Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Notices 4697 

The times shown above are for the full 

Committee meeting. Subcommittee 

breakout sessions can be scheduled for 

late in the afternoon of the first day and 

second day and in the morning prior to 

the full Committee meeting on the 

second day. Agendas for these breakout 

sessions will be posted on the NCVHS 

website (URL below) when available. 

Contact Person for More Information: 

Substantive program information as 

well as summaries of meetings and a 

roster of committee members may be 

obtained from Marjorie S. Greenberg, 

Executive Secretary, NCVHS, National 

Center for Health Statistics, Centers for 

Disease Control and Prevention, 3311 

Toledo Road, Room 2402, Hyattsville, 

Maryland 20782, telephone (301) 458– 

4245. Information also is available on 

the NCVHS home page of the HHS Web 

site: http://www.ncvhs.hhs.gov/, where 

further information including an agenda 

will be posted when available. 

Should you require reasonable 

accommodation, please contact the CDC 

Office of Equal Employment 

Opportunity on (301) 458–4EEO (4336) 

as soon as possible. 

Dated: January 20, 2011. 

James Scanlon, 

Deputy Assistant Secretary for Planning and 

Evaluation. 

[FR Doc. 2011–1654 Filed 1–25–11; 8:45 am] 

BILLING CODE 4151–05–P 

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: 

‘‘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. 

This proposed information collection 

was previously published in the Federal 

Register on November 15th, 2010 and 

allowed 60 days for public comment. 

One comment was received. The 

purpose of this notice is to allow an 

additional 30 days for public comment. 

DATES: Comments on this notice must be 

received by February 25, 2011. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s desk officer) or by email at OIRA_submission@omb.eop.gov 

(attention: AHRQ’s desk officer). 

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 familycentered 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 post-implementation 

interviews will be conducted and 

separate interview guides will be used 

for staff and leaders. Preimplementation, 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, 

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4698 Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Notices 

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, patientand 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 semistructured interviews. As such, 

observations will occur postimplementation 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 

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 postimplementation 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 preimplementation and again at postimplementation will be built around the 

CAHPS® Hospital Survey (HCAHPS) 

domains that assess aspects of patientphysician 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. Semistructured interviews will be conducted 

with about 4 hospital staff members 

both pre and post-implementation and 

requires one hour to complete. Semistructured 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 50 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 

hours 

Semi-structured leader interviews—pre-implementation ................................. 3 4 1 12 

Semi-structured leader interviews—post-implementation ............................... 3 4 1 12 

Semi-structured staff interviews—pre-implementation .................................... 3 8 1 24 

Semi-structured staff interviews—post-implementation ................................... 3 8 1 24 

Collection of documentation ............................................................................ 3 2 4 24 

Bi-weekly semi-structured interviews ............................................................... 3 18 30/60 27 

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Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Notices 4699 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Data collection activity Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Focus group with patients ............................................................................... 24 1 90/60 36 

Focus group with patients’ family .................................................................... 24 1 90/60 36 

Focus group with patients & family ................................................................. 24 1 90/60 36 

Staff survey ...................................................................................................... 3 100 15/60 75 

Patient survey .................................................................................................. 884 2 30/60 884

Total .......................................................................................................... 977 na na 1,190 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average 

hourly rate * 

Total cost 

burden 

Semi-structured leader interviews—pre-implementation ................................. 3 12 $43.74 $525 

Semi-structured leader interviews—post-implementation ............................... 3 12 43.74 525 

Semi-structured staff interviews—pre-implementation .................................... 3 24 33.51 804 

Semi-structured staff interviews—post-implementation ................................... 3 24 33.51 804 

Collection of documentation ............................................................................ 3 24 21.16 508 

Bi-weekly semi-structured interviews ............................................................... 3 27 33.51 905 

Focus group with patients ............................................................................... 24 36 20.90 752 

Focus group with patients’ family .................................................................... 24 36 20.90 752 

Focus group with patients & family ................................................................. 24 36 20.90 752 

Staff survey ...................................................................................................... 3 75 33.51 2,513 

Patient survey—pre-implementation ................................................................ 884 884 20.90 18,476 

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 

cost 

Guide Development ................................................................................................................................................. $526,214 $263,107 

Data Collection Activities ......................................................................................................................................... 310,006 155,003 

Data Processing and Analysis ................................................................................................................................. 110,620 55,310 

Project Management ................................................................................................................................................ 20,270 10,135 

Overhead ................................................................................................................................................................. 105,683 52,842 

Total .................................................................................................................................................................. 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: January 11, 2011. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2011–1542 Filed 1–25–11; 8:45 am] 

BILLING CODE 4160–90–M 

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