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 Development and Evaluation of an Electronic Health Record-based Medication Complete Communication (EMC2) Strategy (NCT03652272), a randomized na study. The primary outcome is Medication Specific Knowledge.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03652272 |
| Phase | NA |
| Condition | Medication Adherence |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 301 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Northwestern University |
| Results posted | Yes |
2. Clinical Question
Population
Patients in a trial conducted at Northwestern Endocrinology and ACCESS Community Health Network. The registry describes a focus on medication adherence and on medications selected in advance for the intervention. Further eligibility details are not reported in the registry record.
Intervention
EMC2, a behavioral strategy based in the electronic health record. The described activities include a prescriber alert recommending counseling about medication use and presenting key medication risks. The strategy was intended to inform patients about medication risks and safe use, promote provider education and counseling, and monitor adherence outside visits.
Comparator
Usual care, described as variable provider counseling with limited or variable electronic health record notifications or counseling support. Print medication information was not distributed in clinics, while pharmacy distribution was variable; active surveillance was limited or absent.
Primary question
The primary outcome was medication-specific knowledge, scored from 0 to 100, with higher scores indicating more correct answers. The posted outcome timeframe is baseline. The central clinical question motivating the strategy is whether structured medication communication can support patients’ understanding and safe use of prescribed medicines. The registry record does not report a post-intervention between-group estimate for this primary outcome, so the posted baseline scores do not answer whether EMC2 changed knowledge.
3. Trial Design
This was a randomized, parallel-group trial of the behavioral EMC2 strategy and usual care. The registry identifies masking as none and lists the study phase as not applicable. Enrollment is recorded as 301. The trial was conducted at Northwestern Endocrinology and ACCESS Community Health Network, and its status is completed. The listed start date is 2019-02-08 and the primary completion date is 2021-09-27.
EMC2 was designed around patient movement through a provider visit and a selected list of pre-specified medications. Its described components include a prescriber-facing Best Practices Alert recommending counseling and summarizing key medication risks. The broader strategy was intended to combine patient information, provider counseling, and adherence monitoring outside visits. The usual-care description indicates that counseling and electronic health record support could vary, with limited clinic distribution of print medication materials and variable pharmacy distribution.
The registry reports that recruitment at ACCESS performance sites was halted in March 2021 because of the Covid-19 pandemic and its impact on recruitment, including loss of providers, low patient volume, and low prescription volume. The record does not report the allocation ratio, sequence-generation method, concealment procedure, or detailed eligibility criteria. Those design details should not be inferred from the randomized designation alone. The posted primary outcome is measured at baseline, and a between-group primary-outcome analysis is not reported.
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.
Baseline
| Stage | EMC2 | Usual Care |
|---|---|---|
| STARTED | 143 | 158 |
| COMPLETED | 143 | 158 |
| NOT COMPLETED | 0 | 0 |
3 Month
| Stage | EMC2 | Usual Care |
|---|---|---|
| STARTED | 143 | 158 |
| COMPLETED | 126 | 143 |
| NOT COMPLETED | 17 | 15 |
Reasons for not completing this period:
| Reason | EMC2 | Usual Care |
|---|---|---|
| Withdrawal by Subject | 1 | 1 |
| Lost to Follow-up | 16 | 14 |
Analysis population for the primary outcome, as defined in the registry: This trial was conducted at Northwestern Endocrinology and ACCESS Community Health Network. Due to the Covid-19 pandemic and its impact on recruitment (loss of providers, low patient volume, low prescription volume) at ACCESS performance sites, recruitment was halted in March 2021. The effectiveness of the intervention will be only tested on the Northwestern participants due to statistical power. 2 patients from the intervention group were excluded due to missing outcomes data at follow-up.
