38898 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Decision To Evaluate a Petition To 

Designate a Class of Employees From 

the General Atomics Facility in La 

Jolla, California, To Be Included in the 

Special Exposure Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention, Department of Health 

and Human Services. 

ACTION: Notice. 

SUMMARY: NIOSH gives notice as 

required by 42 CFR 83.12(e) of a 

decision to evaluate a petition to 

designate a class of employees from the 

General Atomics facility in La Jolla, 

California, to be included in the Special 

Exposure Cohort under the Energy 

Employees Occupational Illness 

Compensation Program Act of 2000. The 

initial proposed definition for the class 

being evaluated, subject to revision as 

warranted by the evaluation, is as 

follows: 

Facility: General Atomics. 

Location: La Jolla, California. 

Job Titles and/or Job Duties: All 

Atomic Weapons Employees who 

worked for General Atomics at its 

facility in La Jolla, California, during the 

period from January 1, 1960 through 

December 31, 1969, for a number of 

work days aggregating at least 250 work 

days, occurring either solely under this 

employment or in combination with 

work days within the parameters 

established for one or more other classes 

of employees included in the Special 

Exposure Cohort. 

Period of Employment: January 1, 

1960 through December 31, 1969. 

FOR FURTHER INFORMATION CONTACT: 

Stuart L. Hinnefeld, Director, Division 

of Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health, 4676 Columbia 

Parkway, MS C–46, Cincinnati, OH 

45226, Telephone 877–222–7570. 

Information requests can also be 

submitted by email to DCAS@CDC.GOV. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health. 

[FR Doc. 2014–15988 Filed 7–8–14; 8:45 am] 

BILLING CODE 4163–19–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: 

‘‘Improving Hospital Informed Consent 

With an Informed Consent Toolkit.’’ In 

accordance with the Paperwork 

Reduction Act, AHRQ invites the public 

to comment on this proposed 

information collection. 

DATES: Comments on this notice must be 

received by September 8, 2014. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by 

email 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 

email at doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Improving Hospital Informed Consent 

With an Informed Consent Toolkit 

The ultimate aim of this project is to 

pilot test a toolkit to improve the 

informed consent process in U.S. 

hospitals. Clinical informed consent is 

the process by which a patient is told 

about the risks and benefits of proposed 

treatments or procedures, as well as 

alternatives, and makes a decision based 

on that information. Informed consent 

may be jeopardized by incorrect 

clinician assumptions about patient 

comprehension, the manner in which 

consent is sought, and poor readability 

of consent forms (Paasche-Orlow et al., 

2013). All too frequently, patients do 

not understand the risks, benefits, and 

alternatives of their treatments even 

after signing a consent form (Braddock 

et al., 1999; Sudore et al., 2006). Deidentified accreditation data analyzed as 

part of AHRQ’s preliminary research for 

this data collection effort suggest that 

some hospitals are not following the 

basic ethical principles underlying 

informed consent. These data, as well as 

the guidance from the study’s Expert 

and Stakeholder Panel, indicate that 

hospital administrators and clinicians 

could benefit from training on evidencebased practices to improve the informed 

consent process. These include 

improving communication, using 

interpreters to meet the communication 

needs of patients with limited English 

proficiency, using high-quality decision 

aids to support the informed consent 

discussion, and using teach-back to 

verify patient understanding (Temple 

University Health System, 2009). 

Hospital system changes that can 

facilitate these practices include 

improving hospitals’ informed consent 

policies and enhancing the 

infrastructure that supports the 

informed consent process (e.g., 

interpreter services, high-quality 

decision aids, easy-to-understand 

forms). 

Building upon a previously published 

guide, a review of the literature, and the 

aforementioned analysis of de-identified 

accreditation data, AHRQ has developed 

a new Informed Consent Toolkit. 

Toolkit content will be delivered via 

two training modules of approximately 

one hour each (one for hospital leaders, 

the other for frontline clinical staff), to 

be offered through a Learning 

Management System. Clinical staff 

taking the training will be eligible for 

continuing education (CE) credit. 

