Roberto Izquierdo

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.

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.

Glycemic Control and Health Disparities in Older Ethnically Diverse Underserved Adults With Diabetes: Five-year results from the Informatics for Diabetes Education and Telemedicine (IDEATel) study

OBJECTIVE The Informatics for Diabetes Education and Telemedicine (IDEATel) project randomized ethnically diverse underserved older adults with diabetes to a telemedicine intervention or usual care. Intervention participants had lower A1C levels over 5 years. New analyses were performed to help better understand this difference. RESEARCH DESIGN AND METHODS IDEATel randomized Medicare beneficiaries with diabetes (n = 1,665) to receive home video visits with a diabetes educator and upload glucose levels every 4–6 weeks or usual care (2000–2007). Annual measurements included BMI, A1C (primary outcome), and completion of questionnaires. Mixed-model analyses were performed using random effects to adjust for clustering within primary care physicians. RESULTS At baseline, A1C levels (mean ± SD) were 7.02 ± 1.25% in non-Hispanic whites (n = 821), 7.58 ± 1.78% in non-Hispanic blacks (n = 248), and 7.79 ± 1.68% in Hispanics (n = 585). Over time, lower A1C levels were associated with more glucose uploads (P = 0.02) and female sex (P = 0.002). Blacks, Hispanics, and insulin-users had higher A1C levels than non-Hispanic whites (P < 0.0001). BMI was not associated with A1C levels. Blacks and Hispanics had significantly fewer uploads than non-Hispanic whites over time. Hispanics had the highest baseline A1C levels and showed the greatest improvement in the intervention, but, unlike non-Hispanic whites, Hispanics did not achieve A1C levels <7.0% at 5 years. CONCLUSIONS Racial/ethnic disparities were observed in this cohort of underserved older adults with diabetes. The IDEATel telemedicine intervention was associated with improvement in glycemic control, particularly in Hispanics, who had the highest baseline A1C levels, suggesting that telemedicine has the potential to help reduce disparities in diabetes management.

Comparison of palpation-guided versus ultrasound-guided fine-needle aspiration biopsies of thyroid nodules in an outpatient endocrinology practice.

OBJECTIVE To investigate the role of thyroid ultrasonography in our outpatient endocrine practice. METHODS We compared the efficacy of ultrasound-guided fine-needle aspiration biopsy (US-FNAB) of thyroid nodules with that of palpation-guided aspiration (P-FNAB) and determined the malignancy rates of palpable and nonpalpable nodules. All patients referred for assessment of thyroid nodular disease from October 1997 through August 2001 were included in the study. Fine-needle aspirations were performed by palpation guidance until October 1999, after which US-FNAB was exclusively performed. All thyroid examinations, ultrasound imaging, and aspiration biopsies were performed by the same endocrinologist in an office-based setting. Histopathologic and cytologic diagnoses were compared for patients who underwent thyroidectomy. RESULTS A total of 376 nodules in 276 patients were aspirated during a 47-month period. P-FNAB was used on 157 nodules, and US-FNAB was performed on 219 nodules (both procedures were done on 21 nodules). For palpable thyroid nodules that were resected, the cytologic diagnostic accuracy rate was 60.9% and 80% for P-FNAB and US-FNAB, respectively. With use of ultrasound guidance, the sensitivity, positive predictive value, and negative predictive value increased significantly. In addition, the inadequate specimen rate decreased from 11.2% in the P-FNAB group to 7.1% in the US-FNAB group. Among the nodules that were not palpable, the malignancy rate was similar to that for the palpable thyroid nodules (5.1% versus 6.8%). CONCLUSION US-FNAB improved the cytologic diagnostic accuracy, sensitivity, and positive predictive value and reduced the false-negative rate in comparison with P-FNAB. The malignancy rate for nonpalpable thyroid nodules was similar to that for palpable nodules.

Psychosocial Outcomes of Telemedicine Case Management for Elderly Patients With Diabetes The randomized IDEATel trial

Diabetes case management (DCM) may improve medical outcomes (1,2). Case managers coordinate care and often provide a mix of interventions, e.g., telephone outreach, education, reminders. However, the efficacy of DCM is unclear. Three systematic reviews lend only limited support for the efficacy of DCM for improving glycemic control but none for lipid, weight, or blood pressure benefits (3–5). DCM studies typically target biomedical outcomes and ignore potential psychosocial effects. Yet, psychosocial variables (e.g., depression, anxiety, social support) relate to hyperglycemia, complications, adherence, and quality of life (6–11). Thus, a positive impact of DCM on these factors is important. Two studies did assess psychosocial outcomes of DCM and found improved self-efficacy and satisfaction (cluster visit) (12) and quality of life (dietitian-led DCM group) (13). Because barriers (e.g., distance, weather) limit DCM access, telemedicine can be used. A review of telemedicine versus face-to-face trials concluded that, while feasible and acceptable, there is little evidence that telemedicine has clinical benefits (14). Our team published results of a trial of telemedicine DCM versus usual care for elderly diabetic patients (15). The intervention resulted in significant improvements in glycemic control, blood pressure, and total and LDL cholesterol (16). The purpose of the Informatics for Diabetes Education and Telemedicine (IDEATel) project, funded by the Centers for Medicare and Medicaid Services, is to evaluate the feasibility and effectiveness of telemedicine with a diverse, medically underserved, elderly diabetic sample. The purpose of this study is to assess the impact of the IDEATel intervention on secondary psychosocial outcomes. A detailed description of the IDEATel study design has been previously reported (15,16). Medicare recipients were recruited if they were aged ≥55 years, diagnosed with diabetes, and without moderate/severe impairments or comorbidities. Research nurses blinded to the groups …

