Agency Information Collection Activities: Proposed Collection; Comment Request
| Published date | 04 February 2020 |
| Citation | 85 FR 6190 |
| Record Number | 2020-02112 |
| Section | Notices |
| Court | Agency For Healthcare Research And Quality,Health And Human Services Department |
6190
Federal Register / Vol. 85, No. 23 / Tuesday, February 4, 2020 / Notices
PICOTS (P
OPULATIONS
, I
NTERVENTIONS
, C
OMPARATORS
, O
UTCOMES
, T
IMING
, S
ETTINGS
)—Continued
PICOTS Inclusion key question 1:
Prostaglandin inpatient vs. out-
patient
Inclusion key question 2: Me-
chanical method inpatient vs
outpatient
Inclusion key question 3: Out-
patient comparison of methods Inclusion key question 4: Fetal
surveillance Exclusion
Outcomes ..................
Maternal Harms ......... •Hemorrhage requiring trans-
fusion
c
.
•Postpartum hemorrhage by
mode (vaginal, cesarean)
c
.
•Hemorrhage requiring trans-
fusion
c
.
•Postpartum hemorrhage by
mode (vaginal, cesarean)
c
.
•Hemorrhage requiring trans-
fusion
c
.
•Postpartum hemorrhage by
mode (vaginal, cesarean)
c
.
•Hemorrhage requiring trans-
fusion
c
.
•Postpartum hemorrhage by
mode (vaginal, cesarean)
c
.
Outcomes not listed in inclusion
criteria.
•Uterine infection (i.e.,
choriamnionitis, administra-
tion of antibiotics in labor
other than GBS prophylaxis)
c
.
•Uterine infection (i.e.,
choriamnionitis, administra-
tion of antibiotics in labor
other than GBS prophylaxis)
c
.
•Uterine infection (i.e.,
choriamnionitis, administra-
tion of antibiotics in labor
other than GBS prophylaxis)
c
.
•Uterine infection (i.e.,
choriamnionitis, administra-
tion of antibiotics in labor
other than GBS prophylaxis)
c
.
•Placental abruption, Uterine
rupture.
•Umbilical cord prolapse
•Duration of time between
hospital admission to birth
that is insufficient to enable
complete GBS prophylaxis
antibiotics administration per
CDC guidelines.
•Placental abruption ...............
•Uterine rupture
•Umbilical cord prolapse
•Duration of time between
hospital admission to birth
that is insufficient to enable
complete GBS prophylaxis
antibiotics administration per
CDC guidelines.
•Placental abruption, Uterine
rupture.
•Umbilical cord prolapse
•Duration of time between
hospital admission to birth
that is insufficient to enable
complete GBS prophylaxis
antibiotics administration per
CDC guidelines.
•Placental abruption ...............
•Uterine rupture
•Umbilical cord prolapse
•Duration of time between
hospital admission to birth
that is insufficient to enable
complete GBS prophylaxis
antibiotics administration per
CDC guidelines.
Timing ........................ Maternal outcomes ...................
•From CR initiation to within
1-week following delivery.
Infant outcomes
•Immediately following deliv-
ery.
Maternal outcomes ...................
•From CR initiation to within
1-week following delivery.
Infant outcomes
•Immediately following deliv-
ery.
Maternal and additional out-
comes (i.e., breastfeeding,
maternal mood, mother-baby
attachment).
•From CR initiation to 1-year
postpartum.
Infant outcomes
•Immediately following deliv-
ery.
Maternal outcomes ...................
•From CR initiation to within
1-week following delivery.
Infant outcomes
•Immediately following deliv-
ery.
KQ 1,2,4: Outcomes occurring
after 1-week post delivery.
KQ3: Outcomes for
breastfeeding, mother-infant
attachment, and maternal
mood occurring after 1 year
post-delivery.
Setting ....................... •Inpatient versus outpatient
settings. •Inpatient versus outpatient
settings. •Outpatient setting .................. •Inpatient and outpatient set-
tings.
Study design ............. •Randomized Controlled
Trials; recent high quality
Systematic Reviews; if RCT
evidence for benefits is insuf-
ficient, include large, high
quality cohort studies com-
paring inpatient and out-
patient setting.
•Randomized Controlled
Trials; recent high quality
Systematic Reviews; if RCT
evidence for benefits is insuf-
ficient, include large, high
quality cohort studies com-
paring inpatient and out-
patient setting.
•Randomized Controlled
Trials; recent high quality
Systematic Reviews; if RCT
evidence for benefits is insuf-
ficient, include large, high
quality cohort studies com-
paring inpatient and out-
patient setting.
•Randomized Controlled
Trials; recent high quality
Systematic Reviews; if RCT
evidence for benefits is insuf-
ficient, include large, high
quality cohort studies com-
paring inpatient and out-
patient setting.
Case series, pre-post studies,
case reports.
•Include high quality cohort
and case-control studies for
harms.
