This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Pharmacist Intervention to Improve Smoking Cessation (NCT06943287), a randomized na study. The primary outcome is Number of Interactions With Pharmacist.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06943287 |
| Phase | NA |
| Condition | Smoking Cessation |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 80 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University of Iowa |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns smokers being screened for lung cancer with low-radiation-level chest computed tomography (CT). The registry record does not report additional eligibility criteria or describe how potential participants were identified and approached.
Intervention
Participants assigned to the intervention group were asked to complete a baseline survey, speak remotely with a pharmacist at baseline and at 2, 4, 6, 8, 10, and 12 weeks, and complete an exit survey. The primary outcome counts phone calls completed with the research pharmacist over 12 weeks.
Comparator
Participants assigned to the control group were asked to complete a baseline survey and an exit survey. They did not complete pharmacist phone calls, so the primary phone-call count does not provide a meaningful two-group comparison.
Primary question
The study description raises two questions: whether screened smokers would participate and talk with a pharmacist about cessation, and whether the intervention group would be more likely than the control group to report smoking cessation. The posted primary outcome measures intervention-group calls, rather than cessation or willingness directly. Numerical results for willingness to participate are not reported in the registry record. A secondary outcome records successful quit attempts, but the posted primary result alone cannot answer the cessation question.
3. Trial Design
The registry describes a randomized, open-label, parallel-group behavioral intervention study, with an enrollment of 80 and a status of completed. The listed phase is NA. The study start date is 2025-08-11 and the primary completion date is 2026-07-06. The sponsor is the University of Iowa.
The intervention was remote pharmacist support. The intervention group was asked to complete a baseline survey, have pharmacist phone calls at baseline and at 2, 4, 6, 8, 10, and 12 weeks, and complete an exit survey. The control group was asked to complete baseline and exit surveys, without pharmacist calls. The registry record does not report the allocation ratio or describe the sequence-generation or assignment-concealment procedures. It also does not report additional details about the intervention content or how closely the planned schedule was followed.
The primary outcome is the number of pharmacist phone calls completed by intervention participants over 12 weeks. Its posted result is 183 calls among 41 participants. The control group has no phone-call result because its participants did not complete calls with the pharmacist. Safety results use 42 participants at risk in the intervention group and 38 in the control group. The secondary successful-quit-attempt outcome has results for 35 intervention participants and 30 control participants. The registry record does not explain these differing outcome denominators or identify the population used for each analysis.
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
| Stage | Pharmacist Intervention Group | Control Group |
|---|---|---|
| STARTED | 42 | 38 |
| COMPLETED | 35 | 30 |
| NOT COMPLETED | 7 | 8 |
Reasons for not completing this period:
| Reason | Pharmacist Intervention Group | Control Group |
|---|---|---|
| Withdrawal by Subject | 1 | 1 |
| Lost to Follow-up | 6 | 7 |
Analysis population for the primary outcome, as defined in the registry: Participants in the Control Group did not complete phone calls with the pharmacist.
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.
| Characteristic | Unit | Pharmacist Intervention Group | Control Group | Total |
|---|---|---|---|---|
| Participants analysed | 42 | 38 | 80 | |
| Age, Continuous | Years | 64.6 (SD 5.4) | 63.3 (SD 6.1) | 64.0 (SD 5.8) |
| Sex: Female, Male: Female | Participants | 28 | 21 | 49 |
| Sex: Female, Male: Male | Participants | 13 | 10 | 23 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 3 | 4 |
| Race (NIH/OMB): White | Participants | 34 | 28 | 62 |
| Race (NIH/OMB): More than one race | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 | 0 | 2 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 35 | 28 | 63 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 6 | 3 | 9 |
| Region of Enrollment: United States | Participants | 42 | 38 | 80 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Interactions With Pharmacist, measured over 12 weeks.
| Element | Registry entry |
|---|---|
| Result type | Count Of Units |
| Measure of spread | not applicable |
| Unit | Phone Calls |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint counts the phone calls intervention participants completed with the research pharmacist over 12 weeks. The registry posts 183 calls for 41 participants in the intervention group. This is a count of interactions, not a measure of how many participants quit smoking or how willing screened smokers were to enroll.
