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 A Trial of Behavioral Economic Interventions to Reduce Cardiovascular Disease (CVD) Risk (NCT01346189), a randomized na study. The primary outcome is Change in LDL From Baseline to 12 Months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01346189 |
| Phase | NA |
| Condition | Cardiovascular Disease |
| Allocation | Randomized |
| Design model | Factorial |
| Masking | None (open label) |
| Enrollment | 1503 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Pennsylvania |
| Results posted | Yes |
2. Clinical Question
Population
Patients with poor cholesterol control who were at very high risk for cardiovascular disease, cared for by primary care physicians at Geisinger Health System and University of Pennsylvania outpatient clinics.
Intervention
Behavioral economic incentives linked to LDL goals: payments to physicians, payments to patients, or payments shared between physicians and patients. The incentive approaches included statin-adherence feedback for physicians, as described for the relevant arms.
Comparator
Usual care, listed as the control arm.
Primary question
How did LDL cholesterol change from baseline to 12 months across the incentive approaches and usual care? The registry record does not report the numerical primary outcome results, so the size and precision of any between-group differences are not available from that record.
The trial was designed to examine whether incentive arrangements tied to cholesterol goals were associated with increased statin use and lower LDL cholesterol. The registry description focuses on patients with poor cholesterol control and very high cardiovascular risk, and identifies LDL change as the primary endpoint. It also lists change in LDL from baseline to 15 months as a secondary outcome.
The intervention descriptions specify quarterly payments linked to achieving an LDL reduction of at least 10 mg/dL relative to baseline LDL or the prior quarter’s target LDL. The physician-only approach also included daily statin-adherence information for physicians. In the patient-only approach, payments were made to patients. In the combined approach, physician and patient shared payments evenly, and physicians received daily adherence information. The registry record does not state the amounts of the payments.
The clinical question is therefore about the effect of offering these incentive strategies in the trial setting, not about the effect of statins themselves. Because the primary outcome estimates are not reported in the registry record, it is not possible to describe the observed direction, magnitude, or statistical precision of the comparisons from the registry information.
3. Trial Design
The registry describes a randomized, cluster-randomized controlled trial with a factorial model and four arms: physician incentives, patient incentives, physician and patient combined incentives, and usual care. The study was not masked. The registry lists the phase as not applicable. Enrollment was 1503.
The trial enrolled patients with poor cholesterol control who were considered at very high risk for cardiovascular disease. The participating settings were primary care physicians and patients at Geisinger Health System and University of Pennsylvania outpatient clinics. The registry identifies cardiovascular disease as the condition under study. Its brief description says the investigators planned to test behavioral economic approaches intended to increase statin use and reduce LDL cholesterol.
In the physician incentive arm, quarterly payments depended on a patient meeting the specified LDL goal, and physicians had daily statin-adherence information. In the patient incentive arm, quarterly payments went to the patient based on reaching the goal. In the combined arm, physician and patient shared the payment evenly, with daily adherence information available to physicians. The usual-care arm is listed without an additional intervention description.
Cluster randomization means that assignment was made at the level of groups rather than treating every participant’s assignment as independent. This matters statistically because outcomes within the same cluster may be more alike than outcomes across clusters. An analysis that ignores clustering can misstate uncertainty. The registry description identifies this cluster-randomized structure; the number and definition of clusters are not reported in the registry record.
The registry gives a start date of 2011-09, a primary completion date of 2014-08, and a completed status. It does not report the allocation details beyond randomization and the factorial model, such as the specific factors or their assignment structure. The sample-size justification, planned interim analyses, and full statistical analysis plan are not reported in the registry record. The primary endpoint is change in LDL from baseline to 12 months, while change from baseline to 15 months is listed as a secondary outcome.
