11.14.2023 Supporting Statement A FINAL

Supporting Statement A

Evidence Based Telehealth Network Program Measures

OMB Control No. 0906-0043

Terms of Clearance: Revision

A. Justification

1. Circumstances Making the Collection of Information Necessary

The Health Resources and Services Administration’s (HRSA) Office for the Advancement of Telehealth (OAT) is requesting Office of Management and Budget (OMB) approval for performance and clinical measure forms which collect information on grantee activities for the Evidence-Based Telehealth Network Program.

OAT seeks a revision of a currently approved information collection of measures for the Office for the Advancement of Telehealth’s Evidence-Based Telehealth Network Program. This program involves cooperative agreements administered in accordance with section 330I of the Public Health Service Act (42 U.S.C. 254c-14), as amended. The purpose of this program is to fund evidence-based projects that utilize telehealth technologies through telehealth networks to expand access to, and improve access to and the quality of, health care services. This program will work to help assess the effectiveness of evidence-based practices with the use of telehealth for patients, providers, and payers.

In the Evidence Based Telehealth Network Program Report, the adjusted data collection instrument includes the addition, removal, and revision of measures, with 27 total data elements addressing patient encounter information. The current measures focus on behavioral health, and the proposed adjusted measures include additional primary service options of primary care, acute care, maternal care, substance use disorder and chronic care management in alignment with the Notice of Funding Opportunity. Four additional elements were added to capture enrollment dates, preferred languages, zip code and encounter date. Outcome measures were also expanded to include six new data elements including smoking status, vaping status, medications, blood pressure, Hemoglobin A1C and height and weight.

The estimated burden for this collection instrument has decreased since the data collection frequency is changing from monthly to quarterly.

In addition, the Performance Improvement Measurement System (PIMS) electronic reporting system, built into the Electronic Handbook (EHB) web-based portal, is used by award recipients to submit information to HRSA. This annual data collection specifically ensures awarded projects adequately fulfill the authorized goals for the Telehealth Network Program. This revision allows for information and measures collected from grantees in the PIMS to be aligned more closely with the Notice of Funding Opportunity and assists in clarifying program measures and impact. These adjustments allow OAT to gain a more thorough understanding of how to utilize telehealth technologies to improve access to, and improve the quality of, health care services.

2. Purpose and Use of Information Collection

OAT is proposing to conduct data collection of grantee information for the Evidence Based Telehealth Network Program. This program provides funding to support evidence-based projects that use telehealth technologies through telehealth networks to increase access to health care services in rural areas, frontier communities, medically underserved areas, and for medically underserved populations.

The developed measures support OAT’s objective to contribute to the evidence base for assessing the effectiveness of telehealth care services for patients, providers, and payers. The measures also enable HRSA and OAT to capture data that illustrate the impact and scope of federal funding along with assessing these efforts. Quarterly collected data will provide quantitative information about the funded programs, specifically the characteristics of improving access to needed health services and improving health outcomes. The measures cover the principal topic areas of interest to OAT, including: (a) population demographics; (b) access to health care; (c) cost savings and cost-effectiveness; and (d) clinical outcomes.

These assessments will provide valuable information from the Evidence-Based Telehealth Network Program, enabling HRSA to assess the success of the program. Collecting performance measures will ensure that funded projects have demonstrated a need for services in their communities and utilize those federal funds effectively to provide services to meet those needs. This information includes:

• Demographics for the Telehealth Network Program user population;

• The types of settings where telehealth services are provided;

• The types of telehealth services that are funded through the program;

• Access to telehealth services funded through the program;

• The impact of cost effectiveness/cost savings on the population served; and

• The degree to which funding has affected patient care access among the population served.

Reports from the database are capable of identifying and guiding OAT’s response to the needs of the grantee recipient and OAT programing. The database:

• Provides uniformly defined data for OAT grant programs;

• Yields evidence-based information that may be lacking in national and state research; and

• Facilitates the electronic transmission of data by the grantees, through use of standard formats and definitions.

