ROMEO: rethink organization to improve education and outcomes

Publisher Website
Google Scholar
Abstract
Aims Scarcity of resources, expertise and evidence‐based models have so far limited delivery of patient‐centred diabetes education. We have developed and validated a group care approach that is applicable to everyday clinical practice and cost‐effective in improving metabolic control, knowledge of diabetes, health behaviours, and quality of life in Type 2 diabetes. A clinical trial (ROMEO) was planned to evaluate applicability and reproducibility of group care in other outpatients facilities and assess its impact on a larger patient population. Methods Multicentre, randomized, controlled clinical trial of group vs. individual care in the routine management of Type 2 diabetes. Nine hundred patient aged < 80, with diabetes of ≥1 year known duration, treated by either diet alone or diet and oral agents, will be recruited in 15 centres and followed for 4 years. Training of physicians, nurses and dieticians included preparation of operating manual and videos, interactive sessions, and evaluation of local facilities and resources. Results Primary measurements: 3‐monthly HbA1c, fasting blood glucose, body weight, waist–hip ratio, yearly blood lipids, and bi‐yearly assessment of knowledge of diabetes, health behaviours and quality of life. Secondary outcomes: systolic and diastolic blood pressure, evaluation of ECG for ischaemia and QT interval, hypoglycaemic and anti‐hypertensive medication and cardiovascular events. Analysis will be by intention‐to‐treat. Discussion If ROMEO confirms that group care can be successfully implemented in different clinics, a novel clinico‐pedagogic tool will have been acquired to support patient‐centred education, improve lifestyle and outcomes, support team work, enhance providers’ attitudes and competencies and ameliorate diabetes care organization.