Agency Information Collection Activities: Proposed Collection; Comment Request

 
CONTENT
Federal Register, Volume 84 Issue 84 (Wednesday, May 1, 2019)
[Federal Register Volume 84, Number 84 (Wednesday, May 1, 2019)]
[Notices]
[Pages 18541-18543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08766]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
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SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve the proposed information collection
project ``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
[email protected].
    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
[email protected].
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
[[Page 18542]]
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.
[[Page 18543]]
                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
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Training of AIM Team Leads......................             387               1               8           3,096
Frontline staff rosters developed byAIM Team                 258               6            0.08             124
 Leads..........................................
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             258               1            0.33              85
 Leads..........................................
Self-administered baseline surveys with clinical             774               1            0.42             325
 staff..........................................
Qualitative semi-structured interviews with AIM               25               1            1.00              25
 Team Leads.....................................
Self-administered implementation surveys with                774               1            0.50             387
 clinical staff at 6 months.....................
Self-administered implementation surveys with                774               1            0.50             387
 clinical staff at 18 months....................
Self-administered implementation surveys with                774               1            0.50             387
 clinical staff at 30 months....................
DUA for AIM data................................             258               1            0.08              21
                                                 ---------------------------------------------------------------
    Total.......................................          36,048              NA              NA          54,654
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    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.
                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours        wage  rate*       burden
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Training of AIM Team Leads......................             387           3,096          $49.83     $154,273.68
Frontline staff rosters developed byAIM Team                 258             124           49.83        6,178.92
 Leads..........................................
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             258              85           49.83        4,235.55
 Leads..........................................
Self-administered baseline surveys with clinical             774             325           66.32          21,554
 staff..........................................
Qualitative semi-structured interviews with AIM               25              25           49.83        1,245.75
 Team Leads.....................................
Self-administered implementation surveys with                774             387           66.32       25,665.84
 clinical staff at 6 months.....................
Self-administered implementation surveys with                774             387           66.32       25,665.84
 clinical staff at 18 months....................
Self-administered implementation surveys with                774             387           66.32       25,665.84
 clinical staff at 30 months....................
DUA for AIM data................................             258              21           49.83        1,046.43
                                                 ---------------------------------------------------------------
    Total.......................................          36,048          54,716  ..............    1,489,998.34
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* 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]
 BILLING CODE 4160-90-P