Medicare payments, healthcare service use, and telemedicine implementation costs in a randomized trial comparing telemedicine case management with usual care in medically underserved participants with diabetes mellitus (IDEATel).

Objective To determine whether a diabetes case management telemedicine intervention reduced healthcare expenditures, as measured by Medicare claims, and to assess the costs of developing and implementing the telemedicine intervention. Design We studied 1665 participants in the Informatics for Diabetes Education and Telemedicine (IDEATel), a randomized controlled trial comparing telemedicine case management of diabetes to usual care. Participants were aged 55 years or older, and resided in federally designated medically underserved areas of New York State. Measurements We analyzed Medicare claims payments for each participant for up to 60 study months from date of randomization, until their death, or until December 31, 2006 (whichever happened first). We also analyzed study expenditures for the telemedicine intervention over six budget years (February 28, 2000- February 27, 2006). Results Mean annual Medicare payments (SE) were similar in the usual care and telemedicine groups, $9040 ($386) and $9669 ($443) per participant, respectively (p>0.05). Sensitivity analyses, including stratification by censored status, adjustment by enrollment site, and semi-parametric weighting by probability of dropping-out, rendered similar results. Over six budget years 28 821 participant/months of telemedicine intervention were delivered, at an estimated cost of $622 per participant/month. Conclusion Telemedicine case management was not associated with a reduction in Medicare claims in this medically underserved population. The cost of implementing the telemedicine intervention was high, largely representing special purpose hardware and software costs required at the time. Lower implementation costs will need to be achieved using lower cost technology in order for telemedicine case management to be more widely used.

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.

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.

Telemedicine home blood pressure measurements and progression of albuminuria in elderly people with diabetes.

We assessed whether home blood pressure monitoring improved the prediction of progression of albuminuria when added to office measurements and compared it with ambulatory blood pressure monitoring in a multiethnic cohort of older people (n=392) with diabetes mellitus, without macroalbuminuria, participating in the telemedicine arm of the Informatics for Diabetes Education and Telemedicine Study. Albuminuria was assessed by measuring the spot urine albumin:creatinine ratio at baseline and annually for 3 years. The ambulatory sleep:wake systolic blood pressure ratio was categorized as dipping (ratio: < or =0.9), nondipping (ratio: >0.9 to 1.0), and nocturnal rise (ratio: >1.0). In a repeated-measures mixed linear model, after adjustment that included office pulse pressure, home pulse pressure was independently associated with a higher follow-up albumin:creatinine ratio (P=0.001). That association persisted (P=0.01) after adjusting for 24-hour pulse pressure and nocturnal rise, which were also independent predictors (P=0.02 and P=0.03, respectively). Cox proportional hazards models examined the progression of albuminuria (n=74) as defined by cutoff values used by clinicians. After the adjustment for office pulse pressure, the hazards ratio (95% CI) per 10-mm Hg increment of home pulse pressure was 1.34 (range: 1.1 to 1.7; P=0.01). Home pulse pressure was not an independent predictor in the model including ambulatory monitoring data; a nocturnal rise was the only independent predictor (P=0.035). Cox models built separately for home pulse pressure and ambulatory monitoring exhibited similar calibration and discrimination. In conclusion, nocturnal blood pressure elevation was the strongest predictor of worsening albuminuria. Home blood pressure measurements added to office measurements and may constitute an adequate substitute for ambulatory monitoring.

Nocturnal blood pressure elevation predicts progression of albuminuria in elderly people with type 2 diabetes.

Ambulatory 24-hour pulse pressure predicts progression of albuminuria in persons with diabetes mellitus. The authors assessed whether nocturnal blood pressure (BP) patterns added predictive information and examined the multivariate-adjusted association of nocturnal BP patterns with progression of urine albumin excretion during follow-up in a multiethnic cohort of older people (n=957) with type 2 diabetes mellitus who were free of macroalbuminuria. Albuminuria was assessed by spot urine measurement of albumin-to-creatinine ratio at baseline and annually for 3 years. Participants were categorized according to their sleep/wake systolic BP ratio as dippers (ratio 0.9 to 1; n=475), and nocturnal BP risers (ratio >1; n=187). The proportion exhibiting progression of albuminuria in dippers, nondippers, and risers was 17.6%, 22.9%, and 27.3%, respectively (P for linear trend = .01). A nocturnal BP rise was independently associated with progression of albuminuria (hazard ratio, 1.68; 95% confidence interval [CI], 1.09-2.60; P=.02), whereas office pulse pressure was not. When ambulatory 24-hour pulse pressure was added to the model, the nocturnal BP rise remained an independent predictor of progression of albuminuria (hazard ratio, 1.58; 95% CI, 1.02-2.45; P=.04). Nocturnal nondipping (without BP increase) was not an independent predictor. In conclusion, nocturnal BP rise on ambulatory monitoring is superior to office BP to predict worsening of albuminuria in elderly individuals with type 2 diabetes and adds to the information provided by 24-hour pulse pressure.

