Collaborative Care for Opioid Dependence And Pain Pilot Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Collaborative Care for Opioid Dependence And Pain Pilot Study (NCT04121546), a randomized na study. The primary outcome is Opioid Dose Change.

2. Clinical Question

This is a pilot study, and the registry describes random assignment to telecare or usual care. The trial was intended to evaluate a collaborative-care approach in people living with chronic pain and opioid dependence. The outcome focuses on dose change rather than a broader assessment of pain, functioning, or the experience of care. Change in PROMIS Pain Interference is listed as a secondary outcome, but a result for that measure is not reported in the registry record.

The question is clinically and statistically distinct from asking whether opioid dose changed within either arm. A comparative question requires interpreting the difference between the randomized groups, with uncertainty around that comparison. The record gives a mean percentage reduction for each arm, but the primary-outcome summary includes one participant per arm. It does not provide a comparison estimate or its uncertainty. These summaries therefore describe the recorded outcomes for the analyzed participants; they do not establish how the arms would compare in a larger or more complete sample.

3. Trial Design

The registry describes a randomized, parallel-group pilot study with a single masking designation. Participants were assigned to either the Telecare Intervention arm or the Usual Care arm. The registry does not identify who was masked, so the masking procedure cannot be described more specifically. It also does not report the randomization method, allocation concealment, or whether assignments were stratified.

The study record lists enrollment as 6. The primary completion date is 2022-02-01, and the start date is 2020-09-18. The current status in the record is terminated. These registry entries describe the study record; they do not explain why the study was terminated or how termination affected recruitment, follow-up, or analysis. Such explanations are not reported in the registry record.

The intervention arm received the telecare intervention, while the control arm received usual care. The study is listed as phase NA. The registry describes the study as a pilot focused on collaborative care for opioid dependence and pain. It does not provide a protocol-level account of intervention delivery, treatment adherence, or co-interventions.

For the primary outcome, the analysis population is described as participants who completed the 12 week survey. The posted outcome summaries list one analyzed participant in each arm. That is a much narrower basis for interpretation than the listed enrollment would suggest, and the record does not explain the gap. It is not reported whether participants who did not contribute the primary outcome differed from those who did, or why their data were unavailable.

The record lists two outcome measures and one secondary outcome, Change in PROMIS Pain Interference. It reports zero analyses. No trial-specific statistical analysis plan, sample-size justification, interim-analysis plan, or explanation of the termination is reported in the registry record. The design labels alone do not establish how the investigators planned to analyze or interpret the primary endpoint.

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: Participants who completed the 12 week survey were included for analysis.

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 Opioid Dose Change, measured over 12 weeks.

The primary endpoint is Opioid Dose Change, defined as the percentage change in daily opioid dose measured in morphine milligram equivalents, or MME. The time frame is 12 weeks, and the registry describes the endpoint summary as a mean. The stated unit is percentage of MME reduction. In practical terms, the measure expresses how much a participant’s daily opioid dose changed relative to the participant’s dose before the follow-up measurement; the record does not specify further calculation details.

A dose expressed in MME provides a standardized way to describe opioid dosage across opioid medications. Reporting percentage change places dose change in relation to the starting dose rather than presenting only an absolute dose change. This can be useful when starting doses vary, although the registry record does not describe the participants’ starting doses or the formula used for the percentage calculation.

The endpoint is used to address the study’s stated focus on assisting opioid tapering. It is a measure of dose change, not a direct measure of pain relief, function, quality of life, or safety. The secondary outcome, Change in PROMIS Pain Interference, addresses a different aspect of the study question, but its result is not reported in the registry record.

The posted means are 62.5% for the intervention arm and 50.0% for usual care. The outcome summary lists one participant in each arm, and the reported full range is the same as the mean within each arm. With one observation contributing to each arm summary, these values give little information about variation among participants. The record does not provide an uncertainty interval or an estimable comparison for the endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a mean and reports a full range. These labels describe the type of summary, not the method used to compare arms. A mean is the arithmetic average of observed values. A range describes the lowest and highest observations recorded. When an arm summary contains one participant, its mean and range cannot describe how outcomes vary across people in that arm. In this record, the mean and both range endpoints coincide within each arm.

What would an arm comparison estimate?

A randomized comparison generally focuses on a contrast between groups, rather than treating each arm’s summary as a separate conclusion. The contrast might be expressed as a difference in means, with an uncertainty interval that reflects the amount of information and the variation in the data. The registry does not report such an estimate for the primary endpoint. No recalculated comparison is available in the record, so there is no basis for interpreting a numerical contrast or attaching a precision statement to it.

A confidence interval is a statistical description of uncertainty around an estimated effect under a specified analysis. A narrow interval usually indicates greater precision than a wide interval, while an interval spanning a range of materially different effects indicates uncertainty about the size and direction of the effect. This is a general explanation; the registry record does not report a confidence interval for the primary outcome. A p-value, if available, would answer a different and narrower question about compatibility with a specified null model. No such value is reported either.

