Supporting Statement A 0935-0265 The AHRQ Safety Program for Telemedicine - Improving Antibiotic Use

The Agency for Healthcare Research and Quality (AHRQ) requests a revision of the currently approved AHRQ Safety Program for Telemedicine: Improving Antibiotic Use and Improving the Diagnostic Process (“AHRQ Safety Program for Telemedicine”). The AHRQ Safety Program for Telemedicine aims to help practices improve care within the telemedicine setting by developing a culture of patient safety and improving communication and teamwork between healthcare providers (HCPs) and staff and among HCPs and patients. The AHRQ Safety Program for Telemedicine was last approved by the OMB on April 21, 2023, and will expire on April 30, 2026. The OMB control number for the AHRQ Safety Program for Telemedicine is 0935-0265. Supporting documents for the current AHRQ Safety Program for Telemedicine can be downloaded from OMB’s website at: https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202303-0935-001.

First, the 2023 AHRQ Safety Program for Telemedicine materials submitted for OMB clearance included materials for two cohorts: the diagnostic process cohort and the improving antibiotic use cohort. The diagnostic process cohort was cancelled prior to the cohort’s start date. Therefore, this revision removes all references to the diagnostic process cohort including removal of all data collection tools specific to the cohort, updated versions of the annualized cost and burden tables, and removal of the reference to “Improving the Diagnostic Process” in the Safety Program name.

Second, the 2023 AHRQ Safety Program for Telemedicine materials submitted for OMB clearance included a single version of the Structural Assessment and Participant Experience Survey to be completed by all participants in the improving antibiotic use cohort. However, following pre-recruitment discussions with our Technical Expert Panel (TEP) and potential participants, we have learned that our target audience for the improving antibiotic use cohort is comprised of healthcare providers from two distinctly different settings (brick-and-mortar and telemedicine-only) settings. Providers that practice in brick-and-mortar settings provide care both in-person and via telemedicine whereas providers that practice in telemedicine-only settings provide care exclusively using telemedicine. Therefore, we are proposing the following revisions to account for the differences in the two practice settings.

Structural Assessment and Participant Experience Surveys: The 2023 AHRQ Safety Program for Telemedicine materials submitted for OMB clearance included a single version of the Structural Assessment and Participant Experience Survey to be completed by all participants in the improving antibiotic use cohort. We propose administering two different versions of the Structural Assessment and Participant Experience Survey for the improving antibiotic use cohort. One version will be administered to participants practicing in brick-and-mortar settings and one version to participants practicing in telemedicine-only settings.

Medical Office Survey on Patient Safety Culture (MOSOPS): The 2023 AHRQ Safety Program for Telemedicine materials submitted for OMB clearance included completion of the MOSOPS by all participating staff across all participating practices. In this revision, we propose administering the MOSOPS to HCPs practicing in brick-and-mortar settings only. The MOSOPS was designed to assess key characteristics of HCPs working in-person in a single medical office and results are unlikely to be reliable or valid if administered among HCPs practicing in telemedicine-only settings. We have updated the estimated annual burden hours to reflect the reduced number of respondents to MOSOPS (see Table 1 below).

Schedule of Assessment Activities: We propose revising the Schedule of Assessment Activities to include an additional three months of baseline antibiotic use data to better understand pre-intervention prescribing rates. Baseline antibiotic use data will now include data from March 2024 to August 2024.This is consistent with the prior AHRQ Safety Program for Improving Antibiotic Use. This change to the date range within the existing baseline data requested in the original OMB submission will not increase the estimated annualized burden hours.
Other Materials: The Draft Interview Guide for Semi-Structured Interviews (Improving Antibiotic Use cohort only), the Antibiotic Prescription Data Template, and the Instructions for the Antibiotic Prescription Data Template include revisions based on lessons learned from the TEP and conversations with participants from the prior AHRQ Safety Program for Improving Antibiotic Use.

