TY - JOUR AU - A. Sanchez AU - J. I. Pijoan AU - Sainz de Rozas AU - I. Lekue AU - R. San Vicente AU - J. A. Quindimil AU - R. Rotaeche AU - A. Etxeberria AU - C. Mozo AU - M. Martinez-Cengotitabengoa AU - M. Monge AU - C. Gómez-Ramírez AU - L. Vivanco AU - V. Martin AU - N. Merino-Inda AU - M. Llarena AU - Gonzalez Saenz de Tejada AU - A. Garcia-Alvarez A1 - AB - BACKGROUND: The DE-imFAR study aims to compare the effectiveness of several de-implementation strategies targeting clinicians' decision-making processes to reduce potentially inappropriate prescribing (PIP) of statins for cardiovascular disease (CVD) primary prevention. METHODS: A partially randomized, cluster implementation trial with an active comparator group, involving family physicians (FPs) with non-zero incidence rates of PIP of statins in 2021, was conducted in 13 integrated healthcare organizations (IHOs) in the Basque Health Service. All eligible FPs (n = 621) were exposed to (1) a non-reflective decision assistance (DA) strategy based on reminders. FPs from two IHOs were randomized to additionally receive one of two increasingly intensive reflective strategies: (2) a knowledge dissemination decision information (DI) strategy (n = 59), or (3) a DI strategy plus audit and feedback (A&F) self-reflective decision (SRD) strategy (n = 59). The main outcome was the change from baseline to 12 months after deployment in the likelihood of receiving new PIP of statins and advice on lifestyle modifications, estimated with generalized mixed effects models, in 45- to 74-year-old low cardiovascular risk patients with elevated cholesterol levels but no diagnosed CVD. RESULTS: After FPs' exposure to the corresponding strategies, rates of statin PIP decreased significantly in all groups (p < 0.001). Concerning study's main observational comparisons between strategies, though the reduction obtained by the DI and SRD strategies were 33% (adjusted OR: 0.77; 95% CI: 0.58-1.01) and 6% (aOR: 0.94; 95% CI: 0.73-1.23) higher compared to the change from the DA, estimated differences did not reach statistical significance (p = 0.07). When comparing the two reflective strategies together (DI + SRD) with the non-reflective (DA), a significant difference (p = 0.038) was observed, being the odds of receiving PIP of statins 19% lower (aOR: 0.81; 95% CI: 0.66-0.99). In the experimental comparison between reflective strategies (SRD vs. DI), providing A&F to FPs showed no additional effect (p = 0.30). CONCLUSIONS: De-implementation strategies that targeted clinical decision-making were effective in reducing PIP of statins for CVD primary prevention. Strategies that targeted reflective thinking and increased awareness of low-value prescribing showed a trend toward greater effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT04022850. Registered 17 July 2019. AD - Primary Care Research Unit of Bizkaia, Deputy Directorate of Healthcare Assistance, Osakidetza-Basque Health Service, Biobizkaia Health Research Institute, Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Plaza Cruces s/n, Barakaldo, E-48903, Bizkaia, Spain. alvaro.sanchezperez@osakidetza.eus.; Clinical Epidemiology Unit, Osakidetza-Basque Health Service, Biobizkaia Health Research Institute, Barakaldo, Spain.; CIBER de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain.; Primary Care Pharmacy Unit, Ezkerraldea-Enkarterri-Cruces Integrated Health Organization, Osakidetza-Basque Health Service, Biobizkaia Health Research Institute, Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Barakaldo, Spain.; Zumarraga Health Center, Goierri-Alto Urola Integrated Health Organization, Osakidetza-Basque Health Service, Zumarraga, Spain.; Sestao Health Center, Barakaldo-Sestao Integrated Health Organization, Osakidetza-Basque Health Service, Sestao, Spain.; Primary Care Research Unit of Gipuzkoa, Health Care Directorate, Osakidetza-Basque Health Service, Biogipuzkoa Health Research Institute, Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Donostia-San Sebastian, Spain.; Primary Care Pharmacy, Donostialdea Integrated Health Organization, Osakidetza-Basque Health Service, Hernani, Spain.; Biogipuzkoa Health Research Institute, Donostia-San Sebastian, Spain.; School of Pharmacy, University of the Basque Country (UPV/EHU), Basque Sustainable Pharmacy and Biotherapies Research Group, Vitoria-Gasteiz, Spain.; Osakidetza-Basque Health Service, Bioaraba Health Research Institute, Vitoria-Gasteiz, Spain.; Faculty of Health Sciences, International University of La Rioja (UNIR), Neurohealth Research Group, Logroño, Spain.; Muskiz Health Center, Ezkerraldea-Enkarterri-Cruces