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 Department of Health and Human Services Agency for Healthcare Research and Quality
 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: “Development of the Guide to Patient and Family Engagement in Health Care Quality and Safety in the Hospital Setting.” In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
 DATES: Comments on this notice must be received by January 14, 2011.
 ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
                        ( print page 69675)
                        Reports Clearance Officer, AHRQ, by e-mail at 
                        *doris.lefkowitz@AHRQ.hhs.gov.* 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 e-mail at 
                        *doris.lefkowitz@AHRQ.hhs.gov.*


SUPPLEMENTARY INFORMATION:  Proposed Project Development of the Guide to Patient and Family Engagement in Health Care Quality and Safety in the Hospital Setting Improving the quality and safety of health care in the United States is one of the most significant challenges facing the American health care system. Too many Americans continue to receive health care that is not grounded in a reliable evidence base of what is proven appropriate, safe, and effective. Extensive studies conducted during recent decades demonstrate that the U.S. health care system provides continuing unwarranted variation and costly, inefficient, and simply unsafe care. Involving patients and families in improving quality and safety in hospitals has the potential to improve health care experiences, delivery, and outcomes. AHRQ has been at the forefront of supporting increased involvement for patients, families, and the public in all aspects of health care. This project will develop a program to help patients, families, and health professionals in the hospital support one another to improve quality and safety. To accomplish these goals, patients and families must be able to express what they want from their hospital care and how they want to be involved and then effectively communicate this information with health professionals. Conversely, health professionals must be able to understand what patients want to do and what is appropriate for them to do and feel that they have the system supports and tools to facilitate these actions. To address this issue and help fulfill AHRQ's mission of health care quality improvement, AHRQ will develop a set of interventions and materials, entitled the Guide to Patient and Family Engagement in Health Care Quality and Safety in the Hospital Setting (“the Guide”), for use by patients, their family members, health care professionals, and hospital leaders to foster patient and family engagement around the issues of hospital safety and quality. The goals of this project are to: (1) Identify the barriers and facilitators to implementing the Guide, including how barriers were overcome; (2) Assess staff satisfaction with the Guide and change in staff behavior before and after implementation of the Guide including organizational culture with respect to patient- and family engagement and patient- and family-centered care; (3) Assess patient satisfaction with the Guide and change in patient experience of care before and after implementation of the Guide including patient/family involvement in their own health care and patient/family involvement in quality improvement and patient safety activities; and (4) Refine the Guide as necessary to improve implementation and effectiveness. The Guide will be tested in three hospitals which will vary in terms of size, location, teaching status, and ownership. This study is being conducted by AHRQ through its contractor, the American Institutes for Research (AIR), pursuant to AHRQ's statutory authority to promote health care quality improvement by conducting and supporting research that develops and presents scientific evidence regarding all aspects of health care, including the development and assessment of methods for enhancing patient participation in their own care and for facilitating shared patient-physician decision-making. 42 U.S.C. 299(b)(1)(A). Method of Collection To achieve the goals of this project the following data collections will be implemented: (1) Semi-structured interviews will be conducted in-person with hospital staff and hospital leaders from each of the participating health care facilities. Both pre- and postimplementation interviews will be conducted and separate interview guides will be used for staff and leaders. Pre-implementation, the interviews will focus on current knowledge, attitudes and beliefs around patient and family engagement and on the current organizational culture and climate surrounding patient and family engagement. Post-implementation, interviews will be conducted to understand the hospital's experiences implementing the Guide interventions, including how easy or difficult the Guide was to implement; the perceived effects of the Guide implementation; and the sustainability of the Guide interventions. (2) Collection of documentation from each participating facility. The purpose of this collection of documentation is to gather documentation of the implementation of the Guide and to document policies and procedures related to patient and family engagement through a review of records and other materials. To the extent that it is available, the following types of documentation will be collected: ○ Background on organizational structure and vision. ○ Policies and procedures related to Component 1 and Component 2 strategies of the Guide. ○ Tools used to foster communication between patients, family members and health care team. ○ Policies and procedures related to patient and family engagement, patient- and family-centered care, quality and safety. This task will consist of forwarding emails and or photocopying and sending documents to the project team both pre- and post-implementation. (3) Bi-weekly semi-structured interviews will be conducted by telephone with the implementation coordinators from each participating facility. At each hospital site, an implementation coordinator will be responsible for overseeing implementation activities and serving as a primary point-of-contact. Interviews with these individuals will provide a complete understanding of the Guide implementation and the ability to track the implementation in real time. These interviews will occur bi-weekly for 9 months. (4) Observation of Guide implementation around different activities targeted in the Guide components. The purpose of these observations is to directly assess how the Guide is being implemented and to determine which follow up questions from the semi-structured interview protocol should be prioritized or removed during the in-person semi-structured interviews. As such, observations will occur post-implementation only. Observations will be conducted by the project staff so this data collection does not impose a burden on the participating hospitals; therefore it is not included in Exhibit 1. (5) Focus groups with patients and family members at each of the participating sites. The purpose of these groups is to elicit information about patients' and families' experiences of care at the hospital along with their reactions to tools in the Guide and their implementation. Three focus groups of up to 8 individuals will be conducted at each hospital post implementation. One 