Exhibit 1. Estimated Annualized Burden Hours (See Section 12)
Form Name	Number of Respondents*	Number of Responses per Respondent	Hours per Response	Total Burden Hours
Structural Assessment (telemedicine-only and brick-and-mortar)	188	2	0.2	75
AHRQ Medical Office Survey on Patient Safety Culture (MOSOPS) (brick-and-mortar only)	438	2	0.5	438
Participant Experience Survey (telemedicine-only and brick-and-mortar)	188	1	0.33	62
Semi-structured qualitative interviews (telemedicine-only and brick-and-mortar)	18	1	1	18
EHR data (telemedicine-only and brick-and-mortar)	225	18	1	4,050
Total				4,643
*Annualized number of respondents is based on maximum practices recruited, assuming 50% of the practices are telemedicine-only and 50% are brick-and-mortar, and 75% response rate for forms 1 and 3, 50% response rate for form 2, and 90% response rate for forms 4 and 5.

A. Justification

1. Circumstances that make the collection of information necessary

The mission of the Agency for Healthcare Research and Quality (AHRQ) set out in its authorizing legislation, The Healthcare Research and Quality Act of 1999 (see https://www.ahrq.gov/sites/default/files/wysiwyg/policymakers/hrqa99.pdf), is to enhance the quality, appropriateness, and effectiveness of health services, and access to such services, through the establishment of a broad base of scientific research and through the promotion of improvements in clinical and health systems practices, including the prevention of diseases and other health conditions. AHRQ shall promote health care quality improvement by conducting and supporting:

1. Research that develops and presents scientific evidence regarding all aspects of health care; and

2. The synthesis and dissemination of available scientific evidence for use by patients, consumers, practitioners, providers, purchasers, policy makers, and educators; and

3. Initiatives to advance private and public efforts to improve health care quality.

Also, AHRQ shall conduct and support research and evaluations, and support demonstration projects, with respect to (A) the delivery of health care in inner-city areas, and in rural areas (including frontier areas); and (B) health care for priority populations, which shall include (1) low-income groups, (2) minority groups, (3) women, (4) children, (5) the elderly, and (6) individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care.

Background for this Collection

Telemedicine visits have increased dramatically in response to the COVID-19 pandemic and resulting changes in third-party payer reimbursement policies¹. Telemedicine visits increased from 0.3 percent of all ambulatory visits in 2019 to 23.6 percent by Spring 2020.² Given this rapid growth, the need to ensure safe and appropriate patient care in this setting is urgent. Telemedicine has many benefits, such as facilitating continuity of care; improving access beyond normal hours; reducing patients’ travel burden; overcoming health care provider (HCP) shortages; and providing support for patients managing chronic health conditions.³ However, transferring clinical practices from an in-person to a virtual environment poses potential risks. Many HCPs have never received formal training in using telemedicine effectively to diagnose and treat patients virtually. Additionally, inadequate internet access, which disproportionately impacts rural and minority populations, and struggles accessing telemedicine platforms may force video-based telemedicine visits to transition to audio-only or to be skipped.⁴

This program aims to improve antibiotic use among telemedicine practices by implementing the AHRQ- and Johns Hopkins Armstrong Institute for Patient Safety and Quality (JHAI)-developed Comprehensive Unit-based Safety Program (CUSP) approach. The CUSP approach improves safety culture at the practice level, enables harm prevention, and engages providers who are on the front lines⁵ while integrating technical and adaptive/cultural approaches to making sustainable change.⁶

This program constitutes the first large-scale implementation of a quality improvement effort for improving antibiotic use in telemedicine. Given the need for clearer guidance and evidence-based telemedicine practices for clinicians and potential for positive impact on outcomes, as described below, this area was chosen.