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 | Physician Incentives | Patient Incentives | Physician and Patient Combined Incentives | Usual Care/Control |
|---|---|---|---|---|
| STARTED | 433 | 358 | 346 | 366 |
| COMPLETED | 417 | 341 | 332 | 355 |
| NOT COMPLETED | 16 | 17 | 14 | 11 |
Reasons for not completing this period:
| Reason | Physician Incentives | Patient Incentives | Physician and Patient Combined Incentives | Usual Care/Control |
|---|---|---|---|---|
| Withdrawal by Subject | 7 | 5 | 3 | 5 |
| Physician Decision | 4 | 0 | 0 | 0 |
| Moved | 3 | 0 | 4 | 0 |
| Other | 2 | 4 | 7 | 3 |
| Death | 0 | 3 | 0 | 0 |
| Non-health system primary care physician | 0 | 5 | 0 | 0 |
| Travel | 0 | 0 | 0 | 3 |
Analysis population for the primary outcome, as defined in the registry: Subjects were lost to follow-up, or withdrawn for other reasons. Thus the number analyzed at the 12 month time point does not equal the number analyzed during 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.
| Characteristic | Unit | Physician Incentives | Patient Incentives | Physician and Patient Combined Incentives | Usual Care | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 433 | 358 | 346 | 366 | 1503 | |
| Age, Continuous | years | 61.68 (SD 8.67) | 62.41 (SD 8.63) | 62.03 (SD 8.64) | 61.70 (SD 8.89) | 61.99 (SD 8.70) |
| Sex: Female, Male: Female | Participants | 179 | 164 | 135 | 161 | 639 |
| Sex: Female, Male: Male | Participants | 254 | 194 | 211 | 205 | 864 |
| Race/Ethnicity: White, non-Hispanic | Participants | 360 | 265 | 285 | 289 | 1199 |
| Race/Ethnicity: African American, non-Hispanic | Participants | 57 | 72 | 42 | 61 | 232 |
| Race/Ethnicity: Other non-Hispanic | Participants | 8 | 10 | 6 | 7 | 31 |
| Race/Ethnicity: Hispanic | Participants | 6 | 10 | 7 | 7 | 30 |
| Race/Ethnicity: Missing | Participants | 2 | 1 | 6 | 2 | 11 |
| Annual Household Income, No., $: <50,000 | Participants | 193 | 145 | 134 | 163 | 635 |
| Annual Household Income, No., $: 50,000 to 100,000 | Participants | 144 | 129 | 126 | 124 | 523 |
| Annual Household Income, No., $: >100,000 | Participants | 85 | 76 | 68 | 68 | 297 |
| Education: <College | Participants | 148 | 107 | 102 | 129 | 486 |
| Education: Some college | Participants | 118 | 102 | 108 | 105 | 433 |
| Education: College and postcollege graduate | Participants | 165 | 148 | 133 | 131 | 577 |
| Marital Status: Single | Participants | 64 | 59 | 43 | 59 | 225 |
| Marital Status: Married | Participants | 286 | 236 | 239 | 231 | 992 |
| Marital Status: Other | Participants | 81 | 62 | 60 | 75 | 278 |
| Framingham Risk Score (FRS) | % | 20.1 (SD 9.0) | 19.7 (SD 8.6) | 19.1 (SD 8.7) | 20.1 (SD 8.7) | 19.8 (SD 8.7) |
| Pre-existing coronary artery disease (CAD) | Participants | 143 | 110 | 115 | 148 | 516 |
| Taking cholesterol-reducing medications at baseline | Participants | 166 | 180 | 200 | 166 | 712 |
6. Primary Endpoint
The registry lists the primary outcome as Change in LDL From Baseline to 12 Months, measured over 12 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | mg/dL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in LDL cholesterol from baseline to 12 months, measured in mg/dL. LDL cholesterol is a continuous laboratory measure, so the registry specifies the endpoint as a mean and its dispersion as a 95% confidence interval. The endpoint description refers to change in LDL-C levels.
