Abstract
BackgroundAlthough numerous therapies have been shown to be beneficial in the prevention of myocardial infarction and/or death in patients with coronary disease, these therapies are under-used and this gap contributes to sub-optimal patient outcomes. To increase the uptake of proven efficacious therapies in patients with coronary disease, we designed a multifaceted quality improvement intervention employing patient-specific reminders delivered at the point-of-care, with one-page treatment guidelines endorsed by local opinion leaders ("Local Opinion Leader Statement"). This trial is designed to evaluate the impact of these Local Opinion Leader Statements on the practices of primary care physicians caring for patients with coronary disease. In order to isolate the effects of the messenger (the local opinion leader) from the message, we will also test an identical quality improvement intervention that is not signed by a local opinion leader ("Unsigned Evidence Statement") in this trial.MethodsRandomized trial testing three different interventions in patients with coronary disease: (1) usual care versus (2) Local Opinion Leader Statement versus (3) Unsigned Evidence Statement. Patients diagnosed with coronary artery disease after cardiac catheterization (but without acute coronary syndromes) will be randomly allocated to one of the three interventions by cluster randomization (at the level of their primary care physician), if they are not on optimal statin therapy at baseline. The primary outcome is the proportion of patients demonstrating improvement in their statin management in the first six months post-catheterization. Secondary outcomes include examinations of the use of ACE inhibitors, anti-platelet agents, beta-blockers, non-statin lipid lowering drugs, and provision of smoking cessation advice in the first six months post-catheterization in the three treatment arms. Although randomization will be clustered at the level of the primary care physician, the design effect is anticipated to be negligible and the unit of analysis will be the patient.DiscussionIf either the Local Opinion Leader Statement or the Unsigned Evidence Statement improves secondary prevention in patients with coronary disease, they can be easily modified and applied in other communities and for other target conditions.
Highlights
Numerous therapies have been shown to be beneficial in the prevention of myocardial infarction and/or death in patients with coronary disease, these therapies are underused and this gap contributes to sub-optimal patient outcomes
The mailing of patient-specific reminders about secondary prevention therapies to the primary care physicians of myocardial infarction (MI) survivors in England led to higher rates of cholesterol measurement and recording of cardiac risk factors in these patients, there was no appreciable difference in statin prescribing rates[62]
The principal hypothesis to be tested is: Does a local opinion leader-based quality improvement intervention influence primary care physicians to increase the provision of secondary prevention therapies in their patients with known Coronary artery disease (CAD) compared to usual care? The secondary hypotheses to be tested are: (1) Does the same quality improvement intervention, but without explicit local opinion leader endorsement, improve the provision of secondary prevention maneuvers in CAD patients compared to usual care? And, (2) does local opinion leader endorsement increase the effectiveness of the quality improvement intervention?
Summary
We mention five secondary prevention maneuvers in the local opinion leader and unsigned evidence statements (see Additional Files 1 and 2), we chose to emphasize statin prescribing in the statements (and as our primary outcome measure) because we felt the evidence for using statins in all patients with CAD (regardless of baseline cholesterol level) is more robust than the evidence for the use of ACE inhibitors or beta-blockers in all patients. In order to investigate what factors are associated with changes in the primary outcome (our dependent binary variable), and to control for the possibility of potential imbalances in patient-level characteristics at baseline, multivariable logistic regression analyses will be used to examine those variables that are deemed to be clinically important (i.e., age, gender) or that differ statistically at a p-value < 0.10 between study arms. None of the local opinion leaders received any financial compensation for their participation in the study or endorsement of the evidence summaries
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