Substance Use Treatment and Recovery Team: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Substance Use Treatment and Recovery Team (NCT05086796), a randomized na study. The primary outcome is In-hospital Initiation of MOUD Therapy.

2. Clinical Question

The registry description frames the trial more broadly than the primary endpoint alone. It asks whether a collaborative care team increases use of medication for opioid use disorder and opioid use disorder-focused discharge planning, and improves linkage to follow-up care. The primary comparison addresses in-hospital medication initiation. The listed secondary outcomes concern a specific discharge plan, medication use after discharge, outpatient medical care after discharge, and days with any opioid use during the past 30 days.

The intervention was evaluated in a pragmatic, multi-site setting, with usual care as the comparator. Randomization was stratified by site and prior medication exposure according to the registry summary. The clinical question is therefore about the contrast between assignment to two care approaches in the enrolled inpatient population, not about medication or care-team effects in every person with opioid use disorder.

3. Trial Design

The registry identifies this as a randomized, parallel-group, open-label trial. Participants were assigned to START or usual care, and the study is marked completed. The trial began on 2021-11-11 and its primary completion date is 2023-12-19. The enrollment field lists 325 participants. Separately, the brief summary describes a plan to randomize 414 patients; the registry record does not explain the difference between that planned figure and the enrollment field.

The brief summary describes a pragmatic study conducted at three diverse sites: Cedars-Sinai Medical Center in Los Angeles, the University of New Mexico Hospital in Albuquerque, and Baystate Health in Springfield, Massachusetts. It says randomization was stratified by site and prior medication for opioid use disorder exposure. The registry identifies Cedars-Sinai Medical Center as the sponsor. The intervention arm received the collaborative START approach, while the comparator arm received usual care. No masking was used.

The primary outcome population is described as all participants who met eligibility criteria and were randomized to one of the two arms. The posted arm counts for this outcome are 164 in START and 161 in usual care. The endpoint is a binary participant count: whether medication for opioid use disorder was initiated before discharge. The registry describes the inpatient stay as averaging 7 days.

The registry lists four secondary outcomes: an opioid use disorder-specific discharge plan, any post-discharge medication use, post-discharge outpatient medical care, and past 30-day number of days with any opioid use. Results are present for the first three in the posted secondary analyses. A result for days with any opioid use is not reported in the registry record. The original statistical analysis plan, including the rationale for the original target enrollment and details of any planned interim analyses, is 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

Analysis population for the primary outcome, as defined in the registry: Intention-to-treat: All participants who met eligibility criteria and were randomized to one of the two arms.

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: Intention-to-treat population defined as all participants who met eligibility criteria, consented, and were randomized to one of the two treatment arms.

6. Primary Endpoint

The registry lists the primary outcome as In-hospital Initiation of MOUD Therapy, measured over During the inpatient stay, an average of 7 days.

The primary endpoint is the number of participants who initiated medication for opioid use disorder before hospital discharge. Initiation is defined as use of any FDA-approved pharmacotherapy for opioid use disorder, including buprenorphine, naltrexone, and methadone. The registry specifies that this is a binary outcome assessed during the inpatient stay, described as averaging 7 days.

This endpoint captures whether a participant started medication during the hospitalization; it does not measure duration of treatment, adherence, or whether treatment continued after discharge. Those are distinct questions. Post-discharge medication use is listed separately as a secondary outcome over 30 days.

For a binary outcome, each participant is classified according to whether the event occurred. The posted primary counts are 94 of 164 participants assigned to START and 43 of 161 assigned to usual care. Comparing the proportions with an event gives an interpretable contrast between the randomized groups. The registry also reports a risk ratio, which compares the event risks in the two groups, and the recalculation reports a risk difference, which expresses the absolute contrast on the probability scale.

General: an endpoint such as medication initiation is useful for assessing whether a care approach changes a concrete treatment process during a defined period. It is not by itself a complete measure of recovery, quality of life, long-term treatment engagement, or overall clinical benefit. Those broader outcomes require their own definitions and data.