AHRQ will pilot test the toolkit to 

assess: 

• Facilitators of and barriers to 

implementing the toolkit 

• Effectiveness of the toolkit in 

improving informed consent processes 

and relevant outputs and outcomes 

Pilot test results will be used to 

improve the toolkit and provide 

information to hospitals considering 

using it to improve their informed 

consent processes. The pilot test will 

take place in four hospitals. Each 

participating hospital will be asked to: 

• Train the leaders of their choosing 

using the training module Champion 

improvements in their informed consent 

policies and processes based on the 

information and tools in the leader 

training. 

• Train frontline staff members in 

four units, including at least one 

surgical unit. Using the frontline 

training module. 

• Implement improvement initiatives 

over a period of two to six months in 

participating units based on materials 

presented in the frontline training. 

Æ In at least one unit implementation 

will last at least three months and use 


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Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices 38899 

at least one of the techniques 

presented in the training (e.g., use 

teach-back to confirm patient 

understanding, use high quality 

decision aids, overcome 

communication barriers) 

• Conduct and cooperate with 

assessment activities: 

Æ In at least one unit, use the Rapid 

Feedback Patient Survey. 

Æ In at least one surgical unit, collect 

surgical cancellation and delay rates. 

Æ Collect other metrics to assess the 

effectiveness of the informed consent 

toolkit. 

Æ Cooperate with project team in the 

data collection efforts described below. 

This study is being conducted by 

AHRQ through its contractor, Abt 

Associates Inc., pursuant to AHRQ’s 

statutory authority to conduct and 

support research on health care and on 

systems for the delivery of such care, 

including activities with respect to the 

quality, effectiveness, efficiency, 

appropriateness and value of health care 

services and with respect to quality 

measurement and improvement. 42 

U.S.C. 299a(a)(1) and (2). 

Method of Collection 

The following data collections efforts 

will be pursued in participating 

hospitals to achieve project goals: 

1. The Hospital Informed Consent 

Baseline and Final Assessment will be 

completed by the four hospitals 

participating in the pilot testing at 

baseline and upon completion of the 

implementation period. The assessment, 

completed by the hospital’s designated 

liaison to the project and the leaders of 

the participating units (unit leaders), 

will describe each hospital’s informed 

consent policies and processes (e.g., 

procedures that require signed informed 

consent forms, clinical staff roles and 

responsibilities in informed consent, 

when interpreter services should be 

used), and document any changes that 

occurred as a result of toolkit 

implementation. Questions will include 

both open-ended questions (e.g., 

descriptions of process) and Likert scale 

questions (1 to 5) regarding the extent to 

which essential components are covered 

in informed consent discussions (e.g., 

benefits and risks of alternatives) and 

evidence-based practices to improve the 

informed consent process are used. 

2. Pre-/Post-Training Quiz. A quiz is 

given both before and after the training 

to measure whether knowledge (related 

to the content in the Toolkit) increases 

after completing the training module(s) 

and to identify potential Toolkit 

improvements. The pre-test is given 

after the participant registers for the 

training but before they begin the course 

content. Immediately after the 

participant completes the course 

content, they will be given the post test. 

The post quiz will also include a 

separate section with questions 

regarding learner’s reactions to and 

evaluation of the Toolkit training. A 

post quiz score of 80% will be used as 

the threshold to obtain CE credits. There 

will be a pre/post quiz for each training 

module. 

3. The Monthly Check-In Call. A 

project team member will hold a 

monthly check-in call with hospital 

liaisons and unit leaders to assess the 

progress of implementation of training 

programs and improvement initiatives 

at each hospital and within each unit. 

Check-in calls will occur monthly for up 

to six months. Each call will be up to 

30 minutes in duration. 

4. Frontline Clinical Staff Survey. A 

brief survey will be administered 

electronically to all clinicians who take 

the frontline staff training, both prior to 

training and approximately two to three 

months after completing it. Hospital 

liaisons will provide email addresses for 

the staff who will be invited to complete 

the training from each participating 

unit. These email addresses will be used 

to send clinicians the pre and posttraining surveys. The survey will collect 

information about clinicians’ selfreported use of evidence-based practices 

described in the frontline staff training, 

a self-assessment rating of their 

informed consent effectiveness, 

attitudes regarding patients’ rights in 

informed consent, and reported learning 

and implementation experiences. The 

survey will also collect information 

about the clinician and their 

background (e.g., years in practice, 

practitioner type) and department. The 

survey will consist largely of closedended questions (e.g., scale or Likert 

response options) with several openended questions. 

