[Federal Register Volume 85, Number 224 (Thursday, November 19, 2020)]
[Notices]
[Pages 73716-73718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25574]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-21-21AT; Docket No. CDC-2020-0114]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled Evaluation of Venous
Thromboembolism Prevention Practices in U.S. Hospitals. This proposed
study is designed to support a framework for improving hospital venous
thromboembolism (VTE) prevention practices through the evaluation of
current VTE prevention practices in U.S. adult general medical and
surgical hospitals.
DATES: CDC must receive written comments on or before January 19, 2021.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0114 by any of the following methods:
[ballot] Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
[ballot] Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (regulations.gov) or by U.S. mail to the address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7118; Email:
[email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information,
[[Page 73717]]
including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected; and
4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submissions of responses.
5. Assess information collection costs.
Proposed Project
Evaluation of Venous Thromboembolism Prevention Practices in U.S.
Hospitals--New--National Center on Birth Defects and Developmental
Disabilities (NCBDDD), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
Venous thromboembolism (VTE), which includes deep vein thrombosis
(DVT) and pulmonary embolism (PE), is an important and growing public
health problem. Each year in the U.S., it is estimated that VTE affects
as many as 900,000 people, is responsible for up to 100,000 deaths, and
is associated with healthcare costs of approximately $10 billion.
Recurrence after a VTE is common, and complications include post-
thrombotic syndrome and chronic thromboembolic pulmonary hypertension.
Over half of VTE events are associated with recent hospitalization or
surgery and most occur after discharge. An analysis of the National
Hospital Discharge Survey from 2007 to 2009 estimated that almost
550,000 U.S. adult hospitalizations had a discharge diagnosis of VTE
each year. Hospital-associated VTE (HA-VTE) is often preventable but
VTE prevention strategies are not applied uniformly or systematically
across U.S. hospitals and healthcare systems.
The Agency for Healthcare Research and Quality (AHRQ) published a
guide for preventing HA-VTE in 2016. The framework for improving VTE
prevention in hospitalized patients includes a hospital VTE prevention
policy, an interdisciplinary VTE team, standardization of VTE
prevention processes, monitoring of processes and outcomes, and VTE
prevention education for providers and patients. A VTE prevention
protocol includes VTE risk assessment, bleeding risk assessment (risk
of bleeding with anticoagulant prophylaxis) and clinical decision
support for appropriate prophylaxis (i.e., ambulation, anticoagulant
prophylaxis, and/or mechanical prophylaxis) based on both VTE and
bleeding risk assessments.
Despite evidence-based guidelines for VTE prophylaxis in at-risk
hospitalized patients, there is systemic underuse of appropriate VTE
prophylaxis. As many as 70% of HA-VTE events are potentially
preventable but less than half of hospitalized patients receive
appropriate VTE prophylaxis. An implementation gap exists between
evidence-based guidelines for VTE prophylaxis in hospitalized adult
patients and implementation of those guidelines in real-world hospital
settings. The 2008 Surgeon General's Call to Action to Prevent DVT and
PE included instituting formal systems related to risk assessment and
the provision of prophylaxis to high-risk hospitalized patients. For
World Thrombosis Day in 2016, the International Society on Thrombosis
and Haemostasis (ISTH) issued a call to clinical leaders, hospitals,
and payers to work together to make VTE risk assessment for all
hospitalized patients a priority.
In England, The National Venous Thromboembolism Prevention
Programme was launched in 2010 with the goal of reducing preventable
HA-VTE morbidity and mortality (Roberts, 2017). VTE risk assessment was
mandated for all adult patients on admission to an acute hospital
utilizing a previously developed national VTE risk assessment tool/
model. Hospitals were required to report VTE risk assessment rates,
with a financial incentive applied to achieve a target of 90%. This
resulted in an impressive, sustained increase in VTE risk assessment
rates with a corresponding increase in anticoagulant prophylaxis. There
was evidence of significant reductions in HA-VTE and associated
mortality following implementation of this program.