Change from baseline is used to describe how a participant’s LDL level at follow-up differs from their starting level. Comparing changes across randomized groups can help assess whether the groups experienced different average changes during the follow-up period. A confidence interval expresses the uncertainty around an estimated mean; narrower intervals indicate greater precision, while wider intervals indicate less precision. These are general statistical interpretations, not a description of an observed result in this trial.
The registry record does not report the primary endpoint’s group means, confidence intervals, or statistical comparison. It therefore does not establish the observed average change in any arm or the precision of an arm-to-arm contrast. Change in LDL from baseline to 15 months is listed as a secondary outcome, but its numerical result is also not reported in the registry record.
The record notes that some subjects were lost to follow-up or withdrawn for other reasons, and consequently the number analyzed at 12 months did not equal the number analyzed at baseline. It does not provide the analysis population size at each time point or explain how missing 12-month measurements were handled. That information would be relevant to interpreting an estimated change, because the participants contributing follow-up measurements may differ from those initially enrolled.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies LDL change at 12 months as the primary outcome but does not report its numerical results. There are no arm-specific mean changes, confidence intervals, or comparative estimates in the record details. Accordingly, the direction and magnitude of the primary outcome, and the precision with which any difference was estimated, are not reported in the registry record.
The intervention descriptions make clear what was compared: incentives for physicians, incentives for patients, shared incentives, and usual care. These are distinct intervention strategies, with adherence feedback described for physician involvement. Their presence in the trial design does not itself demonstrate that any strategy changed LDL cholesterol or statin use. The registry’s brief description states what the investigators intended to test; it is not a report of the observed effect.
For a continuous outcome such as LDL change, an estimated mean difference describes the average contrast between groups. A confidence interval gives a range of values compatible with the data and analysis assumptions. A small or large interval would influence how precisely the result could be interpreted, but no such interval is reported for this primary endpoint. A p-value or other inferential result is also not reported in the registry record.
The randomized and cluster-randomized design is important when interpreting a comparison. Randomization is intended to make groups comparable on average, while clustering affects the statistical dependence among observations. The registry record notes that a simple individual-level re-analysis would be misleading and that only the sponsor’s own analysis should be used. The sponsor’s numerical primary outcome analysis is not reported in the registry record, so no independent effect estimate should be substituted for it.
The registry also notes that the number analyzed at 12 months differed from the baseline analysis population because subjects were lost to follow-up or withdrawn for other reasons. Without arm-specific follow-up counts, reasons by arm, or a description of the missing-data approach, the potential effect of missing outcomes on the result cannot be assessed from this record.
Safety listings show serious adverse events and deaths recorded by arm, but these counts do not supply evidence about LDL outcomes. They also do not, by themselves, establish that an event was caused by an incentive strategy. The record lists a serious adverse event term, “Pancreatic mass,” at 0.3%; the registry information does not give further context for interpreting that term.
Overall, the record describes the intended comparisons and endpoint but does not provide outcome estimates sufficient to say how the intervention arms compared with usual care. This is a limitation of the results available in the registry record, not a finding that the approaches had no effect.
9. Statistical Methods Explained
The design is described as randomized, cluster-randomized, and factorial. These terms describe different aspects of how the study was organized. Randomization refers to assignment by chance. Cluster randomization means assignment occurs for groups, so participants within a group may share an assignment. A factorial model generally evaluates more than one intervention factor, but the specific factors and assignment structure are not reported in the registry record. The four named arms are the physician incentive, patient incentive, combined incentive, and usual-care groups.
Why clustering matters
When participants belong to clusters, their outcomes may be correlated. For example, participants treated within the same practice or organizational setting can share clinicians, procedures, or local conditions. This is a general explanation of clustering, not a claim about the particular sources of similarity in this trial. If an analysis treats all participant outcomes as independent when they are not, uncertainty can be understated. The registry explicitly cautions that a simple individual-level re-analysis would be misleading and indicates that the sponsor’s own analysis takes precedence. The sponsor’s numerical results are not reported in the registry record.
