Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)

AGENCY:

Health Care Financing Administration, HHS.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Health Care Financing Administration (HCFA), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

We are, however, requesting an emergency review of the Information collections referenced below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. We are requesting an emergency review because the collection of this information is needed prior to the expiration of the normal time limits under OMB's regulations at 5 CFR part 1320. Due to an unanticipated event, we are requesting an emergency review because the data collection and the associated time frame is required by a Congressionally mandated demonstration project (Informatics, Telemedicine, and Education Demonstration Project). This project is defined under Section 4207 of the Balanced Budget Act of 1997 which specifies an overall time frame of four years. In order to meet this overall time frame study the pilot phase for the recruitment of subjects should begin in late August 2000, with the full implementation of the recruitment phase beginning on October 1, 2000. Subject recruitment, in turn, will involve data collection involved in the Paper Reduction Act submission.

HCFA is requesting OMB review and approval of this collection by 8/7/2000, with a 180-day approval period. Written comments and recommendations will be accepted from the public if received by the individuals designated below by 8/3/2000. During this 180-day period, we will publish a separate Federal Register notice announcing the initiation of an extensive 60-day agency review and public comment period on these requirements. We will submit the requirements for OMB review and an extension of this emergency approval.

Type of Information Collection Request: New Collection;

Title of Information Collection: Informatics, Telemedicine, and Education Demonstration Project;

Form No.: HCFA-10014 (OMB# 0938-NEW);

Use: Section 4207 of the Balanced Budget Act of 1997 mandated HCFA to conduct a demonstration project to evaluate the effectiveness of advanced computer and telecommunications technology (“telemedicine”) to manage the care of people with diabetes. HCFA issued a request for proposals and, after review of the responses, selected a consortium led by Columbia University to conduct this project.

The consortium includes the following organizations and departments: Columbia University (Department of Medicine/Division of General Medicine, Department of Medical Informatics, and Russ Berrie Diabetes Center), NewYork Presbyterian Hospital, Harlem Hospital Center (Department of Medicine/Division of General Medicine, and Harlem Renaissance HealthCare Network), The Hebrew Home for the Aged at Riverdale, State University of New York (SUNY) Upstate Medical Center (Department of Medicine/Division of Endocrinology and Metabolism, Department of Family Medicine, Joslin Diabetes Center), Arnot Ogden Hospital, Olean General Hospital, Good Samaritan Hospital, American Diabetes Association, Bell Atlantic Telephone Co., and American TeleCare, Inc.

The project is designed as a randomized controlled trial. Half of the participants will receive the intervention, consisting of a home telemedicine unit and electronic services that can be accessed through this unit, and half will continue to receive usual care. There will be an urban component, to be conducted in northern Manhattan, and a rural component, to be conducted in upstate New York with SUNY, as the hub. Half of the participants will come from the urban area and half from the rural area, and randomization will be blocked within these components. Eligibility for participation requires that subjects be eligible Medicare beneficiaries with diabetes mellitus, reside in a medically underserved area (either MUA or HPSA) at time of enrollment, possess mental and visual capacities required for meaningful participation, and provide written informed consent.

Participants randomized to the intervention group will receive a home telemedicine unit (HTU) consisting of a web-enabled computer with modem connection to an existing telephone line. The HTU has several components: (a) a video camera and microphone that provides 8 frames/sec video and voice conferencing with nurse case managers at the Berrie Diabetes Center at Columbia University (urban component) or the Joslin Diabetes Center at SUNY Upstate Medical Center (rural component), (b) an FDA-approved home glucometer and blood pressure cuff (connected to the HTU through a generic medical device data port) to enable uploading of home fingerstick glucose and blood pressure data into a high performance computer database (NewYork Presbyterian Hospital Clinical Information System ), (c) access to patients = own clinical data through graphic and other data displays, and (d) access to a special educational web page to be created for the project by the American Diabetes Association in English and Spanish and in regular and low-literacy versions in each language.

Nurse case managers will receive training in diabetes management, following the Veterans Hospital Administration diabetes guidelines, and in the use of computer-based case management tools. These tools will facilitate monitoring and interactions with patients through videoconferencing. The HTU devices will be provided by American TeleCare, Inc. Installation, training, help desk support, and de-installation of the HTUs at the end of the project will be provided by Gentiva HealthServices.

