The Agency for Healthcare Research and
Quality (AHRQ) requests to revise and extend the currently approved
AHRQ Safety Program for Improving Antibiotic Use. The AHRQ Safety
Program for Improving Antibiotic Use aims to help facilities
implement antibiotic stewardship programs and to reduce unnecessary
antibiotic prescribing. The Safety Program has already been
implemented in a pilot of integrated delivery systems and a
national cohort of 400 acute care hospitals, and is currently being
implemented in a national cohort of 500 long-term care facilities.
The AHRQ Safety Program for Improving Antibiotic Use was last
approved by OMB on September 25, 2017 and will expire on September
30, 2020. The request for extension is to allow for completion of
activities and data collection in the AHRQ Safety Program, which
are scheduled to occur through March 30, 2021. The OMB control
number for the AHRQ Safety Program for Improving Antibiotic Use is
0935-0238. All of the supporting documents for the current AHRQ
Safety Program for Improving Antibiotic Use can be downloaded from
OMB’s website at https://omb.report/icr/201707-0935-003 The 2017
AHRQ Safety Program for Improving Antibiotic Use OMB clearance
included one response for the Structural Assessment and the Medical
Office Survey on Patient Safety Culture (MOSOPS) but did not
include electronic health record (EHR) data or a second response
for the Structural Assessment or MOSOPS. This was because our OMB
clearance expiration date fell in the middle of the planned 4th
cohort, set in ambulatory care settings, so the second Structural
Assessment and MOSOPS were not within the timeframe, and EHR data
collection would have been incomplete. In addition, we were not
certain that the ambulatory care practices would be able to access
EHR data, however based on the experience of the pilot cohort, we
believe that many ambulatory practices can access this data, and
that these practices are more likely to feasibly participate in the
AHRQ Safety Program. The revision also updates the estimated annual
burden accordingly, and includes changes to the data collection
forms which will be used for the ambulatory care cohort based on
lessons learned during the pilot cohort. Antibiotics can have
serious adverse effects including Clostridium difficile infections
(CDI), organ dysfunction, allergic reactions, and the development
of antibiotic resistance on both a patient level and population
level. This project will assist acute care, long-term care and
ambulatory care settings across the United States in adopting and
implementing antibiotic stewardship programs, which are coordinated
efforts to improve the use of antibiotics by promoting the
selection of the optimal antibiotic regimen, dose, route of
administration, and duration of therapy. More specifically, this
project has the following goals: • Identify best practices in the
delivery of antibiotic stewardship in the acute care, long-term
care and ambulatory care settings • Adapt the Comprehensive
Unit-Based Safety Program (CUSP) model to enhance antibiotic
stewardship efforts in the health care settings • Assess the
adoption of CUSP for antibiotic stewardship and evaluate the
effectiveness of the intervention in the participating health care
systems • Develop a bundle of technical and adaptive interventions
and associated tools and educational materials designed to support
enhanced antibiotic stewardship efforts • Provide technical
assistance and training to health care organizations nationwide,
using a phased approach, to implement effective antibiotic
stewardship programs and interventions • Improve communication and
teamwork between health care workers surrounding antibiotic
decision-making • Improve communication between health care workers
and patients/families surrounding antibiotic
decision-making
US Code:
42
USC 299 Name of Law: Healthcare Research and Quality Act of
1999
This revision to the current
clearance adds the monthly HER data collection and endline data
collection activities for the ambulatory care cohort, which are
scheduled to begin in December 2019 and end in January 2021. The
estimated annual burden has been adjusted accordingly.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Form Attachment M Monthly template for ambulatory care EHR data extracts (updated
Attachment Q Ambulatory TEP Members.docx
Monthly template for ambulatory care EHR data extracts (updated