Antibiotic resistance causes two million infections per year with antibiotic-resistant organisms and 35,000 deaths per year in the U.S.⁷ Meanwhile, infection-related complaints account for a large proportion of telemedicine visits. Among the most common diagnoses treated in direct-to-consumer (DTC) telemedicine are upper respiratory infections (URIs) and sinusitis (35-85 percent of visits) and urinary tract infections (UTIs, 9-12 percent of visits). Two-thirds of telemedicine visits for URIs inappropriately result in antibiotic prescriptions.⁸ ⁹ ¹⁰ ¹¹ These statistics underscore the need for improving antibiotic use in telemedicine, but implementation requires addressing multiple barriers,¹² including: consumer desire for antibiotics that may influence HCPs’ prescribing behaviors;¹³ ¹⁴ HCPs’ unawareness of their own prescribing practices; time pressures; absence of established therapeutic relationships (in DTC telemedicine); limited infrastructure for implementing antibiotic stewardship interventions; unfamiliarity with local antibiograms; inability to perform a PE; and lack of access to diagnostic testing.¹² Moreover, regulations encouraging antibiotic stewardship in ambulatory care and relevant tools are not specific to telemedicine practices.^9,¹⁵^,¹⁶^,¹⁷^,¹⁸^,¹⁹

This program will incorporate CUSP strategies to improve antibiotic prescribing in telemedicine. The program goals are to:

Identify best practices in implementing interventions to improve antibiotic use in telemedicine.
Determine how best to adapt CUSP to enhance antibiotic use in telemedicine.
Use a CUSP approach to design and implement the interventions for improving antibiotic use across telemedicine practices.
Reduce inappropriate antibiotic prescribing among telemedicine practices.

AHRQ is requesting a 3-year clearance to perform the data collection activities needed to assess the adoption of the program and evaluate its effectiveness in the participating practices. The program will be comprised of 300 to 500 clinic-based and telemedicine-only practices from all 10 Health and Human Services regions.

To achieve the goals of the AHRQ Safety Program for Telemedicine (“Safety Program”), the following data collection activities will be implemented for the Improving Antibiotic Use cohort, which will take place August 2024 – December 2025. This is contingent upon receiving OMB approval.

Structural Assessments: A brief online assessment will be completed by a leader/champion from each brick-and-mortar practice or telemedicine-only organization to understand their infrastructure and capacity to implement the Safety Program. One version of the Structural Assessment was included in the original OMB submission. This revision includes separate versions for brick-and-mortar and telemedicine-only settings.
The Medical Office Survey on Patient Safety Culture (MOSOPS): This survey will be completed by all participating staff at brick-and mortar practices to assess patient safety issues, medical errors, and event reporting practices. This survey was to be completed by all participants in the original OMB submission. This revision excludes participants in telemedicine-only settings from completing the MOSOPS.
Participant Experience Survey Antibiotic Use Cohort: A brief online assessment will be completed by a leader/champion from each practice to assess how participants approached implementation of the Safety Program. One version of the Participant Experience Survey was included in the original OMB submission. This revision includes separate versions for brick-and-mortar and telemedicine-only settings.
Semi-Structured Qualitative Interviews: A proportion of practices will be selected to participate in telephone/virtual discussions to understand the facilitators and barriers to implementing the Safety Program. A draft Interview Guide for Semi-Structured Interviews was included in the original OMB submission. This revision includes a prompt to potentially skip a section on the role of nursing in stewardship if not applicable to the practice.
Electronic Health Record (EHR) data: Diagnostic codes and any associated antibiotics prescribed will be extracted from the EHRs of participating practices. An Antibiotic Prescription Data Template was included in the original OMB submission. This revision includes modifications to the template to simplify the data collection process for participants.

The Safety Program is being conducted by AHRQ through its contractor, NORC at the University of Chicago (NORC) and NORC’s subcontractor, the Johns Hopkins University (JHU). The AHRQ Safety Program for Telemedicine is being undertaken pursuant to AHRQ’s mission to enhance the quality, appropriateness, and effectiveness of health services, and access to such services, through the establishment of a broad base of scientific research and through the promotion of improvements in clinical and health systems practices, including the prevention of diseases and other health conditions. 42 U.S.C. 299.

