Feasibility and Preliminary Efficacy of an Opioid Stewardship Program in Hospitalized Patients With Chronic Pain: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Feasibility and Preliminary Efficacy of an Opioid Stewardship Program in Hospitalized Patients With Chronic Pain (NCT05370326), a randomized na study. The primary outcome is Days to Hospital Day of Enrollment.

2. Clinical Question

3. Trial Design

The registry describes a randomized, parallel-group pilot trial with no masking. It lists Yale University as sponsor and records the study as completed. The listed enrollment is 52. The record gives the study start as 2022-07-07 and primary completion as 2022-11-01. The phase is listed as not applicable.

Participants were assigned to an Enhanced Opioid Stewardship Program or standard of care. The enhanced program was tailored to hospitalized patients with chronic pain and opioid dependence and included real-time guidance from an addiction medicine and pain-trained physician/pharmacist team. The registry record does not describe the activities included in standard care, the allocation procedure beyond randomization, or the masking of outcome assessors.

The primary endpoint is days to hospital day of enrollment, defined in relation to admission and discharge dates. It is reported as a mean with standard error. The registry lists an approximate timeframe of 3 months. The number analyzed for this endpoint was 36 in the enhanced-program arm and 16 in standard care, while the total enrolled was 52. The reason for the difference between total enrollment and endpoint analysis counts is not reported in the registry record.

The registry names secondary outcomes covering guideline-based opioid care, pain intensity and interference, depression, patient satisfaction, hospital readmissions, and emergency department visits. It also describes the study as focused on feasibility and preliminary efficacy. The protocol’s original sample-size assumptions, detailed allocation procedures, and planned statistical analysis beyond the reported analysis 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

Analysis population for the primary outcome, as defined in the registry: All participants that were screened for eligibility

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: Participants randomized in the study.

6. Primary Endpoint

The registry lists the primary outcome as Days to Hospital Day of Enrollment, measured over approximately 3 months.

The primary endpoint, “Days to Hospital Day of Enrollment,” measures the number of days to the hospital day on which enrollment occurred, in relation to the admission and discharge dates. It is reported as a continuous measure, summarized by a mean and standard error for each randomized group. The registry lists an approximate timeframe of 3 months.

This endpoint describes the timing of enrollment during a hospitalization. It is distinct from the secondary outcomes measuring pain, interference, depression, satisfaction, and post-hospital service use. The registry does not explain why this timing measure was selected as the primary endpoint, so its intended role in assessing feasibility or preliminary efficacy is not reported in the registry record.

In general, a mean gives the average observed value in a group, while a standard error describes the estimated uncertainty around that group mean. The difference between group means summarizes the observed contrast on the endpoint’s days scale. It does not, by itself, establish why the groups differed or indicate whether the measure reflects a clinically important outcome. Interpretation also depends on the analysis method, uncertainty interval, and the endpoint’s prespecified role.

7. Results Posted in the Registry

• Enhanced Opioid Stewardship Program: mean 9.66 versus 10.56 on control; difference -0.90 (95% CI -5.91 to 4.11), standardized effect d = -0.12; z-test p = 0.725.

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.

Change in Pain Intensity Measured by the Brief Pain Inventory - Severity

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • Enhanced Opioid Stewardship Program: mean -0.46 versus -0.23 on control; difference -0.23 (95% CI -1.49 to 1.03), standardized effect d = -0.13; z-test p = 0.721.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Enhanced Opioid Stewardship Program and the control. The interval gives the range of effects that remain compatible with the data.

Change in Pain Intensity Measured by the Brief Pain Inventory - Interference

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • Enhanced Opioid Stewardship Program: mean -1.21 versus -0.62 on control; difference -0.59 (95% CI -2.18 to 1.00), standardized effect d = -0.22; z-test p = 0.468.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Enhanced Opioid Stewardship Program and the control. The interval gives the range of effects that remain compatible with the data.

Change in Depression Measured by the Patient Health Questionnaire

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • Enhanced Opioid Stewardship Program: mean -0.56 versus -0.35 on control; difference -0.21 (95% CI -1.33 to 0.91), standardized effect d = -0.11; z-test p = 0.714.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Enhanced Opioid Stewardship Program and the control. The interval gives the range of effects that remain compatible with the data.