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 | EMC2 | Usual Care | Total |
|---|---|---|---|---|
| Participants analysed | 143 | 158 | 301 | |
| Age, Continuous | years | 52.58 (SD 13.99) | 53.61 (SD 14.88) | 53.12 (SD 14.44) |
| Sex: Female, Male: Female | Participants | 82 | 95 | 177 |
| Sex: Female, Male: Male | Participants | 61 | 62 | 123 |
| Race/Ethnicity, Customized: Hispanic | Participants | 20 | 21 | 41 |
| Race/Ethnicity, Customized: Non-Hispanic White | Participants | 50 | 82 | 132 |
| Race/Ethnicity, Customized: Non-Hispanic Black | Participants | 60 | 41 | 101 |
| Race/Ethnicity, Customized: Non-Hispanic Others/Multiracial | Participants | 11 | 13 | 24 |
| Education: Less than High School | Participants | 10 | 4 | 14 |
| Education: High School Graduate | Participants | 59 | 59 | 118 |
| Education: College Graduate | Participants | 73 | 94 | 167 |
6. Primary Endpoint
The registry lists the primary outcome as Medication Specific Knowledge, measured over Baseline.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | score (0-100) |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is medication-specific knowledge, expressed as a score from 0 to 100. It covers knowledge of the medication’s indication, risks or warnings, and side effects. Risk or warning knowledge was scored as correct or incorrect for each item; side-effect knowledge included whether the patient knew at least two side effects. Correct answers were graded blindly by two reviewers, with disagreement resolved by a third pharmacist. The score represents the percent correct of possible points, and a higher value indicates a better outcome.
Knowledge is relevant to a medication communication strategy because understanding a medicine’s purpose, risks, and side effects is part of the intended patient-facing information. The registry describes the strategy as aiming to inform patients about medication risks and safe use. Knowledge is nevertheless distinct from adherence and from clinical outcomes: a score captures responses to knowledge questions, not whether medication was taken as prescribed or whether health changed.
The registry lists the primary outcome timeframe as baseline. Thus, the posted values describe knowledge at that time, rather than a change after exposure to the intervention. The registry record does not report a follow-up primary-outcome estimate or a treatment-effect analysis for this endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted baseline least-squares mean medication-specific knowledge score was 63.82 for EMC2, with a 95% confidence interval from 59.53 to 68.11. For usual care, the score was 62.8, with a 95% confidence interval from 58.8 to 66.8. Both scores use the registry’s 0-to-100 scale, on which higher scores represent a greater proportion of correct possible points. The confidence intervals overlap. These figures describe the groups at baseline; they are not estimates of a post-intervention effect.
A confidence interval communicates uncertainty around an estimated group mean under the analysis used. It is not a range containing every participant’s score, and overlap between two intervals is not itself a formal test of a difference. The registry record does not report a between-group estimate, a test statistic, or a p-value for this continuous outcome. The listed endpoint timeframe is baseline, and the record indicates that a two-arm comparison for this continuous endpoint is not estimable in the posted results. Accordingly, the baseline values cannot establish whether knowledge changed, or whether any change differed between the randomized groups.
The outcome is reported as a least-squares mean, a model-based mean rather than necessarily a raw arithmetic average. The model specification and any covariates are not reported in the registry record. The arm-specific confidence intervals communicate precision for each posted mean, but they do not supply the missing treatment contrast or its uncertainty. No adjusted or unadjusted between-arm estimate is posted for this outcome.
The trial record lists medication adherence outcomes among the secondary outcomes, including “Medication Adherence- Ask 12” and “Medication Adherence - Proper Use.” Their presence indicates that adherence was also considered, but the registry entries reported for the primary endpoint do not establish what happened on those outcomes. The registry record does not report their results.
Interpretation should therefore remain descriptive. The scores show the recorded baseline level of medication-specific knowledge in each arm and the uncertainty around those arm-level estimates. They do not show the effect of EMC2, demonstrate equivalence between groups, or establish a relationship between knowledge and adherence. The record reports randomization, but randomization alone does not turn baseline measurements into estimates of an intervention effect.
