Large Simple Trials and Knowledge Generation in a Learning Health System Workshop Summary (2013) / Chapter Skim
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3 Examples of Large Simple Trials
3 Examples of Large Simple Trials
Pages 19-26
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Event and Economic Evaluation (MI FREEE) trial was done in part nership with a payer to test whether the elimination of out of-pocket expenses for medications taken after a myocardial infarction would improve patient adherence to prescription medications and clinical outcomes.
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Choudhry, Department of Medicine, Brigham and Women's Hospital, and associate professor, Harvard Medical School, reviewed the Post-Myocardial Infarction Free Rx (Prescription) Event and Economic Evaluation (MI FREEE)
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These trials' findings have been concordant with the results of other trials with much higher costs per participant. Manson noted that the studies mentioned above were conducted with health professional populations to facilitate the collection of informed consent and to ensure high rates of compliance with the consumption of the medications as directed, high response rates to questionnaires, and approval for medical record review.
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Some observational evidence indicates that the out-of-pocket costs of medications prescribed after a heart attack are a major factor in the high degree of nonadherence to doctors' orders. To determine whether this is the case, the MI FREEE trial tested whether elimination of out-of-pocket expenses for medications prescribed after an MI would increase the percentage of patients who continue to take their medications as prescribed and therefore improve clinical outcomes and was described by Niteesh K
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systems for identification of potential participants, data collection, and provision of decision support tools for parents and clinicians. High Five for Kids was an NIH-funded trial examining whether evidence-based interventions to reduce obesity in children ages 2 through 6 years are effective in a primary care setting rather than a research setting (Taveras, 2011)
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As in the High Five for Kids trial, the EHR system is being leveraged to simplify recruitment and to provide best practice alerts and decision support tools to guide clinicians with evidence-based recommendations for patient management, instructions on how to follow up with that patient, what referrals to make, and what patient instructions to print. Taveras noted that the study is also using electronic patient portals for communication between health educators and the families and patients.
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The HOPE trial found a highly statistically significant reduction in the primary endpoint -- the composite of cardiovascular death, non-fatal MI, and stroke -- and for each of the individual components of the composite endpoint with the use of ramipril compared with the reduction achieved with the use of placebo. Devereaux explained that the HOPE trial was designed as an LST because the intent was to see if a treatment would have a relatively modest but highly significant effect on the incidence on a common major health condition that, if successful, would be easy for physicians to apply in clinical practice.
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