2. Purpose and Use of Information

This data collection effort will be part of a comprehensive evaluation strategy to assess the adoption of the Safety Program among telemedicine practices; measure the effectiveness of the Safety Program among the participating practices and evaluate how providers experienced the program as well as the perceived usefulness of the Safety Program’s education materials and metrics; and understand drivers of antibiotic prescribing among practices.

The evaluation is formative in nature as AHRQ seeks information on the implementation and effectiveness of CUSP in a novel setting—telemedicine. The evaluation will utilize a pre-post design, comparing data collected at baseline and at the end of the Safety Program within each cohort.

Structural Assessments: The structural assessment will be administered to the Safety Program leader/champion at each participating brick-and-mortar practice or telemedicine-only organization at baseline (pre-intervention) and at the end of the intervention. The data will provide information about the practices or organizations, any existing quality improvement initiatives currently in place, their existing infrastructure and capacity to carry out the program, as well as changes in the infrastructure and quality improvement activities as a result of participation in the Safety Program. Data from the pre- and post-intervention time points will be analyzed to assess the extent to which the Safety Program had an impact on practices’ infrastructure. Based on feedback from the TEP and conversations with telemedicine-only organizations, this revision includes distinct versions of the Structural Assessment for brick-and-mortar practices and telemedicine-only organizations. Attachments A and B contain the Structural Assessments for participants in brick-and-mortar settings and telemedicine-only settings, respectively.

The AHRQ Medical Office Survey on Patient Safety Culture (MOSOPS): The MOSOPS will be administered to all participating staff at brick-and-mortar practices at baseline (pre-intervention) and at the end of the intervention. The survey collects information on patient safety issues, patient safety culture, medical errors, and event reporting. The data will be used to assess changes in safety culture following implementation of the Safety Program. Based on feedback from the TEP and conversations with telemedicine-only organizations, this revision excludes telemedicine-only organizations from completing the MOSOPS. The survey is contained in Attachment C.

Participant Experience Survey: The participant experience survey will be administered to the clinical leader/champion at each practice at endline (post-intervention). The survey will assess how participants approached implementation of the Safety Program. Based on feedback from the TEP and conversations with telemedicine-only organizations, this revision includes changes to the Participant Experience Survey as well as unique versions for brick-and-mortar and telemedicine-only participants. Attachments D and E contain the Participant Experience Surveys for participants in brick-and-mortar and telemedicine-only settings, respectively.

Semi-structured qualitative interviews: At the end of the intervention, telephone/virtual discussions will be scheduled with one to two HCPs from approximately 20 practices. The qualitative data collected will help AHRQ understand the characteristics of teams associated with successful implementation and improvements in outcomes, barriers to a successful implementation of the Safety Program, and drivers of outcomes (i.e., antibiotic prescribing). This revision includes changes to the semi-structured interview guide. The guide is contained in Attachment F.

Electronic Health Record (EHR) data: Every month starting at baseline (pre-intervention) until the end of the intervention, each participating practice will extract antibiotic prescribing data from their EHR system. The data will be submitted quarterly using a secure online data submission portal. The prescribing data will evaluate changes in antibiotic usage, clinical outcomes, and other effectiveness measures resulting from participation in the Safety Program. Based on feedback from participants in the prior AHRQ Safety Program, this updated version includes revisions to the EHR template to simplify the data requested in the template from aggregate to visit-level. The antibiotic prescription data template is contained in Attachment G and the instructions for the antibiotic prescription data extraction are contained in Attachment H.

3. Use of Improved Information Technology

To minimize respondent burden and to permit the electronic submission of survey responses and data collection forms, the structural assessment, AHRQ MOSOPS, participant experience survey, and antibiotic prescription data template will be web-based and deployed using a well-designed, low burden, and respondent-friendly survey administration process. In addition, the EHR data extracted by practice staff that are requested for this program may already be collected by practices as part of their ongoing quality improvement initiatives.

