Agency Information Collection Activities: Proposed Collection; Comment Request, 58349-58352 [2014-22698]
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58349
Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices
*** The Disclosure Statement Form and the Change of Listing Information form may be submitted by individual PSOs in different years. Due to
changes in their operations, a PSO can submit more than one Change of Listing Information in a year. OCR is anticipating considerable variation
in the number of complaints per year. Hence, the total for each year is expressed as an average of the expected total over the three year collection period.
**** The Profile Form collects data from listed PSOs each calendar year. The prior version of this form, the PSO Information Form, began collecting data from listed PSOs each calendar year in 2011.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form
Total
burden
hours
Average
hourly
wage rate
Total cost
Certification for Initial Listing Form ..................................................................
Certification for Continued Listing Form ..........................................................
Two Bona Fide Contracts Requirement Form .................................................
Disclosure Statement Form .............................................................................
Profile Form .....................................................................................................
Patient Safety Confidentiality Complaint Form ................................................
Change of Listing Information .........................................................................
Common Formats ............................................................................................
17
16
30
2
77
3
24
1,000
306
128
30
6
231
1
2
100,000
$35.93
35.93
35.93
35.93
35.93
35.93
35.93
35.93
$10,994.58
4,599.04
1,077.90
215.58
8,299.83
35.93
71.86
3,593,000.00
Total ..........................................................................................................
1,169
100,704
NA
3,618,294.72
* Based upon the mean of the hourly wages for healthcare practitioner and technical occupations, 29–0000, National Compensation Survey,
May 2013, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ (https://www.bls.gov/oes/current/oes_nat.htm#29-0000).
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: September 18, 2014.
Richard Kronick,
AHRQ Director.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
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:
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Proposed Project
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
Improving Hospital Informed Consent
With Training on Effective Tools and
Strategies
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project:
‘‘Improving Hospital Informed Consent
with Training on Effective Tools and
Strategies.’’ In accordance with the
Paperwork Reduction Act, 44 U.S.C.
3501–3521, AHRQ invites the public to
comment on this proposed information
collection.
This proposed information collection
was previously titled and published as
‘‘Improving Hospital Informed Consent
with an Informed Consent Toolkit’’ in
the Federal Register on July 9th, 2014
and allowed 60 days for public
comment. AHRQ received one
substantive comment. The purpose of
this notice is to allow an additional 30
days for public comment.
DATES: Comments on this notice must be
received by October 29, 2014.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by
email at OIRA_submission@
The ultimate aim of this project is to
pilot test training modules to improve
the informed consent process in U.S.
hospitals.
Clinical informed consent is the
process by which a patient is told about
the risks and benefits of proposed
treatments or procedures, as well as
alternatives, and makes a decision based
on that information. Informed consent
may be jeopardized by incorrect
clinician assumptions about patient
comprehension, the manner in which
consent is sought, and poor readability
of consent forms (Paasche-Orlow et al.,
2013). All too frequently, patients do
not understand the risks, benefits, and
alternatives of their treatments even
after signing a consent form (Braddock
et al., 1999; Sudore et al., 2006). Deidentified accreditation data analyzed as
part of AHRQ’s preliminary research for
this data collection effort suggest that
some hospitals are not following the
basic ethical principles underlying
informed consent. These data, as well as
the guidance from the study’s Expert
and Stakeholder Panel, indicate that
hospital administrators and clinicians
could benefit from training on evidencebased practices to improve the informed
AGENCY:
SUMMARY:
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Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices
consent process. These include,
improving communication, using
interpreters to meet the communication
needs of patients with limited English
proficiency, using high-quality decision
aids to support the informed consent
discussion, and using teach-back to
verify patient understanding (Temple
University Health System, 2009).
Hospital system changes that can
facilitate these practices include
improving hospitals’ informed consent
policies and the infrastructure that
supports the informed consent process
(e.g., interpreter services, high-quality
decision aids, easy-to-understand
forms).