7. Results Posted in the Registry

• Substance Use Treatment and Recovery Team (START): 57.3% (94/164) versus 26.7% (43/161) on control; risk difference 30.6 percentage points (95% CI 20.4 to 40.8), risk ratio 2.15 (1.61–2.86); unadjusted two-proportion z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

OUD-specific Discharge Plan

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Substance Use Treatment and Recovery Team (START): 49.4% (81/164) versus 27.3% (44/161) on control; risk difference 22.1 percentage points (95% CI 11.8 to 32.4), risk ratio 1.81 (1.34–2.43); unadjusted two-proportion z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for Substance Use Treatment and Recovery Team (START) than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Any Post-discharge MOUD Utilization

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Substance Use Treatment and Recovery Team (START): 52.4% (65/124) versus 30.8% (32/104) on control; risk difference 21.7 percentage points (95% CI 9.2 to 34.1), risk ratio 1.70 (1.22–2.38); unadjusted two-proportion z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for Substance Use Treatment and Recovery Team (START) than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Post-discharge Outpatient Medical Care

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Substance Use Treatment and Recovery Team (START): 34.4% (42/122) versus 18.3% (19/104) on control; risk difference 16.2 percentage points (95% CI 4.9 to 27.4), risk ratio 1.88 (1.17–3.03); unadjusted two-proportion z-test p = 0.006.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for Substance Use Treatment and Recovery Team (START) than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary outcomes with posted results show a consistent direction: each of the three reported care-process outcomes has a higher event risk in the START group than in usual care. The registry-reported risk ratios for those analyses are above 1, and their reported confidence intervals are also above 1. This pattern is directionally aligned with the primary result, which concerns medication initiation during the inpatient stay.

The secondary outcomes extend the question from in-hospital initiation to discharge planning and care after discharge. They are related to the intervention's stated goals, but each captures a distinct process and time window. A discharge plan is not the same outcome as medication initiation, and post-discharge service use does not itself measure longer-term recovery or medication continuity.

The registry lists four secondary outcomes, including past 30-day number of days with any opioid use. A result for that outcome is not reported in the registry record. The pattern across outcomes therefore cannot be taken as a complete account of all listed secondary questions.

General: secondary outcomes are often interpreted with more caution than a prespecified primary outcome because multiple comparisons create more opportunities for apparently notable findings by chance. Whether the trial adjusted for multiple testing, ranked outcomes, or designated any secondary endpoint as confirmatory is not reported in the registry record. The unadjusted secondary analyses consequently carry less evidential weight than a single primary analysis with a prespecified role. Their consistency can be informative, but it does not remove the need to consider multiplicity, outcome-specific denominators, and the missing result for one listed outcome.

The post-discharge outcomes also have fewer participants in their denominators than the primary outcome. The registry does not explain these denominator differences or report the handling of missing observations. The overall secondary pattern should therefore be understood as a description of the outcomes with posted estimates, not as proof that the intervention changed every aspect of post-discharge care.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• OUD-specific Discharge Plan
• Any Post-discharge MOUD Utilization
• Post-discharge Outpatient Medical Care
• Past 30-day Number of Days With Any Opioid Use

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is binary: a participant either initiated medication for opioid use disorder before discharge or did not. The registry reports counts by randomized group, and the posted unadjusted recalculation compares the event risks in START and usual care. The primary population is described as intention-to-treat, meaning participants are analyzed according to their assigned group rather than according to treatment actually received. The registry does not give further detail on how the stated population was implemented in the analysis.

What do the risk difference and risk ratio describe?

General: a risk difference subtracts one group's event risk from the other group's event risk. It expresses the contrast on the absolute probability scale. For the primary outcome, the recalculated risk difference is 0.306, with an interval from 0.204 to 0.408. A risk ratio divides one group's event risk by the other group's event risk. A value above 1 indicates a higher event risk in the numerator group under the stated comparison. The recalculated primary risk ratio is 2.146, with an interval from 1.609 to 2.862. These measures describe the same binary outcome in different ways; neither alone describes why the groups differed.

What does randomization contribute?

General: random assignment is intended to make the groups comparable, on average, with respect to both measured and unmeasured characteristics at the point of assignment. This supports an interpretation of the contrast by assigned group, subject to the trial's conduct, outcome measurement, missing data, and analysis. The registry says assignment was randomized and that the brief summary describes stratification by site and prior medication exposure. Details of sequence generation, concealment, and implementation are not reported in the registry record.

The parallel design means participants were assigned to one group rather than crossing between the two approaches. The study was open label, so masking was absent. General: when participants and care teams know the assignment, behavior and care processes can potentially be influenced by that knowledge. Whether this affected these outcomes cannot be determined from the registry entries alone.

How should the p-value be read?

The unadjusted recalculation for the primary outcome reports p < 0.001. General: a p-value describes how unusual results at least as incompatible with a specified null model would be if that model and the analysis assumptions were correct. It is not the probability that the null hypothesis is true, nor a measure of the size or clinical importance of the effect. The registry's own primary analysis does not report a p-value.

