Notice2024-15250
Agency Information Collection Activities: Proposed Collection; Comment Request
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Published
July 11, 2024
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 133 (Thursday, July 11, 2024)</title>
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[Federal Register Volume 89, Number 133 (Thursday, July 11, 2024)]
[Notices]
[Pages 56875-56878]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/">www.reginfo.gov/public/do/</a> 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
<a href="/cdn-cgi/l/email-protection#de8c9b8e918c8a8d9d929b9f8c9f909d9b919898979d9b8c9ebfb6acaff0b6b6adf0b9b1a8"><span class="__cf_email__" data-cfemail="6e3c2b3e213c3a3d2d222b2f3c2f202d2b212828272d2b3c2e0f061c1f4006061d40090118">[email protected]</span></a>.
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: <a href="https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202303-0935-001">https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202303-0935-001</a>. 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:
<bullet> Identify best practices in implementing interventions to
improve antibiotic use in telemedicine.
<bullet> Determine how best to adapt CUSP to enhance antibiotic use
in telemedicine.
<bullet> Use a CUSP approach to design and implement the
interventions for improving antibiotic use across telemedicine
practices.
<bullet> 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
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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
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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:'' <a href="https://www.bls.gov/oes/current/oes_stru.htm">https://www.bls.gov/oes/current/oes_stru.htm</a>.
\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
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