Unlike England, the U.S. has no national VTE prevention program
with hospital risk assessment rates tied to financial incentives and no
national VTE risk assessment tool/model. Various VTE risk assessment
models (RAMs) have been developed and published to identify
hospitalized patients whose risk for VTE is high enough to offset the
risk of bleeding with anticoagulant prophylaxis. However, there is no
standardized RAM currently in use across U.S. hospitals and healthcare
systems. Implementation of risk assessment varies in terms of the
patient population (e.g., medical vs. surgical), time frames (e.g., on
admission, on transfer to another unit), method of administration
(i.e., electronic vs. paper), person/s performing the risk assessment
(e.g., physician, nurse, pharmacist), type of RAM (e.g., quantitative
vs. qualitative), and linkage to a clinical decision support tool for
appropriate VTE prophylaxis.
An evaluation of the extent to which U.S. hospitals utilize VTE
risk assessment is needed to better understand the landscape around VTE
prevention practices in real-world hospital settings in order to guide
efforts and inform interventions to reduce the burden of HA-VTE. CDC is
funding The Joint Commission to evaluate VTE prevention practices in
U.S. hospitals. The Joint Commission has had a role in patient safety
through standards and performance measurement. It is the measure
steward for two electronic clinical quality measures (eCQMs) on VTE
prevention available for Center for Medicare and Medicaid Services
Inpatient Quality Reporting and Joint Commission hospital accreditation
since 2016. However, these two VTE prevention eCQMs only address the
initiation of VTE prophylaxis within a specified timeframe; they do not
assess the patient's level of VTE risk or the appropriateness of
prophylaxis.
For this project, The Joint Commission, in collaboration with CDC,
developed a survey on hospital VTE prevention practices. The survey was
piloted in nine hospitals and their feedback was used to improve the
survey. After OMB approval, the survey will be implemented by The Joint
Commission as a one-time data collection in a nationally representative
sample of U.S. adult general medical and surgical hospitals. No
individual-level data will be collected. CDC will not receive any
individual or hospital identifiable information.
The overall purpose of this project is to evaluate current VTE
prevention practices in a nationally representative sample of U.S.
hospitals (American Hospital Association adult general medical and
surgical hospital service category) in order to support a framework for
HA-VTE prevention. The information collected in this hospital survey
will be used to improve understanding of hospital VTE prevention
practices, which will guide efforts and inform interventions to reduce
the burden of HA-VTE. Specifically, the information collected on
hospital VTE prevention policy and protocol, VTE prevention team, VTE
data collection and reporting, VTE risk assessment, VTE prophylaxis
safety considerations (i.e., bleeding risk assessment), ambulation
protocol, VTE prevention education for providers and
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patients, and VTE prophylaxis monitoring and support will be used to
assess the extent to which hospitals apply these components of the
framework for HA-VTE prevention. The responses to specific VTE
prevention practices can be used to assess VTE prevention practices by
hospital characteristics (e.g., bed size, urban vs. rural location,
teaching vs. non-teaching status) to better target efforts or
interventions to improve HA-VTE prevention. Information collected on
the barriers to establishing a hospital-wide VTE prevention policy will
be helpful in addressing these challenges. Information will be
collected on both adult general medical and surgical units since VTE
prevention practices differ by specialty. Information on VTE risk
assessment (e.g., who conducts the assessment, when is it performed,
mandatory or optional, format, type of RAM) will improve understanding
of real-world hospital VTE risk assessment practices. Information on
the capacity of hospitals to collect data on VTE risk assessment will
be helpful in determining the feasibility of VTE risk assessment as a
VTE prevention performance measure. The data collected can also serve
as a baseline for evaluation of future HA-VTE prevention initiatives.
Estimated Annualized Burden Hours
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Average
Number of Number burden per Total burden
Type of respondents Form name respondents responses per response (in hours
respondent hours)
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The Director of Patient Safety Recruitment 384 1 15/60 96
and Quality, the Chairperson material:
of the Patient Safety Implementation
Committee, other quality email and
improvement professional. project
information
sheet.
The Director of Patient Safety Evaluation of 384 1 1 384
and Quality, the Chairperson Venous
of the Patient Safety Thromboembolism
Committee, other quality Prevention
improvement professional. Practices in
U.S. Hospitals
Questionnaire.
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Total..................... ................ .............. .............. .............. 480
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2020-25574 Filed 11-18-20; 8:45 am]
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