5. Interview and Site Visit Guide. Site 

visits and interviews will be conducted 

at each of the four participating 

hospitals. Each site visit will occur over 

a two-day period at least three months 

after sites have trained the majority of 

their staff on the participating units. The 

project team will conduct up to 18 indepth interviews at each pilot site with 

hospital leaders and frontline clinicians. 

Leaders will include hospital 

champions spearheading the pilot test 

in their hospital (such as chiefs of 

surgery, department chairs, chief 

anesthesiologist/head of anesthesiology, 

nurse managers, charge nurses, nurse 

educators, patient safety/quality 

officers, legal/risk management officers) 

and leaders of units where the toolkit 

was piloted. Frontline clinician 

interviewees will be selected by unit 

leaders or hospital liaisons from the 

units where the toolkit was piloted. 

Liaisons and unit leaders will be asked 

to nominate a range of clinicians from 

those who embraced changes to those 

who were less willing to implement 

changes. Site visits will also involve 

limited observation (e.g., to observe 

documentation of informed consent 

completion, view new signage to remind 

clinicians to verify patient 

understanding in an informed consent 

discussion). The project team will also 

obtain relevant organizational 

documents (e.g., informed consent 

policies, training completion rates, 

implementation tracking data) and data 

(e.g., surgical cancellation rates). 

Interviews will capture qualitative data 

regarding clinician learning, toolkit 

implementation, behavior, and results 

pertaining to patient engagement. 

6. Rapid Feedback Patient Survey. 

Hospitals participating in the pilot test 

will be required to implement the Rapid 

Feedback Patient Survey provided in 

the Toolkit in a subset of patients in at 

least one participating unit to capture 

patient’s understanding of the 

information conveyed during the 

informed consent process, and their 

satisfaction with the informed consent 

discussion and process. Time to 

complete the rapid feedback patient 

survey is estimated at five minutes. We 

expect hospitals to administer this 

survey to at least 50 patients before 

implementation and 50 patients after 

implementation in at least one unit and 

randomize selection of patients to 

minimize potential bias. 

Other outcome and output data from 

administrative records or electronic 

medical records (Secondary Data). 

Hospitals will also be asked to report on 

their rates of surgical cancellations and 

delays in at least one participating 

surgical unit, since prior research 

suggests that these rates can be 

improved (i.e., reduction in 

cancellations and some delays) when 

strategies such as teach-back were used 

in the informed consent process (NQF, 

2005). Hospitals may also select other 

outcome measures of interest based on 

administrative records or electronic 

medical records. They may also report 

on output data such as number of 

informed consent forms improved or 

number of staff present during a teachback or quality improvement exercise. 

Since these data collections involve 

extractions from existing clinic records 

or use of administrative records, they 

pose only minimal data collection 

burden to the hospital, specifically the 

person who needs to collect the data 

(i.e., hospital liaison or unit leader). 


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38900 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices 

The purpose of the proposed data 

collection effort is to obtain information 

needed to modify and enhance the 

Informed Consent Toolkit and to 

provide information to hospitals 

considering using the toolkit to improve 

their informed consent processes. Since 

this is only a pilot study in 4 sites, 

outcomes or impacts will not be 

generalizable. 

The data collected will help the 

project team: (1) understand the 

facilitators and barriers of implementing 

the tools and recommended 

improvements to informed consent 

policies and processes, and (2) assess 

the effectiveness of the toolkit in 

improving informed consent processes 

and other outcomes in four pilot 

implementation sites. The data 

collection effort may also provide 

insights that could guide dissemination 

of the toolkit. For example, if it was 

found that specific units (e.g., surgical 

units) across the pilot test hospitals 

strongly benefited from implementing a 

specific strategy suggested in the toolkit, 

then AHRQ could tailor and target its 

dissemination of the toolkit to those 

individuals and organizations that 

represent them. Once revisions are 

made based on results of the pilot study, 

the toolkit will be published on AHRQ’s 

Web site. A manuscript describing the 

pilot study and its results will also be 

produced for publication in a peerreviewed journal. 

