Martinez, Kathryn

Background Statin Choice is a shared decision-making encounter tool embedded in the electronic health record. Objective To describe the association between the use of Statin Choice, statin prescriptions by clinicians, prescription fills (primary adherence), and statin adherence at 12 mo (secondary adherence). Design Observational cohort study at the Cleveland Clinic Health System. Subjects Statin-naïve adults aged 40 to 75 y with a 10-y atherosclerotic cardiovascular disease (ASCVD) risk of ≥5% and a primary care appointment between January 2020 and July 2021. Main Measures The primary exposure was the use of Statin Choice during a clinical encounter. We measured whether the use of Statin Choice was associated with statin prescriptions. We measured statin adherence based on pharmacy fill data at 60 d (primary adherence) and 12 mo (secondary adherence). We used mixed-effects logistic regression to estimate the adjusted odds of statin prescriptions and adherence at the 3 time points by the use of Statin Choice. Key Results Among 17,001 statin-naïve patients, 13% viewed Statin Choice and 7% were prescribed a statin. The median ASCVD risk was 10%. Patients who were shown Statin Choice had 9.04 higher odds of being prescribed a statin compared with patients not shown Statin Choice (95% confidence interval [CI]: 7.86–10.4). Among patients prescribed a statin, the use of Statin Choice was associated with 5.75 higher odds of primary adherence compared with usual care (95% CI: 4.22–7.83). At 12 mo, Statin Choice use was significantly associated with adherence in the unadjusted analysis (OR: 1.58; 95% CI: 1.05–2.08) but was not significant after adjustment for patient factors. Patients shown Statin Choice had an average of 12 mg/dL reduction in low-density lipoprotein cholesterol at 12 mo (95% CI: −16 mg/dL, −10) compared with those not shown Statin Choice. Conclusion In this observational study, Statin Choice use was strongly associated with statin prescription and fills and weakly associated with adherence to statins for up to 1 y. A randomized trial is needed to confirm causality. Highlights Statin Choice is an electronic health record–embedded shared decision-making encounter tool available for free in many health care systems. Small randomized controlled trials have found modest associations between the use of Statin Choice and statin adherence using patient-reported data. In our large study using pharmacy fill data, clinician use of Statin Choice during a medical encounter was associated with significantly greater patient adherence with statins up to 1 y later. Exposure to Statin Choice was associated with a significant reduction in low-density lipoprotein cholesterol over 1 y.

Shared decision making (SDM) has been advocated to improve patient care, patient decision acceptance, patient-provider communication, patient motivation, adherence, and patient reported outcomes. Documentation of SDM is endorsed in several society guidelines and is a condition of reimbursement for selected cardiovascular and cardiac arrhythmia procedures. However, many clinicians argue that SDM already occurs with clinical encounter discussions or the process of obtaining informed consent and note the additional imposed workload of using and documenting decision aids without validated tools or evidence that they improve clinical outcomes. In reality, SDM is a process and can be done without decision tools, although the process may be variable. Also, SDM advocates counter that the low-risk process of SDM need not be held to the high bar of demonstrating clinical benefit and that increasing the quality of decision making should be sufficient. Our review leverages a multidisciplinary group of experts in cardiology, cardiac electrophysiology, epidemiology, and SDM, as well as a patient advocate. Our goal is to examine and assess SDM methodology, tools, and available evidence on outcomes in patients with heart rhythm disorders to help determine the value of SDM, assess its possible impact on electrophysiological procedures and cardiac arrhythmia management, better inform regulatory requirements, and identify gaps in knowledge and future needs.