THE IDEATEL PROJECT:
OVERVIEW, DESIGN, AND EVALUATION

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Steven Shea, M.D.

Rationale
The Centers for Medicare and Medicaid Services (CMS; previously the Health Care Financing Administration [HCFA]), the federal agency responsible for the Medicare and Medicaid programs, does not reimburse health care providers for electronically delivered health care services, except under very limited circumstances within demonstration projects. Only face-to-face services are reimbursable. Access to face-to-face health care services may be impeded in rural areas by geography, weather, and shortages of providers, particularly specialists. In urban areas obstacles to access include language, culture, disempowerment, and shortages of providers willing to take care of the urban poor. Telemedicine which supports interactions that are both distant and asynchronous. has the potential to reduce these barriers and the relay to improve access, quality of care, and health outcomes.

Gaps in Knowledge
Although telemedicine is conceptually promising, and efforts have been made to evaluate a variety of activities involving different applications of telemedicine, the gaps in this knowledge base are substantial. One comprehensive review of published telemedicine experience identified 455 telemedicine projects (362 in the U.S.), of which 50 provided services in patients’ homes.¹ The relative lack of substantive findings from these evaluation efforts is due to several factors, including the difficulty and cost of conducting robust technology evaluation, lack of studies using randomized designs with controls, small sample sizes, short-term follow-up, and lack of multi-disciplinary evaluation teams with experience in measuring and analyzing process, outcomes, and cost data. Thus, the clinical effectiveness of telemedicine, both in general and in specific clinical contexts, its acceptability to patients and providers, its cost, and its relative cost-effectiveness remain poorly documented.

The IDEATel Project
The Balanced Budget Act of 1997 mandated HCFA to conduct a demonstration project to evaluate the feasibility, acceptability, effectiveness, and cost-effectiveness of telemedicine to manage the care of people with diabetes. A New York State consortium (see list at end of chapter) received a 4-year grant award beginning in February, 2000, to conduct this project, which we named Informatics for Diabetes Education and Telemedicine (IDEATel).²

Rationale for Focus on Diabetes
Diabetes is common and costly in the Medicare-eligible population, and its complexity offers opportunities for effective case management using home telemedicine. An estimated 15.7 million people in the U.S. have diabetes,² and 18-20% of men and women aged 60-74 years are affected. The prevalence of type 2 diabetes increases with age and obesity. The U.S. population is aging and the prevalence of obesity is increasing, so that the population burden of diabetes will continue to increase. Diabetes is the leading cause of blindness in adults aged 20-74,³ and diabetic neuropathy is a major risk factor for amputations. Diabetes is also the leading cause of end-stage renal disease and dialysis in the U.S, accounting for about 40% of incident cases.⁴ The estimated cost of diabetes in 1997 was $98.2 billion, including $44 billion in direct medical costs.5 People over age 65 account for about two-thirds of all costs.⁵

Effectiveness of Treatments for Diabetes
Data for both type 1 and type 2 diabetes show that improved glycemic control and blood pressure control lessen the incidence and progression of the microvascular complications of diabetes, including neuropathy, nephropathy, and retinopathy.^6-8 Dilated eye examinations provide effective detection of early diabetic retinopathy, and photocoagulation is effective early treatment. Diabetic neuropathy can be detected by careful physical examination, and proper foot care can reduce ischemic limb damage. Aggressive treatment of hypertension and dyslipidemia are effective and cost-effective in reducing the macrovascular complications of diabetes, including coronary artery and cerebrovascular disease.^8-12 Tighter glycemic control may also impact favorably on macrovascular disease. Thus, extensive evidence from clinical trials and observational studies supports the benefit of a multi-faceted approach to the prevention and treatment of the micro- and macrovascular complications of diabetes.

Target Populations in IDEATel
IDEATel is targeted to populations with the greatest need for intervention. Eligibility criteria require that participants have diabetes mellitus, be over the age of 55 and have Medicare, and live in a federally designated medically underserved area at the time of enrollment. The urban component, with its hub at Columbia-Presbyterian Medical Center in New York City, enrolled patients living in the northern Manhattan communities of Harlem, Washington Heights, and Inwood. Of the 777 patients in the urban arm of the project, 97% are African American or Hispanic. The rural component, with its hub at SUNY Upstate Medical University in Syracuse, enrolled 886 patients across an 800 mile span of New York State reaching from Buffalo in the west to the Hudson headwaters in the East of the State. These patients are predominantly non-Hispanic white and rural.

Study Design
Potential participants are identified from panels of primary care providers who are cooperating with the project. Potential participants are sent a letter inviting participation and then screened by telephone for eligibility and interest. Medicare beneficiary status and residence in a medically underserved area are verified. Participants then undergo a baseline examination at which written informed consent, clinical data, and blood samples are obtained. Randomization occurs after completion of the baseline visit, with half the participants randomized to intervention and half to control. Randomization is blocked within primary care provider panels. Follow-up examinations are done at one and two years after the baseline visit. The main clinical outcomes are glycosylated hemoglobin, lipid, and blood pressure levels. Data on process of care, general health outcomes, and satisfaction are collected at these visits. In addition, health care utilization data are collected every three months by telephone, including data on hospital and diagnostic, outpatient, home care, and pharmacy services.

