An integrated chronic care program for patients with atrial fibrillation: Study protocol and methodology for an ongoing prospective randomised controlled trial

Background: Adherence to guidelines for the management of atrial fibrillation (AF) is often poor, although this is associated with improved morbidity and mortality in such patients. Increasing numbers of programs are designed to enhance appropriate counselling, treatment and coordinated care delivery including the nurse-led, guidelines-based, softwaresupported integrated chronic care program (ICCP) for patients with AF reported here. Objectives: This paper outlines the study protocol and methodology currently being used to evaluate the effectiveness of a newly developed nurse-led, guideline-based, softwaresupported ICCP for patients with AF. Design and methods: Evaluation of the ICCP is currently being carried out in the outpatient care setting known as the AF-Clinic. A prospective randomised controlled trial is currently underway in the outpatient AF-Clinic of a University Hospital in the Netherlands in cooperation with the collaborating university. The primary outcome measures are cardiovascular hospitalisation and/or death. Secondary outcome measures include guideline adherence, patient knowledge about their condition, quality of life, satisfaction and other outcome measurements such as cost-effectiveness. Participants: It was calculated that 698 participants are needed to demonstrate discernible outcomes in relation to the primary endpoint (349 patients in each group) with follow-up after 1 year. Results: The study started in January 2007 and the first results are expected in the beginning of 2010. Conclusions: It is hypothesised that the ICCP may contribute towards closing the gap between guideline recommendations and current practice in the management of atrial fibrillation. Furthermore, it is hypothesised that the program has the potential to optimise the management of AF patients and improve the efficiency and coordination of patient care. This may lead to better patient outcomes including improved quality of life and patient satisfaction in such patients.