Practices will receive access to the online data collection platform and detailed instructions on completing the online forms and EHR data submissions.

4. Efforts to Identify Duplication

AHRQ’s Safety Program for Telemedicine can synergize with and complement existing national initiatives aimed at improving antibiotic prescribing across health care settings in the U.S. Regulations encouraging antibiotic stewardship in ambulatory care and tools for antibiotic stewardship in ambulatory care are not specific to telemedicine practices. To our knowledge, there are currently no other Federal initiatives which aim to improve antibiotic use specifically within telemedicine. AHRQ’s Safety Program for Telemedicine will incorporate CUSP strategies to improve antibiotic use by developing a culture of patient safety while considering and catering to the unique structure and culture of different telemedicine environments.

AHRQ is an active participant on FedTel, a Federal Advisory Telemedicine working group. There is a monthly teleconference led by the Health Resources & Services Administration, in which various Federal agencies (Centers for Medicare & Medicaid Services, Indian Health Service, National Institutes of Health) present projects they are working on in the telemedicine arena. The participation ensures no duplication of efforts on a federal level will ensue.

5. Involvement of Small Entities

The information collected may involve small entities, as some of the participating practices may only employ a handful of HCPs. For this program, only items that provide critical information for conducting the evaluation will be included, and the information being requested has been held to the absolute minimum required for the intended use.

6. Consequences if Information is Collected Less Frequently

This data collection effort will be part of a comprehensive evaluation strategy to assess the adoption of the Safety Program among participating practices; measure the effectiveness of the Safety Program among participating practices; evaluate participants’ experience and approaches implementing the Safety Program; and understand the characteristics of teams and senior leaders that are associated with successful implementation and improvements in outcomes. The planned frequency of the data collection activities is necessary to accurately assess the adoption and effectiveness of the program.

The Structural Assessment will be administered at baseline (pre-intervention) and at the end of the intervention to measure the extent to which the program was adopted by the participating practices.

The AHRQ MOSOPS will be collected at baseline (pre-intervention) and at the end of the intervention to measure the changes in patient safety culture resulting from participation in the Safety Program.

The Participant Experience Survey will be collected at the end of the intervention to assess participant engagement and progress; understand providers’ experience using materials and participating in the Safety Program; and identify processes used and changes made to implement and sustain the Safety Program.

The semi-structured interviews will be conducted at the end of the intervention among a sample of practices (approximately 20) to collect qualitative information on the implementation of the program.

The Electronic Health Record (EHR) data will be collected each month and submitted quarterly starting in the baseline (pre-intervention) period until the end of the intervention to measure changes in antibiotic usage resulting from the intervention.

7. Special Circumstances

This request is consistent with the general information collection guidelines of 5 CFR 1320.5(d)(2). No special circumstances apply.

8. Federal Register Notice and Outside Consultations

8.a. Federal Register Notice

As required by 5 CFR 1320.8(d), notice was published in the Federal Register on April 29, 2024 on page 33349 for 60 days (see Attachment I).

8.b. Outside Consultations

NORC and JHU are consulting with a technical expert panel (TEP) to provide expertise and guidance to develop the plan and design for this program, and each phase, including the development of the CUSP for telemedicine toolkit and evaluation for which this data collection is designed. The TEP consists of individuals with knowledge and experience in telemedicine and antibiotic stewardship including knowledge of application of antibiotic stewardship in telemedicine settings. One in-person TEP meeting was held on September 12, 2023 and a second TEP meeting was held virtually in March 2024.

The TEP is providing critical feedback on all aspects of this program, including reviewing the proposed plan for the toolkit and project approach, including the participant experience assessment plan.

AHRQ has consulted with other Federal partners including the CDC and the CMS to ensure synergistic efforts are being undertaken and that there is no duplication of Federal initiatives.

9. Payments/Gifts to Respondents

No remuneration of respondents or participating practices is planned.