School-Centered Telemedicine for Children with Type 1 Diabetes Mellitus

OBJECTIVES To test the feasibility and effectiveness of telemedicine to improve care of children with type 1 diabetes in schools. STUDY DESIGN Subjects, ages 5 to 14 years (grades kindergarten through eighth) were randomized to usual care (18 students; 13 schools) or intervention (23 students; 12 schools). Usual care included medical visits every 3 months and communication between school nurse and diabetes team as needed by phone. The intervention group received usual care plus a telemedicine unit in the school nurse office to videoconference between the school nurse, child, and diabetes team every month. Hemoglobin A1c and pediatric quality of life were measured every 3 months for 1 year. Analyses used multilevel modeling. RESULTS A1c values increased from baseline to 6 months for students in the usual care group and decreased in the telemedicine cohort (P < .02). Lower A1c levels in the telemedicine group were maintained over the next several months, and significant improvements in several subscales of the Pediatric Diabetes Quality of Life questionnaire were observed. In the telemedicine group, urgent diabetes-related calls initiated by the school nurse were significantly reduced, and there were fewer hospitalizations and emergency department visits. CONCLUSIONS A school telemedicine program can improve diabetes care in grades kindergarten through eighth.

Adherence to diabetes self care for white, African-American and Hispanic American telemedicine participants: 5 year results from the IDEATel project

Objectives. Adherence to diabetes self care is poor for Hispanic American and African-American patients. This study examined the change in adherence over time and in response to a telemedicine intervention for elderly diabetes patients in these groups compared to white diabetes patients. We also examined whether adherence mediated the effect of the intervention on glycemic control (A1c). Design. The Informatics for Diabetes Education and Telemedicine project randomized medically underserved Medicare patients (n=1665) to telemedicine case management (televideo educator visits, individualized goal-setting/problem solving) or usual care. Hispanic and African-American educators delivered the intervention in Spanish if needed. Main outcome measures. Annual assessment included A1c and self-reported adherence (Summary of Diabetes Self-Care Activities scale). A simple model (only time and group terms) and a model with covariates (e.g., age) were examined for baseline and 5 years of follow-up. SAS PROC Mixed was used with non-linear terms to examine mediating effects of adherence on A1c, by performing tests of the mediating path coefficients. Results. Over time, self-reported adherence improved for the treatment group compared to usual care (p<0.001). There was no significant interaction with racial/ethnic group membership, i.e., all groups improved. However, minority subjects were consistently less adherent than whites. Also, greater comorbidity and diabetes symptoms predicted poorer adherence, greater duration of diabetes and more years of education predicted better adherence. Adherence was a significant mediator of A1c (p<0.001). Conclusions. A unique, tailored telemedicine intervention was effective in achieving improved adherence to diabetes self care. However, African-American and Hispanic American participants were less adherent than white participants at all time points despite an individualized and accessible intervention. The finding that adherence did mediate glycemic control suggests that unique interventions for minority groups may be needed to overcome this disparity.

Lessened decline in physical activity and impairment of older adults with diabetes with telemedicine and pedometer use: results from the IDEATel study

OBJECTIVE to examine the effects of the Informatics for Diabetes Education and Telemedicine (IDEATel) telemedicine intervention and pedometer use on physical activity (PA) and impairment in older adults with diabetes. DESIGN randomised clinical trial. Subjects ethnically diverse medically underserved Medicare beneficiaries with diabetes (n= 1,650). METHODS participants received home videovisits with a diabetes educator every 4-6 weeks or usual care. All received a pedometer. Annual measurements included hemoglobin A1c, Comprehensive Assessment and Referral Evaluation Activities of Daily Living, Diabetes Self-Care Activities, Charlson Comorbidity Index, Luben Social Support and pedometer use. Mixed model analyses were performed using random effects to adjust for clustering within primary care physicians. RESULTS in the telemedicine group compared with the usual care group, the rate of decline in PA (P= 0.0128) and physical impairment (PI) (P= 0.0370) was significantly less over time. Significant mean endpoint differences were observed for PA (P= 0.003). Pedometer use was significantly associated with PA (P= 0.0006) and PI (P< 0.0001). Baseline characteristics associated with greater PA included having fewer comorbid conditions (P= 0.0054), less depression (P< 0.0001), more social networking (P< 0.0001), lower BMI (P< 0.0001), male gender (P< 0.0001) and lower hemoglobin A1c level (P= 0.0045). Similar predictors were observed for PI, except duration of diabetes also predicted increased impairment (P< 0.0001). Significant indirect effects were observed through use of the pedometer on reduced decline in PA (P= 0.0024, 0.0013) and PI (P= 0.0024, P< 0.0001). CONCLUSIONS this telemedicine intervention reduced rates of decline in PA and impairment in older adults with diabetes. Pedometers may be a helpful inexpensive adjunct to diabetes initiatives delivered remotely with emerging technologies. ClinicalTrials.gov identifier NCT 00271739.

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,

Psychosocial outcomes of telemedicine case management for elderly patients with diabetes: IDEATel, a randomized trial

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