Sample size was determined using least detectable difference calculations, and was based on balancing adequacy of statistical power and involvement of the smallest number of subjects. Outcome parameters considered in these calculations included glycosylated hemoglobin, blood pressure levels, and others. These calculations assumed blocked randomization (urban and rural components), repeat measures at one and two years of follow-up, and attrition rates at two years of fifteen percent in the intervention group and twenty percent in the control group. The attrition assumption, which was purposely conservative, projects that approximately twelve hundred of the original fifteen hundred people randomized will fully complete the study. Baseline mean levels and standard deviations for glycosylated hemoglobin and systolic and diastolic blood pressures were based on reviews of published observational studies for subjects sixty five years of age and older.

The sample size is adequate for an intervention effect on systolic blood pressure of 5 mm Hg reduction. Unadjusted for clustering and unreliability, with n=600 completers in each group, power is 0.97, while for an effect of 3 mmHg power is approximately 0.68. For glycosylated hemoglobin, it is noteworthy that tight glucose control in type 2 diabetics has a relatively modest effect compared to duration of diabetes on this parameter. Recent data (UKPDS 33; Lancet 1998; 352:837-53) show that glycosylated hemoglobin levels continued to rise over time in both the intensively treated and control groups, although intervention resulted in lower levels compared to control. The power analysis indicated that a difference in mean glycosylated hemoglobin level of 0.6% (7.9% vs. 8.5% in the two groups) could be detected with a sample size of n=138 per group; adjustment for the cluster effect increased this number to 207 per group.

Thus, the study is adequately powered to detect a difference of this magnitude in the overall study, and also possibly in subgroups defined by race/ethnicity, sex, or by urban/rural source. The study is not over-powered, since the intervention effect for this variable may be smaller, due to the older age and longer duration of diabetes in the subjects, and because subgroup analysis would be highly desirable.

Project evaluation will comprise the following: (a) Feasibility will be assessed by whether the implementation is successful, (b) acceptability will be assessed by whether participants can use the devices effectively, like the devices and the electronic service delivery model of care, and are satisfied with their care, (c) effectiveness will be evaluated primarily by comparing mean and adjusted mean levels of clinical outcomes in the intervention vs. control groups, and (d) cost-effectiveness will be assessed based on effectiveness, measures of health care services utilization, and technology and service costs of the intervention.

The demonstration will include collection of a comprehensive array of clinical, demographic, utilization, physician and patient satisfaction, and other data. Clinical data will be collected from all (intervention and control) participants at three visits: Visit 1 (baseline), Visit 2 (one year follow-up), and Visit 3 (two year follow-up). These data will include consent, demographics, medical and medication history, blood pressure, anthropometric data, fasting blood sample, and questionnaire data regarding health care service utilization, health status, smoking status, and satisfaction with care. Additional evaluation data will be collected from all participants by telephone at three-month intervals between the in-person visits. These data will focus on health care utilization and smoking status.

Clinical data will be collected from participants in the intervention arm of the study through the HTU. Participants will be encouraged to use the HTU to interact with the nurse case manager and to take an active role in self-monitoring of home glucose and blood pressure levels. These data will be used in the clinical management of the intervention arm participants by the project nurse case managers as well as the participants own primary care providers, who will also receive these data. Intervention group participants may provide as little or as much of this category of data as they choose.

Frequency: Quarterly;

Affected Public: Business or other for-profit, and Individuals or Households;

Number of Respondents: 5,550;

Total Annual Responses: 10,043;

Total Annual Hours: 19,999.

To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access HCFA's Web Site address at http://www.hcfa.gov/regs/prdact95.htm,, or E-mail your request, including your address, phone number, to Paperwork@hcfa.gov, or call the Reports Clearance Office on (410) 786-1326.

Interested persons are invited to send comments regarding the burden or any other aspect of these collections of Information requirements. However, as noted above, comments on these Information collection and recordkeeping requirements must be mailed and/or faxed to the designees referenced below, by 8/3/2000:

Health Care Financing Administration, Office of Information Services, Security and Standards Group, Division of HCFA Enterprise Standards, Attention: Dawn Willinghan, Room N2-14-26, 7500 Security Boulevard, Baltimore, Maryland 21244-1850, and

Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, Fax Number: (202) 395-6974 or (202) 395-5167, Attn: Allison Herron Eydt, HCFA Desk Officer.