A cluster-aware analysis accounts for the study’s assignment and dependence structure when estimating uncertainty. The registry record does not identify the specific statistical model, variance estimator, or other technical details used by the sponsor. Those methods are not reported in the registry record, so the actual handling of clustering cannot be assessed from the information available.
Mean change and confidence intervals
The primary measure is mean change in LDL from baseline to 12 months. A mean summarizes the average observed change in a group, while a comparison between groups addresses whether their average changes differ. The registry specifies a 95% confidence interval as the measure of dispersion. In general, a confidence interval communicates estimation uncertainty under the analysis assumptions; it is not a guarantee that the true value lies within the interval. No primary estimates or confidence intervals are reported in the registry record, so their magnitudes and precision cannot be described.
The measure is continuous, and its units are mg/dL. The registry also lists change in LDL from baseline to 15 months as a secondary outcome. It does not provide the secondary outcome estimates or describe whether the same analysis approach was used at both follow-up times.
Multiplicity and statistical planning
Multiplicity arises when investigators assess more than one outcome, comparison, or time point. When many statistical tests are conducted, the chance of at least one apparently notable result can increase. This is a general statistical concern. The registry lists two outcome measures and does not list any analyses. The method, if any, used to address multiple outcomes or comparisons is not reported in the registry record. The exact set of planned statistical comparisons is also not reported.
The registry record does not report a sample-size justification or a prospective power calculation for the trial. Any sample-size illustrations based on the observed effect are planning illustrations rather than observed power. In general, such illustrations show how a hypothetical effect size relates to the amount of information needed under stated assumptions; they do not indicate the probability that this completed trial detected an effect. The observed primary effect needed for such an illustration is not reported in the registry record.
Missing observations and analysis population
The primary outcome description says that some subjects were lost to follow-up or withdrawn for other reasons, and that the number analyzed at 12 months did not equal the number analyzed at baseline. This signals that the follow-up analysis did not include the same number of observations as the baseline analysis. The registry does not report exact analysis counts, reasons for loss by arm, or the statistical method used to handle missing outcomes.
Missing data can affect interpretation when the participants with observed follow-up outcomes differ systematically from those without them. This is a general issue; the registry does not establish whether such differences occurred in this trial. Methods such as imputation or model-based approaches require assumptions about the missingness process. The chosen method and its assumptions are not reported in the registry record, so the robustness of the primary result to missing data cannot be evaluated from this information.
The record also does not report the planned analysis population definition, such as whether all randomized clusters or participants were intended to be included regardless of adherence. It would therefore be inappropriate to infer an intention-to-treat approach, a per-protocol approach, or another population definition.
Reading the available evidence
For this trial, the design description supplies meaningful context, but the registry record does not report the sponsor’s primary outcome estimates or inferential results. The design terms should not be mistaken for outcome findings. Any statistical interpretation of treatment differences, precision, or significance would require the sponsor’s analysis results, which are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome, change in LDL from baseline to 12 months, and a secondary outcome, change in LDL from baseline to 15 months. It records two outcome measures and no analyses. The list of outcomes does not tell whether the study tested multiple contrasts among all four arms, used a smaller prespecified set of comparisons, or assessed additional outcomes not included in the registry listing. The analysis plan and any procedure for controlling multiplicity are not reported in the registry record.
Multiplicity is a general concern when several statistical comparisons are made: the more opportunities to find an apparently notable result, the greater the chance of a chance finding across the set. Whether and how that concern was addressed in this trial cannot be determined from the registry record. No p-values or primary outcome estimates are reported in the registry record.
The outcome description states that subjects were lost to follow-up or withdrawn for other reasons, so the number analyzed at 12 months differed from the number analyzed at baseline. Exact counts, reasons for withdrawal, and the distribution of missing observations across arms are not reported in the registry record. The method used to handle missing outcomes, and the assumptions behind it, are also not reported.
