[Federal Register Volume 85, Number 188 (Monday, September 28, 2020)]
[Notices]
[Pages 60787-60790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21295]


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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 ``AHRQ Safety Program for Improving Surgical Care and 
Recovery.'' This proposed information collection was previously 
published in the Federal Register on July 28th, 2020 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 30 days after date of 
publication.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email at 
[email protected].

SUPPLEMENTARY INFORMATION:

[[Page 60788]]

Proposed Project

AHRQ Safety Program for Improving Surgical Care and Recovery

    This is a quality improvement project that aims to provide 
technical assistance to hospitals to help them implement evidence-based 
practices to improve outcomes and prevent complications among patients 
who undergo surgery. Enhanced recovery pathways are a constellation of 
preoperative, intraoperative, and postoperative practices that decrease 
complications and accelerate recovery. A number of studies and meta-
analyses have demonstrated successful results. In order to facilitate 
broader adoption of these evidence-based practices among U.S. 
hospitals, this AHRQ project will adapt the Comprehensive Unit-based 
Safety Program (CUSP), which has been demonstrated to be an effective 
approach to reducing other patient harms, to enhanced recovery of 
surgical patients. The approach uses a combination of clinical and 
cultural (i.e., technical and adaptive) intervention components. The 
adaptive elements include promoting leadership and frontline staff 
engagement, close teamwork among surgeons, anesthesia providers, and 
nurses, as well as enhancing patient communication and engagement. 
Interested hospitals will voluntarily participate.
    This project has the following goals:
     Improve outcomes of surgical patients by disseminating and 
supporting implementation of evidence-based enhanced recovery practices 
within the CUSP framework.
     Develop a bundle of technical and adaptive interventions 
and associated tools and educational materials to support 
implementation.
     Provide technical assistance and training to hospitals for 
implementing enhanced recovery practices.
     Assess the adoption and evaluate the effectiveness of the 
intervention among the participating hospitals.
    This project is being conducted by AHRQ through its contractor, 
Johns Hopkins Armstrong Institute for Patient Safety and Quality (JHU), 
with subcontractors, University of California, San Francisco, American 
College of Surgeons (ACS) and Westat, 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 achieve the goals of this project the following data collections 
will be implemented:
    Safety culture survey. The project team will assess changes in 
perioperative safety culture in hospitals since the inception of the 
program by requesting that hospitals ask their staff to complete the 
safety culture survey at the beginning of the program. Hospitals 
receive their survey results and then debrief their staff on their 
safety culture and identify opportunities for further improvement. JHU 
will provide technical assistance for this effort. Participating 
hospitals will promote awareness of the survey among their staff, 
coordinate implementation of the survey, encourage staff to complete 
the survey and provide staff time to do so, and organize their local 
debrief of the reports of their hospital's results. JHU will assist 
this effort by providing an electronic portal for hospital staff to 
anonymously submit the survey, and by analyzing the data and sending a 
report to the hospital. Data will also be analyzed in aggregate across 
all participating hospitals to evaluate the impact of the overall 
quality improvement effort on measured safety culture.
    Patient experience survey. Hospitals will also assess the impact of 
participation in the project on the patient's experience with care. 
AHRQ intends to assist hospitals in assessing patient experience by 
adapting the CAHPS[supreg] (Consumer Assessment of Healthcare Providers 
and Systems) Outpatient and Ambulatory Surgery Survey for use in a 
hospital setting and adding in selected questions adapted from other 
surveys, including Hospital CAHPS, the CAHPS Surgical Survey, and 
PROMIS (Patient Reported Outcomes Measurement Information System). The 
approach minimizes burden on the hospitals but will yield important 
information that will then be used to further drive improvements in the 
patient's experience with the healthcare system.
    A pre-implementation assessment of patient experience will be done 
with patients before the project is implemented at the hospital. A 
post-implementation assessment of patient experience will be done after 
the project is implemented, surveying patients that were treated on the 
enhanced recovery pathway at participating hospitals.
    The survey will be administered by Westat. Hospitals will provide 
patient contact information to the project team after execution of a 
data use agreement. This information will be provided to Westat to send 
the survey to patients on behalf of the hospital. Westat will provide a 
summative report to each hospital with the hospital's results to 
promote additional local quality improvement work.
    While the primary purpose of both surveys is the hospital's quality 
improvement purpose, the data will also be analyzed in aggregate across 
all participating hospitals to evaluate the impact of the overall 
quality improvement effort.
    Readiness and Implementation Assessments: Semi-structured 
qualitative interviews. Semi-structured qualitative interviews will be 
conducted with key stakeholders at participating hospitals (e.g., 
project leads, physician project champions, etc.). These include a 
readiness assessment conducted after a hospital's enrollment in the 
project and an implementation assessment conducted after a period of 
implementation. The readiness assessment will help identify which, if 
any, technical components of the enhanced surgical care and recovery 
intervention already exist at the hospital, project management and 
resources, clinician engagement, leadership engagement and potential 
barriers and facilitators to implementation. The implementation 
assessment will evaluate what elements of the enhanced recovery 
practices have been adopted, resources invested, team participation, 
major barriers (e.g., medications, equipment, trained personnel), and 
leadership participation. These assessments will help identify training 
needs of hospitals and inform the JHU team's approach. In addition, the 
results will inform the JHU team's understanding of local adaptations 
of the intervention and the degree to which intervention fidelity 
impacts changes in outcomes.
    Site visits. Semi-structured site visits will be conducted at a 
subset of participating hospitals. Sites will be selected using the 
following criteria: (1) Active participation (2) geographic location; 
and (3) willingness to host the research team. Findings will help 
inform the JHU's project implementation strategy. Information from 
these visits will be critical in understanding if and how team and/or 
leadership issues may affect implementation of enhanced recovery 
practices, including how this may differ across surgical service lines. 
Interviews will help uncover misalignments in role clarity, needed time 
and resources, best practices, and potential enablers of and barriers 
to enhanced surgical care and recovery implementation. Site visits will 
be conducted at approximately 4