Without collection of this data, it would be difficult to ascertain the collective impact of these programs across all Telehealth Network Program grantees and determine of how funding has improved the characteristics and outcomes mentioned above.

Lack of such data would also impede future efforts to create resources and funding opportunities that are able to address the gaps and healthcare needs presented in the data findings.

3. Use of Improved Information Technology and Burden Reduction

The Evidence-Based Telehealth Network Program utilizes electronic collection. The Evidence-Based Telehealth Network Program collection uses the Direct-to-Consumer Telehealth Evidence Collection (D-TEC) tool on the REDCap® platform, which is an 100% electronic and a web-based application for data collection. This tool will support the evidence-based clinical measures data elements in a pre-established form. Respondents are also able to use formatted files which allows for flexibility based on preference for and ease of response submissions.

The OAT PIMS tool is 100% electronic within HRSA’s Electronic Handbook. The system design provides pre-formatted and interactive data entry that helps assure standardized data across the Telehealth Network Programs and greatly simplifies the data entry process. The grantee provides sites and service information, and the system only generates forms based on this data.

Instructions are included with each data collection tool. The time burden is minimal since there is no written data entry element for program staff due to the electronic transmission from grantee systems to the PIMS; additionally, there is less chance of error in translating data and analysis of the data.

4. Efforts to Identify Duplication and Use of Similar Information

There is no other data source available for this specific grant, which tracks the activities of grantees participating in the Telehealth Network Program. The information is not intended to reflect all telehealth activity nationwide; it reflects only the activity of the telehealth programs funded by HRSA’s OAT.

5. Impact on Small Businesses or Other Small Entities

Every effort has been made to ensure the data requested is data that is currently being collected by the grantee projects or can be easily incorporated into normal project procedures. Data being requested is useful in determining whether grantee goals and objectives are being met. The data collection activities will not have a significant impact on small entities.

6. Consequences of Collecting the Information Less Frequently

Respondents will respond to this data collection on a quarterly and annual basis. This information is needed by OAT and HRSA to measure effective use of grant dollars, identify approaches that can be used to enhance the evidence-base for telehealth and report on progress toward strategic goals and objectives. Without collection of this data and at this frequency, it would be difficult to ascertain the collective impact of the Evidence Based Telehealth Network Program and determine how funding has helped to improve health outcomes. Collecting the data less frequently may impact the evaluation and may increase burden for respondents, requiring grantees to submit larger amounts of data at one point in time. There are no legal obstacles to reduce the burden.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This project is consistent with the guidelines in 5 CFR 1320.5.

8. Comments in Response to the Federal Register Notice/Outside Consultation

Section 8A:

A 60-day Federal Register Notice was published in the Federal Register on August 18, 2023, vol. 88, No. 159; pp. 56640-41 (56640- 56641). A 30-day Federal Register Notice was published in the Federal Register on November 29, 2023, vol. 88, No. 228; pp. 83419-20 (83419- 83420). There were no public comments.

Section 8B:

HRSA’s Rural Telehealth Research Center has a cooperative agreement with the Office for the Advancement of Telehealth. As the lead researcher, HRSA’s Rural Telehealth Research Center was consulted to conduct a literature review but found there were no comparable existing measures and research.

9. Explanation of any Payment/Gift to Respondents

Respondents will not receive any payments or gifts.

10. Assurance of Confidentiality Provided to Respondents

The D-TEC Tool that includes data from the Evidence-Based Telehealth Network Program is maintained by HRSA grantees, and not by HRSA. HRSA maintains the PIMS tool which does not collect data about individuals; therefore, the Privacy Act is not applicable to this activity. The proposed performance measures will be used only in aggregate data for program activities. Data will be kept private to the extent allowed by law.