Building upon a previously published
guide, a review of the literature, and the
aforementioned analysis of de-identified
accreditation data, AHRQ has developed
two new Informed Consent training
modules of approximately 1 hour each
(one for hospital leaders, the other for
health care professionals), to be offered
through a Learning Management
System. Health care professionals taking
the training will be eligible for
continuing education (CE) credit.
In the project’s next phase, AHRQ
will pilot test the training modules to
assess:
• Facilitators and barriers of
implementing the tools and
recommended improvements in the
training modules
• Effectiveness of the training
modules in improving informed consent
processes and relevant outputs and
outcomes
Pilot test results will be used to
improve the training modules and
provide information to hospitals
considering using the training modules
to improve their informed consent
processes. The pilot test will take place
in four hospitals. Each participating
hospital will be asked to:
• Deliver the leader training module
to hospital leaders of their choosing
• Champion improvements in their
informed consent policies and processes
based on the information and tools in
the leader training
• Deliver the health care professional
training module to health care
professionals in four units, including at
least one surgical unit
• Implement improvement initiatives
over a period of two to six months in
participating units based on materials
presented in the health care professional
training
Æ In at least one unit: Implementation
will last at least three months and use
at least one of the techniques presented
in the training (e.g., use teach-back to
confirm patient understanding, use high
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quality decision aids, overcome
communication barriers)
• Conduct and cooperate with
assessment activities.
Æ In at least one unit, use the Rapid
Feedback Patient Survey.
Æ In at least one surgical unit, collect
surgical cancellation and delay rates.
Æ Collect other metrics to assess the
effectiveness of the informed consent
training modules.
Æ Cooperate with project team in the
data collection efforts described below.
This study is being conducted by
AHRQ through its contractor, Abt
Associates Inc., pursuant to AHRQ’s
statutory authority to conduct and
support research on healthcare and on
systems for the delivery of such care,
including activities with respect to the
quality, effectiveness, efficiency,
appropriateness and value of healthcare
services and with respect to quality
measurement and improvement. 42
U.S.C. 299a(a)(1) and (2).
Method of Collection
The following data collections efforts
will be pursued in participating
hospitals to achieve project goals:
1. The Hospital Informed Consent
Baseline and Final Assessment will be
completed by the four hospitals
participating in the pilot testing at
baseline and upon completion of the
implementation period. The assessment,
completed by the hospital’s designated
liaison to the project and the leaders of
the participating units (unit leaders),
will describe each hospital’s informed
consent policies and processes (e.g.,
procedures that require signed informed
consent forms, clinical staff roles and
responsibilities in informed consent,
when interpreter services should be
used), and document any changes that
occurred as a result of implementing the
training modules. Questions will
include both open-ended questions (e.g.,
descriptions of process) and Likert scale
questions (1 to 5) regarding the extent to
which essential components are covered
in informed consent discussions (e.g.,
benefits and risks of alternatives) and
evidence-based practices to improve the
informed consent process are used.
2. Pre-/Post-Training Quiz. The
purpose of the Pre/post-Training Quiz is
to measure whether knowledge (related
to the content in the training modules)
increases after completing the training
module(s) and to identify potential
training module improvements. The
pre-test is given after the participant
registers for the training but before they
begin the course content. Immediately
after the participant completes the
course content, they will be given the
post test. The post quiz will also include
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a separate section with questions
regarding learner’s reactions to and
evaluation of the training modules. A
post quiz score of 80% will be used as
the threshold to obtain CE credits. There
will be a pre/post quiz for each training
module.
3. The Monthly Check-In Call. A
project team member will hold a
monthly check-in call with hospital
liaisons and unit leaders to assess the
progress of implementation of training
and improvement initiatives at each
hospital and within each unit. Check-in
calls will occur monthly for up to six
months. Each call will be up to 30
minutes in duration.