Why does the number of observations matter?

With very few observations, an individual value can strongly determine a group summary. The observed means may therefore be highly sensitive to the particular participants whose data are available. Statistical uncertainty is also difficult to characterize when there is little information about the spread of outcomes. The posted summaries list one participant in each arm; they do not provide a basis for estimating the range of outcomes that might occur across other participants.

Over-dispersion is a general concern when observed variability is greater than a model assumes. If an analysis assumes less variability than is present, its uncertainty estimates can be too small and its conclusions too confident. Conversely, a suitable model should reflect the outcome’s distribution and the data available. The registry does not report an inferential model, a variance estimate, or a method for addressing over-dispersion. Given the sparse outcome summaries, claims about the suitability of any particular model would be speculative.

What do the planning assumptions mean?

The record describes a planning illustration based on the observed effect, not the trial’s own design. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The effect to detect is defined as a stated fraction of the observed effect. These are planning assumptions, not evidence that the study was designed or conducted according to them. The record does not report the protocol’s sample-size justification.

Sample-size planning asks how many participants per arm would be needed to detect a chosen effect under a particular statistical model and assumptions. Such calculations depend on the effect size, variability, significance threshold, desired power, allocation, and analysis method. Planning illustrations based on an observed effect are especially dependent on that observed value, which can be unstable when the outcome summaries are based on very few participants. They should be read as hypothetical design scenarios, not as observed power or as proof that the trial could answer its question.

Observed power is not a substitute for an uncertainty interval around the actual treatment contrast. Once study results are available, the estimate and its uncertainty are more informative than a calculation that uses the observed effect to retrospectively describe power. In this record, no comparative estimate or uncertainty interval is reported. Any planning illustration should therefore be treated only as a conditional example under its stated assumptions.

What is not documented?

The registry does not report the primary analysis method, handling of missing outcome data, assumptions about the outcome distribution, covariate adjustment, or a prespecified treatment-effect measure. It does not report whether any interim analyses were planned or conducted. These details matter because different analysis choices can change the estimate, uncertainty, or population to which an inference applies. Their absence means the posted arm summaries cannot be tied to a fully described inferential analysis.

The record lists a single masking designation but does not say who was masked. It identifies random allocation but does not describe the sequence-generation or concealment procedures. These are features of study conduct rather than properties that can be inferred from the outcome values. Overall, the statistical information supports a limited descriptive reading of the posted arm summaries. It does not support a conclusion about comparative effectiveness, precision, or the model that would have been most appropriate.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists Opioid Dose Change as the primary outcome and Change in PROMIS Pain Interference as a secondary outcome. Although the record lists two outcome measures, it reports zero analyses and provides no result for the secondary outcome. A multiplicity adjustment or other plan for handling multiple outcomes is not reported in the registry record.

Multiplicity is a general statistical issue that arises when several outcomes, time points, or comparisons are examined. Considering many results can increase the chance that an apparently notable finding arises by chance. A prespecified analysis plan can clarify which outcome is primary and how other tests or estimates will be interpreted. Here, the registry identifies a primary endpoint and a secondary outcome, but it does not report the planned testing strategy, hierarchy, or any adjustment. No claims about multiplicity-controlled inference can therefore be made.

The primary-outcome population is described as participants who completed the 12 week survey. The posted summaries list one participant in each arm. The registry enrollment is 6, but the record does not explain the difference between enrollment and the number represented in the outcome summaries. It does not report the number of missing surveys, reasons for missingness, or whether missingness was related to treatment assignment or outcome values.

Missing-data methods are not reported in the registry record. It is not stated whether the analysis used only observed survey completers, imputed missing outcomes, or applied another approach. The wording about survey completers identifies the population included for analysis, but does not establish why data from other participants were unavailable or whether the analyzed participants remained comparable between arms. Without that information, the risk of bias from incomplete outcome data cannot be assessed.

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.

Most frequent non-serious adverse event terms

The registry reports serious adverse events for participants at risk in each arm. In the intervention arm, 2 participants were listed as at risk and 0 as affected by serious adverse events. In the usual-care arm, 4 participants were listed as at risk and 0 as affected. The record reports 0 deaths in each arm. No serious-event terms are listed.

The record also gives an other-adverse-event category. In the intervention arm, 2 participants were listed as at risk and 1 as affected; in usual care, 4 were listed as at risk and 0 as affected. These are counts as recorded, not estimates of comparative risk. They should be read in light of the small at-risk groups and the absence of a statistical comparison or uncertainty interval.

Adverse-event summaries do not establish whether the arms differ in safety. The registry record does not provide event descriptions for the other-adverse-event entry, details about severity or timing, or a fuller account of how events were collected. Zero recorded serious events in these small groups does not establish that serious events could not occur. The figures describe only the safety information posted in this record.

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

The posted primary outcome records mean percentage reductions in daily MME of 62.5% for the intervention arm and 50.0% for usual care. These values describe the participants whose data appear in the outcome summaries. They do not provide a reliable estimate of how telecare compares with usual care in the population the study sought to address. Each arm summary lists one participant, and the record provides no estimable between-arm analysis or measure of uncertainty.

