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 & Pilot of the Technology-Enabled Alliance for Medication Therapy Management (NCT04575155), a randomized na study. The primary outcome is Medication Reconciliation.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04575155 |
| Phase | NA |
| Condition | Polypharmacy |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 119 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Northwestern University |
| Results posted | Yes |
2. Clinical Question
Population
The study addressed adults taking complex prescription regimens in the context of polypharmacy. The stated intervention aim concerned older patients, and the primary outcome analysis excluded participants lost to follow-up at two months after baseline. The registry record does not provide further eligibility details in the posted outcome description.
Intervention
The TEAM Strategy linked Walgreens pharmacists with primary care through a shared electronic health record. Participants assigned to this arm were to receive at least one pharmacist call about their complex regimens; pharmacists had read/write record access. The intervention was intended to support medication therapy management and communication with primary care providers.
Comparator
Enhanced Usual Care allowed a Walgreens pharmacist read-only access to the medical record. The registry description says this access was already in place for patients at the five targeted health centers. The contrast was therefore between the TEAM intervention with read/write access and pharmacist contact, and enhanced usual care with read-only access.
Primary question
The primary outcome was the number of medication discrepancies per medication, assessed from baseline to two months. Discrepancies combined omissions and commissions, with the follow-up count modeled using the number of prescribed medications as an offset and adjusted for baseline discrepancies and confounding variables. The posted results give arm-specific estimates, but no arm-to-arm analysis is posted.
3. Trial Design
This was a randomized, double-masked, parallel-group study of the Technology-Enabled Alliance for Medication Therapy Management, or TEAM. The registry lists an enrollment of 119 and a status of completed. The listed start date is 2020-10-23, and the listed primary completion date is 2022-10-31. The study was sponsored by Northwestern University and listed under polypharmacy.
The two arms were TEAM Strategy and Enhanced Usual Care. In the TEAM arm, pharmacists were to have read/write access to patients’ electronic health records and to make at least one call to help with complex prescription regimens. In the comparator arm, pharmacists had read-only access. The registry describes the shared-record arrangement as a link between Walgreens community pharmacies and Access Community Health Network primary care practices using the Epic electronic health record platform.
The stated aims extended beyond the primary outcome: they included evaluating intervention fidelity and efficacy for provider counseling, medication reconciliation, and safe regimen use; exploring implementation barriers for patients, providers, pharmacies, and practices; and determining intervention costs from community pharmacy and primary care perspectives. The posted results include one primary outcome measure and no posted secondary outcome measures. The registry record does not report the roles covered by double masking, the randomization procedure, or further details of allocation implementation.
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 | TEAM Strategy | Enhanced Usual Care |
|---|---|---|
| STARTED | 61 | 58 |
| COMPLETED | 61 | 58 |
| NOT COMPLETED | 0 | 0 |
2 Month
| Stage | TEAM Strategy | Enhanced Usual Care |
|---|---|---|
| STARTED | 61 | 58 |
| COMPLETED | 54 | 54 |
| NOT COMPLETED | 7 | 4 |
Reasons for not completing this period:
| Reason | TEAM Strategy | Enhanced Usual Care |
|---|---|---|
| Withdrawal by Subject | 1 | 1 |
| Lost to Follow-up | 5 | 3 |
| Ineligible | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Participants were excluded from the analysis if they were lost to followup at the 2months post baseline.
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: 61 intervention participants initially completed baseline, however one participant was later deemed ineligible and was removed from analysis.
| Characteristic | Unit | TEAM Strategy | Enhanced Usual Care | Total |
|---|---|---|---|---|
| Participants analysed | 60 | 58 | 118 | |
| Age, Continuous | years | 61.0 (SD 7.4) | 60.7 (SD 6.3) | 60.8 (SD 60.0) |
| Sex: Female, Male: Female | Participants | 36 | 29 | 65 |
| Sex: Female, Male: Male | Participants | 24 | 29 | 53 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 17 | 17 | 34 |
| Race (NIH/OMB): White | Participants | 40 | 39 | 79 |
| Race (NIH/OMB): More than one race | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Interview Language: English | Participants | 28 | 26 | 54 |
| Interview Language: Spanish | Participants | 32 | 32 | 64 |
6. Primary Endpoint
The registry lists the primary outcome as Medication Reconciliation, measured over Baseline-2 months.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | number of discrepancies per medication |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was medication reconciliation, measured as the number of medication discrepancies per medication from baseline to two months. The registry defines a discrepancy as either an omission—a medication listed in the electronic health record that the patient reported not taking—or a commission—a medication the patient reported taking that was absent from the record. The total count combines both types.