Estimated Annual Respondent Burden 

Exhibit 1 presents estimates of the 

reporting burden hours for the data 

collection efforts. Time estimates are 

based on prior experiences with pilot 

testing materials in hospitals and what 

can reasonably be requested of 

participating hospitals. The number of 

respondents listed in column A, Exhibit 

1 reflects a projected 80 percent 

response rate for data collection efforts 

2a, 2b, 4, and 6 below. 

1. The Hospital Informed Consent 

Baseline and Final Assessment will 

establish a baseline and final assessment 

of each hospital’s informed consent 

policies and processes that is completed 

by the site liaisons (one per hospital) 

and unit leaders (four per hospital) and 

will take each person 30 minutes to 

complete each time. 

2. Pre-/Post-Training Quiz will be 

administered after participants register 

for the training but before they begin the 

course (pre-test), and immediately after 

participants complete the course 

content (post-test). There will be a prepost quiz for each module. Each quiz 

will take 20 minutes to complete: 

a. Frontline Staff Pre-/Post-Training 

Quiz: We assumed 40 frontline staff per 

unit for a total of 160 staff per hospital 

and a total of 640 across all four 

hospitals. We assumed 512 frontline 

staff will complete the pre-/post-training 

quiz based on an estimated 80 percent 

response rate. 

b. Hospital Leader Pre-/Post-Training 

Quiz: We assumed eight leaders per 

hospital for a total of 32 across all four 

hospitals. We assumed 26 will complete 

the pre-/post-training quiz based on an 

estimated 80 percent response rate. 

3. The Monthly Cheek-In Calls will 

occur with hospital liaisons and four 

unit leaders for a total of five 

individuals per hospital to assess the 

progress of implementation of training 

programs at each site and within each 

unit. Check-in calls will occur monthly 

for six months and will each take 30 

minutes. 

4. Frontline Clinical Staff Survey. A 

brief survey will be emailed to all 

clinicians both prior to training and 

approximately two to three months after 

completing the training. We assumed 40 

frontline staff per unit for a total of 160 

staff per hospital and a total of 640 

across all four hospitals. We assumed 

512 frontline staff will complete the 

survey based on an 80 percent response 

rate. It is expected to take 15 minutes to 

complete. 

5. Interview and Site Visit Guide. 

Each site visit will occur over a two-day 

period and include up to 18 one hour 

interviews in each pilot site, with: 

a. Two hospital leaders (e.g., legal, 

risk management) and four unit leaders 

(six per hospital). 

b. Three front-line clinicians in each 

of four units (12 per hospital). 

6. Rapid Feedback Patient Survey. 

The Rapid Feedback Patient Survey will 

be given to 100 patients (50 patients 

before implementation and 50 patients 

after) immediately following an 

informed consent discussion. It should 

take five minutes to complete. We 

assumed 100 patients per hospital for a 

total of 400 across all four hospitals. We 

assumed 320 patients will complete the 

survey based on an 80 percent response 

rate. 

7. Other outcome and output data 

from administrative records or 

electronic medical records (Secondary 

Data). These secondary data will be 

provided by the hospital liaison or unit 

leaders. We have assumed five hours for 

each hospital liaison and unit lead to 

collect and provide these data. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Data collection method or project activity A. Number of 

respondents 

B. Number of 

responses per 

respondent 

C. Hours per 

response 

D. Total 

burden hours 

1. Hospital Informed Consent Baseline and Final Assessment ...................... 20 2 1 40 

2a. Frontline Staff Pre-/Post-Training Quiz * ................................................... 512 2 20/60 341 

2b. Hospital Leader Pre-/Post-Training Quiz * ................................................ 26 2 20/60 17 

3. Monthly Check-in ......................................................................................... 20 6 30/60 60 

4. Frontline Clinical Staff Survey * ................................................................... 512 1 15/60 128 

5a. Interview—Clinical Staff ............................................................................. 48 1 1 48 

5b. Interview—Hospital Leaders ...................................................................... 24 1 1 24 

6. Rapid Feedback Patient Survey * ................................................................ 320 1 15/60 27 

7. Secondary data ........................................................................................... 4 1 5 20 

Total .......................................................................................................... ........................ na na 705 

* Number of respondents (Column A) reflects a sample size assuming an 80% response rate for these data collection efforts. 