IDEATel Project Consortium
Columbia University, New York, NY:
• Department of Medicine/Division of General Medicine
• Department of Medical Informatics
• Naomi Berrie Diabetes Center
New York Presbyterian Hospital, New York, NY
St. Luke's-Roosevelt Hospital Center,
• Division of General Medicine.
Harlem Hospital Center, New York, NY:
• Department of Medicine/Division of General Medicine
Harlem Renaissance HealthCare Network, New York, NY
The Hebrew Home for the Aged at Riverdale, Bronx, NY
State University of New York (SUNY) Upstate Medical University, Syracuse, NY:
• Department of Medicine/Division of Endocrinology, Diabetes and Metabolism
• Department of Family Medicine
• Joslin Diabetes Center (Syracuse, NY)
University Hospital, Syracuse, NY
Arnot Ogden Medical Center, Elmira, NY
Bassett Healthcare, Cooperstown, NY
Olean General Hospital, Olean, NY
Samaritan Medical Center, Watertown, NY
American Diabetes Association, Alexandria, VA
American TeleCare, Inc., Eden Prairie, MN
Gentiva Health Care, Inc., Melville, NY
Verizon, Inc., Reston, VA
Crosshair Technologies, Inc., Scarsdale, NY

Intervention
The project provides home installation of a home telemedicine unit (HTU)(American Telecare, Inc.; Eden Prairie, MN) for the intervention groups. The HTU has four main functions: synchronous videoconferencing, self-monitoring of fingerstick glucose and blood pressure, messaging, and Web access. The device is a Web-enabled computer with modem connection to an existing telephone line. The HTU has several components: a video camera (8 frames/sec) and microphone for video-voice conferencing with a nurse case manager at either the Berrie Diabetes Center (urban component) or Joslin Diabetes Center (rural component); a home glucose meter and a blood pressure cuff connected to a generic medical device data post, so that home readings can be uploaded into a high-performance computer database (the New York Presbyterian Hospital clinical information system repository¹³); secure messaging including e-mail; and access to a special diabetes education web page in English and Spanish created for the project by the American Diabetes Association. The clinical database and project data security implementation support patient access to their own clinical data through the HTU.

Policy Implications
IDEATel is designed to provide data to inform policy in several areas. First, the project is designed to demonstrate the feasibility of large-scale Web-based systems for electronic delivery of health care services. Second, the project is intended to demonstrate that such systems can meet the data security requirements of the Health Insurance Portability and Accountability Act (HIPAA).¹⁴ Third, if the intervention proves to be effective and cost-effective, the results of the project evaluation may lead to broadening of reimbursement policies for electronically delivered health care services. Reimbursement issues will depend in part on the payment mechanism. For example, the question of what constitutes a reimbursable service unit is central in a fee-for-service payment environment, while the preferences of patients regarding substitution of electronic for face-to-face services may be more important in a capitated environment. Reimbursement policies will also require standards of documentation, for purposes of audit and quality review, and potentially also the separation of technology from service costs. Fourth, the legal environment in which the medical and nursing professions are credentialed, licensed, held accountable, disciplined, and insured for malpractice are largely based in the 50 states. There are differences among states in almost all of these areas, and a variety of limitations resulting from state-based licensure impede the electronic delivery of health care services across state boundaries.¹⁵

References
1. Hersh WR, Wallace JA, Patterson PK, et al. Telemedicine for the Medicare Population. Rockville, MD: Agency for Healthcare Research and Quality. July 2001. Evidence Report/Technology Assessment 24. AHRQ publication 01-E011. Available at: http://www.ahrq.gov/clinic/telemedsum.htm.

2. Shea S, Starren J, Weinstock RS, et al. Columbia University’s Informatics for Diabetes Education and Telemedicine (IDEATel) Project: Rationale and design. J Am Med Inform Assoc 2002;9:49-62.

3. National Institute of Diabetes and Digestive and Kidney Diseases. Diabetes Statistics. Bethesda, MD: NIDDKD, March 1999. NIH publication 99-3892. Available at: http://www.niddk.nih.gov/health/diabetes/pubs/dmstats/dmstats.htm. Accessed Nov 16, 2001.

4. U.S. Renal Data System. USRDS 1995 Annual Data Report. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Apr 1995:25-38.

5. American Diabetes Association. Economic consequences of diabetes mellitus in the U.S. in 1997. Diabetes Care 1998;21:296-309.

6. U.K. Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulfonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837-53.

7. UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patents with type 2 diabetes (UKPDS 34). Lancet 1998;352:854-65.

8. UK Prospective Diabetes Study (UKPDS) Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes (UKPDS 38). BMJ 1998;317:703-13.

9. Pyorala K, Pedersen TR, Kjekshus J, Faergeman O, Olsson AG. Thorgeirsson G. Cholesterol lowering with simvastatin improves prognosis of diabetic patients with coronary heart disease: a subgroup analysis of the Scandinavian Simvastatin Survival Study (4S). Diabetes Care 1997;20:614-20.

10. Brown JB, Pedula KL, Bakst AW. The progressive cost of complications in type 2 diabetes mellitus. Arch Intern Med 1999;159:1873-80.

11. Hansson L, Zanchetti A, Carruthers SG, et al. Effects of intensive blood pressure lowering and low-does aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomized trial. Lancet 1998;351:1755-62.

12. UK Prospective Diabetes Study (UKPDS) Group. Cost effectiveness analysis of improved blood pressure control in hypertensive patients with type 2 diabetes (UKPDS 40). Br Med J 1998;317:720-6.

13. Hripcsak G, Cimino JJ, Sengupta S. Web CIS: large scale deployment of a web-based clinical information system. Proc AMIA Annu Symp 1999:804-8.

14. The Health Insurance Portability and Accountability Act of 1996. HIPAA Web page. Available at: http://www.hcfa.gov/hipaa/hipaahm.htm. Accessed April 24, 2001.

15. Grigsby J, Sanders JH. Telemedicine: where it is and where it’s going. Ann Intern Med 1998;129:123-7.

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