10. Assurance of Confidentiality

Individuals will be assured of the confidentiality of their replies under Section 944(c) of the Public Health Service Act. 42 U.S.C. 299c-3(c). That law requires that information collected for research conducted or supported by AHRQ that identifies individuals or establishments be used only for the purpose for which it was supplied.

Information that can directly identify the respondent, such as name and/or social security number will not be collected. A statement of confidentiality will appear on the online survey and contain the following statement:

The confidentiality of your responses is protected by Sections 944(c) and 308(d) of the Public Health Service Act [42 U.S.C. 299c-3(c) and 42 U.S.C. 242m(d)]. Information that could identify you will not be disclosed unless you have consented to that disclosure.

The data will be collected by AHRQ’s contractor, NORC. All practice and respondent-level data, as well as survey response data, will be stored on NORC’s secure servers.

11. Questions of a Sensitive Nature

There are no questions of a sensitive nature.

12. Estimates of Annualized Burden Hours and Costs

Exhibit 1 shows the estimated annualized burden hours for the respondents’ time to complete the structural assessment, AHRQ patient safety culture survey, participant experience survey, semi-structured qualitative interviews, and EHR data extractions (collected monthly and submitted quarterly). Data will be collected from up to 500 practices. For the two-year clearance period, the estimated annualized burden hours for the data collection activities are 4,643.

Exhibit 1. Estimated Annualized Burden Hours
Form Name	Number of Respondents*	Number of Responses per Respondent	Hours per Response	Total Burden Hours
Structural Assessment (telemedicine-only and brick-and-mortar)	188	2	12/60	75
AHRQ Medical Office Survey on Patient Safety Culture (MOSOPS) (brick-and-mortar only)	438	2	30/60	438
Participant Experience Survey (telemedicine-only and brick-and-mortar)	188	1	20/60	62
Semi-structured qualitative interviews (telemedicine-only and brick-and-mortar)	18	1	1	18
EHR data (telemedicine-only and brick-and-mortar)	225	18	1	4,050
Total				4,643

*Annualized number of respondents is based on maximum practices recruited, assuming 50% of the practices are telemedicine-only and 50% are brick-and-mortar, and 75% response rate for forms 1 and 3, 50% response rate for form 2, and 90% response rate for forms 4 and 5.

Exhibit 2 shows the estimated annualized cost burden based on the respondents’ time to complete the data collection forms. The total cost burden is estimated to be $366,163.

Exhibit 2. Estimated Annualized Cost Burden

Form Name	Number of Respondents*	Total Burden Hours	Average Hourly Wage Rate**	Total Burden Cost
Structural Assessment	188	75	$119.54^a	$8,966
AHRQ Medical Office Survey on Patient Safety Culture (MOSOPS)
Physicians	219	219	$119.54^a	$26,179
Other Health Practitioners	219	219	$34.04^b	$7,455
Participant Experience Survey	188	62	$119.54^a	$7,411
Semi-structured qualitative interviews	18	18	$119.54^a	$2,152
EHR data (Improving Antibiotic Use cohort only)	225	4,050	$76.79^c	$311,000
Total	1,056	4,643		$366,163

** Annualized number of respondents is based on maximum practices recruited, assuming 50% of the practices are telemedicine-only and 50% are brick-and-mortar, and 75% response rate for forms 1 and 3, 50% response rate for form 2, and 90% response rate for forms 4 and 5.

**National Compensation Survey: Occupational wages in the United States May 2023 “U.S. Department of Labor, Bureau of Labor Statistics:” https://www.bls.gov/oes/current/oes_stru.htm

^a Based on the mean wages for 29-1299 Physicians, All Other

^b Based on the mean wages for 29-9099 Miscellaneous Health Practitioners and Technical Workers: Healthcare Practitioners and Technical Workers, All Other

^c Based on an average of the mean wages for 29-1299 Physicians, All Other and 29-9099 Miscellaneous Health Practitioners and Technical Workers: Healthcare Practitioners and Technical Workers, All Other

13. Estimates of Annualized Respondent Capital and Maintenance Costs

Capital and maintenance costs include the purchase of equipment, computers or computer software or services, or storage facilities for records, as a result of complying with this data collection. There are no direct costs to respondents other than their time to participate in the program.

