Supporting Post MI Risk Modification Intervention Via Telemedicine Evaluation

PURPOSE OF STUDY Cardiovascular disease (CVD) is the leading cause of death in the U.S., accounting for over one third of deaths. Of these, coronary heart disease (CHD) accounts for the greatest proportion of morbidity and mortality with an estimated 770,000 Americans having a first myocardial infarction (MI) and an additional 430,000 having a recurrent MI in 2008.

To date, much of the focus on improvement of evidence-based medical therapy has been on the 'in-hospital' care phase, yet the greater challenge in improving CHD outcomes is in the transition from hospital to home.

We are testing two novel CVD risk reduction interventions for providing tailored disease-management support for patients who recently had a MI. The first intervention will utilize home BP monitors for all in this intervention arm, an interactive web-based tool based on Microsoft's HealthVault technology (for data transmission, tracking and communication), and nurse telephone disease-management to expand CVD risk management beyond the walls of the hospital and clinics. This intervention builds on our prior extensive experience in hypertension management including randomized interventional evaluation in over 2000 patients. This proven approach is now being enhanced with novel technology and a broader application namely secondary prevention. Combined, it has the potential to enhance post MI access, and quality of care, and ultimately, to improve patient outcomes. The second intervention, similar to the other invention arm, will utilize home BP monitors the same interactive web-based tool based on Microsoft's HealthVault technology (for data transmission, tracking, and communication), however, the second intervention arm will include a web-based disease-management to expand CVD risk management. Thus, the two intervention arms will be similar with the difference being whether individuals receive feedback from a nurse using a tailored behavioral telephone based intervention or use a tailored web-based intervention without direct communication with a nurse. The two arms will allow us to test the clinical impact and cost of using a tailored web-intervention as compared to having nurses implement a tailored intervention.

DESIGN AND PROCEDURES The study is a three-arm design of up to 600 patients who were hospitalized post-MI are recruited from a large hospital and randomized to either the education group (control group) or one of the two intervention groups. Patients randomized to one of the two intervention groups will receive a home BP monitor, trained in it's use and will have access to an interactive web-based tool based on Microsoft's HealthVault technology (for data transmission, tracking and communication). Those in the intervention arms will receive either a nurse telephone disease-management intervention or web-based disease-management intervention. Those randomized to the educational control arm, will receive usual care and information on CHD. The 12 months effects of the intervention will be evaluated.

For baseline assessments of the outcomes, the study will obtain BP, nonfasting LDL, and Hb A1c. Patients will also be surveyed about demographics and health behaviors during the baseline and 12 months. After the patient has completed the measurement battery, patients will be randomly assigned to the educational control group or the intervention group, respectively. The project's masters-level statistician will perform the entire study randomization before patient enrollment begins. Participants will be randomized using a computerized random number generator in blocks (size <10) within a single stratification factor, diabetic status. Additionally, because there are two nurse interventionists delivering the intervention in the nurse-intervention arm, patients will be randomly allocated to a nurse in a blocked fashion to ensure approximate even distribution of patients between nurses. At all follow-up measures, the RA assigned to measure BP and obtain survey information will not be blinded as to which group the patient is randomized.