Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices 58349 

*** The Disclosure Statement Form and the Change of Listing Information form may be submitted by individual PSOs in different years. Due to 

changes in their operations, a PSO can submit more than one Change of Listing Information in a year. OCR is anticipating considerable variation 

in the number of complaints per year. Hence, the total for each year is expressed as an average of the expected total over the three year collection period. 

**** The Profile Form collects data from listed PSOs each calendar year. The prior version of this form, the PSO Information Form, began collecting data from listed PSOs each calendar year in 2011. 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form Number of 

respondents 

Total 

burden 

hours 

Average 

hourly 

wage rate 

Total cost 

Certification for Initial Listing Form .................................................................. 17 306 $35.93 $10,994.58 

Certification for Continued Listing Form .......................................................... 16 128 35.93 4,599.04 

Two Bona Fide Contracts Requirement Form ................................................. 30 30 35.93 1,077.90 

Disclosure Statement Form ............................................................................. 2 6 35.93 215.58 

Profile Form ..................................................................................................... 77 231 35.93 8,299.83 

Patient Safety Confidentiality Complaint Form ................................................ 3 1 35.93 35.93 

Change of Listing Information ......................................................................... 24 2 35.93 71.86 

Common Formats ............................................................................................ 1,000 100,000 35.93 3,593,000.00 

Total .......................................................................................................... 1,169 100,704 NA 3,618,294.72 

* Based upon the mean of the hourly wages for healthcare practitioner and technical occupations, 29–0000, National Compensation Survey, 

May 2013, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ (http://www.bls.gov/oes/current/oes_nat.htm#29-0000). 

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. 

Dated: September 18, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–22700 Filed 9–26–14; 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: 

‘‘Improving Hospital Informed Consent 

with Training on Effective Tools and 

Strategies.’’ In accordance with the 

Paperwork Reduction Act, 44 U.S.C. 

3501–3521, AHRQ invites the public to 

comment on this proposed information 

collection. 

This proposed information collection 

was previously titled and published as 

‘‘Improving Hospital Informed Consent 

with an Informed Consent Toolkit’’ in 

the Federal Register on July 9th, 2014 

and allowed 60 days for public 

comment. AHRQ received one 

substantive comment. The purpose of 

this notice is to allow an additional 30 

days for public comment. 

DATES: Comments on this notice must be 

received by October 29, 2014. 

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). 

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 Training on Effective Tools and 

Strategies 

The ultimate aim of this project is to 

pilot test training modules 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 


tkelley on DSK3SPTVN1PROD with NOTICES
58350 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices 

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 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 

two new Informed Consent training 

modules of approximately 1 hour each 

(one for hospital leaders, the other for 

health care professionals), to be offered 

through a Learning Management 

System. Health care professionals taking 

the training will be eligible for 

continuing education (CE) credit. 

In the project’s next phase, AHRQ 

will pilot test the training modules to 

assess: 

• Facilitators and barriers of 

implementing the tools and 

recommended improvements in the 

training modules 

• Effectiveness of the training 

modules in improving informed consent 

processes and relevant outputs and 

outcomes 

Pilot test results will be used to 

improve the training modules and 

provide information to hospitals 

considering using the training modules 

to improve their informed consent 

processes. The pilot test will take place 

in four hospitals. Each participating 

hospital will be asked to: 

• Deliver the leader training module 

to hospital leaders of their choosing 

• Champion improvements in their 

informed consent policies and processes 

based on the information and tools in 

the leader training 

• Deliver the health care professional 

training module to health care 

professionals in four units, including at 

least one surgical unit 

• Implement improvement initiatives 

over a period of two to six months in 

participating units based on materials 

presented in the health care professional 

training 

Æ In at least one unit: Implementation 

will last at least three months and use 

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 

training modules. 

