A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study

Abstract

CONTEXT Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions and lower access to care. OBJECTIVES To examine the effectiveness of a telemedicine intervention to achieve clinical management goals in older, ethnically diverse, medically underserved patients with diabetes. DESIGN, Setting, and Patients A randomized controlled trial was conducted, comparing telemedicine case management to usual care, with blinded outcome evaluation, in 1,665 Medicare recipients with diabetes, aged >/= 55 years, residing in federally designated medically underserved areas of New York State. Interventions Home telemedicine unit with nurse case management versus usual care. Main Outcome Measures The primary endpoints assessed over 5 years of follow-up were hemoglobin A1c (HgbA1c), low density lipoprotein (LDL) cholesterol, and blood pressure levels. RESULTS Intention-to-treat mixed models showed that telemedicine achieved net overall reductions over five years of follow-up in the primary endpoints (HgbA1c, p = 0.001; LDL, p < 0.001; systolic and diastolic blood pressure, p = 0.024; p < 0.001). Estimated differences (95% CI) in year 5 were 0.29 (0.12, 0.46)% for HgbA1c, 3.84 (-0.08, 7.77) mg/dL for LDL cholesterol, and 4.32 (1.93, 6.72) mm Hg for systolic and 2.64 (1.53, 3.74) mm Hg for diastolic blood pressure. There were 176 deaths in the intervention group and 169 in the usual care group (hazard ratio 1.01 [0.82, 1.24]). CONCLUSIONS Telemedicine case management resulted in net improvements in HgbA1c, LDL-cholesterol and blood pressure levels over 5 years in medically underserved Medicare beneficiaries. Mortality was not different between the groups, although power was limited. Trial Registration http://clinicaltrials.gov Identifier: NCT00271739.

Figure 1

Flow Diagram of the IDEATel Randomized Controlled Trial of Telemedicine. Abbreviations: CMS, Centers for Medicare and Medicaid Services; HPSA, Health Professionals Shortage Area; MUA, Medically Underserved Area. Dropped out refers to subjects who communicated that they wished to drop out of the study at some time during the follow-up period; some of these subjects returned for a follow-up examination. 1665 individuals were included in at least one of the analyses of the primary outcomes. A few participants did not provide any measures of a specific primary outcome and could not be included in the analyses of that outcome. The number of deaths in ▶ reflects deaths before dropout. An additional 124 participants died (usual care = 42, intervention = 82) after they dropped out of the study and were included in the intention-to-treat survival analyses.

Figure 2

Adjusted Means of Hemoglobin A1c, LDL Cholesterol, and Systolic Blood Pressure. Panel (A) Plots of predicted outcomes based on a non-linear model without covariates. Quadratic term p = 0.011; exponential × group term p = 0.001. Equation: Ŷ = 7.19−0.13*group+0.09*time-0.04*group*(time)²+ 1.47* e^−time+ 1.28* group × e^{− time} (Time was measured in months from baseline, but the graphic above shows annual points. To enhance readability, the plot symbols and error bars for the intervention group have been offset. Error bars represent 95% confidence intervals.). Panel (B) Plots of predicted outcomes based on a non-linear model without covariates. Exponential × group term p < 0.001. Equation: Ŷ = 100.23–8.21* group-2.63* time+ 2.14* group × time+ 35.76* group × e^−time (Time was measured in months from baseline, but the graphic above shows annual points. To enhance readability, the plot symbols and error bars for the intervention group have been offset. Error bars represent 95% confidence intervals.). Panel (C) Plots of predicted outcomes based on a linear model without covariates. Systolic blood pressure: group × time term p = 0.024. Equation: Ŷ = 142.19–0.95* group − 0.34* time − 0.56* group × time. Diastolic blood pressure: group × time term p < 0.001. Equation: Ŷ = 70.76–0.04* group − 0.41* time − 0.43* group × time (Time was measured in months from baseline, but the graphic above shows annual points. To enhance readability, the plot symbols and error bars for the intervention group have been offset. Error bars represent 95% confidence intervals.).