Notice2023-04220
Agency Information Collection Activities: Proposed Collection; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 2, 2023
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 the proposed 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 December 15th, 2022 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 88 Issue 41 (Thursday, March 2, 2023)</title>
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<body><pre>[Federal Register Volume 88, Number 41 (Thursday, March 2, 2023)]
[Notices]
[Pages 13119-13121]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-04220]
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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 the proposed 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 December 15th, 2022 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 April 3, 2023.
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/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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#75111a071c065b1910131e1a021c010f35343d27245b1d1d065b121a03"><span class="__cf_email__" data-cfemail="ea8e85988399c4868f8c81859d839e90aaaba2b8bbc4828299c48d859c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Proposed Project
The AHRQ Safety Program for Telemedicine: Improving the Diagnostic
Process and Improving Antibiotic Use
Telemedicine visits have increased dramatically in response to the
COVID-19 pandemic and resulting changes in third-party payer
reimbursement policies. Telemedicine visits increased from 0.3 percent
of all ambulatory visits in 2019 to 23.6 percent by Spring 2020. 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. 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 be skipped.
This program aims to improve two at-risk areas 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: (1) the diagnostic process
for breast, colorectal, and lung cancer; and (2) antibiotic stewardship
(AS). The CUSP approach improves safety culture at the practice level,
enables harm prevention, and engages providers who are on the front
lines while integrating technical and adaptive/cultural approaches to
making sustainable change.
This program constitutes the first large-scale implementation of a
quality improvement effort for the cancer diagnostic process and AS in
telemedicine. These areas were chosen given the need for clearer
guidance and evidence-based telemedicine practices for clinicians and
potential for positive impact on outcomes. This program will
incorporate CUSP strategies to improve the diagnostic process for
breast, colorectal, and lung cancer and to improve antibiotic
prescribing in telemedicine. The program goals are to:
<bullet> Identify best practices in implementing interventions to
improve the cancer diagnostic process and AS in telemedicine.
<bullet> Determine how best to adapt CUSP to enhance the cancer
diagnostic process and AS in telemedicine.
This study is being conducted by AHRQ through its contractor,
contractor, NORC at the University of Chicago (NORC) and NORC's
subcontractors, the Johns Hopkins Armstrong Institute of Patient Safety
and Quality (JHAI) and Baylor College of Medicine (Baylor), pursuant to
AHRQ's statutory authority to conduct and support research on health
care and on systems for the delivery of such care, including activities
with respect to the quality, effectiveness, efficiency,
[[Page 13120]]
appropriateness and vale of healthcare services and with respect to
quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2).
Method of Collection
To achieve the goals of the AHRQ Safety Program for Telemedicine
(``Safety Program''), primary and secondary data collection activities
will include:
(1) Structural Assessment: A brief online assessment will be
completed by a leader/champion from each practice to understand
practices' infrastructure and capacity to implement the Safety Program.
(2) AHRQ Office Readiness Survey: A brief online Office Readiness
Survey will be completed by all participating staff from each practice
in the cancer diagnostic process cohort to understand practices'
readiness for implementation of the Safety Program.
(3) The AHRQ Surveys on Patient Safety Culture: The Medical Office
Survey on Patient Safety Culture (MOSOPS) (both cohorts) and a
Diagnostic Safety Supplement (cancer diagnostic process cohort only)
will be completed by all participating staff to assess patient safety
issues, medical errors, and event reporting practices.
(4) Participant Experience Survey: A brief online assessment will
be completed by a leader/champion from each practice to assess how
practices approached implementation of the Safety Program.
(5) Semi-structured Qualitative Interviews: A proportion of
practices from both cohorts will be selected to participate in
telephone/virtual discussions to understand the facilitators and
barriers to implementing the Safety Program.
(6) Clinical Data Collection Form: Practices in the cancer
diagnostic process cohort will complete a Clinical Data Collection Form
for patients suspected of having breast, colorectal, or lung cancer.
(7) Electronic Health Record (EHR) Data: Practice-level antibiotic
usage and clinical outcomes data will be extracted from the EHRs of
practices in the AS cohort.
