Cardiology · Medical Literature
Educational intervention to improve adherence after acute coronary syndrome.
Abstract
Patients discharged with a diagnosis of acute coronary syndrome (ACS) are at increased risk for recurrent cardiovascular events. Improved adherence to treatment has been associated with better outcomes. The objective of this study was to evaluate the effect of an educational intervention on medication adherence in patients following ACS. A single-center, randomized, open-label, controlled clinical trial with parallel groups and a six-month follow-up. Sixty-three patients were randomized to the mixed educational intervention group and sixty-nine to the control group. Baseline characteristics were similar between groups: 82.6% were male, with a median age of 56 years (IQR 51-61), 73.5% had completed primary education. Mean ejection fraction (EF) was 47.7% (SD 12.33). Most patients were discharged with more than four medications, with a median of seven (IQR 6.0-8.0) tablets per day. At one month, adherence was 80.0% in the intervention group and 66.2% in the control group (RR 1.21; 95% CI 0.97-1.50; p = 0.12). At three months, adherence was 79.7% vs. 77.4% (RR 1.03; 95% CI 0.85-1.24; p = 0.94), and at six months -the primary endpoint- 73.3% vs. 71.9% (RR 1.02; 95% CI 0.82-1.27; p = 1.00). No significant differences were observed between groups in the occurrence of clinical events. The educational intervention was well accepted and feasible to implement, but it did not result in improved medication adherence or a reduction in clinical events over the medium term.
Clinical relevance
Does a mixed educational intervention, compared with usual care, improve medication adherence at six months in patients discharged after acute coronary syndrome? __SNAPSHOT__ {"studyDesign":"Single-center, randomized, open-label, controlled clinical trial with parallel groups","setting":"Single center; country not reported in the abstract","sampleSize":"n=132 (intervention: n=63, control: n=69)","population":"Adults discharged with a diagnosis of acute coronary syndrome; 82.6% male; median age 56 years (IQR 51–61); 73.5% with primary education completed; mean ejection fraction 47.7% (SD 12.33); majority discharged on >4 medications (median 7 tablets/day, IQR 6.0–8.0)","intervention":"Mixed educational intervention (specific components—e.g., written materials, counseling, telephone follow-up—not further described in the abstract)","comparator":"Control group (presumed usual care; exact comparator content not described in the abstract)","primaryOutcome":"Medication adherence at six months","followUp":"6 months, with interim assessments at 1 and 3 months","fundingSource":"Not reported"}
Key findings
At six months (primary endpoint), medication adherence was 73.3% in the intervention group versus 71.9% in the control group (RR 1.02; 95% CI 0.82–1.27; p-value not fully reported in the supplied abstract text, but contextually non-significant given the point estimate and confidence interval spanning unity). The absolute risk difference was 1.4 percentage points (calculated), and the NNT is not clinically meaningful given the non-significant direction of effect. At one month, adherence was 80.0% vs. 66.2% in favor of the intervention (RR 1.21; 95% CI 0.97–1.50; p=0.12); this trend did not reach statistical significance. At three months, adherence was 79.7% vs. 77.4% (RR 1.03; 95% CI 0.85–1.24; p=0.94), again non-significant. Across all three time points, confidence intervals crossed 1.0 and p-values exceeded conventional thresholds, indicating no statistically significant benefit of the educational intervention on medication adherence at any measured time point. Adverse events and safety data were not reported in the abstract.
Practice implications
This trial did not demonstrate a statistically significant improvement in medication adherence at 6 months—or at any interim time point—following a mixed educational intervention compared with usual care in ACS patients. The only numerically notable signal was a trend toward higher adherence at one month (absolute difference ~13.8 percentage points [calculated]; RR 1.21), but this did not reach statistical significance (p=0.12) and was not sustained at three or six months. The findings should be interpreted cautiously: the trial was underpowered (n=132), the educational intervention is incompletely described in the abstract, and the open-label design introduces performance and detection bias. Both groups maintained relatively high absolute adherence rates (>70%) throughout follow-up, which may indicate a ceiling effect or selection of motivated participants. These results are broadly consistent with prior systematic review evidence showing no significant difference between educational interventions and usual care for medication adherence in ACS populations. The findings do not support a change in standard practice based on this trial alone. Importantly, only the abstract was available for review; full-text analysis including methods, blinding procedures, adherence measurement tools, attrition, and secondary outcomes could materially alter interpretation. __LIMITATIONS__ Small sample size (n=132) likely underpowered to detect modest but clinically meaningful differences in adherence rates.,Open-label design introduces performance bias (participants and providers aware of allocation) and detection bias, particularly relevant when the outcome (adherence) relies on self-report or non-blinded assessment.,The nature of the 'mixed educational intervention' is not described in the abstract; inability to assess intervention fidelity, intensity, or reproducibility.,The control condition (usual care) is not defined, making it impossible to assess the baseline educational exposure in the comparator arm.,High absolute adherence rates in both groups at baseline and follow-up suggest possible ceiling effect or selection of a motivated, health-literate cohort, limiting generalizability.,Adherence measurement tool not specified in the abstract; self-report measures are prone to social desirability bias and overestimate true adherence.,The p-value at the six-month primary endpoint was truncated in the supplied abstract; the exact value is not confirmed.,Population skewed toward males (82.6%), younger patients (median age 56), and those with relatively preserved or mildly reduced EF; results may not generalize to older patients, women, or those with severely reduced EF.,Attrition, intention-to-treat versus per-protocol analysis, and handling of missing data are not described.,Funding source not reported; potential conflicts of interest cannot be assessed.,Only the abstract was available; full-text review is required before definitive conclusions can be drawn. __BOTTOM_LINE_CATEGORY__ low_certainty __BOTTOM_LINE__ This small, open-label RCT found no statistically significant improvement in medication adherence at 6 months following a mixed educational intervention in post-ACS patients, with both groups maintaining adherence above 70% throughout. A numerically larger but non-significant trend favoring the intervention at one month was not sustained, and results are consistent with the existing literature showing limited benefit of educational interventions alone on ACS medication adherence. This study does not provide sufficient evidence to change current practice, and larger, adequately powered trials with standardized adherence measures and well-characterized multicomponent interventions are needed.