyses leaves important questions unanswered. Clear counts, denominators, follow-up definitions, and analysis methods are necessary to interpret implementation outcomes without overstating what a pilot design can establish.

15. 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 direct limitation of the registry record is that the primary feasibility result is not reported. Although enrollment is recorded as 219, the endpoint specifically requires enrollment and completion of the baseline assessment. The record does not report how many participants completed that assessment, so the primary outcome cannot be reconstructed from the enrollment total.

The study is a single-group pilot with allocation recorded as NA and no comparator listed. It therefore does not support a randomized comparison or a direct estimate of outcomes relative to another care approach. This is a design limitation for causal interpretation, regardless of whether within-group outcomes are available.

The registry lists 10 outcome measures but 0 analyses. Results for the listed secondary outcomes on outpatient care after release are not reported in the registry record. Analysis methods, missing-data procedures, analysis populations, and multiplicity handling are also not reported. Without these details, the precision and robustness of any outcome estimate cannot be assessed.

The brief summary describes an aim to enroll 220 people, while registry enrollment is 219. The record does not provide a sample-size justification or explain the relationship between the enrollment aim and the final enrollment. No inference about the reason for the difference is warranted.

Safety information is limited to the listed counts: 0 participants affected by serious adverse events and 0 affected by other adverse events among 209 at risk, plus 2 deaths. Event details and attribution are not reported. These limitations are specific to what the registry records and should not be filled by assumptions about protocol procedures or unlisted analyses.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Criminal Justice Coordinated Transitional Care — NCT05376371.
• Registry record last updated 2025-11-17; status last verified 2025-11.
• Results first posted 2025-11-17.
• 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.

19. Record Summary

Criminal Justice Coordinated Transitional Care (NCT05376371) is a completed, single-group pilot implementation study sponsored by the University of Wisconsin, Madison. It evaluated CJC-TraC, an adapted Coordinated Transitional Care intervention intended to assist incarcerated individuals with HIV, hepatitis C, or substance use disorder in transitioning their health care. The record lists enrollment of 219, a start date of 2022-11-29, and a primary completion date of 2024-12-03.

The primary outcome is the number of participants who enrolled and completed the baseline assessment at enrollment, up to 1 day. Its result is not reported in the registry record. Secondary outcomes concern non-emergency outpatient care following release; numerical results and analyses are not listed. The registry records 10 outcome measures and 0 analyses. Adverse-event entries list 0 serious and 0 other events among 209 at risk, and 2 deaths; further details are not reported.