4. Health Care Professional Survey. A
brief survey will be administered
electronically to all clinicians who take
the health care professionals training,
both prior to training and approximately
2–3 months after completing it. Hospital
liaisons will provide email addresses for
the staff who will be invited to complete
the training from each participating
unit. These email addresses will be used
to send health care professionals the pre
and post-training surveys. The survey
will collect information about
clinicians’ self-reported use of evidencebased practices described in the training
module, a self-assessment rating of their
informed consent effectiveness,
attitudes regarding patients’ rights in
informed consent, and reported learning
and implementation experiences. The
survey will also collect information
about the clinician and their
background (e.g., years in practice,
practitioner type) and department. The
survey will consist largely of closedended questions (e.g., scale or Liken
response options) with several openended questions.
5. Interview and Site Visit Guide. Site
visits and interviews will be conducted
at each of the four participating
hospitals. Each site visit will occur over
a two-day period at least 3 months after
sites have trained the majority of their
staff on the participating units. The
project team will conduct up to 18 indepth interviews at each pilot site with
hospital leaders and frontline clinicians.
Leaders will include hospital
champions spearheading the pilot test
in their hospital (such as chiefs of
surgery, department chairs, chief
anesthesiologist/head of anesthesiology,
nurse managers, charge nurses, nurse
educators, patient safety/quality
officers, legal/risk management officers)
and leaders of units where the training
modules were piloted. Health care
professional interviewees will be
selected by unit leaders or hospital
liaisons from the units where the
training modules were piloted. Liaisons
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and unit leaders will be asked to
nominate a range of clinicians from
those who embraced changes to those
who were less willing to implement
changes. Site visits will also involve
limited observation (e.g., to observe
documentation of informed consent
completion, view new signage to remind
clinicians to verify patient
understanding in an informed consent
discussion). The project team will also
obtain relevant organizational
documents (e.g., informed consent
policies, training completion rates,
implementation tracking data) and data
(e.g., surgical cancellation rates).
Interviews will capture qualitative data
regarding clinician learning, training
modules implementation, behavior, and
results pertaining to patient
engagement.
6. Rapid Feedback Patient Survey.
Hospitals participating in the pilot test
will be required to implement the Rapid
Feedback Patient Survey provided in
the training modules in a subset of
patients in at least one participating unit
to capture patient’s understanding of the
information conveyed during the
informed consent process, and their
satisfaction with the informed consent
discussion and process. Time to
complete the rapid feedback patient
survey is estimated at 5 minutes. We
expect hospitals to administer this
survey to at least 50 patients before
implementation and 50 patients after
implementation in at least 1 unit.
Other outcome and output data from
administrative records or electronic
medical records (Secondary Data).
Hospitals will also be asked to report on
their rates of surgical cancellations and
delays in at least one participating
surgical unit, since prior research
suggests that these rates can be
improved (i.e., reduction in
cancellations and some delays) when
strategies such as teach-back were used
in the informed consent process (NQF,
2005). Hospitals may also select other
outcome measures of interest based on
administrative records or electronic
medical records. They may also report
on output data such as number of
informed consent forms improved or
number of staff present during a teachback or quality improvement exercise.
Since these data collections involve
extractions from existing clinic records
or use of administrative records, they
pose only minimal data collection
burden to the hospital, specifically the
person who needs to collect the data
(i.e., hospital liaison or unit leader).
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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-
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58351
post quiz for each module. Each quiz
will take 20 minutes to complete:
a. Health care professionals Pre-/PostTraining Quiz: We assumed 40 health
care professionals per unit for a total of
160 staff per hospital and a total of 640
across all four hospitals. We assumed
512 health care professionals will
complete the pre-/post-training quiz
based on an estimated 80% response
rate.
b. Hospital Leader Pre-/Post-Training
Quiz: We assumed 8 leaders per
hospital for a total of 32 across all four
hospitals. We assumed 26 will complete
the pre-/post-training quiz based on an
estimated 80% response rate.
3. The Monthly Check-In Calls will
occur with hospital liaisons and four
unit leaders for a total of 5 individuals
per hospital to assess the progress of
implementation of training programs at
each site and within each unit. Checkin calls will occur monthly for six
months and will each take 30 minutes.