Value of ambulatory arterial stiffness index and 24-h pulse pressure to predict progression of albuminuria in elderly people with diabetes mellitus.

BACKGROUND: Ambulatory 24-h pulse pressure predicts progression of albuminuria in people with diabetes mellitus. It is not known whether the ambulatory arterial stiffness index (AASI) may add to that prediction. METHODS: We compared the multivariate-adjusted association of AASI and 24-h pulse pressure with progression of urine albumin excretion during follow-up in a multiethnic cohort of older people with type-2 diabetes mellitus. The baseline evaluation included office and 24-h ambulatory blood pressure (BP) measurements, and a spot urine measurement of albumin-to-creatinine ratio (ACR). The ACR measurements were repeated annually during 3 years. RESULTS: The AASI was >or=0.55 units in 47% of those exhibiting progression of albuminuria, and in 37% of those without progression (P = .004), whereas 24-h pulse pressure was >or=65 mm Hg in 50% and 38% of those with and without progression, respectively (P = .001). In repeated measures mixed linear model (n = 1043), after adjustment for several covariates including office pulse pressure, AASI in the fourth quartile was independently associated with higher follow-up ACR (P = .024). However, that association did not persist after adjusting for 24-h pulse pressure, which was an independent predictor (P < .001). Cox proportional hazards models examined progression of albuminuria in 957 participants without macroalbuminuria at baseline. The hazard ratio (95% CI) for AASI >or=0.55 units was 1.37 (1.02-1.83) after multivariable adjustment, including office pulse pressure. But AASI was not an independent predictor after adjustment for ambulatory pulse pressure, which was again an independent predictor (P = .033). CONCLUSIONS: Ambulatory 24-h pulse pressure outperformed AASI in predicting progression of albuminuria in elderly people with type 2 diabetes.

Recruitment and enrollment of rural and urban medically underserved elderly into a randomized trial of telemedicine case management for diabetes care.

Our goal was to identify reasons for enrollment or refusal to participate in a randomized trial of telemedicine case management of diabetes. We performed a prospective survey of participants and non-participants during recruitment for the Informatics for Diabetes Education and Telemedicine (IDEATel) study, a randomized trial of telemedicine case management of diabetes mellitus in medically underserved elderly. There were two recruitment areas: urban New York City, and rural upstate New York. A Participant Questionnaire (PQ) was administered at the baseline IDEATel visit, and a Non-Participant Questionnaire (NPQ) was administered during the recruitment telephone call. Both questionnaires listed possible responses; subjects could choose more than one response or give their own. Of 1,660 IDEATel participants, 99.7% completed the PQ. Most frequent reason for participation was the belief that the technology could help them (52% and 42% of urban and rural respondents, respectively). Of the 2,231 subjects refusing participation, 28% answered the NPQ (90% of respondents were from rural area). Most frequent reasons not to participate in the rural area were being too busy (23%), and discomfort with the technology (22%), and in the urban area the belief that the technology could not help them (71%), discomfort with it (52%), and not liking to participate in studies (52%). In multivariate analysis (rural respondents only), knowing how to use a computer was an independent predictor of participation (p < 0.001). In conclusion, perceptions and beliefs regarding technology, including the expectation to benefit from it, played an important role in the decision to participate.

Ambulatory pulse pressure and progression of urinary albumin excretion in older patients with type 2 diabetes mellitus.

We studied whether ambulatory blood pressure monitoring added to office blood pressure in predicting progression of urine albumin excretion over 2 years of follow-up in a multiethnic cohort of older people with type-2 diabetes mellitus. Participants in the Informatics for Diabetes Education and Telemedicine study underwent a baseline evaluation that included office and 24-hour ambulatory blood pressure measurement and a spot urine measurement of albumin-to-creatinine ratio (ACR). Measurements of albumin-to-creatinine ratio were repeated 1 and 2 years later. In bivariate analyses, ambulatory 24-hour pulse pressure was the blood pressure variable most strongly associated with follow-up ACR. Repeated-measures mixed linear models (n = 1040) were built adjusting for baseline ACR ratio, clustered randomization, time to follow-up, and multiple covariates. When both were entered into the model, ambulatory 24-hour pulse pressure and office pulse pressure were independently associated with follow-up ACR (beta [SE] = 0.010 [0.002], P < 0.001, and 0.004 [0.001], P = 0.002, respectively). Cox proportional hazards models examined associations with progression of albuminuria in 954 participants without macroalbuminuria at baseline, adjusting for all of the covariates independently associated with follow-up ACR in mixed linear models. Ambulatory 24-hour pulse pressure, but not office pulse pressure, was independently associated with progression of albuminuria (P = 0.015 and 0.052, respectively). The adjusted hazards ratio (95% CI) per each 10-mm Hg increment in ambulatory pulse pressure was 1.23 (1.04 to 1.42). In conclusion, ambulatory pulse pressure may provide additional information to predict progression of albuminuria in elderly diabetic subjects above and beyond office blood pressure.