The result does not establish that the intervention caused a greater reduction, that usual care produced a particular effect, or that the approaches are equivalent. Those conclusions would require an interpretable comparative estimate and adequate information about its uncertainty. The registry does not report such an estimate. It is also not possible to infer that the trial found no effect merely because no analysis is posted.

The endpoint is limited to opioid dose change. It does not by itself establish changes in pain, daily functioning, or other patient-important outcomes. Although Change in PROMIS Pain Interference is listed as secondary, its result is not reported in the registry record. The adverse-event counts offer limited descriptive safety information and do not resolve comparative safety.

The listed enrollment is 6, while the primary outcome summaries include one participant per arm. The registry says the primary analysis included those who completed the 12 week survey, but does not explain the missing outcome information or the reason for termination. These gaps make it difficult to assess whether the observed summaries represent the randomized participants or whether incomplete follow-up may have affected interpretation.

The most defensible reading is narrow: the record documents the posted outcome values and the small number of observations contributing to them, but leaves the comparative effect, its precision, and the influence of missing data unresolved. It does not support a clinical recommendation or a general conclusion about the intervention.

13. Why This Trial Matters Statistically

This study illustrates why a randomized design and a posted arm summary are not, by themselves, enough to answer a comparative question. Random allocation can support a fair comparison when outcomes are collected and analyzed in a way that preserves the intended comparison. But the primary summaries in this record contain one participant per arm, and there is no reported inferential comparison. The design label cannot compensate for the limited information in the available outcome summaries.

The contrast between the registry enrollment of 6 and the primary-outcome summaries is also statistically important. The record identifies survey completion as the primary analysis population, but does not explain which participants contributed data or why others are not represented. Transparent reporting of participant flow and missing outcome data helps readers evaluate selection and interpretability. Those details are not reported in the registry record.

The study also demonstrates the distinction between an observed summary and a precise estimate. A mean is a useful descriptive quantity, but the amount of uncertainty around it depends on the number of observations and their variability. With one posted observation per arm, the recorded means do not characterize the spread of possible outcomes. Without a comparison estimate and uncertainty interval, numerical differences between arm summaries should not be treated as firm evidence of an effect.

Finally, planning illustrations and observed results serve different purposes. A sample-size scenario based on an observed effect describes what a hypothetical future design might require under stated assumptions. It does not show that the pilot had adequate power, and it does not transform sparse observations into a conclusive comparison. The registry’s limited reporting makes this a useful example of why outcome completeness, analysis transparency, and uncertainty estimates are central to interpreting pilot trial data.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The primary limitation is the very limited number of observations in the posted outcome summaries: one participant per arm. The registry lists enrollment as 6, but the record does not explain why the primary outcome summaries include fewer participants. This makes the results highly sensitive to the observations available and prevents a meaningful assessment of variation between participants.

The record reports no estimable two-arm comparison and zero analyses. It does not provide an uncertainty interval, standard error, or p-value for the primary outcome. The posted arm means therefore cannot establish the size or precision of a comparative effect. The lack of an estimate should not be interpreted as evidence of no effect or equivalence.

Incomplete reporting limits assessment of missing data. The primary analysis population is described as survey completers, but reasons for non-completion, the amount of missing data, and the handling of missing outcomes are not reported in the registry record. The record also does not explain the terminated status or its implications for recruitment and follow-up.

Further limitations include the absence of a detailed intervention description, a description of usual care, and information about who was masked. The randomization procedure and statistical analysis plan are not reported. The secondary outcome has no posted result, and no multiplicity strategy is reported. Safety information is also sparse: serious-event counts are reported, but event descriptions and fuller collection details are not.

These limitations are specific to what the registry record documents. They do not establish that particular procedures were or were not carried out; they indicate that the record does not report them. The outcome summaries should consequently be treated as limited descriptive information rather than a complete account of the trial’s comparative findings.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Collaborative Care for Opioid Dependence And Pain Pilot Study — NCT04121546.
• Registry record last updated 2024-03-01; status last verified 2024-02.
• Results first posted 2024-03-01.
• 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

The Collaborative Care for Opioid Dependence And Pain Pilot Study is listed as a randomized, parallel-group pilot study with a single masking designation and a terminated status. The registry lists Indiana University as sponsor, enrollment of 6, a start date of 2020-09-18, and a primary completion date of 2022-02-01.

The primary outcome is mean percentage change in daily opioid MME at 12 weeks. The posted means are 62.5% in the intervention arm and 50.0% in usual care, with one participant represented in each arm. No estimable two-arm comparison is reported. Change in PROMIS Pain Interference is listed as a secondary outcome, but its result is not reported in the registry record.

The record lists zero analyses and does not report the primary statistical method, missing-data handling, or the reason for termination. The outcome values and safety counts are descriptive and do not establish a comparative treatment effect or its precision.