A Randomized Trial Comparing Telemedicine Case Management with Usual Care in Older, Ethnically Diverse, Medically Underserved Patients with Diabetes Mellitus

Methods: The authors conducted a randomized, controlled trial comparing telemedicine case management to usual care, with blinding of those obtaining outcome data, in 1,665 Medicare recipients with diabetes, aged 55 years or greater, and living in federally designated medically underserved areas of New York State. The primary endpoints were HgbA1c, blood pressure, and low-density lipoprotein (LDL) cholesterol levels. Results: In the intervention group (n 5 844), mean HgbA1c improved over one year from 7.35% to 6.97% and from 8.35% to 7.42% in the subgroup with baseline HgbA1c $7% (n 5 353). In the usual care group (n 5 821) mean HgbA1c improved over one year from 7.42% to 7.17%. Adjusted net reductions (one-year minus baseline mean values in each group, compared between groups) favoring the intervention were as follows: HgbA1c, 0.18% (p 5 0.006), systolic and diastolic blood pressure, 3.4 (p 5 0.001) and 1.9 mm Hg (p , 0.001), and LDL cholesterol, 9.5 mg/dL (p , 0.001). In the subgroup with baseline HgbA1c $7%, net adjusted reduction in HgbA1c favoring the intervention group was 0.32% (p 5 0.002). Mean LDL cholesterol level in the intervention group at one year was 95.7 mg/dL. The intervention effects were similar in magnitude in the subgroups living in New York City and upstate New York. Conclusion: Telemedicine case management improved glycemic control, blood pressure levels, and total and LDL cholesterol levels at one year of follow-up. j J Am Med Inform Assoc. 2006;13:40–51. DOI 10.1197/jamia.M1917. The past decade has seen an explosion of interest in informatics resources that can be used directly by patients and consumers. A wide variety of systems has been fielded. Patients have been given access to hospital-based electronic medical records (EMRs). Personal health records have been developed for use directly by patients; synchronous videoconferencing has been used for patient education, monitoring, and motivation; and remote monitoring has been used to capture disease-specific measurements electronically, such as blood glucose or vital signs. With the advent of the World Wide Web, Web sites have been developed to provide disease-specific education, and e-mail has been used increasingly for interactions between patients and providers. More recently, Web-based messaging has been viewed as a way to circumvent some of the limitations of traditional e-mails. Despite the number and variety of technical approaches that have been developed, several authors have noted the relative scarcity of rigorous evaluations. The relative lack of substantive telemedicine evaluation data is related to multiple issues, including the underlying difficulty and cost of conducting robust evaluation, lack of studies using randomized Affiliations of the authors: Departments of Medicine (SSh, WP, LF, RG, RAL), Biomedical Informatics (SSh, JS, MA, CH), and Radiology (JS) and Naomi Berrie Diabetes Center (RG), Columbia University, New York, NY; Departments of Epidemiology (SSh) and Biostatistics (EP), Joseph Mailman School of Public Health, Columbia University, New York, NY; Joslin Diabetes Center and Division of Endocrinology, Diabetes and Metabolism, SUNY Upstate Medical University, Syracuse, NY (RSW, REI, SM); Department of Veterans Affairs, VA Medical Center, Syracuse, NY (RSW); Research Division of the Hebrew Home for the Aged at Riverdale, Bronx, NY (JT, SSi, DH); Stroud Center, Columbia University, and New York State Psychiatric Institute, New York, NY (JT); Department of Family Medicine, SUNY Upstate Medical University, Syracuse, NY (LTW); Department of Medicine, Harlem Hospital Center, New York, NY (LC). Supported by Cooperative Agreement 95-C-90998 from the Centers for Medicare and Medicaid Services. We acknowledge the contributions of Dr. Paul D. Clayton to the conceptualization of this project and to the creation of the clinical medical informatics infrastructure at Columbia University Medical Center and of Drs. Edward Shortliffe and George Hripcsak in providing support for that infrastructure. This paper is dedicated to the memory of Catherine Tuck, MD. 40 SHEA ET AL., Randomized Trial Comparing Telemedicine Case Management