The named secondary outcomes span several domains: guideline-concordant opioid care during hospitalization, pain severity, pain interference, depression, patient satisfaction, hospital readmissions, and emergency department visits. The detailed continuous comparisons for pain severity, pain interference, and depression report group means and two-sided t-test results. Their posted confidence intervals include zero. Taken together, these results do not present a consistent, statistically clear separation between the randomized groups across the detailed continuous outcomes.

The secondary outcomes address questions that are distinct from the primary endpoint, which measures days to the hospital day of enrollment. Pain and depression measures may add context to a pilot focused on stewardship, but they do not convert the primary timing result into a direct measure of pain management or safety. The listed readmission, emergency department, satisfaction, and guideline-based outcomes also represent different aspects of care. Numeric results for those outcomes are not reported in the registry record.

In general, secondary analyses carry less weight as confirmatory evidence when many outcomes are examined, especially when no adjustment for multiple testing is reported. Repeated testing can make chance findings more likely. The registry record does not report a multiplicity strategy or identify which secondary outcomes, if any, were designated as confirmatory. Thus, the secondary findings should be considered exploratory and interpreted in light of their uncertainty, rather than as independent proof of an overall effect.

The registry describes the trial as a pilot assessing feasibility and preliminary efficacy. The range of outcome domains is consistent with gathering preliminary information, but the registry record does not report a formal feasibility criterion or explain how each secondary outcome contributed to a feasibility assessment. The record’s limits on reported results mean that a complete comparison across all named secondary outcomes is not possible.

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

• Number of Guideline-based Care Elements in Use Considered Guideline Concordant Care With Opioids for Pain During Hospitalization.
• Change in Pain Intensity Measured by the Brief Pain Inventory - Severity
• Change in Pain Intensity Measured by the Brief Pain Inventory - Interference
• Change in Depression Measured by the Patient Health Questionnaire
• Patient Satisfaction Measured Using a Patient Satisfaction Survey
• Count of Participants With Hospital Re-admissions at 30 Days After Hospitalization
• Count of Participants With Emergency Department Visit(s) at 30 Days After Hospitalization

9. Statistical Interpretation

10. Statistical Methods Explained

The primary comparison is a difference in means for a continuous endpoint. Each arm’s primary result is reported as a mean and standard error: 9.66 days with standard error 1.12 for the enhanced program, and 10.56 days with standard error 2.3 for standard care. A mean difference expresses the contrast between group averages in the endpoint’s original unit, days. The simple recalculation expresses the contrast as enhanced program minus standard care; its estimate is -0.9 days.

What does a confidence interval describe?

In general, a confidence interval represents uncertainty in an estimate under the assumptions of the statistical method. It gives a range of values compatible with the observed data and method; it is not a guarantee that the true value lies in that particular interval. For the primary recalculation, the 95% confidence interval runs from -5.914 to 4.114. The registry’s own analysis reports a 95% interval from -3.67 to 5.46. Both include zero, so neither interval excludes no difference between group means. Their width also indicates that the estimated contrast is not precise enough to pin down a narrow range of possible effects.

What does the p-value add?

In general, a p-value describes how unusual data at least as incompatible with a null hypothesis would be if that null hypothesis and the statistical model were correct. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of an effect. The simple unadjusted primary calculation gives p = 0.725; the registry reports p = 0.69 from a two-sided t-test. These values do not show a statistically clear difference under the respective analyses. They should be interpreted alongside the estimates and intervals, not as a standalone verdict.

Why can the posted and recalculated estimates differ?

The registry reports its own two-sided t-test as a mean difference of 0.89, with a 95% confidence interval from -3.67 to 5.46. The simple recalculation from the posted summary statistics is -0.9, with a 95% interval from -5.914 to 4.114. The directions and interval limits are not identical. The recalculation is an unadjusted calculation from the posted summaries; it is not a substitute for the sponsor’s analysis. The registry record does not explain the differences in the estimates or intervals. The sponsor’s own analysis takes precedence when describing the trial’s reported analysis.

What do standard errors and unequal group counts mean?

In general, a standard error estimates the sampling uncertainty of a mean. It is different from a standard deviation, which describes variation among individual observations. A smaller group and greater variability can contribute to less precise estimates. The primary analysis counts are 36 and 16, rather than equal-sized groups. The registry record does not report why the endpoint counts differ from one another or from total enrollment. It also does not report whether any model adjustment was used for the sponsor’s primary analysis beyond identifying a two-sided t-test in the posted result.