9. Statistical Methods Explained
What does a least-squares mean represent?
A least-squares mean is a model-based estimate of a group mean. In general, a statistical model can account for specified factors when estimating group values. Which factors were included, how the model was fitted, and whether any assumptions were checked are not reported in the registry record. The label should therefore be read as the type of estimate posted, not as evidence of a particular adjustment strategy.
The endpoint is continuous: each patient’s knowledge is represented by a score on a bounded scale. In general, continuous outcomes can preserve more information than collapsing scores into categories, because differences in score levels remain visible. The score’s clinical interpretation still depends on what the scale measures and how scores relate to meaningful changes. A threshold for clinically important change is not reported in the registry record.
How should the confidence intervals be read?
The posted confidence intervals express uncertainty in the estimated arm-specific means. In general, a confidence interval is constructed by a method that would capture the target quantity at its stated rate over repeated applications under the method’s assumptions. It does not mean that there is a 95% probability that a fixed true value lies inside this particular interval. The confidence intervals in the record are 95% intervals, but the method used to calculate them is not reported.
Arm-specific intervals do not replace an interval for the contrast between arms. To assess a treatment contrast, readers need an estimate comparing the groups and a measure of uncertainty for that estimate, obtained with an appropriate analysis. The record does not post such a contrast for the primary continuous outcome. In general, interval overlap is not a stand-alone test of whether two groups differ; a direct comparison uses the uncertainty of the contrast itself.
Why does the baseline timeframe matter?
Baseline measurement describes the outcome before the intervention is evaluated over time. In general, a baseline value can characterize the study groups or inform a later analysis, but it is not by itself an intervention response. A randomized design supports causal comparisons when outcomes are analyzed in a way that preserves the intended comparison and addresses the relevant follow-up data. The posted primary endpoint is explicitly at baseline, and the registry record does not report the follow-up comparison needed to interpret an intervention effect on knowledge.
It is also important to distinguish a group mean from individual experience. A mean score summarizes a group and does not indicate that every participant had a score near that mean. No participant-level score distribution is reported in the registry record. The confidence intervals describe precision of the group means, not the spread of individual scores.
What does randomization contribute?
Randomization is intended, in general, to make assigned groups comparable on average at allocation and to reduce confounding in a properly analyzed comparison. The registry labels this study randomized, but does not report the sequence-generation or allocation-concealment procedures. Nor does it post a primary-outcome treatment contrast. It would therefore be inappropriate to infer that the baseline means demonstrate balance on all relevant factors, or that the observed scores estimate a causal effect.
The trial is listed as unmasked. The knowledge answers were graded blindly by two reviewers, and a third pharmacist resolved discordant grading. This describes blinding of answer grading, not masking of patients or providers to assigned care. In general, blinded outcome assessment can reduce bias in scoring, while not eliminating every source of bias in a trial. The registry does not report further details about the reviewers’ procedures.
How should missing analysis details be handled?
Statistical interpretation depends on details such as the analysis population, handling of incomplete observations, covariate adjustment, and prespecified analysis methods. These details are not reported in the registry record. The record reports no posted analyses for the trial and indicates that a two-arm continuous-endpoint comparison is not estimable in the posted results. This absence is not a finding of no effect; it means the posted baseline estimates do not provide a comparative effect estimate.
In general, missing outcome data can affect both the precision and potential bias of an estimate, depending on why observations are unavailable and how the analysis handles them. The registry record does not describe missingness at the participant level or an imputation method. No assumptions about those matters should be substituted for the absent analysis information.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two secondary outcomes: “Medication Adherence- Ask 12” and “Medication Adherence - Proper Use.” It reports three outcome measures in total. The multiplicity strategy, if any, for interpreting several outcomes is not reported in the registry record. In general, considering several outcomes can increase the chance of at least one apparently unusual result when each is assessed separately. Methods such as prespecifying a hierarchy or adjusting inference can address that concern, but the record does not identify such a method.
