De-imFAR phase II project: a study protocol for a cluster randomised implementation trial to evaluate the effectiveness of de-implementation strategies to reduce low-value statin prescribing in the primary prevention of cardiovascular disease
Jose Ignacio Pijoan,
Ricardo San Vicente,
Rafael Rotaeche,
Arturo García-Alvarez,
Gonzalo Grandes,
Alvaro Sanchez,
Rita Sainz de Rozas,
Itxasne Lekue,
Jose Antonio Quindimil,
Arritxu Etxeberria,
Carmela Mozo,
Monica Martinez-Cengotitabengoa,
Monica Monge,
Cristina Gómez-Ramírez,
Ricardo Samper,
Mikel Ogueta Lana,
Sara Celorrio,
Nerea Merino-Inda,
Marta Llarena,
Marta Gonzalez Saenz de Tejada
Affiliations
Jose Ignacio Pijoan
4 Clinical Epidemiology Unit, Osakidetza-Basque Health Service, Barakaldo, Spain
Ricardo San Vicente
7 Zumarraga Health Center, Goierri-Alto Urola Integrated Health Organization, Osakidetza-Basque Health Service, Zumarraga, Spain
Rafael Rotaeche
9 Primary Care Research Unit of Gipuzkoa, Organization of Integrated Health Services of Gipuzkoa, Osakidetza-Basque Health Service, Biogipuzkoa Health Research Institute, Donostia-San Sebastian, Spain
Arturo García-Alvarez
1 Primary Care Research Unit of Bizkaia, Deputy Directorate of Healthcare Assistance, Osakidetza-Basque Health Service, Barakaldo, Spain
Gonzalo Grandes
1 Primary Care Research Unit of Bizkaia, Deputy Directorate of Healthcare Assistance, Osakidetza-Basque Health Service, Barakaldo, Spain
Alvaro Sanchez
1 Primary Care Research Unit of Bizkaia, Deputy Directorate of Healthcare Assistance, Osakidetza-Basque Health Service, Barakaldo, Spain
Rita Sainz de Rozas
2 Biocruces Bizkaia Health Research Institute, Barakaldo, Spain
Itxasne Lekue
2 Biocruces Bizkaia Health Research Institute, Barakaldo, Spain
Jose Antonio Quindimil
8 Sestao Health Center, Barakaldo-Sestao Integrated Health Organization, Osakidetza-Basque Health Service, Sestao, Spain
Arritxu Etxeberria
10 Primary Care Pharmacy, Donostialdea Integrated Health Organization, Osakidetza-Basque Health Service, Hernani, Spain
Carmela Mozo
10 Primary Care Pharmacy, Donostialdea Integrated Health Organization, Osakidetza-Basque Health Service, Hernani, Spain
Monica Martinez-Cengotitabengoa
11 School of Pharmacy, University of the Basque Country, Vitoria-Gasteiz, Spain
Monica Monge
13 Muskiz Health Center, Ezkerraldea-Enkarterri-Cruces Integrated Health Organization, Osakidetza-Basque Health Service, Muskiz, Spain
Cristina Gómez-Ramírez
14 Cardiology Department, Cruces University Hospital, Ezkerraldea-Enkarterri-Cruces Integrated Health Organization, Osakidetza-Basque Health Service, Barakaldo, Spain
Ricardo Samper
15 Corporate Pharmacy Service, Directorate of Healthcare Assistance, Central Services, Osakidetza-Basque Health Service, Vitoria-Gasteiz, Spain
Mikel Ogueta Lana
16 Subdirectorate of Quality and Health Information Systems, Central Services, Osakidetza-Basque Health Service, Vitoria-Gasteiz, Spain
Sara Celorrio
17 Barakaldo-Sestao Integrated Health Organization, Osakidetza-Basque Health Service, Barakaldo, Spain
Nerea Merino-Inda
2 Biocruces Bizkaia Health Research Institute, Barakaldo, Spain
Marta Llarena
2 Biocruces Bizkaia Health Research Institute, Barakaldo, Spain
Marta Gonzalez Saenz de Tejada
2 Biocruces Bizkaia Health Research Institute, Barakaldo, Spain
Introduction This study aims to reduce potentially inappropriate prescribing (PIP) of statins and foster healthy lifestyle promotion in cardiovascular disease (CVD) primary prevention in low-risk patients. To this end, we will compare the effectiveness and feasibility of several de-implementation strategies developed following the structured design process of the Behaviour Change Wheel targeting key determinants of the clinical decision-making process in CVD prevention.Methods and analysis A cluster randomised implementation trial, with an additional control group, will be launched, involving family physicians (FPs) from 13 Integrated Healthcare Organisations (IHOs) of Osakidetza-Basque Health Service with non-zero incidence rates of PIP of statins in 2021. All FPs will be exposed to a non-reflective decision assistance strategy based on reminders and decision support tools. Additionally, FPs from two of the IHOs will be randomly assigned to one of two increasingly intensive de-implementation strategies: adding a decision information strategy based on knowledge dissemination and a reflective decision structure strategy through audit/feedback. The target population comprises women aged 45–74 years and men aged 40–74 years with moderately elevated cholesterol levels but no diagnosed CVD and low cardiovascular risk (REGICOR<7.5%), who attend at least one appointment with any of the participating FPs (May 2022–May 2023), and will be followed until May 2024. We use the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to evaluate outcomes. The main outcome will be the change in the incidence rate of PIP of statins and healthy lifestyle counselling in the study population 12 and 24 months after FPs’ exposure to the strategies. Moreover, FPs’ perception of their feasibility and acceptability, and patient experience regarding the quality of care received will be evaluated.Ethics and dissemination The study was approved by the Basque Country Clinical Research Ethics Committee and was registered in ClinicalTrials.gov (NCT04022850). Results will be disseminated in scientific peer-reviewed journals.Trial registration number NCT04022850.
