[Federal Register Volume 82, Number 95 (Thursday, May 18, 2017)]
[Notices]
[Pages 22831-22833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10065]


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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 Enhancing Surgical Care and 
Recovery.''

DATES: Comments on this notice must be received by July 17, 2017.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
[email protected].
    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 
[email protected].

SUPPLEMENTARY INFORMATION: 

Proposed Project

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, AHRQ invites the public to comment on this proposed information 
collection. The AHRQ Safety Program for Enhancing Surgical Care and 
Recovery 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 after 
surgery. The approach uses a combination of clinical and cultural 
(i.e., technical and adaptive) intervention components, which 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


[[Page 22832]]


    This project is being conducted by AHRQ through its contractor 
Johns Hopkins University; with subcontractors Westat, and the American 
College of Surgeons. The AHRQ Safety Program for Enhancing Surgical 
Care and Recovery is being undertaken pursuant to AHRQ's mission to 
enhance the quality, appropriateness, and effectiveness of health 
services, and access to such services, through the establishment of a 
broad base of scientific research and through the promotion of 
improvements in clinical and health systems practices, including the 
prevention of diseases and other health conditions. 42 U.S.C. 299.

Method of Collection

    To achieve the goals of this project the following data collections 
will be implemented: (1) Safety Culture Survey. Hospitals will assess 
the impact of participation in the project on perioperative safety 
culture by having their staff members who will be part of the enhanced 
recovery program complete a survey from the AHRQ Surveys on Patient 
Safety Culture (SOPS) at the beginning and end of the program. The 
hospital's enhanced recovery project team will receive their survey 
results and then debrief their staff on their safety culture and 
identify opportunities for further improvement. The national project 
team will provide technical assistance for this effort. Participating 
hospitals will promote awareness of the survey among their staff, 
coordinate implementation of the survey, encourage and provide staff 
the time to complete the survey, and organize a local debrief of the 
reports of their hospital's results. The national project team will 
assist this effort by providing an electronic portal for hospital staff 
to anonymously complete 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.
    (2) Patient Experience Survey--Hospitals will also assess the 
impact of participation in the project on patients' experience with 
care. This will be done via administration of a patient experience 
survey to patients discharged after a qualifying surgery. Patients will 
receive a pre-implementation assessment of patient experience after a 
qualifying surgery and a post-implementation assessment of patient 
experience will be administered to patients were treated in the 
enhanced recovery program at participating hospitals. The survey will 
be administered by the national project team. Hospitals will provide 
patient contact information to the project team after execution of a 
data use agreement. This information will be provided to the national 
project team to send the survey to patients on behalf of the hospital. 
The national project team will provide a summative report to each 
hospital with the hospital's results to promote additional local 
quality improvement work. Data will also be analyzed in aggregate 
across all participating hospitals to evaluate the impact of the 
overall quality improvement effort on patient experience of care.
    (3) 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 recovery after surgery 
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 national team's approach. In 
addition, the results will inform the national team's understanding of 
local adaptations of the intervention and the degree to which 
intervention impacts changes in outcomes.
    (4) Site visits--Semi-structured site visits will be conducted at a 
subset of participating hospitals. Findings will help inform the 
national 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 after surgery 
practices, including how this may differ across surgical services. 
Interviews will help uncover and clarify misalignments in roles, needed 
time and resources, best practices, and potential enablers of and 
barriers to enhanced recovery after surgery implementation. Site visits 
will be conducted at approximately 4 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

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Safety culture survey...........................          12,000               1            0.25           3,000
Patient experience survey.......................           1,800               1            0.37             666
Readiness and Implementation assessment.........             720               1               1             720
Site visits.....................................              40               1               8             320
                                                 ---------------------------------------------------------------
    Total.......................................          14,560             N/A             N/A           4,706
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[[Page 22833]]


                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                                                      Average
                    Form name                        Number of     Total burden     hourly wage     Total cost
                                                    respondents        hours          rate *          burden
----------------------------------------------------------------------------------------------------------------
Safety culture survey...........................           6,000           1,500     \a\ $101.04        $151,560
Safety culture survey...........................           6,000           1,500       \b\ 34.70          52,050
Patient experience survey.......................           1,800             666       \d\ 23.86          15,891
Readiness and Implementation assessment.........             360             360      \a\ 101.04          36,374
Readiness and Implementation assessment.........             360             360       \c\ 52.58          18,929
Site visits.....................................              20             160      \a\ 101.04          16,166
Site visits.....................................              20             160       \c\ 52.58           8,413
                                                 ---------------------------------------------------------------
    Total.......................................          14,560           4,706             N/A         299,383
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National Compensation Survey: Occupational wages in the United States May 2016 ``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 29-1060 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, 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 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.

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017-10065 Filed 5-17-17; 8:45 am]
 BILLING CODE 4160-90-P