The record does not define the primary analysis population or say whether participants were analyzed according to their randomized assignment. It does not describe interim analyses or stopping rules. Those details should not be inferred from the trial’s completed status or from its randomized design.
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 |
|---|---|---|---|
| Physician Incentives | 0 | 433 | 0.0% |
| Patient Incentives | 0 | 358 | 0.0% |
| Physician and Patient Combined Incentives | 1 | 346 | 0.3% |
| Usual Care/Control | 0 | 366 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Physician Incentives | 2 of 433 |
| Patient Incentives | 3 of 358 |
| Physician and Patient Combined Incentives | 0 of 346 |
| Usual Care/Control | 1 of 366 |
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 |
|---|---|
| Physician Incentives | 0 of 433 |
| Patient Incentives | 0 of 358 |
| Physician and Patient Combined Incentives | 0 of 346 |
| Usual Care/Control | 1 of 366 |
Most frequent serious adverse event terms
| Event term | Organ system | Physician Incentives | Patient Incentives | Physician and Patient Combined Incentives | Usual Care/Control |
|---|---|---|---|---|---|
| Pancreatic mass | Surgical and medical procedures | 0 of 433 | 0 of 358 | 1 of 346 | 0 of 366 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Physician Incentives | Patient Incentives | Physician and Patient Combined Incentives | Usual Care/Control |
|---|---|---|---|---|---|
| Elevated Alanine Aminotransferase (ALT) | Blood and lymphatic system disorders | 0 of 433 | 0 of 358 | 0 of 346 | 1 of 366 |
Serious events with the highest arm-level rate: pancreatic mass (0.3%).
The registry lists serious adverse event counts by arm, along with the number at risk. In the physician incentives arm, 433 were at risk and 0 had a serious adverse event; deaths were 2. In the patient incentives arm, 358 were at risk and 0 had a serious adverse event; deaths were 3. In the physician and patient combined incentives arm, 346 were at risk and 1 had a serious adverse event; deaths were 0. In the usual care/control arm, 366 were at risk and 0 had a serious adverse event; deaths were 1.
These are descriptive counts from the registry. They should not be read as evidence that an event was caused by an intervention, or that one arm was safer than another. The record does not provide a comparative statistical analysis of these safety figures or details about causes of death. The listed number at risk is relevant context for the counts, but no additional rate or comparison is calculated.
The registry identifies “Pancreatic mass” as a top serious adverse event term and lists 0.3%. It does not report further context for the term in the information available, including an arm attribution. The figures should therefore be interpreted as registry safety listings, not as a causal assessment.
12. What the Result Does, and Does Not, Mean
This trial asks a focused statistical question: whether incentive approaches directed to physicians, patients, or both were associated with different LDL changes than usual care. Its randomized, cluster-randomized design is relevant to answering that question, and the primary endpoint is specified as mean change in LDL from baseline to 12 months.
However, the registry record does not report the numerical primary outcome results. It gives no arm-specific mean changes, confidence intervals, or comparative estimates. Consequently, the available information does not establish whether the groups differed, how large a difference may have been, or how precisely any contrast was estimated. The absence of a result in the registry record is not evidence that the interventions had no effect.
The registry’s descriptions of payment rules explain the intended intervention contrast, but they do not show that participants or physicians changed behavior, that statin use changed, or that LDL changed. The outcome estimates would be needed to assess the primary endpoint. The listed secondary endpoint at 15 months likewise has no numerical result reported in the registry record.
The missing follow-up information also matters. The record states that the number analyzed at 12 months was not the same as at baseline because subjects were lost to follow-up or withdrawn. Without analysis counts and the missing-data method, readers cannot assess how complete follow-up was or how missing observations were incorporated into the analysis.