As a measure of intervention engagement, a call count can describe whether participants had contact with the pharmacist and the total amount of contact recorded. It may therefore help characterize delivery and participation in the intervention. The count alone does not show how calls were distributed across participants: the registry record does not report each participant’s count, a mean, a spread, or completion at each scheduled time. Nor does the count establish whether the calls changed smoking behavior.
The control group was not assigned pharmacist calls, so zero calls in that group would reflect the study design rather than a comparable engagement outcome. The primary endpoint is consequently descriptive of the intervention arm, not a randomized contrast between groups. The registry record does not report a primary comparative analysis of cessation. The quit-attempt outcome is secondary and addresses a different question.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary posted result is 183 completed pharmacist phone calls among 41 intervention participants over 12 weeks. It describes the recorded volume of contact in that group. It does not show how many participants completed a particular number of calls, whether every planned contact was attempted, or whether participants changed their smoking behavior. Those details are not reported in the registry record.
There is no equivalent primary call count for the control group: control participants did not complete pharmacist calls. This is a structural feature of the study, not evidence of a treatment-group difference in call completion. The primary outcome therefore cannot be used as a direct between-group estimate of cessation, nor does it quantify willingness to participate among all screened smokers. The registry record does not report a numerical result for that willingness question.
The registry also posts a secondary result for successful quit attempts: 8 of 35 participants in the intervention group and 3 of 30 in the control group. The unadjusted comparison has p = 0.168. Its risk-difference confidence interval crosses zero, so the posted data do not pin down the direction or size of a group difference with precision. A confidence interval describes a range of values compatible with the data under the analysis assumptions; an interval spanning the no-difference value signals uncertainty about the direction of the contrast. The p-value is not a measure of the probability that either group is better, and it does not establish equivalence.
This secondary result is based on fewer participants than the registry’s total enrollment, and the record does not explain the outcome denominators or report a missing-data analysis. The interval is broad, consistent with limited precision. The record lists no reported analyses, so no adjusted or sponsor-reported inferential result is available to compare with the unadjusted comparison. The result should therefore be read as an exploratory description of the posted secondary data, not as a definitive answer about cessation.
Overall, the primary outcome documents intervention contact, while the secondary quit-attempt outcome is the posted result most directly related to cessation. Neither establishes whether smokers approached for screening were willing to participate, and the primary result is not a comparative measure of quitting. The registry record does not report additional numerical results for the other listed secondary outcomes.
9. Statistical Methods Explained
What does randomization contribute?
Random assignment is intended to make the groups comparable, on average, with respect to factors measured and unmeasured before assignment. That purpose applies to outcomes that can be compared across groups. Here, the primary phone-call endpoint is defined only for intervention participants, because control participants did not have pharmacist calls. Randomization does not turn that one-arm count into a comparative effect estimate. The registry record does not describe the randomization procedure, allocation ratio, or any adjustment for baseline characteristics.
How should the primary count be read?
A count outcome records how many events or units occurred. The posted primary value is 183 phone calls among 41 intervention participants over 12 weeks. The total does not reveal how calls were distributed among participants or whether the number of calls was similar across individuals. No dispersion measure or participant-level distribution is reported. General statistical note: count outcomes can vary substantially from person to person, and their variability can be greater than a simple model assumes. Over-dispersion matters because a model that understates variability can produce confidence intervals that are too narrow. The registry record does not report a model or dispersion estimate for this endpoint, and no two-arm comparison is estimable from the posted primary results.
What does the secondary comparison estimate?
The successful-quit-attempt outcome is reported as a count of participants with an event in each group: 8 of 35 in the intervention group and 3 of 30 in the control group. The unadjusted risk-difference comparison has p = 0.168. A risk difference expresses the contrast between the event proportions in the two groups; zero represents no difference. Its posted confidence interval crosses zero. General statistical note: a confidence interval conveys the range of effect sizes reasonably compatible with the data and the calculation method. A wide interval signals imprecision; it should not be read as proving either an effect or no effect.
