Medtronic has announced the first patient enrolment in the IMPROVE Brady (Registry to improve the adoption of consensus treatment guidelines) clinical trial, which will evaluate the impact of physician led improvement initiatives on the diagnosis and treatment of patients with a sinus node dysfunction. Particularly daunting in countries with underserved populations, sinus node dysfunction may lead to bradycardia.
During the study, physicians will use evidence-based guidelines and recommended therapies to treat underserved populations through standardised healthcare processes and patient education. The prospective, multicentre study will analyse up to 14,850 patients in nine countries, including India, Bangladesh, Mexico, Peru, Argentina, Uruguay, Russia, Hungary and China.
“Previous studies have shown that physicians can be very successful in accelerating guideline based care among patients in a real-world setting. It is our hope that this largescale, global study will show that education and other initiatives can improve diagnosis, use of appropriate therapies and the overall quality of life for these patients who previously have been underserved,” said Dwight Reynolds, professor and chief of the Cardiovascular Section at the University of Oklahoma College of Medicine, Oklahoma City, USA.
Approximately 10 hospitals in each of the emerging market countries will participate in the trial, which will be conducted in two phases. In phase I, physicians will assess and treat patients per their institution’s standard care practice. Information will be collected regarding how the patient was diagnosed and whether the patient was treated with a pacemaker. After completion of this phase, study investigators will participate in an educational workshop and will be given tools to help them make process improvements within their respective practices. After study investigators implement the tools in phase II, data from the two phases will be compared to demonstrate the influence of process improvement measures on patient care.
The educational workshop and physician toolkit are the specific interventions being examined in the study. The toolkit will include: diagnostic algorithms, informational videos and resources to educate patients about sinus node dysfunction, available treatment options and information on benefits and risks associated with the various treatments.
“We are committed to improving patient care and providing access to clinically-validated medical solutions in emerging markets,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “Through educational initiatives that advocate for evidence-based therapies, we hope to encourage worldwide adoption of consensus treatment guidelines – such as those developed and supported by the top cardiovascular physician societies in the world – to provide the best quality of care to all patients with heart rhythm disorders.”
Patient enrolment in phase I of the IMPROVE Brady study (the control group) will occur for approximately 12 months, or until each region has enrolled 550 patients. Phase II enrolment will occur for approximately 18 months, or until 1,100 patients per country have been enrolled. The anticipated study duration, from first patient enrolment in phase I to last patient follow-up in phase II, is 4.5 years for each emerging market participating in the study.