Grantees are responsible for meeting requirements of the HHS regulations for the protection of human subjects from research risks, including the following: (1) discuss plans to seek Institutional Review Board (IRB) approval or exemption; (2) develop all required documentation for submission of research protocol to IRB; (3) communicate with IRB regarding the research protocol; (4) communicate about IRB’s decision and any IRB subsequent issues with HRSA.

11. Justification for Sensitive Questions

Race and ethnicity data are collected within the data instrument. This information will help OAT gain a more thorough understanding of how different demographics utilize telehealth technologies through telehealth to improve access to, and improve the quality of, health care services. These measures will be deidentified for the data collection.

12. Estimates of Annualized Hour and Cost Burden

12A. Estimated Annualized Burden Hours

Table 1: Estimated Annualized Burden Hours

Type of Respondent	Form Name	Number of Respondents	Number of Responses per Respondent	Total Responses	Average Burden per Response (in hours)	Total Burden Hours
Project Director	Evidence-Based Telehealth Network Program Report	11	4	44	31	1,364
Project Director	Telehealth Performance Measurement Report	11	1	11	5	55
	Total	11*		55		1,419

* HRSA estimates 11 unique respondents, each completing the two forms.

These estimates were determined by consultations with a sample of six current grantees from the program. These grantees were sent a draft of the questions that pertain to their program. They were asked to estimate how much time it would take to respond to the questions.

It should also be noted that the burden is expected to vary across the grantees. This variation is tied primarily to the type of program activities specific to the grantee’s project and current data collection system.

12B. Estimated Annualized Burden Costs

The Department of Labor website was used to determine the appropriate wage rate for respondents (http://www.bls.gov/bls/blswage.htm). Because the forms will be completed by Project Directors, the wage category used was “Management Occupations”, which has a median wage of $51.62 per hour. When calculating the estimated annual burden costs (see Table 3), the median wage is multiplied by 2 to account for overhead costs, for a total of $103.24.

Table 3: Estimated Annual Burden Costs

Type of Respondent	Total BurdenHours	Hourly Median Wage Rate (x2)	Total Respondent Costs
Project Director	1,419	$103.24	$ 146,497.56
Total			$ 146,497.56

* Source: https://www.bls.gov/oes/current/oes110000.htm. Hourly median wage multiplied by 2 to account for overhead costs.

13. Estimates of other Total Annual Cost Burden to Respondents or Recordkeepers/Capital Costs

Other than their time, there is no cost to respondents.

14. Annualized Cost to Federal Government

The contract task that supports this collection is for approximately $ 488,000 per year. This includes contracts and cooperative agreements/grants supporting program and program measurement.

Staff at OAT monitor the grants and provide guidance to grantee project staff at a cost of 40% FTE at $66,980.16 per year (832 hours per year at $53.67 per hour at a GS-13 Step 1 salary level, multiplied by 1.5 to account for overhead costs).

The total annual cost to the federal government is $554,980.16 per year, which rounds down to $554,980 in ROCIS.

15. Explanation for Program Changes or Adjustments

With this change, the total estimated burden hours are less since the currently approved measure package is for 14 grantees instead of the current 11 grantees in the program. Some of the data elements are being updated, but the frequency of data collection is changing from monthly to quarterly.

16. Plans for Tabulation, Publication, and Project Time Schedule

Planning is underway for determining how to analyze the data with the Rural Telehealth Research Center. Collective data may be used to document the impact and success of program. Data collection will begin approximately two weeks after OMB clearance and continue throughout the remainder of the project period, or as soon as possible. The data collection will take place throughout the Evidence-Based Telehealth Network Program that goes through August 31, 2026. Following, the Telehealth Research Center will propose a project to focus on analysis and manuscript development. This information will be used for publications. Additionally, OAT may include select measures and data points as part of the annual budget justification and as part of legislatively-required reporting.

17. Reason(s) Display of OMB Expiration Date is Inappropriate

The OMB number and Expiration date will be displayed on every page of every form/instrument.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

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