The term unadjusted refers to the recalculation from the posted summary counts rather than a model adjusted for covariates. The registry analysis method is not named. Its reported risk ratio should therefore be distinguished from the separate unadjusted recalculation, and no adjustment characteristics should be inferred from the reported estimate.

Why can the distinction between counts and risks matter?

The posted counts are numbers of participants with an event, while the denominators differ between randomized groups. A raw count alone does not account for the number of participants assessed in each arm. Risk-based comparisons use both the event count and the corresponding denominator. General: for binary outcomes, the interpretation depends on a clear event definition and on knowing who is included in the denominator. The registry defines the primary event and identifies its analysis population, but does not describe missing-data procedures.

There is no dispersion parameter for these binary outcomes. General: over-dispersion is principally a concern for models in which observed variability can exceed the variability assumed by a particular count or probability model. It is not a separate measure reported for this endpoint, and no over-dispersion adjustment is described in the registry record.

What can be inferred from the statistical plan?

The registry includes posted reported estimates and unadjusted recalculations, but the original statistical analysis plan is not reported in the registry record. The analysis method for the sponsor-reported estimates is not named. The record also does not report details of covariate adjustment, interim analyses, missing-data methods, or multiplicity control. Those features should not be reconstructed from the estimates alone.

The planning illustrations use the observed effect as a starting point, with stated fractions of that effect and assumptions of a two-sided significance level of 0.05, equal allocation, and a normal approximation. General: planning calculations describe hypothetical sample sizes under stated assumptions; they do not establish what the original trial was designed to detect and do not replace the observed trial results.

11. Confidence Intervals and Precision

The recalculated primary risk difference is 0.306, with a 95% confidence interval from 0.204 to 0.408. The recalculated risk ratio is 2.146, with a 95% confidence interval from 1.609 to 2.862. Both intervals exclude their respective null values: 0 for a risk difference and 1 for a risk ratio. The unadjusted p-value is <0.001.

The registry's own primary analysis reports a risk ratio of 2.10 with a 97.5% confidence interval from 1.51 to 2.91. Because its interval uses a different confidence level from the recalculated interval, the widths and bounds should not be compared as if they were constructed on the same basis. The registry does not name the method used for this reported analysis.

General: a confidence interval conveys uncertainty about an estimated contrast under the assumptions of the analysis. A narrower interval indicates greater precision for that estimate, while a wider interval indicates more uncertainty. An interval does not account automatically for every possible source of bias, such as outcome misclassification, missing data, or departures from the analysis assumptions.

The primary comparison is based on 164 participants in START and 161 in usual care. The secondary post-discharge analyses use smaller denominators than the primary endpoint, and the record does not explain the difference. Those smaller denominators affect how precisely the corresponding contrasts can be estimated. The reported confidence intervals for the three posted secondary outcomes likewise express uncertainty for their own estimates, not for outcomes absent from the record.

Statistical precision is not the same as clinical importance. The risk difference and risk ratio communicate magnitude on different scales, while the interval indicates uncertainty on that scale. The registry record does not supply a threshold for a clinically important difference, so the estimates cannot be classified against such a threshold from the posted information alone.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations based on the observed effect, not the trial's original design assumptions. For the binary outcomes in this analysis, the figures are participants per arm, rather than total events. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect equal to the stated fraction of the observed effect. The trial's own original design assumptions are not reported in the registry record.

The 80% power column gives the number of participants per arm estimated to be needed, under those assumptions, for an 80% chance of detecting the specified effect if it is the true effect and the model assumptions hold. The 90% power column gives the corresponding planning count for a 90% chance. These are prospective planning quantities, not descriptions of what happened in the completed trial.

The rows use 100%, 75%, and 50% of the observed effect as alternative planning targets. A smaller effect is harder to distinguish from random variation, so planning for a smaller effect requires more participants. The listed counts can therefore change substantially across effect assumptions. They are illustrations tied to the observed data and should not be read as a validation of the enrollment target, a reconstruction of the original protocol, or a guarantee that the stated power would be achieved in practice.