Office and ambulatory blood pressure are independently associated with albuminuria in older subjects with type 2 diabetes.

Blood pressure strongly predicts microalbuminuria and later progression to renal failure in people with diabetes. Ambulatory blood pressure monitoring seems to be superior to office blood pressure in predicting progression to microalbuminuria in type 1 diabetes. The associations of ambulatory blood pressure with office blood pressure and microalbuminuria in type 2 diabetes remain unclear. We studied the association of office blood pressure taken with an automated device and ambulatory blood pressure with spot urine albumin:creatinine ratio in 1180 older people with type 2 diabetes participating in the Informatics for Diabetes Education and Telemedicine Study. Office and awake systolic blood pressure were independently associated with albuminuria (P<0.001 for both) in a multivariate linear regression analysis that adjusted for age, gender, duration of diabetes, hemoglobin A1c, number of antihypertensive medications, and use of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker. Twelve percent of participants had well-controlled office blood pressure but not ambulatory blood pressure, whereas 14% had well-controlled ambulatory but not office blood pressure. The prevalence of microalbuminuria and macroalbuminuria in these subgroups was intermediate between those with well-controlled or uncontrolled blood pressure by both methods. We found, in a multiethnic group of older subjects with type 2 diabetes, that office systolic blood pressure and awake systolic ambulatory blood pressure exhibited independent associations with degree of albuminuria.

A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus.

BACKGROUND: Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions who experience barriers to access to care or a high burden of illness. 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 = 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 > or =7% (n = 353). In the usual care group (n = 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 = 0.006), systolic and diastolic blood pressure, 3.4 (p = 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 > or =7%, net adjusted reduction in HgbA1c favoring the intervention group was 0.32% (p = 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.

Cardiovascular autonomic neuropathy is associated with microalbuminuria in older patients with type 2 diabetes.

OBJECTIVE: Cardiovascular autonomic neuropathy is associated with microalbuminuria in young and middle-aged patients with type 2 diabetes. We examined this relationship and the potential mediating role of blood pressure in older patients. RESEARCH DESIGN AND METHODS: At least two of three components of cardiovascular autonomic testing were completed by 132 patients (mean age 70 +/- 5.6 years). Relative rankings on each of the components were averaged to create a summary heart rate variability (HRV) measure. The urine microalbumin-to-creatinine ratio (milligrams albumin/grams creatinine) was calculated. Blood pressure was measured at rest and by 24-h ambulatory recording. RESULTS: Urine microalbumin-to-creatinine ratio was higher in those with lower HRV (mean urine microalbumin-to-creatinine ratio 28, 56, and 191 mg/g from the highest to lowest tertile of HRV; P < 0.0001). Resting and ambulatory blood pressure levels were negatively correlated with HRV and positively correlated with urine microalbumin-to-creatinine ratio. In multivariate analysis adjusting for age, duration of diabetes, HbA(1c), and HDL cholesterol, HRV and blood pressure were both independently associated with urine microalbumin-to-creatinine ratio, with no evidence that either mediates the effect of the other. CONCLUSIONS: Cardiovascular autonomic neuropathy and blood pressure are independently associated with microalbuminuria in older patients with type 2 diabetes.

Columbia University's Informatics for Diabetes Education and Telemedicine (IDEATel) Project: rationale and design.

The Columbia University Informatics for Diabetes Education and Telemedicine (IDEATel) Project is a four-year demonstration project funded by the Centers for Medicare and Medicaid Services with the overall goals of evaluating the feasibility, acceptability, effectiveness, and cost-effectiveness of telemedicine in the management of older patients with diabetes. The study is designed as a randomized controlled trial and is being conducted by a state-wide consortium in New York. Eligibility requires that participants have diabetes, are Medicare beneficiaries, and reside in federally designated medically underserved areas. A total of 1,500 participants will be randomized, half in New York City and half in other areas of the state. Intervention participants receive a home telemedicine unit that provides synchronous videoconferencing with a project-based nurse, electronic transmission of home fingerstick glucose and blood pressure data, and Web access to a project Web site. End points include glycosylated hemoglobin, blood pressure, and lipid levels; patient satisfaction; health care service utilization; and costs. The project is intended to provide data to help inform regulatory and reimbursement policies for electronically delivered health care services.