Implementation project protocols to address obesity and hypertension in primary care practices in a large, integrated health system

Abstract Background Implementation of evidence-based practices into routine clinical care within a health system remains a challenge. Rigorous evaluation of clinical implementation efforts with data collection guided by an implementation science framework can provide significant insight into variation in outcomes across the health system as well as learnings related to contextual factors that may contribute to both clinical and implementation outcomes. We describe the protocols for two implementation projects, each of which aims to implement into routine practice previously published research findings of a care delivery innovation addressing management of a chronic disease within primary care settings. Methods The two implementation projects include Implementation of Intensive Lifestyle Treatment for Weight Loss in Primary Care Settings and Implementation of Effective Hypertension Management Approaches, each funded through the Patient-Centered Outcomes Research Institute Health Systems Implementation Initiative (PCORI HSII) program. Both care delivery innovations will be implemented in 56 primary care practices (suburban, urban, rural) in one health system in Northeast Ohio and will involve alignment of clinical, operational, and evaluation teams. For the weight loss project, we will build on our health system model of shared medical appointments led by multidisciplinary teams to deliver a group visit intervention for patients with obesity (body mass index >/=30 kg/m2). The primary outcome will be change in body weight. For the hypertension project, we will implement an intensive home blood pressure management program for patients with uncontrolled blood pressure (>150/95 mmHg) with follow-up every 2-4 weeks with a pharmacist or advanced practice provider. The primary outcome will be change in systolic blood pressure. Each care model will be implemented in primary care practices utilizing a randomized stepped-wedge design. Specific implementation strategies will be utilized, and implementation outcomes collected utilizing an implementation framework. Adaptations at the practice group level will be documented. Discussion The two implementation projects described have the potential to significantly improve treatment for both obesity and uncontrolled hypertension in primary care practices in one health system. Clinical effectiveness and implementation outcomes will be collected and will inform scale-up of the programs as well as need for tailoring of future health system implementation efforts. Trial registration NCT07268417(Initial Release Date 11/13/2025): Group Medical Appointments for Intensive Lifestyle Treatment for Obesity in Cleveland Clinic Primary Care Practices (ACTIVATE OC) NCT07232017(Initial Release Date 11/14/2025): Implementation of Intensive Hypertension Management Approaches: Cleveland Clinic (IN-HOME BP).