The measure is intended to capture mismatches between the medical record and the patient’s reported medication use. Such mismatches are relevant to medication reconciliation because the intervention was designed to help pharmacists identify and communicate medication challenges for primary care review. A discrepancy was considered resolved at the two-month follow-up if the pharmacist indicated that the medication should be removed from or added to the medication list.
The endpoint description says that the two-month discrepancy count was modeled with the number of prescribed medications as an offset, while accounting for baseline discrepancies and confounding variables. The posted outcome is expressed as a least-squares mean with a 95% confidence interval. The registry record does not give a separate breakdown of omissions and commissions in the posted results, nor does it post a comparative estimate for the difference between arms.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted arm-specific estimates for medication discrepancies per medication are 0.14 for TEAM Strategy, with a 95% confidence interval of 0.08 to 0.23, and 0.17 for Enhanced Usual Care, with a 95% confidence interval of 0.1 to 0.29. These are the registry’s reported least-squares means. The confidence intervals convey uncertainty around each arm’s estimate; they are not intervals for the difference between arms.
The registry record does not post a direct between-arm estimate, confidence interval, or inferential test for this endpoint. The analysis listings contain no posted analyses, and the record flags the two-arm comparison as not estimable for a continuous endpoint. Accordingly, these arm-specific values do not establish the size or precision of a treatment contrast. It is not appropriate to calculate or infer a difference, ratio, or significance test from the arm-level summaries.
As a general statistical point, an arm-specific confidence interval describes uncertainty in an estimate under the model used to produce it. A comparative question requires an estimate of the contrast itself, with its own uncertainty and analysis details. The overlap or non-overlap of separate arm-specific intervals is not a substitute for that contrast. No conclusion about statistical significance can be drawn from the posted arm-level estimates alone.
The endpoint model was described as a multivariate Poisson regression, with the count of prescribed medications used as an offset and adjustment for baseline discrepancies and confounding variables. Thus, the estimates should be understood as model-based results rather than raw counts of all discrepancies. The registry record does not specify the complete set of confounding variables or provide model diagnostics, so the posted summaries do not allow readers to assess those details.
For the result to be interpreted fully, the arm-to-arm estimate and its uncertainty, the model’s covariates and assumptions, and the analysis population would be useful. Those details are not reported in the registry record. The posted values are descriptive evidence about each arm’s modeled outcome; without the comparative analysis, they do not answer whether outcomes differed between the assigned strategies.
9. Statistical Methods Explained
The registry describes the primary endpoint as a count of medication discrepancies at the two-month follow-up, modeled with multivariate Poisson regression. The posted arm results are least-squares means with 95% confidence intervals. The distinction between the endpoint’s raw definition and its model-based summaries matters: the outcome begins as a count of discrepancies, while the estimates reflect the specified model and adjustments.
Why use a count model?
General explanation: Poisson regression is commonly used when the outcome is a count, such as the number of discrepancies. It relates the expected count to explanatory variables through a model rather than comparing unadjusted averages alone. The model’s suitability depends on assumptions about the count data and their variability. The registry record names the model but does not report diagnostics or a discussion of how those assumptions were assessed.
What does the offset do?
The analysis used the number of prescribed medications as an offset. General explanation: an offset allows a count model to account for different amounts of exposure or opportunity for an event. In this setting, the number of medications provides the stated denominator-like exposure, so the outcome is expressed per medication rather than treating participants with different medication counts as having identical opportunity for discrepancies. The registry describes this modeling choice but does not give further detail on its implementation.
What does adjustment mean?
The registry states that the model controlled for confounding variables and the number of medication discrepancies at baseline. General explanation: adjustment includes selected factors in a model so that the reported estimates account for those factors as specified by the analysis. Accounting for baseline outcome values can address initial differences in the measured outcome, while confounder adjustment is intended to account for other relevant variables. The variables included beyond baseline discrepancies are not reported in the registry record.
How should the estimates and intervals be read?