This is not observed power. The observed results are described by the estimated contrasts and their confidence intervals; a post hoc power calculation does not add information about the uncertainty already conveyed by those estimates. The planning assumptions also do not account for features that are not specified, such as any original adjustment strategy or missing-data approach.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.267; treatment proportion p₁ = 0.573; average p̄ = 0.420.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6980 = 1.3681.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6636 = 0.5585.
4. n = (1.3681 + 0.5585)² / (0.3061)² = 39.6, rounded up to 40 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.267080745341615                          # control proportion
p1 <- 0.573170731707317                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(5086796)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 40 (80% power), 53 (90% power)
 75% of observed effect: n per arm = 70 (80% power), 93 (90% power)
 50% of observed effect: n per arm = 150 (80% power), 201 (90% power)
power.prop.test: 39.6 
Simulated power at n = 40 per arm: 0.814 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry's reported primary analysis gives a risk ratio of 2.10, with a 97.5% confidence interval from 1.51 to 2.91. The unadjusted recalculation from the posted group counts gives a risk ratio of 2.146, with a 95% confidence interval from 1.609 to 2.862, and a risk difference of 0.306, with a 95% confidence interval from 0.204 to 0.408. The recalculation also reports p < 0.001.

The two risk-ratio estimates are close, but they are not identical, and their confidence intervals are reported at different levels. The registry does not identify the method behind its own analysis or provide a p-value for it. Consequently, the reported sponsor analysis should be presented as its own estimate, not assumed to be the same calculation as the unadjusted recalculation. The record does not flag a discrepancy between these analyses.

The recalculation is based on the posted event counts and denominators and is unadjusted. It is useful as a transparent summary of those counts, but it does not establish the exact approach used for the registry's reported estimate. The methods for the reported analysis, including any covariate adjustment, are not reported in the registry record, so a direct methodological reconciliation is not possible.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and four secondary outcomes. It does not report whether the statistical analysis controlled the family-wise chance of false-positive findings across multiple outcomes, used a hierarchy or gatekeeping procedure, or treated secondary outcomes as exploratory. The posted secondary p-values from unadjusted recalculations therefore should not be interpreted as if a multiplicity adjustment had been applied. Whether any such adjustment was part of the trial's original analysis plan is not reported in the registry record.

The registry identifies the primary analysis population as intention-to-treat: all eligible participants randomized to either arm. It does not provide further detail on exclusions after randomization, the handling of protocol deviations, or whether every randomized participant contributed a measured primary outcome. The posted primary arm counts total 325 participants, matching the enrollment field, but this does not by itself establish that there were no missing outcome data or exclusions under all analysis procedures.

The denominators for post-discharge outcomes are smaller than the primary endpoint denominators. The registry record does not report why participants are absent from those denominators, whether data were unavailable, or what methods were used to address missingness. It also does not report sensitivity analyses for missing outcomes. As a result, the extent to which missingness could affect secondary estimates cannot be assessed from the registry entry.

The registry's own analysis methods are not named. Details of model specification, adjustment variables, interim analyses, and prespecified analysis choices are not reported in the registry record. No conclusions about those features should be inferred from the reported risk ratios or confidence intervals. These omissions limit assessment of the analytic safeguards surrounding multiple outcomes and incomplete follow-up.

16. 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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: cardiac arrest (0.6%), necrotizing oft-tissue infection (nsti) (0.6%), hospitalized (0.6%).

The registry reports serious adverse events among 4 of 164 participants in the START group and 3 of 161 in usual care. Other adverse events are reported for 1 participant in START and none in usual care. Deaths are reported for 3 participants in each group. These are counts in the registry record; no comparative safety analysis or confidence intervals are reported.

The listed serious adverse event terms are cardiac arrest, necrotizing oft-tissue infection (NSTI), and hospitalized, each reported as 0.6%. The record does not attribute those listed terms to a particular arm in the displayed summary, nor does it explain whether terms can overlap within a participant. The event counts should therefore be read as descriptive registry reporting, not as a basis for calculating comparative risks or determining causation.

General: adverse event counts can be difficult to interpret when the definitions, ascertainment period, event severity criteria, and relation to the intervention are not fully described. The registry does not provide those details. The small number of reported events also means that the record alone cannot establish whether the groups differ meaningfully in safety. No treatment recommendation follows from these figures.

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

The posted primary data show more participants with in-hospital medication initiation in the START group than in usual care, and the unadjusted estimates quantify that group contrast. The registry's own analysis reports a risk ratio with a confidence interval above 1. Together, these statistics describe the observed randomized-group comparison for the defined inpatient endpoint.

They do not establish that every participant benefited, that medication was continued after discharge, or that long-term opioid use or recovery outcomes changed. Those questions require outcome measures and follow-up data beyond the primary endpoint. The registry lists some post-discharge care outcomes, but a result for the listed measure of days with any opioid use is not reported in the registry record.