Exhibit 2, below, presents the 

estimated annualized cost burden 

associated with the respondents’ time to 

participate in this research. The total 

cost burden is estimated to be about 

$25,270. 


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Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices 38901 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Data collection method or project activity Number of 

respondents 

Total burden 

hours 

Average hourly wage rate * Total cost 

burden 

1. Hospital Informed Consent Baseline and Final Assessment ...................... 20 40 $42.78 $1,711 

2a. Frontline Staff Pre-/Post-Training Quiz ..................................................... 512 341.33 33.62 11,476 

2b. Hospital Leader Pre-/Post-Training Quiz ................................................... 26 17.33 51.95 900 

3. Monthly Check-in ......................................................................................... 20 60 42.78 2,567 

4. Frontline Clinical Staff Survey ..................................................................... 512 128 33.62 4,303 

5a. Interview—Clinical Staff ............................................................................. 48 48 33.62 1,614 

5b. Interview—Hospital Leaders ...................................................................... 24 24 51.95 1,247 

6. Rapid Feedback Patient Survey .................................................................. 320 26.67 22.33 596 

7. Secondary data ........................................................................................... 4 20 42.78 856 

Total .......................................................................................................... ........................ ........................ ........................ 25,270 

The average hourly wage rate of 

$42.78 for the informed consent 

baseline, readiness assessment, and 

monthly check-in was calculated based 

on the 2013 average of the mean hourly 

wage rate for healthcare practitioners 

and medical occupations (all 

professions) of $33.62 and mean hourly 

wage rate for medical and health 

services managers, $51.95. 

The average hourly rate of $33.62 of 

hospital staff pre- and post-training quiz 

and in-depth interviews was calculated 

based on the 2013 average of the mean 

hourly wage rate for healthcare 

practitioners and medical occupations 

(all professions), $33.62. 

The average hourly rate of $51.95 for 

hospital leaders pre- and post-training 

quiz and in-depth interview was 

calculated based on the 2013 mean 

hourly wage rate for medical and health 

services managers, $51.95. 

The average hourly wage rate for 

patients of $22.33 was calculated on the 

2013 mean hourly wage rate for all 

occupations. Mean hourly wage rates for 

these groups of occupations were 

obtained from the Bureau of Labor & 

Statistics on ‘‘Occupational 

Employment and Wages, May 2013’’ 

found at the following URL: http://

www.bls.gov/oes/current/oes_

nat.htm#b29-0000.htm. 

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 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: June 25, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–15807 Filed 7–8–14; 8:45 am] 

BILLING CODE 4160–90–M 

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: ‘‘Taking 

Efficiency Interventions in Health 

Services Delivery to Scale.’’ In 

accordance with the Paperwork 

Reduction Act of 1995, AHRQ invites 

the public to comment on this proposed 

information collection. 

This proposed information collection 

was previously published in the Federal 

Register on April 8th, 2014, and 

allowed 60 days for public comment. No 

comments were 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 August 8, 2014. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by 

email 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 

email at doris.lefkowitz@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Taking Efficiency Interventions in 

Health Services Delivery to Scale 

The primary care workforce is facing 

imminent clinician shortages and 

increased demand. With the 

implementation of the Affordable Care 

Act (ACA), Federally Qualified Health 

Centers (FQHCs) are expected to play a 

major role in addressing the large 

numbers of people who become eligible 

for health insurance as well as continue 

in their role as safety net providers. 

Thus, understanding new models of 

service delivery and improving 

efficiency within FQHCs is of national 

policy import. The proposed data 

collection supports the goal of 

developing a more efficient FQHC 

service delivery model through studying 

outcomes associated with a ‘‘delegate 

model,’’ which is designed to improve 

provider and team efficiency, and the 

spread of this model throughout a large 

FQHC. 

Recent models of practice 

transformation have documented the 

use of an Organized Team Model that 

distributes responsibility for patient 

care among an interdisciplinary team, 

thereby allowing physicians to manage 

a larger panel size while practicing high 

quality care. The delegate model 

requires that all team members perform 


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