The registry record reports no analyses and does not provide a between-group analysis of the primary continuous endpoint. It also does not report an analysis population, the number with observed endpoint data by analysis set, or how missing observations were handled. Enrollment and the arm-specific numbers attached to the posted primary-outcome estimates do not, by themselves, explain who was included in each analysis or why those numbers differ from other group counts.
Recruitment at ACCESS performance sites was halted in March 2021 because of the Covid-19 pandemic and its effects on recruitment, including loss of providers, low patient volume, and low prescription volume. This is relevant context for recruitment, but the record does not quantify its impact on outcome availability or provide a missing-data analysis. The statistical plan, including any interim analyses or multiplicity procedures, is not reported in the registry record. Those methods should not be inferred from the randomized design or from the outcome listings.
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 |
|---|---|---|---|
| EMC2 | 0 | 143 | 0.0% |
| Usual Care | 0 | 158 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| EMC2 | 0 of 143 |
| Usual Care | 0 of 158 |
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 |
|---|---|
| EMC2 | 4 of 143 |
| Usual Care | 6 of 158 |
Most frequent non-serious adverse event terms
| Event term | Organ system | EMC2 | Usual Care |
|---|---|---|---|
| Medication Side Effects | General disorders | 4 of 143 | 6 of 158 |
The registry reports serious adverse events for EMC2 among 143 at risk and for usual care among 158 at risk. The number affected by a serious adverse event is 0 in each group. Deaths are reported as 0 in each group. These are the recorded counts, not estimates of comparative safety.
For other adverse events, the registry reports 4 affected among 143 at risk in EMC2 and 6 affected among 158 at risk in usual care. The record does not provide event descriptions for these other adverse events in the registry record. It lists no top serious adverse-event terms. No event-rate comparison, confidence interval, or statistical test is reported.
In general, adverse-event counts need to be read alongside the group at-risk counts, the period of observation, definitions, and methods for collecting and attributing events. The registry entries provide group counts at risk and affected counts, but do not report enough detail to characterize event severity beyond the serious-event designation, timing, causality assessment, or ascertainment procedures. The counts should not be interpreted as proof that an event cannot occur or that one group is safer. They describe the adverse-event figures posted in the registry record.
12. What the Result Does, and Does Not, Mean
The result that can be described is the baseline medication-specific knowledge score in each randomized group. EMC2 had a posted least-squares mean of 63.82, with a 95% confidence interval of 59.53 to 68.11; usual care had a mean of 62.8, with a 95% confidence interval of 58.8 to 66.8. Higher scores correspond to more correct answers on the registry’s 0-to-100 scale. These estimates indicate the recorded baseline knowledge level and its precision, not a response to treatment.
The result does not establish that EMC2 improved or failed to improve knowledge. The registry record does not report a post-intervention estimate, a between-group contrast, or a test for the primary endpoint. The baseline values also do not establish that the groups were equivalent, even though their confidence intervals overlap. Equivalence requires a suitable comparative analysis and an interpretive margin, neither of which is reported.
Knowledge is only one part of the strategy’s intended pathway. The trial description also refers to provider counseling and monitoring adherence outside visits, and the registry lists adherence as a secondary outcome. The primary knowledge scores do not demonstrate whether patients followed medication instructions, whether provider behavior changed, or whether clinical outcomes changed. Results for the secondary outcomes are not reported in the registry record by the registry record.
The record’s completed status and enrollment figure do not fill the gap in comparative outcome reporting. Recruitment was halted at ACCESS performance sites in March 2021 because of pandemic-related recruitment impacts, but the record does not quantify how that affected the final analyses. The appropriate conclusion is limited: baseline knowledge estimates are posted, while the primary intervention effect and its statistical uncertainty are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial addresses a practical measurement problem in clinical research: a medication communication intervention has several intended steps, and those steps are not interchangeable outcomes. Patient knowledge, provider counseling, medication adherence, and clinical consequences represent different points in a possible pathway. Measuring medication-specific knowledge gives a direct way to describe one intended patient-facing outcome, while the separately listed adherence outcomes reflect another dimension.