Integrated Health Organization, Osakidetza-Basque Health Service, Muskiz, Spain.; Cardiology Department, Cruces University Hospital, Ezkerraldea-Enkarterri-Cruces Integrated Health Organization, Osakidetza-Basque Health Service, Barakaldo, Spain.; Medical Directorate, Barakaldo-Sestao Integrated Health Organization, Osakidetza-Basque Health Service, Biobizkaia Health Research Institute, Barakaldo, Spain.; Quality and Innovation Unit, Barakaldo-Sestao Integrated Health Organization, Osakidetza-Basque Health Service, Biobizkaia Health Research Institute, Barakaldo, Spain.; Biobizkaia Health Research Institute, Barakaldo, Spain.; Biobizkaia Health Research Institute, Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Barakaldo, Spain.; Primary Care Research Unit of Bizkaia, Deputy Directorate of Healthcare Assistance, Osakidetza-Basque Health Service, Biobizkaia Health Research Institute, Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Plaza Cruces s/n, Barakaldo, E-48903, Bizkaia, Spain. AN - 42174713 BT - Implement Sci Commun C5 - Opioids & Substance Use; Education & Workforce CP - 1 DA - 05/2026 DO - 10.1186/s43058-026-00968-1 DP - NLM ET - 20260522 IS - 1 JF - Implement Sci Commun LA - eng N2 - BACKGROUND: The DE-imFAR study aims to compare the effectiveness of several de-implementation strategies targeting clinicians' decision-making processes to reduce potentially inappropriate prescribing (PIP) of statins for cardiovascular disease (CVD) primary prevention. METHODS: A partially randomized, cluster implementation trial with an active comparator group, involving family physicians (FPs) with non-zero incidence rates of PIP of statins in 2021, was conducted in 13 integrated healthcare organizations (IHOs) in the Basque Health Service. All eligible FPs (n = 621) were exposed to (1) a non-reflective decision assistance (DA) strategy based on reminders. FPs from two IHOs were randomized to additionally receive one of two increasingly intensive reflective strategies: (2) a knowledge dissemination decision information (DI) strategy (n = 59), or (3) a DI strategy plus audit and feedback (A&F) self-reflective decision (SRD) strategy (n = 59). The main outcome was the change from baseline to 12 months after deployment in the likelihood of receiving new PIP of statins and advice on lifestyle modifications, estimated with generalized mixed effects models, in 45- to 74-year-old low cardiovascular risk patients with elevated cholesterol levels but no diagnosed CVD. RESULTS: After FPs' exposure to the corresponding strategies, rates of statin PIP decreased significantly in all groups (p < 0.001). Concerning study's main observational comparisons between strategies, though the reduction obtained by the DI and SRD strategies were 33% (adjusted OR: 0.77; 95% CI: 0.58-1.01) and 6% (aOR: 0.94; 95% CI: 0.73-1.23) higher compared to the change from the DA, estimated differences did not reach statistical significance (p = 0.07). When comparing the two reflective strategies together (DI + SRD) with the non-reflective (DA), a significant difference (p = 0.038) was observed, being the odds of receiving PIP of statins 19% lower (aOR: 0.81; 95% CI: 0.66-0.99). In the experimental comparison between reflective strategies (SRD vs. DI), providing A&F to FPs showed no additional effect (p = 0.30). CONCLUSIONS: De-implementation strategies that targeted clinical decision-making were effective in reducing PIP of statins for CVD primary prevention. Strategies that targeted reflective thinking and increased awareness of low-value prescribing showed a trend toward greater effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT04022850. Registered 17 July 2019. PY - 2026 SN - 2662-2211 ST - Comparative effectiveness of non-reflective and reflective strategies to favor de-implementation of low-value prescribing for the primary prevention of cardiovascular disease in primary care: the DE-imFAR cluster randomized implementation trial T1 - Comparative effectiveness of non-reflective and reflective strategies to favor de-implementation of low-value prescribing for the primary prevention of cardiovascular disease in primary care: the DE-imFAR cluster randomized implementation trial T2 - Implement Sci Commun TI - Comparative effectiveness of non-reflective and reflective strategies to favor de-implementation of low-value prescribing for the primary prevention of cardiovascular disease in primary care: the DE-imFAR cluster randomized implementation trial U1 - Opioids & Substance Use; Education & Workforce U3 - 10.1186/s43058-026-00968-1 VL - 7 VO - 2662-2211 Y1 - 2026 ER -