Agency Information Collection Activities: Proposed Collection; Comment Request
| Published date | 01 May 2019 |
| Citation | 84 FR 18541 |
| Record Number | 2019-08766 |
| Section | Notices |
| Court | Agency For Healthcare Research And Quality,Health And Human Services Department |
18541
Federal Register / Vol. 84, No. 84 / Wednesday, May 1, 2019 / Notices
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Agenda items for these meetings are
subject to change as priorities dictate.
Gopal Khanna,
Director.
[FR Doc. 2019–08764 Filed 4–30–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY
: Agency for Healthcare Research
and Quality, HHS.
ACTION
: Notice.
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 ‘‘Safety
Program in Perinatal Care (SPPC)–II
Demonstration Project.’’
DATES
: Comments on this notice must be
received by July 1, 2019.
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
emails at doris.lefkowitz@
AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION
:
Proposed Project
Safety Program in Perinatal Care
(SPPC)–II Demonstration Project
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
AHRQ invites the public to comment on
this proposed information collection.
Maternal mortality and severe maternal
morbidity (SMM) increased significantly
and continuously in the United States
(U.S.) over the past 30 years. A
considerable proportion of these adverse
events are attributable to preventable
harm and unintended consequences
arising from clinical practice and the
system of delivering perinatal care. To
address these alarming trends, AHRQ
has developed the Safety Program in
Perinatal Care (SPPC). During its initial
phase (SPPC–I), the program was
comprised of three pillars: Teamwork
and communication, patient safety
bundles, and in situ simulations.
Despite several promising results, the
evaluation of SPPC–I revealed
considerable hospital attrition due to
heavy data burden and competing safety
initiatives. Also, differences in the local
adaptation of the SPPC–I patient safety
bundles selected by implementation
sites thwarted a meaningful cross-site
comparison of programmatic impact.
The current, second phase of the
program (SPPC–II), focuses on
integrating the teamwork and
communication pillar into patient safety
bundles developed by key professional
organizations and implemented in 20+
U.S. states with technical assistance by
the Alliance for Innovation on Maternal
Health (AIM) program and funding from
the Health Resources and Services
Administration (HRSA). Of note, the
model used by AIM to implement these
bundles is through statewide perinatal
quality collaboratives (PQC) aiming to
enroll all birthing hospitals in the state
in the PQC.
During the Planning Phase of SPPC–
II, the contractor, Johns Hopkins
University (JHU), developed SPPC–II
Training Toolkits for two AIM patient
safety bundles: Obstetric hemorrhage
and severe hypertension in pregnancy.
The aim of the SPPC–II Demonstration
Project is to implement and evaluate an
integrated AIM–SPPC II program that
overlays the SPPC–II Training Toolkits
and the AIM patient safety bundles and
program infrastructure in two states—
Oklahoma (OK), currently implementing
the severe hypertension bundle; and
Texas (TX), currently implementing the
hemorrhage bundle.
Over the next five years, the AIM
program is expected to cover about two
thirds of U.S. states. Therefore, there is
need to determine the feasibility and
impact of the proposed integrated AIM–
SPPC II program, and inform future
government funding decisions regarding
these two programs.
To this end, the SPPC–II
Demonstration Project has the following
goals:
(1) To implement the integrated AIM–
SPPC II program in birthing hospitals in
OK and TX in coordination with AIM
and the respective state PQC;
(2) To assess the implementation of
the integrated AIM–SPPC II program in
these hospitals; and
(3) To ascertain the short- and
medium-term impact of the integrated
AIM–SPPC II program on hospital (i.e.
perinatal unit) teamwork and
communication, patient safety, and key
maternal health outcomes.
This study is being conducted by
AHRQ through its contractor, Johns
Hopkins University (JHU) and the AIM
program, JHU’s subcontractor, 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
To achieve the goals of this project the
following data collections will be
implemented:
(a) Training of AIM Team Leads from
48 birthing hospitals in OK and 210
birthing hospitals in TX (i.e., all birthing
hospitals enrolled in the respective state
PQC) on using teamwork and
communication tools and strategies in
clinical obstetric practice. The training
will be conducted in-person, through a
full-day workshop organized in
collaboration and coordination with the
AIM program and state PQCs, and led
by JHU. Only one such training
workshop will be conducted in OK
using the SPPC–II Toolkit for severe
hypertension in pregnancy. Given the
size of the state, potential long distances
to be traveled by trainees, and the cost-
efficiency of coordinating with back-to-
back regional PQC meetings planned in
TX this fall, five training workshops
will be conducted in this state using the
SPPC–II Toolkit for obstetric
hemorrhage. We expect about half of the
birthing hospitals in both states to send
2 hospital champions, of which one to
be designated as AIM Team Lead, for
training. JHU will keep and bi-annually
update a roster of AIM Team Leads in
each hospital to assess the need for
training of new AIM Team Leads if
turnover occurs. Training workshop
evaluation forms will be distributed for
completion by trainees on a voluntary
basis to assess the perceived utility of
training workshops.