The registry comparison also lists a risk ratio of 2.286 and an odds ratio of 2.667. These are relative measures, contrasting the groups on different scales. Their uncertainty intervals include the no-association value, which is consistent with the uncertainty indicated by the risk-difference interval. Relative measures can appear large while remaining imprecise when the number of observed events is limited. These unadjusted comparisons do not account for any other outcomes or analytic choices.
How should the p-value be interpreted?
The unadjusted p-value of 0.168 describes how unusual data at least as incompatible with a no-difference model would be under the assumptions of that test. It is not the probability that the null hypothesis is true, nor the probability that the observed result occurred by chance. It does not establish that the groups are equivalent. The registry record lists no reported analyses, so the posted comparison is not accompanied by a sponsor-reported inferential analysis or details about the test procedure.
What do the planning numbers mean?
The registry includes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. For planning at 100% of the observed effect, it lists 130 participants per arm for 80% power and 173 participants per arm for 90% power. At 75% of the observed effect, it lists 212 participants per arm for 80% power and 284 participants per arm for 90% power. At 50% of the observed effect, it lists 435 participants per arm for 80% power and 582 participants per arm for 90% power. These are illustrations based on the observed secondary effect, not the trial’s own design justification or observed power. The registry record does not report the original sample-size justification or its assumptions.
General statistical note: power is a planning property that depends on the assumed effect, variability, significance level, allocation, and analysis. A calculation based on an observed effect can be unstable, particularly when event counts are limited. It cannot describe the probability that the completed study detected a true effect. The planning illustration should not be treated as evidence about the trial’s power or as a substitute for the uncertainty in the posted estimate.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists a primary outcome and three secondary outcomes, but reports no analyses. It does not describe a statistical analysis plan, a hierarchy among outcomes, or a procedure for adjusting for multiple comparisons. Without that information, it is not possible to determine whether the displayed unadjusted secondary comparison was planned as the principal cessation analysis or whether other outcomes were also tested. When multiple outcomes are assessed, the chance of at least one apparently unusual result can increase; multiplicity methods are one way to address that issue. Whether such methods were used is not reported in the registry record.
Missing-data handling and analysis populations are also not reported in the registry record. The posted outcome denominators vary: 41 intervention participants contribute to the primary call count, 35 and 30 contribute to the secondary quit-attempt outcome, and the safety results list 42 and 38 participants at risk. The registry does not explain why these denominators differ, whether participants lacked data, or how any missing observations were handled. It does not state whether analyses followed assignment regardless of participation, used only participants with available outcomes, or used another population definition.
The registry record does not report interim analyses, a sample-size justification for the trial, or a protocol-level explanation of analysis decisions. These absences do not show that procedures were or were not used; they limit what can be inferred from the registry results. The planning illustration is based on the observed secondary effect and does not supply the original design rationale. Taken together, the missing analysis details make it difficult to assess the effect of missing observations, multiple testing, or analysis-population choices on the posted results.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Pharmacist Intervention Group | 0 | 42 | 0.0% |
| Control Group | 0 | 38 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Pharmacist Intervention Group | 0 of 42 |
| Control Group | 0 of 38 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Pharmacist Intervention Group | 0 of 42 |
| Control Group | 0 of 38 |
The registry reports zero serious adverse events and zero deaths among 42 participants at risk in the intervention group and 38 in the control group. It also reports zero other adverse events in both groups. No serious adverse-event terms are listed. These are the counts recorded in the registry’s safety results; they are not a comparison of risks adjusted for differences between groups.
Zero recorded events does not establish that the intervention has no risks. Safety counts are descriptive, and their interpretation depends on how events were defined, collected, and followed. The registry record does not report the safety follow-up timeframe, event-collection procedures, or additional detail about severity and relatedness. The counts should therefore be understood as the posted observations in this study, not as a guarantee about safety in other settings or populations.
12. What the Result Does, and Does Not, Mean
The primary result establishes that 183 pharmacist phone calls were recorded among 41 intervention participants over 12 weeks. It is evidence about the amount of contact recorded in the intervention group. It does not reveal how many participants completed all scheduled calls, how contact varied across participants, or how participants experienced the calls. It also does not directly measure smoking cessation.