14. Estimates of Total and Annualized Cost to the Government

Exhibits 3a and 3b show the estimated annualized cost to the government for the contractors and government personnel. The cost is estimated to be $584,877 annually.

The costs associated with the data collection activities for the program include the contractor program development costs and project management costs, as well as the costs to design the data collection protocols, develop and host an online data collection platform, develop and program the online instruments, and provide technical assistance and support to practices for submission of data, data processing, and data analysis.

Exhibit 3a. Estimated Total and Annualized Cost

Cost Component	Total Cost	Annualized Cost
Planning and Development	$375,980	$107,423
Data Collection	$984,670	$281,334
Analysis	$588,834	$168,238
Project Management	$97,587	$27,882
Total	$2,047,071	$584,877

Exhibit 3b. Federal Government Personnel Cost

Activity	Federal Personnel	Annual Salary	% Time	Cost
Management Support: GS-15, Step 5 average	3	176,458	10	52,937.40
Program Management Analysis: GS-14, Step 5	2	150,016	5	15,001.60
Program Management Analysis: GS-13, Step 5 average	1	126,949	15	19,042.35
Total				86,981.35

Annual salaries based on 2023 OPM Pay Schedule for Washington/DC area:

https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2023/DCB.pdf

15. Changes in Hour Burden

As noted earlier, this revision to the current clearance materials reduces the number of responses requested for the MOSOPS by administering it only to brick-and-mortar practices in the improving antibiotic use cohort, which began in June 2024 and will end in December 2025. Because the diagnostic process cohort was cancelled, this revision also reduces the number of responses to the structural assessment, participant experience survey, MOSOPS, and semi-structured qualitative interviews, and removes the collection of clinical data for the diagnostic process cohort. The estimated annualized burden tables (Exhibit A.1 and A.2) have been adjusted accordingly.

16. Time Schedule, Publication and Analysis Plans

The draft schedule of assessment activities is contained in Attachment J which has been updated to remove the diagnostic process cohort and to include an additional three months of EHR data collected during the baseline (pre-intervention) period. This is consistent with prior AHRQ Safety Program for Improving Antibiotic Use cohorts. Baseline data will now be requested retrospectively for March 2024 through August 2024. The exact start date for data collection activities is contingent on the OMB clearance date.

AHRQ will make the final toolkit publicly available on its website. The findings from the program will be submitted for publication in academic journals.

17. Exemption for Display of Expiration Date

AHRQ does not seek this exemption.

18. List of Attachments

Attachment A: Structural Assessment_Antibiotic Use Cohort_Brick and Mortar (updated)

Attachment B: Structural Assessment_Antibiotic Use Cohort_Telemedicine Only (updated)

Attachment C: The Medical Office Survey on Patient Safety Culture (MOSOPS)

Attachment D: Participant Experience Survey_Antibiotic Use Cohort_Brick and Mortar (updated)

Attachment E: Participant Experience Survey_Antibiotic Use Cohort_Telemedicine Only (updated)

Attachment F: Draft Interview Guide for Semi-Structured Interviews_Antibiotic Use Cohort (updated)

Attachment G: Antibiotic Prescription Data Template_Antibiotic Use Cohort (updated)

Attachment H: Instructions for Antibiotic Prescription Data Template_Antibiotic Use Cohort (updated)

Attachment I: 60-Day Federal Register Notice

Attachment J: Schedule of Assessment Activities, 2022-2026 (updated)

1 Medicare Telemedicine Health Care Provider Fact Sheet. Content last reviewed March 2020. Center for Medicare & Medicaid Services. https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet.