(b) Training of all frontline clinical
staff in 48 birthing hospitals in OK and
210 birthing hospitals in TX on
teamwork and communication tools and
strategies will be coordinated by AIM
Team Leads in each hospital by: (a)
Providing unique trainee IDs and
information for them to access 8 training
e-modules online, and (b) using the
JHU-developed facilitator guide
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included in the SPPC–II Toolkits to
facilitate brief, in-person demonstration
sessions on how to use the information
from the training e-modules in clinical
practice. Each of the eight training e-
modules will take about 15 minutes to
complete online, for a total of about 120
minutes. Because these training e-
modules will be accessed and
completed online, tracking of e-module
completion and re-take, needed to
assess overall staff exposure to training,
is possible through the online training
platform.
c) Coaching calls will be organized
monthly and led by JHU to address
program implementation questions and
assist with potential challenges. AIM
Team Leads in all Demonstration
Project hospitals will be invited to join
these calls and ask questions. A list of
coaching call participants and topics
addressed will be maintained by JHU.
(d) AIM Team Lead self-administered
baseline surveys will be made available
2–3 weeks before the AIM Team Leads
training workshop, together with a
corresponding consent form. The
purpose of this survey is to assess key
characteristics of project hospitals,
including human resources, processes
in place for AIM bundle
implementation, and use of teamwork
and communication tools in clinical
practice. Respondents will have the
option to complete the survey online or
on paper, in line with the current
administration of the Hospital Survey
on Patient Safety Culture. The expected
response rate for this survey is 95% in
both states.
(e) Clinical staff self-administered
baseline surveys will be made available
before the first training workshop with
AIM Team Leads, together with a
corresponding consent form. The
purpose of this survey is to assess
baseline levels of previous teamwork
and communication training, overall use
of teamwork and communication tools
and strategies, teamwork and
communication perceptions, experience
with AIM bundle implementation.
Three respondents will be randomly
selected in each hospital using
comprehensive lists of clinical staff
developed by the AIM Team Leads.
These lists will be updated by AIM
Team Leads on a quarterly basis to
capture new hires and staff turnover.
Respondents will be given the option to
complete the survey online or on paper,
in line with the administration of the
national Hospital Survey on Patient
Safety Culture. The expected response
rate for this survey is 85% in both
states.
(f) Qualitative, semi-structured
interviews with AIM Team Leads will
be conducted by phone about 3–4
months after their training workshop to
assess the perceived utility of the
training and assistance needed with the
rollout of training to all frontline
clinical staff using the e-modules and
facilitation sessions to consolidate the
information. An interview guide
developed based on the Consolidated
Framework for Implementation
Research framework will be used to
conduct the interviews, together with a
corresponding consent form.
(g) Clinical staff self-administered
implementation surveys will be made
available at about 6, 18, and 30 months
after the first AIM Team Leads training,
together with a corresponding consent
forms, to assess training knowledge,
transfer, and results such as use of
teamwork and communication tools and
strategies, teamwork and
communication perceptions, experience
with AIM bundle implementation
overlaid with the teamwork and
communication tools. The time points
were chosen to assess: Early adoption
and results of the training (6-month
survey); adoption and results of the
training at the time when unit culture
changes are expected per available
implementation research (18-month
survey); and medium-term program
sustainability (30-month survey). For
each survey, three respondents will be
randomly selected in each hospital
using the most up to date
comprehensive lists of clinical staff
developed by the AIM Team Leads.
Respondents will have the option to
complete these surveys online or on
paper, in line with the administration of
the national Hospital Survey on Patient
Safety Culture. The expected response
rates are 80%, 77.5% and 75% for
surveys completed at 6, 18 and 30
months after AIM Team Leads training
workshops, respectively.
(h) AIM program data will be obtained
from the AIM program, a subcontractor
of JHU’s, under a data use agreement
signed by all hospitals at the state PQC
meetings in the fall of 2019. These data
are needed for the evaluation of the
SPPC–II Demonstration Project to assess
changes in key AIM program processes
and maternal health outcomes, such as
severe maternal morbidity, throughout
the project.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in the
SPPC–II Demonstration Project.
An estimated 387 AIM Team Leads
from the 258 Demonstration Project sites
will be trained during 8-hour workshops
using the SPPC–II Toolkit. An
evaluation form, which will take
approximately 5 minutes to complete,
will be distributed to them at the end of
the workshop, and about 75% of them
(290 AIM Team Leads) are expected to
complete the evaluation. They will also
be asked to extract from an available
human resources computerized database
and update bi-annually rosters of
frontline clinical staff in their units—
first extraction and each update is
expected to take about 5 minutes.
An estimated 15,480 frontline clinical
staff are expected to be trained using the
training e-modules in the SPPC–II
Toolkit. Completion of the 8 e-modules
will take about 2 hours. These trainings
will be complemented by four 15-min
facilitation sessions led by AIM Team
Leads in their respective units. The AIM
Team Leads will track attendance of the
facilitation session, work estimated to
take about 15 minutes after each
session.