Why are secondary findings exploratory?

The registry lists multiple secondary outcomes, including pain severity, pain interference, depression, guideline-based care, satisfaction, readmissions, and emergency department visits. When several outcomes are tested, the chance of obtaining at least one apparently unusual result can increase. In general, multiplicity procedures can address this issue, but the registry record does not report a planned adjustment. The three detailed continuous secondary comparisons each use a two-sided t-test in the registry’s reported analysis. Their results therefore need to be read as exploratory rather than as independent confirmatory evidence.

General statistical interpretation also depends on how participants were analyzed, how missing observations were handled, and whether the statistical plan was specified before results were examined. Those details are not reported in the registry record. No inference should be made about the original design assumptions from the separate planning illustrations: those are based on observed effects, not a reported protocol calculation.

11. Confidence Intervals and Precision

The primary estimate is uncertain. The registry’s reported mean difference is 0.89, with a 95% confidence interval from -3.67 to 5.46. The interval spans zero and includes values on both sides of no difference. Its range is broad enough that the reported estimate does not tightly locate the group contrast. The simple recalculation has an estimate of -0.9 and a 95% interval from -5.914 to 4.114; this interval also includes zero and indicates substantial uncertainty. The registry’s own analysis is the relevant reported analysis, while the recalculation is an unadjusted check from summary statistics.

In general, a confidence interval’s width reflects statistical precision: narrower intervals indicate more precise estimates, while wider intervals leave more uncertainty about the possible values. Precision depends on factors including variability and the amount of information available. The primary endpoint analysis included 36 participants in the enhanced-program arm and 16 in standard care. The standard errors were 1.12 and 2.3, respectively. These figures describe uncertainty around the group means, not the spread of individual participants’ measurements.

The secondary estimates are also uncertain. The registry’s reported 95% confidence intervals for the pain severity, pain interference, and depression comparisons each include zero. The record does not report a threshold defining a clinically important difference for these endpoints. Consequently, the estimates and intervals describe statistical uncertainty but do not by themselves establish whether any difference would be meaningful to patients or clinicians.

In general, a confidence interval should not be read as a range containing a fixed proportion of individual outcomes, nor as proof that all values within it are equally plausible. It is an interval generated by a method with stated assumptions. The registry record does not report all analysis details needed to assess those assumptions fully, including missing-data handling and the analysis population definition.

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 planning illustrations show participants per arm for 80% power and participants per arm for 90% power. They are not total sample sizes and do not represent observed enrollment. In general, power is the probability that a specified analysis will detect an effect of a specified size under its assumptions when that effect is present. The 80% and 90% columns therefore describe two planning targets: the number of participants per group indicated for the calculation to have those respective probabilities of detecting the assumed effect.

The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set as the stated fraction of the observed effect. For continuous outcomes, the figures are participants per arm; time-to-event illustrations, if present, would give total events, but the comparisons described for this trial are continuous outcomes.

Each planning row varies the fraction of the observed effect being targeted. The rows for 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect let readers see how the assumed target affects the participant requirement. Smaller effects need more participants to detect under the same planning assumptions, so the lower-fraction rows have larger per-arm figures. The 90% power target also calls for more participants per arm than the 80% target for the same assumed effect.

These are planning illustrations based on observed estimates, not a reconstruction of the trial’s original design calculation. The trial’s own sample-size assumptions are not reported in the registry record. The figures are not observed power, and they do not indicate that the completed trial had a particular probability of success. They are useful for understanding how assumptions about effect size and power influence planning, not for deciding whether the observed findings are true.

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, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.900; pooled standard deviation σ = 7.550.
2. n = 2 × (1.96 + 0.842)² × 7.550² / -0.900² = 1,104.7, rounded up to 1,105 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
delta <- -0.9                      # observed difference in means
sigma <- 7.55002516552097                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^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 (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5370326)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 1,105 (80% power), 1,479 (90% power)
 75% of observed effect: n per arm = 1,964 (80% power), 2,630 (90% power)
 50% of observed effect: n per arm = 4,419 (80% power), 5,916 (90% power)
power.t.test: 1105.7 
Simulated power at n = 1,105 per arm: 0.796 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-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 reports the sponsor’s primary analysis as a two-sided t-test, with a mean difference of 0.89, a 95% confidence interval from -3.67 to 5.46, and p = 0.69. The simple recalculation from the posted group means and standard errors gives a mean difference of -0.9, a 95% confidence interval from -5.914 to 4.114, and an unadjusted p-value of 0.725. The estimates have opposite signs, and the intervals and p-values are not identical.

