Agency Information Collection Activities: Proposed Collection; Comment Request, 38898-38901 [2014-15807]
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Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 for Healthcare Research and
Quality
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services.
AGENCY:
AGENCY:
ACTION:
Notice.
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.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
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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
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Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
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:
SUMMARY:
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
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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
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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
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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
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38899
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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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
A. Number of
respondents
B. Number of
responses per
respondent
1. Hospital Informed Consent Baseline and Final Assessment ......................
2a. Frontline Staff Pre-/Post-Training Quiz * ...................................................
2b. Hospital Leader Pre-/Post-Training Quiz * ................................................
3. Monthly Check-in .........................................................................................
4. Frontline Clinical Staff Survey * ...................................................................
5a. Interview—Clinical Staff .............................................................................
5b. Interview—Hospital Leaders ......................................................................
6. Rapid Feedback Patient Survey * ................................................................
7. Secondary data ...........................................................................................
20
512
26
20
512
48
24
320
4
2
2
2
6
1
1
1
1
1
1
20/60
20/60
30/60
15/60
1
1
15/60
5
40
341
17
60
128
48
24
27
20
Total ..........................................................................................................
........................
na
na
705
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Data collection method or project activity
C. Hours per
response
D. Total
burden hours
* 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
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associated with the respondents’ time to
participate in this research. The total
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cost burden is estimated to be about
$25,270.
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Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Data collection method or project activity
Total burden
hours
Average hourly wage rate *
Total cost
burden
1. Hospital Informed Consent Baseline and Final Assessment ......................
2a. Frontline Staff Pre-/Post-Training Quiz .....................................................
2b. Hospital Leader Pre-/Post-Training Quiz ...................................................
3. Monthly Check-in .........................................................................................
4. Frontline Clinical Staff Survey .....................................................................
5a. Interview—Clinical Staff .............................................................................
5b. Interview—Hospital Leaders ......................................................................
6. Rapid Feedback Patient Survey ..................................................................
7. Secondary data ...........................................................................................
20
512
26
20
512
48
24
320
4
40
341.33
17.33
60
128
48
24
26.67
20
$42.78
33.62
51.95
42.78
33.62
33.62
51.95
22.33
42.78
$1,711
11,476
900
2,567
4,303
1,614
1,247
596
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: https://
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,
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(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.
[FR Doc. 2014–15807 Filed 7–8–14; 8:45 am]
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:
BILLING CODE 4160–90–M
Proposed Project
Dated: June 25, 2014.
Richard Kronick,
AHRQ Director.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
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.
SUMMARY:
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DATES:
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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]]>Agencies
[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: https://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