The record labels the outcome summaries least-squares means and reports a 95% confidence interval for each arm. General explanation: a confidence interval represents uncertainty in an estimate under the model and its assumptions. It does not indicate that a given percentage of individual participants had outcomes inside the interval, and it does not provide the interval for an arm-to-arm contrast. The reported estimates and intervals are 0.14 (0.08 to 0.23) for TEAM Strategy and 0.17 (0.1 to 0.29) for Enhanced Usual Care.
For the comparative question, the relevant statistical output would ordinarily include an arm-to-arm contrast and its uncertainty, together with the analysis method used to obtain it. No analysis is posted in the registry, and the comparison is flagged as not estimable for a continuous endpoint. Therefore, the arm-specific model summaries cannot be converted into a supported comparative conclusion.
What does “multivariate” tell readers?
The registry uses the term multivariate Poisson regression, but does not explain the model specification in greater detail. General explanation: model labels can indicate how outcomes or explanatory variables are handled, but a label alone is not enough to reconstruct the analysis. The full model equation, the included covariates, any handling of correlation, and checks of fit are not reported in the registry record. Readers should therefore rely on the stated model description without assuming unreported analytic choices.
The registry also notes that a planning illustration may be based on a fraction of the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such an illustration is a planning exercise, not observed power and not evidence that the trial was designed around a particular effect. The registry record does not report the trial’s own sample-size justification. No planning estimate is posted as an observed study result.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome measure, no posted secondary outcome measures, and no posted analyses. It does not report a multiplicity adjustment or a prespecified hierarchy for multiple outcome tests. Since no secondary outcome results are posted, readers cannot determine from this record how multiple outcome testing was addressed, if it was relevant to analyses beyond the listed outcome. The registry record does not report interim analyses or a detailed statistical analysis plan.
For the primary endpoint, the outcome description says participants lost to follow-up at two months after baseline were excluded from the analysis. The posted arm results each report an analysis count of 54. The registry enrollment is 119, but the record does not explain the relationship between enrollment and the outcome analysis counts, or report the reasons for missing follow-up by arm. It also does not report imputation, sensitivity analyses for missing outcomes, or a comparison of included and excluded participants.
As a general statistical consideration, excluding participants with missing follow-up can affect interpretation if missingness is related to the outcome or to assigned group. Whether that concern applies cannot be determined from the posted information. The analysis population is therefore best described as participants with outcome data who were not excluded for loss to follow-up, consistent with the endpoint description; further details are not reported in the registry record.
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 |
|---|---|---|---|
| TEAM Strategy | 0 | 61 | 0.0% |
| Enhanced Usual Care | 0 | 58 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| TEAM Strategy | 0 of 61 |
| Enhanced Usual Care | 0 of 58 |
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 |
|---|---|
| TEAM Strategy | 0 of 61 |
| Enhanced Usual Care | 0 of 58 |
The posted safety counts list 61 participants at risk in the TEAM Strategy group and 58 in Enhanced Usual Care for serious adverse events. The number affected by a serious adverse event is reported as 0 in each group. The record also reports 0 participants affected by other adverse events in each group, and 0 deaths in each group.
These are counts in the registry’s safety fields, not estimates of comparative risk. The at-risk counts differ from the outcome-analysis counts, and the record does not explain the populations or observation period used for the safety figures. It does not provide serious adverse event terms, since no top serious terms are listed, or describe how events were collected or classified.
General explanation: a reported zero means no events were recorded in the stated field for the listed group, not that the possibility of an event has been ruled out. The safety figures should be read within the scope of the registry’s reported counts. They do not establish comparative safety, and the record does not provide enough detail to assess completeness of event ascertainment or the precision of safety estimates.
12. What the Result Does, and Does Not, Mean
The registry reports model-based medication-discrepancy estimates for TEAM Strategy and Enhanced Usual Care at the two-month follow-up. The values are 0.14 and 0.17, respectively, with the stated arm-specific 95% confidence intervals. These results describe the posted summaries for the primary endpoint; they do not, on their own, quantify an arm-to-arm effect.
The result does not show whether one strategy differed from the other under the study’s analysis. The registry has no posted analysis for the two-arm comparison and flags the comparison as not estimable for a continuous endpoint. Without a comparative estimate and its uncertainty, a claim about the direction, magnitude, or statistical significance of an arm difference is not supported by the posted results.
