2017-10065. 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: “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 [e-mail].

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, [phone], or by email at [e-mail].

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

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

Form name	Number of respondents	Number of responses per respondent	Hours per response	Total burden 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

Exhibit 2—Estimated Annualized Cost Burden

Form name	Number of respondents	Total burden hours	Average hourly wage rate *	Total cost 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
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.