GOULD EDU: Primary Results of a Cluster-Randomized Trial of an Educational Intervention to Improve Guideline Adherence and Intensification of Lipid-Lowering Therapy

Abstract

Lead Author's Financial Disclosures Research grants from AstraZeneca, Boehringer Ingelheim; other research support from AstraZeneca; consulting/advisory boards for Alnylam, Amgen, Applied Therapeutics, Astra Zeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Esperion Therapeutics, Janssen, Lexicon, Merck (Diabetes and Cardiovascular), Novo Nordisk, Pharmacosmos, Sanofi, and Vifor Pharma; honoraria from Astra Zeneca, Boehringer Ingelheim, and Novo Nordisk. Study Funding Amgen. Background/Synopsis Despite the benefits of intensive LDL-C lowering in patients with ASCVD, guidelines supporting lower LDL-C goals, and improved access to therapies, implementation in clinical practice remains suboptimal, and strategies to improve guideline adherence are a priority. Objective/Purpose The GOULD EDU study tested the effectiveness of an educational intervention to improve intensification of LLT, LDL-C levels, and LDL-C goal achievement. Methods GOULD was a 2-year, prospective, observational registry in patients with ASCVD on any lipid-lowering therapy (LLT). In the GOULD EDU 1-year extension study, sites were randomized to early (STEP 1) or late (STEP 2) intervention in a stepped-wedge design. The educational intervention included 2 live webinars that reviewed recent LLT guidelines, patterns of LLT and LDL-C control in the US, and opportunities for improvement. In addition, all sites received site-specific, interactive reports of their LLT patterns that were updated throughout the study. Results 56 sites were randomized to STEP 1 (30 sites, 616 patients) or STEP 2 (26 sites, 382 patients). Across all sites, minimal change occurred in LLT during the study (Figure 1). Intervention STEPs 1 and 2 showed similar patterns of minimal LLT intensification and LDL-C change from baseline (BL). Of patients with available LDL-C data (BL: 518/998; study end: 639/998), 38.8% of patients had LDL-C <70 mg/dL at BL, and 36.9% (STEP 1) and 44.5% (STEP 2) had LDL-C <70 mg/dL at study end. Conclusions An educational intervention was not effective in improving LLT intensification, LDL-C levels, or attainment of LDL-C goals in patients with ASCVD. Education alone appears insufficient to improve guideline adherence. Research grants from AstraZeneca, Boehringer Ingelheim; other research support from AstraZeneca; consulting/advisory boards for Alnylam, Amgen, Applied Therapeutics, Astra Zeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Esperion Therapeutics, Janssen, Lexicon, Merck (Diabetes and Cardiovascular), Novo Nordisk, Pharmacosmos, Sanofi, and Vifor Pharma; honoraria from Astra Zeneca, Boehringer Ingelheim, and Novo Nordisk.