4. Health Care Professional Survey. A
brief survey will be emailed to all
clinicians both prior to training and
approximately 2–3 months after
completing the training. We assumed 40
health care professionals per unit for a
total of 160 staff per hospital and a total
of 640 across all four hospitals. We
assumed 512 health care professionals
will complete the survey based on an
80% response rate. It is expected to take
15 minutes to complete.
5. Interview and Site Visit Guide.
Each site visit will occur over a two-day
period and include up to 18 1-hour
interviews in each pilot site, with:
a. Two hospital leaders (e.g., legal,
risk management) and four unit leaders
(six per hospital);
b. Three front-line clinicians in each
of four units (12 per hospital).
6. Rapid Feedback Patient Survey.
The Rapid Feedback Patient Survey will
be given to 100 patients (50 patients
before implementation and 50 patients
after) immediately following an
informed consent discussion. It should
take 5 minutes to complete. We
assumed 100 patients per hospital for a
total of 400 across all four hospitals. We
assumed 320 patients will complete the
survey based on an 80% response rate.
7. Other outcome and output data
from administrative records or
electronic medical records (Secondary
Data). These secondary data will be
provided by the hospital liaison or unit
leaders. We have assumed 5 hours for
each hospital liaison and unit lead to
collect and provide these data.
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Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
A. Number of
respondents
B. Number of
responses per
respondent
1. Hospital Informed Consent Baseline and Final Assessment (Attachment
C) ..................................................................................................................
2a. Health care professionals Pre-/Post-Training Quiz * (Attachment D) .......
2b. Hospital Leader Pre-/Post-Training Quiz * (Attachment E) .......................
3. Monthly Check-in (Attachment F) ................................................................
4. Health Care Professional Survey * (Attachment G) ....................................
5a. Interview—Clinical Staff (Attachment H) ...................................................
5b. Interview—Hospital Leaders (Attachment H) ............................................
6. Rapid Feedback Patient Survey * (Attachment I) ........................................
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
5/60
5
40
341
17
60
128
48
24
27
20
Total ..........................................................................................................
........................
na
na
705
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
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
Number of
respondents
Data collection method or project activity
Total burden
hours
Average
hourly wage
rate *
Total cost
burden
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 ........................................................................................................
tkelley on DSK3SPTVN1PROD with NOTICES
1. Hospital Informed Consent Baseline and Final Assessment (Attachment
C) ................................................................................................................
2a. Health care professionals pre-/post-training quiz (Attachment D) ..........
2b. Hospital leader pre-/post-training quiz (Attachment E) ...........................
3. Monthly Check-in Attachment F) ...............................................................
4. Health Care Professional Survey (Attachment G) ....................................
5a. Interview—Clinical Staff (Attachment H) .................................................
5b. Interview—Hospital Leaders (Attachment H) ..........................................
6. Rapid Feedback Patient Survey (Attachment I) ........................................
7. Secondary data .........................................................................................
........................
..........................
........................
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
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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 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
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automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of Me
proposed information collection. All
comments will become a matter of
public record.
Dated: September 18, 2014.
Richard Kronick,
Director.
[FR Doc. 2014–22698 Filed 9–26–14; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number CDC–2013–0022, NIOSH
153–B]
Issuance of Final Publications
National Institute for
Occupational Safety and Health
AGENCY:
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]]>Agencies
[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]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve the proposed information collection
project: ``Improving Hospital Informed Consent with Training on
Effective Tools and Strategies.'' In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment
on this proposed information collection.
This proposed information collection was previously titled and
published as ``Improving Hospital Informed Consent with an Informed
Consent Toolkit'' in the Federal Register on July 9th, 2014 and allowed
60 days for public comment. AHRQ received one substantive comment. The
purpose of this notice is to allow an additional 30 days for public
comment.
DATES: Comments on this notice must be received by October 29, 2014.
ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by
email at 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
----------------------------------------------------------------------------------------------------------------
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 (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
----------------------------------------------------------------------------------------------------------------
* 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
----------------------------------------------------------------------------------------------------------------
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 (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
----------------------------------------------------------------------------------------------------------------
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/
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