The recalculation is a simple unadjusted calculation based on the posted summary statistics. It does not replace the analysis reported by the sponsor. The sponsor’s own analysis takes precedence for describing the trial’s reported result. The registry record does not explain the difference between the reported and recalculated estimates, so no explanation for the discrepancy should be inferred.

Both analyses report intervals that include zero, and neither shows a statistically clear difference in the primary endpoint. The sponsor’s p-value and interval should be read together with the estimate and the endpoint definition, rather than as evidence about pain outcomes or other measures. The recalculation is best treated as a supplementary check, not as a competing primary result.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists several secondary outcomes in addition to the primary endpoint. These cover guideline-based opioid care, pain, depression, satisfaction, readmissions, and emergency department visits. Examining multiple outcomes creates a multiplicity issue: in general, the more separate statistical tests conducted, the greater the chance that at least one result may appear unusual by chance alone. A prespecified adjustment or testing hierarchy can help manage this issue, but a multiplicity plan is not reported in the registry record.

The posted analyses for the detailed continuous secondary outcomes are two-sided t-tests. The registry record does not report whether these tests were prespecified, whether any additional analyses were conducted, or whether results were adjusted for multiple comparisons. The findings therefore warrant a cautious, exploratory interpretation. The number of analyses recorded does not establish the full set of analyses considered or the testing strategy.

Missing-data handling is also not reported in the registry record. The primary analysis counts are 36 in the enhanced-program arm and 16 in standard care, while enrollment is 52. The record does not state why the analysis counts differ from total enrollment, whether participants lacked endpoint data, or how any missing values were handled. It also does not report an analysis population definition, such as whether the analysis followed all randomized participants or another specified group.

In general, missing observations can affect both precision and the interpretation of a group comparison, particularly if availability of outcome data is related to participant characteristics or outcomes. Without information on the amount, reasons, and handling of missing data, the direction and size of any resulting influence cannot be assessed from the registry record. The protocol’s statistical plan, interim analyses, and original sample-size justification are also not reported in the registry record; no assumptions about them can be inferred from the posted results.

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

Serious events with the highest arm-level rate: cardiorespiratory arrest (2.8%).

The registry reports serious adverse events for 1 of 36 participants in the enhanced-program group and 0 of 16 participants in standard care. It reports other adverse events for 0 of 36 and 0 of 16, respectively. Deaths are recorded for 1 participant in the enhanced-program group and 0 in standard care. The listed serious event term is cardiorespiratory arrest, reported as 2.8%.

These counts describe events recorded in this small pilot trial; they do not establish a comparative safety pattern. The groups have different analysis counts, and few events are reported. In general, small numbers of events yield imprecise comparisons, and a zero count in one group does not establish that an event cannot occur. The registry record does not provide further details about event timing, relatedness, severity criteria, or a formal between-group safety analysis. The figures should therefore be read as descriptive registry reporting, not as proof of a causal relationship or a reliable estimate of relative risk.

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

The posted primary analysis estimates a difference between randomized groups on days to the hospital day of enrollment. The sponsor reports a mean difference of 0.89, with a 95% confidence interval from -3.67 to 5.46 and p = 0.69. The interval includes zero and spans values in both directions. The trial’s primary result therefore does not establish a clear group difference on this timing endpoint. It also does not precisely rule out a range of possible differences.

The outcome is not a direct measure of pain intensity, opioid use, or opioid-related adverse events. The registry lists secondary outcomes addressing some of these broader areas, but the detailed continuous secondary results are also uncertain, and numeric results for some named outcomes are not reported in the registry record. The record does not provide a threshold for judging clinical importance on the primary or secondary measures.

This randomized pilot trial enrolled 52 participants and was described as investigating feasibility and preliminary efficacy. A pilot result can inform future research questions, but this record does not report a formal feasibility benchmark or the original sample-size justification. The posted estimates should not be treated as a definitive answer about the intervention’s effects. Nor does a non-significant p-value prove that there is no effect: in general, a non-significant result may reflect a small effect, uncertainty, or both.

