Agency Information Collection Activities: Proposed Collection; Comment Request

AGENCY:

Agency for Healthcare Research and Quality, HHS.

ACTION:

Notice.

SUMMARY:

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve a revision of the currently approved information collection project: “The AHRQ Safety Program for Telemedicine: Improving the Diagnostic Process and Improving Antibiotic Use.”

This proposed information collection was previously published in the Federal Register on April 29th, 2024 and allowed 60 days for public comment. AHRQ received no substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.

DATES:

Comments on this notice must be received by August 12, 2024.

ADDRESSES:

Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT:

Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at REPORTSCLEARANCEOFFICER@ahrq.hhs.gov.

SUPPLEMENTARY INFORMATION:

Proposed Project

AHRQ Safety Program for Telemedicine: Improving Antibiotic Use

This Information Collection Request (ICR) is for a revision to the AHRQ Safety Program for Telemedicine: Improving the Diagnostic Process and Improving Antibiotic Use. These changes include the removal of the Diagnostic Process Cohort, updates to the Improving Antibiotic Use Data Collection Tools and changing the name of the project to the “AHRQ Safety Program for Telemedicine: Improving Antibiotic Use.” The OMB control number for the AHRQ Safety Program for Telemedicine is 0935-0265 and will expire on April 30, 2026. Supporting documents can be downloaded from OMB's website at: https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202303-0935-001. AHRQ is requesting a new expiration date, three years from approval.

Since the project received OMB approval, there have been two developments that require changes to the project's goals and design. First, the Improving the Diagnostic Process Cohort was canceled because there was insufficient recruitment. Second, the materials approved by OMB for the Improving Antibiotic Use Cohort 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 AHRQ's Technical Expert Panel (TEP) and potential participants, it was learned that the 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. Based on this information AHRQ decided to create separate data collection tools, one for providers in a brick-and-mortar setting, and one for providers in telemedicine only. Practices and providers receive information about the program from newsletters, listservs, and direct outreach through public and private organizations. They attend an information webinar and may join the program if interested and eligible.

As in the currently approved design, the program will incorporate CUSP strategies to improve antibiotic prescribing in telemedicine. The new 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.

To achieve these goals the following data collections will be implemented:

1. Structural Assessment Antibiotic Use Cohort —There will be two versions of the Structural Assessment, one for providers in a brick-and-mortar setting, and one for providers in telemedicine only. Both versions ask the same questions but vary slightly in how they refer to the practice. The assessment asks about the practice's characteristics, experience related to antibiotic stewardship activities, and any existing supports the practice may have in place that are intended to improve antibiotic prescribing. The 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 results will be used to assess changes in the practice's infrastructure and capacity to implement the Safety Program over time. The data will provide information about 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.

2. Medical Office Survey on Patient Safety Culture (MOSOPS): As currently approved, the Safety Program for Telemedicine included completion of the MOSOPS by all participating staff across all participating practices. In this revision, AHRQ will administer 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. 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.

3. Participant Experience Survey Antibiotic Use Cohort —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. The survey will be administered to the clinical leader/champion at each practice at the end of the program (post-intervention). The survey will assess how participants approached implementation of the Safety Program.

4. Semi-Structured Interviews Antibiotic Use Cohort —A proportion of practices from both brick-and-mortar practices and telemedicine-only organizations will be selected to participate in telephone/virtual discussions to understand the facilitators and barriers to implementing the Safety Program. This interview guide includes four core domains that are intended to capture characteristics of health care providers (physicians, nurse practitioners, and physician assistants) and their perception of the AHRQ Safety Program for Telemedicine: Improving Antibiotic Use (“the Safety Program”) on pre- and post-implementation changes. All interviews will occur at the end of the intervention period.

5. Antibiotic Prescription Data Template Antibiotic Use Cohort —Each month starting at baseline (pre-intervention) until the end of the intervention, each participating practice will extract antibiotic prescribing data from their electronic health record (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. Participating practices will submit two key types of data related to antibiotic prescribing: (1) Total antibiotic prescriptions per 100 respiratory tract infection telemedicine visits and (2) Antibiotic prescriptions per 100 antibiotic-inappropriate respiratory tract infection telemedicine visits. This data will be an important way for the practice to monitor its prescribing practices throughout the course of the program and will be used by the assessment team to monitor and describe prescribing trends across practices enrolled in the program.

This study is being conducted by AHRQ through its contractor, NORC at the University of Chicago and Johns Hopkins Medicine, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of healthcare services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2).

Method of Collection

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.

Estimated Annual Respondent Burden

Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in this project.

1. Structural Assessment Antibiotic Use Cohort—The assessment will be administered twice to the Safety Program leader/champion at each participating brick-and-mortar practice or telemedicine-only organization, once at baseline (pre-intervention) and again at the end of the intervention. AHRQ expects 188 respondents at each administration. The Assessment requires 12 minutes to complete.

2. Medical Office Survey on Patient Safety (MOSOPS)—The MOSOPS will be completed by all participating staff at brick-and-mortar practices to assess patient safety issues, medical errors, and event reporting practices. The survey will be completed twice, once 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 survey will be completed by 438 staff members at each administration and requires 30 minutes to complete.

3. Participant Experience Survey Antibiotic Use Cohort—The Participant Experience Survey will be administered once to the Safety Program leader/champion 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 survey is estimated to require 20 minutes to complete.

4. Semi-Structured Interviews Antibiotic Use Cohort—Semi-structured interviews will be conducted at the end of the intervention among clinical and professional support staff from a sample of practices to collect qualitative information on the implementation of the program. Interviews will be conducted with 18 participating practices/organizations and requires one hour to complete.

5. Antibiotic Prescription Data Template Antibiotic Use Cohort—The Antibiotic Prescription Data Template will be completed 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. The data will be extracted from the practice/organization's electronic health records, by a staff member, and entered into the data template. AHRQ expects 225 practices/organizations to extract data monthly for 18 months. Each monthly data extraction should require one hour of a staff members time.

The total burden for the respondents' time to participate in this research is estimated to be 4,644 hours.

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.

Request for Comments

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, comments on AHRQ's information collection are requested with regard to any of the following: (a) whether the proposed collection of information is necessary for the proper performance of AHRQ's health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.