The sample-size illustrations, if considered alongside the trial, are planning scenarios rather than observed power. They cannot replace outcome results or establish that the study was adequately powered for a particular contrast. The trial’s own sample-size justification is not reported in the registry record.
Thus, the record supports a description of the trial’s design, intervention arms, endpoint, and selected safety counts. It does not support a conclusion about the comparative LDL outcome or the effectiveness of any incentive approach.
13. Why This Trial Matters Statistically
The trial raises a useful design question for clinical research: how to evaluate behavior-oriented interventions when the intervention may be delivered through clinicians, patients, or both. The four-arm structure makes those approaches distinguishable in the design, while the usual-care arm provides a comparator. The registry also identifies the study as cluster-randomized, a feature that has direct consequences for statistical analysis.
Clustering is important because participants assigned within a shared group may not provide statistically independent observations. Appropriate uncertainty estimates need to reflect the assignment structure. The registry’s warning against simple individual-level re-analysis is therefore central to interpreting any results: analyses that ignore clustering can give misleading precision. The registry record does not report the sponsor’s numerical analysis, which limits what can be concluded from the record itself.
The endpoint also illustrates the distinction between a well-defined outcome and an available result. LDL change from baseline to 12 months is specified as a continuous mean outcome with a 95% confidence interval. Yet without the estimate and interval, neither effect size nor precision can be assessed. Statistical interpretation requires both a clear endpoint and the reported estimate from the analysis.
Finally, the record notes loss to follow-up and withdrawals. This highlights why the analysis population and missing-data methods are part of the evidence, not merely administrative details. Because those methods and the primary results are not reported in the registry record, the design can be described but the comparative finding cannot be reconstructed from the listed information.
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 outcomes is that the registry record does not report numerical primary or secondary LDL results. It gives no arm-specific means, confidence intervals, or comparative tests. The effect and its precision therefore cannot be assessed from the record.
The trial is described as cluster-randomized, and the record explicitly cautions that a simple individual-level re-analysis would be misleading. The number and definition of clusters, the sponsor’s model, and its approach to estimating uncertainty are not reported in the registry record. The sponsor’s analysis takes precedence over an unadjusted individual-level recalculation, but its numerical results are not reported.
The primary endpoint description notes loss to follow-up or withdrawal and unequal numbers analyzed at baseline and 12 months. Analysis counts, reasons by arm, and the handling of missing outcomes are not reported. The analysis population definition is also not reported, limiting assessment of who contributed to the outcome analysis.
The registry lists two outcome measures, but the analysis plan, multiplicity approach, planned comparisons, sample-size justification, and interim analysis procedures are not reported in the registry record. The factorial label is recorded, but the specific factors and allocation structure are not described. The amount of each incentive is also not reported.
Safety information is limited to the listed counts and a serious adverse event term. The registry does not provide causal attribution or a comparative safety analysis. These limitations concern the information recorded; they do not establish that the underlying trial lacked such procedures or analyses.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Trial of Behavioral Economic Interventions to Reduce Cardiovascular Disease (CVD) Risk — NCT01346189.
- Registry record last updated 2017-12-06; status last verified 2017-10.
- Results first posted 2017-12-06.
- 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
The registry record describes NCT01346189, “A Trial of Behavioral Economic Interventions to Reduce Cardiovascular Disease (CVD) Risk,” sponsored by the University of Pennsylvania. It is listed as a completed, randomized, non-masked, cluster-randomized trial with a factorial model and enrollment of 1503.
The four arms were physician incentives, patient incentives, combined physician and patient incentives, and usual care. The primary endpoint was mean change in LDL from baseline to 12 months, with a 95% confidence interval; change from baseline to 15 months was listed as a secondary outcome.
The record notes that the 12-month analysis included a different number of subjects than the baseline analysis because of loss to follow-up or withdrawals. It lists serious adverse event counts and deaths by arm. Numerical primary outcome estimates, the sponsor’s analysis details, and the missing-data method are not reported in the registry record.