The serious adverse event figures are also descriptive and sparse. They do not establish that the enhanced program caused or prevented an event. The registry record does not include enough detail to make a strong comparative safety assessment. Overall, the results are best understood as preliminary estimates from a small randomized study, with substantial uncertainty and limits in the reported methods and outcome detail.

18. Why This Trial Matters Statistically

This trial is statistically informative because it illustrates the distinction between a pilot study’s preliminary estimates and a precise treatment-effect evaluation. The primary result has a point estimate close to zero on the days scale, but its confidence interval extends across zero and includes a broad range of possible group differences. Looking only at the point estimate or p-value would miss this uncertainty.

The unequal primary endpoint analysis counts also matter for interpretation. The enhanced-program group has 36 participants and standard care has 16. Unequal group sizes can affect the precision of a comparison, especially when the smaller group contributes less information. The registry record does not explain the difference in counts or report how missing observations were addressed, leaving important context unresolved.

The trial also reports several secondary outcomes across pain, depression, care practices, satisfaction, and post-hospital use. That breadth may be useful in a pilot, but multiple outcomes increase the importance of a prespecified analysis and cautious interpretation. A multiplicity plan is not reported in the registry record. Treating one or more secondary findings as decisive without that context would overstate what these data can support.

Finally, the record distinguishes a sponsor-reported analysis from a simple recalculation based on summary statistics. Their estimates and intervals are not identical, which reinforces the importance of stating which analysis is being interpreted. The sponsor’s analysis takes precedence, while the recalculation serves only as an unadjusted supplementary estimate. Clear reporting of analysis populations, missing-data handling, and original design assumptions would help readers assess future evidence.

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.

Several limitations are specific to the registry information for this trial. First, the study enrolled 52 participants, while the primary endpoint analysis includes 36 in the enhanced-program group and 16 in standard care. The reasons for the difference between enrollment and endpoint analysis counts are not reported in the registry record. Missing-data handling and the analysis population definition are also not reported.

Second, standard care is not described in the record beyond its label. The enhanced program’s real-time guidance from an addiction medicine and pain-trained physician/pharmacist team is described, but the exact contrast between the two groups cannot be fully assessed without more detail on usual care. The record also does not report masking of outcome assessment or further details of the randomization procedure.

Third, the primary endpoint measures enrollment timing during hospitalization, not pain or opioid-related harms directly. The reason this measure was selected as primary is not reported. The registry names multiple secondary outcomes, but numeric results for the guideline-based care, satisfaction, readmission, and emergency department outcomes are not reported in the registry record. This limits the ability to assess the full range of outcomes named for the study.

Fourth, the trial is described as a pilot, and the original sample-size justification and planned statistical assumptions are not reported. The registry also does not report a multiplicity strategy, interim analyses, or detailed missing-data methods. The sponsor’s reported primary estimate differs from the simple unadjusted recalculation, and the registry does not explain why. These reporting limits constrain interpretation of precision, analysis choices, and the overall pattern of findings.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Feasibility and Preliminary Efficacy of an Opioid Stewardship Program in Hospitalized Patients With Chronic Pain — NCT05370326.
• Registry record last updated 2024-03-05; status last verified 2024-02.
• Results first posted 2024-01-30.
• 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.

23. Record Summary

The registry describes a completed, randomized, parallel-group pilot trial with no masking, sponsored by Yale University. It enrolled 52 participants with chronic pain and opioid dependence and compared an enhanced opioid stewardship program with standard care. The primary endpoint was days to the hospital day of enrollment, reported as a mean with standard error.

The sponsor’s primary analysis reports a mean difference of 0.89, a 95% confidence interval from -3.67 to 5.46, and p = 0.69. The interval includes zero and indicates substantial uncertainty about the group contrast. The registry also names secondary outcomes in pain, depression, care practices, satisfaction, and post-hospital service use; the detailed continuous secondary comparisons are exploratory and uncertain.

The record does not report the original sample-size justification, missing-data handling, analysis population definition, or multiplicity plan. The results are preliminary and do not establish a clear difference on the primary endpoint or a definitive conclusion about broader clinical outcomes.