[[Page 60789]]

hospitals per year, and each will be 1 day long. The types of hospital 
personnel anticipated to be involved in part or all of the site visit 
include senior leadership, perioperative leadership, and patient safety 
and quality staff. Participating hospitals will receive a structured 
debriefing and brief summary report at the end of the one-day visit.

Estimated Annual Respondent Burden

Safety Culture Survey

    A pre-implementation safety culture survey will be administered as 
a web-based survey to nurses, physicians and other clinical staff 
participating in the project. Based on the experience with response 
rates from the base period of the project and Cohort 1, and the 
approximately 200 new hospitals that will join the project in Cohort 4, 
we anticipate approximately 50 responses each from 20 hospitals, or 
1,000 total responses from hospital staff. Based on earlier experience 
we expect that approximately 50 percent of responses will be from 
physicians and surgeons, and 50 percent will be from nurses.

Patient Experience Survey

    During this period, a post-implementation patient experience survey 
will be administered by mail to patients discharged from the hospital 
in the surgical specialties included in the project. Assuming an 
average of 86 patients being surveyed per hospital, about 3,268 
patients would be surveyed. With a 30% response rate, the patient 
experience survey will be completed by about 980 patients. This survey 
requires about 22 minutes to complete.

Readiness and Implementation Assessments

    A pre-and post-assessment will be administered as a semi-structured 
interview with the hospital project leads (e.g., one physician, one 
nurse). Assuming an average of 2 staff being part of each pre- and 
post-interview per hospital, about 760 staff would be surveyed during 
this period. With a 90% response rate, the readiness and implementation 
assessment will be completed by about 684 staff. This survey requires 
60 minutes to complete.

Site Visits

    Six site visits will be conducted during this period. Assuming an 
average of 3 staff being a part of each site visit, about 18 staff 
would take part in the site visits that will take 4 hours to complete.
    Exhibit 1 shows estimated annualized burden hours, and Exhibit 2 
shows the estimated annualized cost burden associated with the 
respondents' time to participate in this project. The total cost burden 
is estimated to be $96,530 annually.

                                  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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Safety culture survey...........................           1,000               1             .25             250
Patient experience survey.......................             980               1            0.37             363
Readiness and Implementation assessment.........             684               1               1             684
Site visits.....................................              18               1               4              72
                                                 ---------------------------------------------------------------
    Total.......................................           2,681             N/A             N/A           1,368
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
Safety culture survey...........................             500             125     \a\ $121.17         $15,146
Safety culture survey...........................             500             125       \b\ 37.24           4,655
Patient experience survey.......................             980             363       \d\ 27.54           9,997
Readiness and Implementation assessment.........             342             342      \a\ 121.17          41,440
Readiness and Implementation assessment.........             342             342       \c\ 55.37          18,937
Site visits.....................................               9              36      \a\ 121.17           4,362
Site Visits.....................................               9              36       \c\ 55.37           1,993
                                                 ---------------------------------------------------------------
    Total.......................................           2,682           1,368             N/A          96,530
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National Compensation Survey: Occupational wages in the United States May 2019 ``U.S. Department of Labor,
  Bureau of Labor Statistics:'' http://www.bls.gov/oes/current/oes_stru.htm.
\a\ Based on the mean wages for 29-1240 Physicians and Surgeons.
\b\ Based on the mean wages for 29-1141 Registered Nurse.
\c\ Based on the mean wages for 11-9111 Medical and Health Services Managers.
\d\ Based on the mean wages for 00-0000 All Occupations.

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.


[[Page 60790]]


    Dated: September 21, 2020.
Marquita Cullom-Stott,
Associate Director.
[FR Doc. 2020-21295 Filed 9-25-20; 8:45 am]
BILLING CODE 4160-90-P