```

[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Notices]
[Pages 38898-38901]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15807]

-----------------------------------------------------------------------

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). 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 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.
[cir] In at least one unit implementation will last at least three 
months and use

[[Page 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:
    [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 toolkit.
    [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 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 post-training surveys. The survey will 
collect information about clinicians' self-reported 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 closed-ended questions (e.g., scale or Likert 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 three 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 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 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).

[[Page 38900]]

    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 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 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 pre-post 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
----------------------------------------------------------------------------------------------------------------
                                                                   B. Number of
   Data collection method or project activity      A. Number of    responses per   C. Hours per      D. Total
                                                    respondents     respondent       response      burden hours
----------------------------------------------------------------------------------------------------------------
1. Hospital Informed Consent Baseline and Final               20               2               1              40
 Assessment.....................................
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.

[[Page 38901]]

                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden   Average hourly    Total cost
   Data collection method or project activity       respondents        hours        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
1. Hospital Informed Consent Baseline and Final               20              40          $42.78          $1,711
 Assessment.....................................
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
```