ABSTRACT
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.
Subject(s)
Cardiovascular Diseases , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Female , Humans , Male , Clinical Decision-Making , Delivery of Health Care , Primary Prevention/methods , Randomized Controlled Trials as Topic , Adult , Middle Aged , AgedABSTRACT
BACKGROUND: The electronic health record (EHR) allows a detailed study of the primary care consultations and assessment of variability among physicians regarding the implementation of practices for prevention, detection and monitoring of chronic diseases. OBJECTIVES: To describe the variability in the detection and surveillance of chronic conditions in primary care. METHODS: Review of the medical records maintained by 1685 primary care physicians in the Basque Health Service. Estimation of age and sex standardized rates of compliance with evidence-based recommendations and the systematic component of variation (SCV). RESULTS: Compliance with screening recommendations varied from 14.2% for chronic obstructive pulmonary disease (COPD) to 37.2% for hypercholesterolaemia of the at-risk populations. Variability between Primary Care Units (PCUs) was low (SCV(5) (-95) < 0.10) for high blood pressure, hypercholesterolaemia and diabetes and high (SCV(5) (-95) ≥ 0.20) for COPD. Based on the EHR registries, recommendations were followed to in at least 50% of relevant patients according to only 10 of the 44 good care practice (GCP) criteria. For 16 of the GCP criteria, the EHR data indicated compliance to the recommendations in <25% of patients diagnosed. CONCLUSIONS: EHR data indicate that some of the preventative care practices recommended to detect chronic problems in primary care are unevenly implemented across PCUs. Notably, there is less variation in the case of conditions for which evidence-based clinical practice guidelines have been published. The level of monitoring is inadequate for all the conditions studied; particularly in those in which it is less evident that primary care is the right level of the health service to provide this care.
