[Federal Register Volume 85, Number 145 (Tuesday, July 28, 2020)] [Notices] [Pages 45429-45431] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2020-16341] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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.'' DATES: Comments on this notice must be received by 60 days after date of publication of this Notice. 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 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, [[Page 45430]] 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 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 shows the estimated annualized burden hours for the respondents' time to participate in this project. 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 [[Page 45431]] 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. 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........................... 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 ---------------------------------------------------------------------------------------------------------------- Exhibit 2--Estimated Annualized Cost Burden ---------------------------------------------------------------------------------------------------------------- Average Form name Number of Total burden hourly wage Total cost respondents hours 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 ---------------------------------------------------------------------------------------------------------------- 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. Dated: July 23, 2020. Virginia L. Mackay-Smith, Associate Director. [FR Doc. 2020-16341 Filed 7-27-20; 8:45 am] BILLING CODE 4160-90-P