The outcome has a specific scope: it counts omissions and commissions identified by comparing the electronic health record with patient-reported medication use, and uses pharmacist indications about adding or removing medications to define resolution. It is not a report of every aspect of medication therapy management, provider counseling, implementation barriers, costs, or safe regimen use. Although these broader topics were stated aims, no secondary outcome results are posted in the registry record.
The findings should also be interpreted in light of the analysis population and model description. Participants lost to follow-up at two months were excluded from the primary outcome analysis, while additional details about missingness and the adjustment variables are not reported in the registry record. The arm-specific estimates are adjusted model summaries, not simple counts of all participants’ discrepancies.
Overall, the posted data document the primary outcome estimates and the reported safety counts, but leave the comparative effect unresolved. They are not a basis for medical advice or for claims about treatment benefit or lack of benefit.
13. Why This Trial Matters Statistically
This trial’s statistical question is tied to how medication discrepancies are defined and modeled. The outcome combines omissions and commissions, then relates the follow-up count to the number of prescribed medications through an offset. That approach recognizes that participants with different medication counts may have different opportunities for discrepancies. It also makes clear why the endpoint should not be interpreted as a simple unadjusted total.
The design further highlights the distinction between intervention delivery and comparative evaluation. TEAM involved pharmacist contact and read/write electronic health record access, while Enhanced Usual Care involved read-only access. The posted summaries give an estimate for each arm, but do not provide the contrast needed to assess the randomized comparison. A randomized design alone does not replace reporting the comparative estimate, its uncertainty, and the analysis details.
The record also illustrates how missing follow-up affects a reader’s understanding of the analysis population. The primary outcome description excludes participants lost to follow-up, but the registry does not give reasons by arm or report sensitivity analyses. These omissions limit assessment of how well the analyzed participants represent those enrolled.
Finally, the trial aimed to examine fidelity, implementation barriers, and costs as well as medication reconciliation. The registry posts only the primary outcome measure and no secondary outcome results. Statistically, this limits the conclusions available from the record: it documents selected outcome summaries, but not the broader set of planned implementation and cost questions or a formal arm-to-arm result for the primary endpoint.
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 main limitation for interpreting the primary result is the absence of a posted between-arm estimate and inferential analysis. The registry supplies arm-specific least-squares means and confidence intervals, but does not report a contrast or its uncertainty. The comparison is flagged as not estimable for a continuous endpoint, and the registry lists no posted analyses. This prevents a direct assessment of the randomized comparison from the posted results.
The model description is incomplete for independent appraisal. Although the record names multivariate Poisson regression, specifies an offset for the number of prescribed medications, and says that baseline discrepancies and confounding variables were controlled, it does not identify all adjustment variables or report model diagnostics. The record also does not explain the use of the least-squares mean summary with further model details.
Loss to follow-up at the two-month assessment led to exclusion from the primary outcome analysis. Reasons for loss, missingness by arm, and sensitivity analyses are not reported in the registry record. The posted analysis counts are not reconciled with the enrollment figure. The safety counts use different at-risk numbers, and the registry does not describe their observation period or event ascertainment in further detail.
The registry does not report the roles covered by double masking, the randomization procedure, a detailed statistical analysis plan, or the trial’s own sample-size justification. It also posts no secondary outcome results, despite broader stated aims involving implementation and costs. These reporting gaps constrain interpretation of the intervention’s comparative effects and the wider objectives.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Development & Pilot of the Technology-Enabled Alliance for Medication Therapy Management — NCT04575155.
- Registry record last updated 2024-11-26; status last verified 2024-11.
- Results first posted 2024-11-26.
- 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
NCT04575155 is a completed randomized, double-masked, parallel-group study sponsored by Northwestern University, with enrollment listed as 119. It evaluated TEAM Strategy against Enhanced Usual Care for medication therapy management in the context of polypharmacy. The study dates listed in the registry are 2020-10-23 for start and 2022-10-31 for primary completion.
The primary outcome was medication discrepancies per medication from baseline to two months. The registry posts arm-specific model estimates and confidence intervals, but no between-arm analysis. Participants lost to follow-up at two months were excluded from the primary outcome analysis. The posted safety fields report no serious adverse events, other adverse events, or deaths in either group, within the listed safety counts.
The registry lists no posted analyses or secondary outcome results. Further details on the comparative analysis, missing data, masking roles, and sample-size justification are not reported in the registry record.