The score’s construction is also relevant to measurement quality. It incorporates knowledge of indication, risks or warnings, and side effects, with correct responses graded by two blinded reviewers and disagreements resolved by a third pharmacist. That process makes the scoring procedure explicit at a basic level. At the same time, a numeric score does not automatically reveal what change would matter to patients or clinicians; a meaningful-change threshold is not reported in the registry record.
Statistically, the trial illustrates why baseline estimates must be separated from intervention effects. Random allocation is part of the design, but a baseline outcome alone cannot quantify a treatment contrast. A clear comparative estimate and its uncertainty are needed to evaluate an effect. The absence of a posted primary-outcome analysis limits what can be concluded, regardless of the intervention’s rationale or the precision of the arm-specific baseline means.
The recruitment interruption is also important context. Pandemic-related operational effects led to halted recruitment at ACCESS performance sites, and the registry names loss of providers, low patient volume, and low prescription volume. Such context helps readers understand why interpretation may be constrained, although the record does not quantify its effect on the analyses. A transparent distinction between what was measured, what was analyzed, and what remains unreported is central to responsible statistical reading.
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 most consequential limitation for interpretation is that the posted primary endpoint is measured at baseline, while a comparative post-intervention estimate is not reported. The registry record therefore does not support an estimate of EMC2’s effect on medication-specific knowledge. It also does not report a test or confidence interval for a between-group contrast. The listed baseline arm means should not be treated as treatment results.
Important analysis details are absent from the registry record. These include the statistical model specification, any covariates, the analysis population, missing-data procedures, allocation ratio, sequence generation, and allocation concealment. The record does not report the statistical plan, interim analyses, or a multiplicity procedure. These gaps restrict assessment of how the reported least-squares means were generated and how results across outcomes were intended to be interpreted.
The registry describes recruitment being halted in March 2021 at ACCESS performance sites because of pandemic-related impacts, including loss of providers, low patient volume, and low prescription volume. It does not quantify how the interruption affected recruitment, outcome completeness, or the analyses. Although enrollment is recorded as 301, that figure does not resolve those questions or explain the arm-specific outcome analysis counts.
The primary score measures knowledge, not adherence or clinical benefit. The registry lists two adherence outcomes but does not report their results in the registry record. A threshold for meaningful score change is also not reported. Finally, the record’s description of EMC2 and usual care indicates variability in the comparator’s counseling and information support; the amount of variation or implementation fidelity is not reported. These limitations call for a narrow reading of the posted baseline estimates and safety counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Development and Evaluation of an Electronic Health Record-based Medication Complete Communication (EMC2) Strategy — NCT03652272.
- Registry record last updated 2025-03-07; status last verified 2025-02.
- Results first posted 2025-03-07.
- 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
NCT03652272 is a completed randomized, unmasked, parallel-group behavioral trial of EMC2 versus usual care. It was conducted at Northwestern Endocrinology and ACCESS Community Health Network. Enrollment is recorded as 301; the listed start date is 2019-02-08 and primary completion date is 2021-09-27. Recruitment at ACCESS performance sites was halted in March 2021 because of pandemic-related recruitment impacts.
The primary outcome is medication-specific knowledge on a 0-to-100 score, with higher scores indicating better knowledge. Its listed timeframe is baseline. The registry posts arm-specific least-squares means and 95% confidence intervals, but does not report a between-group primary-outcome estimate or test. Medication adherence is listed among two secondary outcomes, with no results reported in the registry record. Serious adverse events and deaths are reported as 0 in both groups; other adverse events are reported as 4 in EMC2 and 6 in usual care.