The AHRQ Safety Program for Improving Antibiotic Use

ICR 201906-0935-002

OMB: 0935-0238

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
New
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Supplementary Document
2019-06-07
Supporting Statement A
2019-06-26
Supporting Statement B
2017-07-27
Supplementary Document
2017-07-27
Supplementary Document
2017-07-27
ICR Details
0935-0238 201906-0935-002
Active 201707-0935-003
HHS/AHRQ
The AHRQ Safety Program for Improving Antibiotic Use
Revision of a currently approved collection   No
Regular
Approved with change 08/30/2019
Retrieve Notice of Action (NOA) 06/26/2019
  Inventory as of this Action Requested Previously Approved
08/31/2022 36 Months From Approved 09/30/2020
63,211 0 56,372
27,064 0 22,442
0 0 0

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
  
None

Not associated with rulemaking

  84 FR 12251 04/01/2019
84 FR 27123 06/11/2019
No

11
IC Title Form No. Form Name
Monthly template for ambulatory care EHR data extracts (updated Attachment M Attachment M: Monthly template for ambulatory care EHR data extracts (updated)
Structural Assessments – Cohort 4 (baseline) b1. Structural Assessments – Cohort 4 (baseline) Attachment B Structural Assessment for Ambulatory Care Setting
AHRQ Patient Safety Culture Surveys:HSOPS, NHSOPS, MOSOPS (Cohort 1) 3a2, 3a3, 3a Attachment G: The Nursing Home Survey on Patient Safety Culture (NHSOPS) ,   Attachment H: The Medical Office Survey on Patient Safety Culture (MOSOPS) ,   Attachment F: The Hospital Survey on Patient Safety Culture (HSOPS)
The AHRQ Safety Program for Improving Antibiotic Use b. HSOPS (Cohort 2) 3b Attachment F: The Hospital Survey on Patient Safety Culture (HSOPS)
EHR data (Cohorts 1, 2, and 3)
Semi-structured qualitative interviews (Cohort 1): Other Health Practitioners 4 - b Attachment J: Draft Interview Guide for Semi-Structured Interviews – Frontline workers
Structural Assessments – Cohorts 1, 2 and 3 (baseline, post-intervention) a1 Structural Assessments – Cohorts 1, 2 and 3, a3 Structural Assessments – Cohorts 1, 2 and 3 , a2 Structural Assessments – Cohorts 1, 2 and 3 Attachment C: Structural Assessment for Long Term Care Setting ,   a2 Structural Assessments – Cohorts 1, 2 and 3 ,   Attachment A: Structural Assessment for Acute Care Setting
Semi-structured qualitative interviews (Cohort 1): Physicians 4 - I Attachment I: Draft Interview Guide for Semi-Structured Interviews – Antibiotic
3. AHRQ Patient Safety Culture Surveys:d. MOSOPS (Cohort 4) 3d Attachment H: The Medical Office Survey on Patient Safety Culture (MOSOPS)
Team Antibiotic Review Form (Cohorts 1, 2, and 3) E, D Attachment E: Completion Guide for Team Antibiotic Review Form ,   Attachment D: Team Antibiotic Review Form
3. AHRQ Patient Safety Culture Surveys:c. NHSOPS (Cohort 3) 3c Attachment G: The Nursing Home Survey on Patient Safety Culture (NHSOPS)

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 63,211 56,372 0 6,839 0 0
Annual Time Burden (Hours) 27,064 22,442 0 4,622 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
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.

$1,887,609
No
    Yes
    No
No
No
No
Uncollected
Erwin Brown 301 427-1652 erwin.brown@ahrq.hhs.gov

  No

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.
06/26/2019


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