This data collection effort will be part of a comprehensive
evaluation strategy to assess the adoption of the Safety Program among
telemedicine practices comprising the cancer diagnostic process and AS
cohorts; 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 in the AS cohort and drivers of timely
follow-up for patients suspected of having breast, colorectal, or
prostate cancer among practices in the cancer diagnostic process
cohort.
The evaluation is largely 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.
Estimated Annual Respondent Burden
Exhibit A.1 shows the estimated annualized burden hours for the
respondents' time to complete the structural assessments, AHRQ office
readiness and patient safety culture surveys, participant experience
surveys, semi-structured qualitative interviews, clinical data
collection instrument (collected for 3 patients monthly and submitted
quarterly), and EHR data extractions (collected monthly and submitted
quarterly). Data will be collected from up to 300 practices providing
telemedicine for the cancer diagnostic process cohort and from up to
500 practices providing telemedicine for the AS cohort. For the three-
year clearance period, the estimated annualized burden hours for the
data collection activities are 5,570.
Exhibit A.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 Assessments (both cohorts)....... 200 2 0.2 80
2. AHRQ Office Readiness Survey (cancer 350 1 0.1 35
diagnostic process cohort only)...............
3. AHRQ Patient Safety Culture Surveys:
a. MOSOPS (both cohorts)................... 933 2 0.5 933
b. Diagnostic Safety Supplement (cancer 350 2 0.2 140
diagnostic process cohort only)...........
4. Participant Experience Survey (both
cohorts):
a. Cancer diagnostic process cohort survey. 75 1 0.17 13
b. AS cohort survey........................ 125 1 0.33 41
5. Semi-structured qualitative interviews (both 24 1 1 24
cohorts)......................................
6. Clinical Data Collection Form (cancer 90 54 0.33 1,604
diagnostic process cohort)....................
7. EHR data (AS cohort)........................ 150 18 1 2,700
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Total...................................... ............... .............. .............. 5,570
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* Annualized number of respondents is based on maximum practices recruited and 75% response rate for forms 1 and
4a and 4b, 50% response rate for forms 2, 3a and 3b, and 90% response rate for forms 5-7.
Exhibit A.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 $576,922.
Exhibit A.2--Estimated Annualized Cost Burden
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Average
Form name Number of Total burden hourly wage Total burden
respondents * hours rate ** cost
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1. Structural Assessments (both cohorts)....... 200 80 a $111.30 $8,904
[[Page 13121]]
2. AHRQ Office Readiness Survey (cancer 350 35 a 111.30 3,896
diagnostic process cohort only)...............
3. AHRQ Patient Safety Culture Surveys:
a. MOSOPS (both cohorts):
i. Physicians.......................... 466 466 a 111.30 51,866
ii. Other Health Practitioners......... 467 467 b 31.19 14,566
b. Diagnostic Safety Supplement (cancer
diagnostic process cohort only):
i. Physicians.......................... 175 70 a 111.30 7,791
ii. Other Health Practitioners......... 175 70 b 31.19 2,183
4. Participant Experience Survey (both cohorts) 200 54 a 111.30 6,010
5. Semi-structured qualitative interviews (both 24 24 a 111.30 2,671
cohorts)......................................
6. Clinical Data Collection Form (cancer 90 1,604 a 111.30 178,525
diagnostic process cohort only)...............
7. EHR data (AS cohort only)................... 150 2,700 a 111.30 300,510
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Total...................................... 3,497 5,917 .............. 576,922
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** Annualized number of respondents is based on maximum practices recruited and 75% response rate for forms 1
and 4, 50% response rate for forms 2, 3a and 3b, and 90% response rate for forms 5-7.
** National Compensation Survey: Occupational wages in the United States May 2021 ``U.S. Department of Labor,
Bureau of Labor Statistics'': <a href="https://www.bls.gov/oes/current/oes_stru.htm#29-0000">https://www.bls.gov/oes/current/oes_stru.htm#29-0000</a>.
\a\ Based on the mean wages for 29-1069 Physicians and Surgeons, All Other.
\b\ Based on the mean wages for 29-9099 Miscellaneous Health 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: February 23, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-04220 Filed 3-1-23; 8:45 am]
BILLING CODE 4160-90-P
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