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[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Notices]
[Pages 58349-58352]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22698]

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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.

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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 OIRAsubmission@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). De-identified 
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 evidence-based practices to improve the 
informed

[[Page 58350]]

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
    [cir] 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.
    [cir] In at least one unit, use the Rapid Feedback Patient Survey.
    [cir] In at least one surgical unit, collect surgical cancellation 
and delay rates.
    [cir] Collect other metrics to assess the effectiveness of the 
informed consent training modules.
    [cir] 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 
evidence-based 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 closed-ended questions (e.g., scale or Liken response 
options) with several open-ended 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 in-depth 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

[[Page 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 teach-back 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 pre-post quiz for each module. Each quiz will 
take 20 minutes to complete:
    a. Health care professionals Pre-/Post-Training 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. Check-in 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.

[[Page 58352]]

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                   B. Number of
   Data collection method or project activity      A. Number of    responses per   C. Hours per      D. Total
                                                    respondents     respondent       response      burden hours
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1. Hospital Informed Consent Baseline and Final               20               2               1              40
 Assessment (Attachment C)......................
2a. Health care professionals Pre-/Post-Training             512               2           20/60             341
 Quiz * (Attachment D)..........................
2b. Hospital Leader Pre-/Post-Training Quiz *                 26               2           20/60              17
 (Attachment E).................................
3. Monthly Check-in (Attachment F)..............              20               6           30/60              60
4. Health Care Professional Survey * (Attachment             512               1           15/60             128
 G).............................................
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               320               1            5/60              27
 I).............................................
7. Secondary data...............................               4               1               5              20
                                                 ---------------------------------------------------------------
    Total.......................................  ..............              na              na             705
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* 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
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                                                     Number of     Total burden   Average hourly    Total cost
   Data collection method or project activity       respondents        hours        wage rate *       burden
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1. Hospital Informed Consent Baseline and Final               20           40             $42.78          $1,711
 Assessment (Attachment C)......................
2a. Health care professionals pre-/post-training             512          341.33           33.62          11,476
 quiz (Attachment D)............................
2b. Hospital leader pre-/post-training quiz                   26           17.33           51.95             900
 (Attachment E).................................
3. Monthly Check-in Attachment F)...............              20           60              42.78           2,567
4. Health Care Professional Survey (Attachment               512          128              33.62           4,303
 G).............................................
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
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    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/
oesnat.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
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