[Federal Register Volume 89, Number 133 (Thursday, July 11, 2024)]
[Notices]
[Pages 56875-56878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15250]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

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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

[[Page 56876]]

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 
[email protected].

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

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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 1--Estimated Annualized Burden Hours
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                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                   respondents *    respondent       response          hours
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1. Structural Assessment........................             188               2           12/60              75
2. MOSOPS (brick-and-mortar only)...............             438               2           30/60             438
3. Participant Experience Survey................             188               1           20/60              63
4. Semi-structured interviews...................              18               1               1              18
5. Antibiotic Prescription Data Template........             225              18               1           4,050
                                                 ---------------------------------------------------------------
    Total.......................................           1,057              na              na           4,644
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* 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.

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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                                   Total burden   Average hourly   Total burden
                            Form name                                  hours       wage rate **        cost
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1. Structural Assessment........................................              75     \a\ $119.54          $8,966
2. AHRQ Medical Office Survey on Patient Safety Culture MOSOPS
 (brick-and-mortar only)........................................
    a. Physicians...............................................             219      \a\ 119.54          26,179
    b. Other Health Practitioners...............................             219       \b\ 34.04           7,455
3. Participant Experience Survey................................              63      \a\ 119.54           7,115
4. Semi-structured qualitative interviews.......................              18      \a\ 119.54           2,152
5. Antibiotic Prescription Data Template........................           4,050       \c\ 76.79         311,000
                                                                 -----------------------------------------------
    Total.......................................................           4,644  ..............         366,163
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** 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 29-1229 Physicians and Surgeons, All Other.
\b\ Based on the mean wages for 29-9099 Other Healthcare Practitioners and Technical Occupations: Healthcare
  Practitioners and Technical Workers, All Other.
\c\ Based on an average of the mean wages for 29-1229 Physicians and Surgeons, All Other and 29-9099 Other
  Healthcare Practitioners and Technical Workers: Healthcare Practitioners and Technical Workers, All Other.

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.

    Dated: July 8, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-15250 Filed 7-10-24; 8:45 am]
BILLING CODE 4160-90-P