Monthly 1-hour coaching calls will be
organized during the first 18 months of
the project and at least one
representative from about half of the
sites is expected to participate at each
coaching call.
Several surveys will be administered
throughout the Demonstration Project,
specifically: Baseline, 20-minute
surveys with AIM Team Leads at each
of 258 sites; baseline, 25-minute surveys
with 3 randomly selected frontline
clinical staff at each of 258 sites; and 30-
minute implementation surveys with 3
randomly selected frontline clinical staff
at each of 258 sites will be conducted
at 6, 18, and 30 months after the initial
training workshops in both states. In
addition, one-hour qualitative
interviews will be conducted with 25
AIM Team Leads in the 2 states about
3–4 months after the initial training
workshops in their respective state.
DUAs will be obtained from each site
in order to access AIM data; their review
and signature will take about 5 minutes
at each site.
The total annual burden hours are
estimated to be 54, 654 hours.
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Federal Register / Vol. 84, No. 84 / Wednesday, May 1, 2019 / Notices
E
XHIBIT
1—E
STIMATED
A
NNUALIZED
B
URDEN
H
OURS
Form name Number of
respondents
Number of
responses per
respondent
Hours per
response Total burden
hours
Training of AIM Team Leads ........................................................................... 387 1 8 3,096
Frontline staff rosters developed byAIM Team Leads .................................... 258 6 0.08 124
Evaluation form for training of AIM Team Leads ............................................ 290 1 0.08 23
Training of frontline clinical staff ...................................................................... 15,480 1 2.00 30,960
Facilitation sessions ......................................................................................... 15,480 4 0.25 15,480
Tracking attendance of facilitation sessions .................................................... 258 4 1.00 1,032
Coaching calls ................................................................................................. 129 18 1.00 2,322
Self-administered baseline surveys with AIM Team Leads ............................ 258 1 0.33 85
Self-administered baseline surveys with clinical staff ..................................... 774 1 0.42 325
Qualitative semi-structured interviews with AIM Team Leads ........................ 25 1 1.00 25
Self-administered implementation surveys with clinical staff at 6 months ...... 774 1 0.50 387
Self-administered implementation surveys with clinical staff at 18 months .... 774 1 0.50 387
Self-administered implementation surveys with clinical staff at 30 months .... 774 1 0.50 387
DUA for AIM data ............................................................................................ 258 1 0.08 21
Total .......................................................................................................... 36,048 NA NA 54,654
Exhibit 2 shows the estimated
annualized cost burden based on the
respondents’ time to submit their data.
The cost burden is estimated to be
$1,489,998.34 annually.
E
XHIBIT
2—E
STIMATED
A
NNUALIZED
C
OST
B
URDEN
Form name Number of
respondents
Total
burden
hours
Average
hourly wage
rate*
Total
cost
burden
Training of AIM Team Leads ........................................................................... 387 3,096 $49.83 $154,273.68
Frontline staff rosters developed byAIM Team Leads .................................... 258 124 49.83 6,178.92
Evaluation form for training of AIM Team Leads ............................................ 290 23 49.83 1,146.09
Training of frontline clinical staff ...................................................................... 15,480 30,960 66.32 2,053,267.20
Facilitation sessions ......................................................................................... 15,480 15,480 66.32 1,026,633.60
Tracking attendance of facilitation sessions .................................................... 258 1,032 49.83 51,424.56
Coaching calls ................................................................................................. 129 2,322 66.32 153,995.04
Self-administered baseline surveys with AIM Team Leads ............................ 258 85 49.83 4,235.55
Self-administered baseline surveys with clinical staff ..................................... 774 325 66.32 21,554
Qualitative semi-structured interviews with AIM Team Leads ........................ 25 25 49.83 1,245.75
Self-administered implementation surveys with clinical staff at 6 months ...... 774 387 66.32 25,665.84
Self-administered implementation surveys with clinical staff at 18 months .... 774 387 66.32 25,665.84
Self-administered implementation surveys with clinical staff at 30 months .... 774 387 66.32 25,665.84
DUA for AIM data ............................................................................................ 258 21 49.83 1,046.43
Total .......................................................................................................... 36,048 54,716 ........................ 1,489,998.34
* National Compensation Survey: Occupational wages in the United States May 2017 ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
a
Hourly wage for nurse-midwives ($48.36; occupation code 29–1161).
b
Weighted mean hourly wage for obstetrician-gynecologists ($113.10; occupation code 29–1064; 30%); nurse-midwives ($49.83; occupation
code 29–1161; 30%); registered nurses ($35.36; occupation code 29–1161; 20%); and nurse practitioners ($51.86; occupation code 29–1171;
20%).
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’s 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.
Gopal Khanna,
Director.
[FR Doc. 2019–08766 Filed 4–30–19; 8:45 am]
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