                    ( print page 69676)
                    focus group will be conducted with patients only, one with family members only and one with patients and family members together. (6) Staff Survey with hospital staff. The purpose of the pre- and post-implementation Staff Survey is to assess changes in organizational culture related to patient safety and engagement, and to assess significant changes in staff knowledge, attitudes, and behaviors. Items from the Medical College of Georgia (MCG) Patient- and Family-Centered Care Culture Survey will be used in this data collection activity. The survey items will be supplemented with questions from AHRQ's Hospital Survey on Patient Safety Culture (HSOPS) and from the Army Medical Department Climate Survey. At each of the three hospital sites, it is estimated that survey responses will be collected from at least 50 health professionals. The same questionnaire will be used at pre- and post-implementation. (7) Patient Survey. The patient survey which will be administered pre-implementation and again at post-implementation will be built around the CAHPS® Hospital Survey (HCAHPS) domains that assess aspects of patient-physician interaction around the hospital stay, including Communication with Nurses, Communication with Doctors, Communication about Medicines, Responsiveness of Hospital Staff, and Discharge Information. These scales directly assess the aspects of the hospital stay and encounters that we are hoping the Guide will affect. Additional questions to address any aspects of care covered by the Guide that are not adequately addressed by the HCAHPS composites will also be included in this survey. Additionally, measures from the Patient Activation Measures (PAM) Survey will also be included. The same questionnaire will be used pre- and post-implementation. Estimated Annual Respondent Burden Exhibit 1 shows the estimated burden hours for the respondents' time to participate in this project. Semi-structured interviews will be conducted with about 4 hospital staff members both pre- and post-implementation and requires one hour to complete. Semi-structured interviews will also be conducted with 2 hospital leaders, pre- and post-implementation, and will take one hour to complete. Collection of documentation will occur twice at each hospital and requires 4 hours to complete. Bi-weekly semi-structured interviews will be conducted with the implementation coordinator at each hospital. A total of 18 interviews per hospital over a 9 month period will occur with each interview taking about 30 minutes. Focus groups will take place separately with patients, their families, and both patients and their families and will last for about an hour and a half. The staff survey will be completed by approximately SO hospital staff members from each hospital, pre- and post-implementation, and requires 15 minutes to complete. The patient survey will be conducted twice, pre- and post-implementation, by about 884 patients across all 3 participating hospitals and will take 30 minutes to complete. The total annualized burden hours are estimated to be 1,190 hours. 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 $27,316. Exhibit 1—Estimated Annualized Burden Hours
Data collection activity
Number of respondents
Number of responses per respondent
Hours per response
Total burden hoursSemi-structured leader interviews—pre-implementation
3
4
1
12Semi-structured leader interviews—post-implementation
3
4
1
12Semi-structured staff interviews—pre-implementation
3
8
1
24Semi-structured staff interviews—pre-implementation
3
8
1
24Collection of documentation
3
2
4
24Bi-weekly semi-structured interviews
3
18
30/60
27Focus group with patients
24
1
90/60
36Focus group with patients' family
24
1
90/60
36Focus group with patients & family
24
1
90/60
36Staff survey
3
100
15/60
75Patient survey
884
2
30/60
884Total
977
na
na
1,190
 Exhibit 2—Estimated Annualized Cost Burden
Form name
Number of 
                             respondents
Total burden hours
Average hourly wage rate*
Total cost 
                             burdenSemi-structured leader interviews—pre-implementation
3
12
$43.74
$525Semi-structured leader interviews—post-implementation
3
12
43.74
525Semi-structured staff interviews—pre-implementation
3
24
33.51
804Semi-structured staff interviews—post-implementation
3
24
33.51
804Collection of documentation
3
24
21.16
508Bi-weekly semi-structured interviews
3
27
33.51
905Focus group with patients
24
36
20.90
752Focus group with patients' family
24
36
20.90
752Focus group with patients & family
24
36
20.90
752Staff survey
3
75
33.51
2,513Patient survey—pre-implementation
884
884
20.90
18,476( print page 69677)Total
977
1,190
n/a
27,316* Based upon the mean of the wages for 11-9111 Medical & Health Services Manager ($43.74), 29-000 Healthcare Practitioner and Technical Occupations ($33.51), 43-6011 Executive Secretaries and Administrative Assistants ($21.16) and 00-0000 All Occupations ($20.90), May 2009 National Occupational Employment and Wage Estimates. United States, “U.S. Department of Labor, Bureau of Labor Statistics.” 
                        *http://www.bls.gov/​oes/​current/​oes_​nat.htm#b29-0000.*
 Estimated Annual Costs to the Federal Government Exhibit 3 below breaks down the costs related to this study. Since this study will span two years, the costs have been annualized over a two year period. The total annualized cost is estimated to be $536,396.50. Exhibit 3—Estimated Total and Annualized Cost
Cost component
Total cost
Annualized costGuide Development
$526,214
$263,107Data Collection Activities
310,006
155,003Data Processing and Analysis
110,620
55,310Project Management
20,270
10,135Overhead
105,683
52,842Total
1,072,793
536,396.50
 Request for Comments In accordance with the above-cited Paperwork Reduction Act legislation, 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 healthcare research and healthcare 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: November 1, 2010. Carolyn M. Clancy, Director.


[FR Doc. 2010-28368 Filed 11-12-10; 8:45 am] BILLING CODE 4160-90-M