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 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 

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 implementing the 

training modules. 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. The 

purpose of the Pre/post-Training Quiz is 

to measure whether knowledge (related 

to the content in the training modules) 

increases after completing the training 

module(s) and to identify potential 

training module 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 training modules. 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 

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. Health Care Professional Survey. A 

brief survey will be administered 

electronically to all clinicians who take 

the health care professionals training, 

both prior to training and approximately 

2–3 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 health care professionals the pre 

and post-training surveys. The survey 

will collect information about 

clinicians’ self-reported use of evidencebased practices described in the training 

module, 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 Liken 

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 3 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 training 

modules were piloted. Health care 

professional interviewees will be 

selected by unit leaders or hospital 

liaisons from the units where the 

training modules were piloted. Liaisons 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices 58351 

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, training 

modules 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 training modules 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 5 minutes. We 

expect hospitals to administer this 

survey to at least 50 patients before 

implementation and 50 patients after 

implementation in at least 1 unit. 

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). 

The purpose of the proposed data 

collection effort is to obtain information 

needed to modify and enhance the 

Informed Consent training modules and 

to provide information to hospitals 

considering using the training modules 

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 training modules 

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 training modules. 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 training modules, then 

AHRQ could tailor and target its 

dissemination of the training modules to 

those individuals and organizations that 

represent them. Once revisions are 

made based on results of the pilot study, 

the training modules 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 peer-reviewed 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% 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 (1 per hospital) and 

unit leaders (4 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. Health care professionals Pre-/PostTraining Quiz: We assumed 40 health 

care professionals per unit for a total of 

160 staff per hospital and a total of 640 

across all four hospitals. We assumed 

512 health care professionals will 

complete the pre-/post-training quiz 

based on an estimated 80% response 

rate. 

b. Hospital Leader Pre-/Post-Training 

Quiz: We assumed 8 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% response rate. 

3. The Monthly Check-In Calls will 

occur with hospital liaisons and four 

unit leaders for a total of 5 individuals 

per hospital to assess the progress of 

implementation of training programs at 

each site and within each unit. Checkin calls will occur monthly for six 

months and will each take 30 minutes. 

4. Health Care Professional Survey. A 

brief survey will be emailed to all 

clinicians both prior to training and 

approximately 2–3 months after 

completing the training. We assumed 40 

health care professionals per unit for a 

total of 160 staff per hospital and a total 

of 640 across all four hospitals. We 

assumed 512 health care professionals 

will complete the survey based on an 

80% 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 1-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 5 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% 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 5 hours for 

each hospital liaison and unit lead to 

collect and provide these data. 


tkelley on DSK3SPTVN1PROD with NOTICES
58352 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices 

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 (Attachment 

C) .................................................................................................................. 20 2 1 40 

2a. Health care professionals Pre-/Post-Training Quiz * (Attachment D) ....... 512 2 20/60 341 

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

3. Monthly Check-in (Attachment F) ................................................................ 20 6 30/60 60 

4. Health Care Professional Survey * (Attachment G) .................................... 512 1 15/60 128 

5a. Interview—Clinical Staff (Attachment H) ................................................... 48 1 1 48 

5b. Interview—Hospital Leaders (Attachment H) ............................................ 24 1 1 24 

6. Rapid Feedback Patient Survey * (Attachment I) ........................................ 320 1 5/60 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. 

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 (Attachment 

C) ................................................................................................................ 20 40 $42.78 $1,711 

2a. Health care professionals pre-/post-training quiz (Attachment D) .......... 512 341 .33 33.62 11,476 

2b. Hospital leader pre-/post-training quiz (Attachment E) ........................... 26 17 .33 51.95 900 

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

4. Health Care Professional Survey (Attachment G) .................................... 512 128 33.62 4,303 

5a. Interview—Clinical Staff (Attachment H) ................................................. 48 48 33.62 1,614 

5b. Interview—Hospital Leaders (Attachment H) .......................................... 24 24 51.95 1,247 

6. Rapid Feedback Patient Survey (Attachment I) ........................................ 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 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 Me 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: September 18, 2014. 

Richard Kronick, 

Director. 

[FR Doc. 2014–22698 Filed 9–26–14; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket Number CDC–2013–0022, NIOSH 

153–B] 

Issuance of Final Publications 

AGENCY: National Institute for 

Occupational Safety and Health 


tkelley on DSK3SPTVN1PROD with NOTICES