The trial was randomized, pragmatic, multi-site, and open label according to the registry. Randomization supports comparison by assigned group, but it does not eliminate uncertainty from missing outcomes, measurement practices, or limitations in reporting. The record does not describe missing-data methods, a multiplicity strategy, or the method for the sponsor-reported estimates. The post-discharge denominators are smaller than the primary denominators, with no explanation in the registry entry.

General: statistical evidence about a group contrast is not a guarantee that the same result will occur in every setting or population. Applicability depends on how closely other settings and patients resemble those in the trial. This record describes hospitalized patients at three named sites and does not provide enough information to establish generalizability to all people with opioid use disorder or all care systems.

The findings are best read as evidence about the measured processes in this randomized trial, with uncertainty represented by the reported intervals and with limits from incomplete methodological reporting. They do not by themselves establish the overall clinical value of the care model, its effect on outcomes not measured, or the causes of the observed difference.

18. Why This Trial Matters Statistically

This trial is statistically notable because it evaluates a multi-component care approach through randomized assignment in a pragmatic inpatient setting. The primary endpoint is a concrete binary process measure with counts reported in both groups. That makes the contrast interpretable in terms of the proportion of participants who began medication before discharge, while the risk ratio and risk difference convey the comparison on relative and absolute scales.

The registry also reports outcomes across the transition from inpatient care to discharge planning and post-discharge services. Looking across related outcomes can help readers assess whether the primary process result sits within a broader pattern of care delivery. At the same time, secondary endpoints raise questions about multiplicity, outcome-specific denominators, and how consistently outcomes were measured. Those methods are not fully described in the record.

The sponsor-reported primary estimate and an unadjusted recalculation from the posted counts are close but distinct. Reading both makes clear why estimates should be accompanied by their methods and confidence levels, rather than reduced to a single number. The registry does not name the method behind the reported analysis, which limits a full comparison of analytic choices.

The trial also illustrates the difference between observed results and planning illustrations. Sample-size calculations based on the observed contrast can show how required enrollment changes under alternative effect assumptions, but they do not reveal the original study design rationale or the power of the completed trial. The registry's stated original assumptions are not reported. These distinctions matter when translating trial statistics into evidence without overstating what the record can establish.

19. 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 entry does not report the original statistical analysis plan, the rationale for the original enrollment target, details of any interim analyses, or the method used for the sponsor-reported estimates. The enrollment field lists 325, while the brief summary describes a plan to randomize 414 patients; the reason for the difference is not reported in the registry record.

The trial was open label. The registry does not describe outcome ascertainment procedures or whether those assessing outcomes were independent of care assignment. Because several outcomes involve care processes, the absence of masking is relevant when considering whether knowledge of assignment could have influenced delivery or recording of care. The available record does not establish that such influence occurred.

The primary endpoint is narrowly defined as medication initiation before discharge. It does not establish treatment continuation, long-term engagement, or broader recovery outcomes. The post-discharge analyses use smaller denominators than the primary analysis, and the registry does not explain the difference or report missing-data methods. The listed outcome concerning days with any opioid use has no result reported in the registry record.

The registry does not report how multiplicity across primary and secondary outcomes was handled. The secondary findings should therefore be read with caution. The record also does not provide sufficient detail to assess model assumptions or adjusted analyses. Finally, the trial's three-site setting and inpatient population limit what can be concluded about populations and care settings not represented in the registry description.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Substance Use Treatment and Recovery Team — NCT05086796.
• Registry record last updated 2025-01-23; status last verified 2025-01.
• Results first posted 2025-01-14.
• 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.

23. Record Summary

NCT05086796 is a completed randomized, parallel-group, open-label pragmatic trial of the Substance Use Treatment and Recovery Team versus usual care for hospitalized patients with opioid use disorder. The registry lists an enrollment of 325 and describes three participating sites. The primary endpoint is initiation of FDA-approved medication for opioid use disorder before discharge.

The posted primary counts are 94 of 164 participants in START and 43 of 161 in usual care. The registry-reported risk ratio is 2.10, with a 97.5% confidence interval from 1.51 to 2.91. An unadjusted recalculation reports a risk difference of 0.306 and a risk ratio of 2.146. Posted secondary results cover discharge planning and post-discharge care; the listed opioid-use-days outcome has no result reported in the registry record. Details of missing-data handling, multiplicity control, and the sponsor analysis method are not reported.