2 Weiner JP, Bandeian S, Hatef E, Lans D, Liu A, Lemke KW. In-Person and telehealth ambulatory contacts and costs in a large US insured cohort before and during the COVID-19 pandemic. JAMA Netw Open. 2021;4(3):e212618.

3 Telehealth for Providers: What You Need to Know. Content last reviewed March 2021. Center for Medicare & Medicaid Services. https://www.cms.gov/files/document/telehealth-toolkit-providers.pdf.

4 Anderson M. Mobile technology and home broadband. Pew Research Center. 2019. https://www.pewresearch.org/internet/2019/06/13/mobile-technology-and-home-broadband-2019/.

5 Pronovost PJ, King J, Holzmueller CG, et al. A web-based tool for the comprehensive unit-based Safety Program (CUSP). Jt Comm J Qual Patient Saf 2006; 32:119-29.

6 Core CUSP Toolkit. Content last reviewed August 2019. Agency for Healthcare Research and Quality, Rockville, MD. https://www.ahrq.gov/hai/cusp/modules/index.html.

7 CDC. Antibiotic Resistance Threats in the United States, 2019. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2019.

8 Martinez KA, Rood M, Jhangiani N et al. Patterns of use and correlates of patient satisfaction with a large nationwide direct to consumer telemedicine service. J Gen Intern Med 2018; 33: 1768–73.

9 Martinez KA, Rood M, Jhangiani N et al. Association between antibiotic prescribing for respiratory tract infections and patient satisfaction in direct-to-consumer telemedicine. JAMA Intern Med 2018; 178: 1558–60.

10 Jain T, Mehrotra A. Comparison of direct-to-consumer telemedicine visits with primary care visits. JAMA Netw Open 2020; 3: e2028392.

11 Ray KN, Shi Z, Gidengil CA, Poon SJ et al. Antibiotic prescribing during pediatric direct-to-consumer telemedicine visits. Pediatrics 2019; 143: e20182491.

12 Lucy X Li, Julia E Szymczak, Sara C Keller, Antibiotic stewardship in direct-to-consumer telemedicine: translating interventions into the virtual realm. Journal of Antimicrobial Chemotherapy. 2022; 77(1): 13-15.

13 Szymczak JE, Keller SC, Linder JA. "I Never Get Better Without an Antibiotic": antibiotic appeals and how to respond. Mayo Clin Proc 2021; 96:543-6.

14 Miller BJ, Carson KA, Keller S. Educating patients on unnecessary antibiotics: personalizing potential harm aids patient understanding. J Am Board Fam Med 2020; 33:969-77.

15 Sanchez GV, Fleming-Dutra KE, Roberts RM, Hicks LA. Core elements of outpatient antibiotic stewardship. MMWR Morb Mortal Wkly Rep 2016; 65:1-12.

16 Participation Options Overview. CMS Quality Payment Program. U.S. Centers for Medicare & Medicaid Services, Baltimore, MD. https://qpp.cms.gov/mips/overview.

17 R3 Report Issue 23: Antimicrobial Stewardship in Ambulatory Health Care. Issue 23. June 20, 2019. The Joint Commission. https://www.jointcommission.org/standards/r3-report/r3-report-issue-23-antimicrobial-stewardship-in-ambulatory-health-care/.

18 Foster CB, Martinez KA, Sabella C et al. Patient satisfaction and antibiotic prescribing for respiratory infections by telemedicine. Pediatrics 2019; 144: e20190844.

19 Rastogi R, Martinez KA, Gupta N et al. Management of urinary tract infections in direct-to-consumer telemedicine. J Gen Intern Med 2020; 35: 643–8.

File Type	application/vnd.openxmlformats-officedocument.wordprocessingml.document
File Title	OMB Clearance Application
Author	hamlin-ben
File Modified	0000-00-00
File Created	2024-07-22

Supporting Statement A 0935-0265 The AHRQ Safety Program for Telemedicine - Improving Antibiotic Use