The posted secondary quit-attempt result compares 8 of 35 intervention participants with 3 of 30 control participants. The unadjusted comparison is imprecise: its confidence interval crosses the no-difference value, and p = 0.168. The result does not establish that the groups differ, and it does not demonstrate that they are equivalent. The registry record does not report a sponsor analysis, missing-data approach, or complete analysis plan that could clarify the robustness of this comparison.
The study description also asks whether screened smokers would participate and speak with a pharmacist. A count of calls among intervention participants does not measure the proportion of eligible or approached smokers who agreed to participate. Numerical results for willingness are not reported in the registry record. The primary call outcome and the secondary quit-attempt outcome thus address distinct parts of the study’s stated questions, with important details about both analyses absent.
These data can describe intervention contact and provide an uncertain secondary comparison for quit attempts. They cannot by themselves establish the intervention’s effect on smoking cessation, the general acceptability of pharmacist support, or the safety of the intervention beyond the recorded events. Those conclusions would require information and analyses not reported in the registry record.
13. Why This Trial Matters Statistically
Statistically, this study highlights the distinction between an implementation measure and a clinical outcome. Counting pharmacist interactions can describe whether a remote intervention involved contact, but it is not interchangeable with measuring cessation. Because control participants did not receive pharmacist calls, the primary endpoint has no like-for-like control result. A randomized design is informative for between-group questions only when the outcome is defined and measured in a comparable way across groups.
The record also illustrates why counts and denominators need context. The primary result is a total number of calls, while the quit-attempt result is reported as participants with an event in each group. The available data do not describe the distribution of calls, explain differing outcome denominators, or show how missing observations were handled. Those omissions limit interpretation even when the posted numbers are clear.
Finally, the secondary cessation comparison is uncertain, and the registry record does not report a statistical analysis plan or multiplicity handling. This makes it important to distinguish a descriptive signal from a prespecified, confirmatory analysis. The planning illustration uses the observed effect and should not be confused with the trial’s original sample-size rationale or with observed power. Together, these points make the record useful for understanding which questions the posted outcomes can answer—and which remain unresolved.
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 endpoint is a one-arm count: the control group did not complete pharmacist calls. It therefore does not support a direct randomized comparison of intervention exposure or a direct estimate of cessation effectiveness. The total number of calls also does not show whether contact was distributed evenly or whether participants completed each scheduled call.
The registry record does not report numerical results for willingness to participate, even though this is one of the questions in the study description. Among the listed secondary outcomes, numerical results are available for successful quit attempts, but results for nicotine replacement therapies and non-medication tools are not reported in the registry record. The quit-attempt comparison is based on fewer participants than the listed total enrollment, and the reasons for the differing denominators are not reported.
Further limitations include the absence of a reported analysis plan, missing-data procedures, analysis-population definitions, multiplicity methods, and original sample-size justification. The registry record does not describe how the intervention was delivered in practice or provide participant-level call data. It also does not report the safety follow-up timeframe or event-collection methods. These gaps restrict assessment of precision, completeness, and generalizability. They do not establish that any particular procedure was omitted; they mean the registry record does not supply information needed to evaluate it.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pharmacist Intervention to Improve Smoking Cessation — NCT06943287.
- Registry record last updated 2026-08-31; status last verified 2026-07.
- Results first posted 2026-08-31.
- 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.
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18. Record Summary
NCT06943287, titled “Pharmacist Intervention to Improve Smoking Cessation,” is a completed, randomized, open-label, parallel-group behavioral study sponsored by the University of Iowa. The registry lists enrollment of 80 and a primary completion date of 2026-07-06.
The primary outcome counts pharmacist calls over 12 weeks. The registry posts 183 calls among 41 intervention participants; control participants did not complete pharmacist calls. For the secondary successful-quit-attempt outcome, the posted counts are 8 of 35 in the intervention group and 3 of 30 in the control group, with an unadjusted p-value of 0.168. Numerical results for the other listed secondary outcomes are not reported in the registry record.
The primary result describes intervention contact rather than a comparative cessation effect. The secondary comparison is uncertain, and the registry record does not report a statistical analysis plan, missing-data procedures, or multiplicity handling.