•Include high quality cohort
and case-control studies for
harms.
•Include high quality cohort
and case-control studies for
harms.
•Include high quality cohort
and case-control studies for
harms.
c
(Bolded) items indicate Primary Outcomes.
CR = cervical ripening; CD = cesarean delivery; KQ = Key Question; ROM = rupture of membrane; CDC = Centers for Disease Control and Prevention; L&D = labor and delivery; RCTs = ran-
domized controlled trials.
Dated: January 29, 2020.
Virginia L. Mackay-Smith,
Associate Director, Office of the Director,
AHRQ.
[FR Doc. 2020–02058 Filed 2–3–20; 8:45 am]
BILLING CODE 4160–90–P
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:
‘‘Evaluating the Dissemination and
Implementation of PCOR to Increase
Referral, Enrollment, and Retention
through Automatic Referral to Cardiac
Rehabilitation (CR) with Care
Coordination.’’ 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 60 days after date of
publication.
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
Evaluating the Dissemination and
Implementation of PCOR to Increase
Referral, Enrollment, and Retention
through Automatic Referral to Cardiac
Rehabilitation (CR) With Care
Coordination
The aim of AHRQ’s TAKEheart
project is to (a) raise awareness about
the benefits of cardiac rehabilitation
(CR) after myocardial infarction or
coronary revascularization, then to (b)
disseminate knowledge about the best
practices to increase referrals to CR,
and, finally, (c) to increase CR uptake.
Currently over two-thirds of eligible
cardiac patients are not referred to CR
despite extensive evidence of its
effectiveness in preventing subsequent
morbidity; national estimates of referral
range from 10–34%. To help improve
CR rates, the Million Hearts
®
Cardiac
Rehabilitation Collaborative—an
initiative co-led by the Centers for
Disease Control and Prevention (CDC)
and the Centers for Medicare &
Medicaid Services (CMS)—developed a
Cardiac Rehabilitation Change Package
(CRCP) and established a national goal
of 70% participation in CR by 2022 for
eligible patients. Recognizing that
widespread adoption of the CRCP could
help hospitals enhance CR rates, the
CDC turned to AHRQ with a request that
AHRQ consider disseminating and
implementing evidence for CR and
practices that promote CR. The CRCP is
designed to facilitate this dissemination
and implementation process.
AHRQ reviewed this request in the
context of its Patient Centered
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Outcomes Research Dissemination and
Implementation initiative and judged
the CDC nomination to have a high level
of fit with AHRQ’s criteria of having a
substantial evidence base, high potential
impact, and high feasibility for wide
dissemination and implementation
Outreach with stakeholders indicates
that this initiative aligns well but does
not duplicate work by NIH; PCORI; CMS
and CDC.
The core recommendations in the
CDC package are, first to spread
adoption of automatic referral system—
where patients after cardiovascular
events are referred by the Electronic
Health Record to rehabilitation unless
the cardiologist actively decides not to
refer because of medical ineligibility.
The second core recommendation is use
of a care coordinator to guide patients
through referral has resulted in the most
significant increases in referral to CR.
TAKEheart will facilitate dissemination
and implementation of Automatic
Referral with Care Coordination in
selected, diverse hospitals nationwide
which demonstrate their readiness.
AHRQ will evaluate TAKEheart to
assess:
•the extent and effectiveness of the
dissemination and implementation
efforts
•the uptake and usage of Automatic
Referral with Care Coordination and
•levels of referral to CR at the end of
the intervention.
Evaluation results will be used to
improve the intervention and to provide
guidance for future AHRQ
Dissemination and Implementation
projects. Two cohorts of ‘‘Partner
Hospitals,’’ up to 125 hospitals in total,
will receive training that disseminates
the importance of CR and ways to
enhance CR referral and then engages
them in efforts to implement Automatic
Referral with Care Coordination over
twelve month periods. The evaluation
will ascertain the diversity of hospitals
engaged, the activities that contributed
to (or hindered) their efforts, and the
types of support which they report
having been most (and least) useful.
This information will be used to
improve recruitment, technical
assistance, and tools for the second
cohort.
In addition, hospitals—including
those involved in the dissemination and
implementation support for Partner
Hospitals—will be invited to attend
Affinity Group virtual meetings
organized around specific topics of
interest which are not intrinsic to
Automatic Referral with Care
Coordination. Hospital staff engaged in
Affinity Groups will create a vibrant
Learning Community. The evaluation
will determine which Affinity Groups
engaged the most participants of the
Learning Community, and which
resources participants determined the
most useful. This information will be
used to develop resources which will be
available on a new, permanent website
dedicated to improving CR.
This study is being conducted by
AHRQ through its contractor, Abt
Associates Inc., pursuant to AHRQ’s
statutory authority to disseminate
government-funded research relevant to
comparative clinical effectiveness
research. 42 U.S.C. 299b-37(a).
Method of Data Collection
To collect data on the many facets of
the intervention, we will use multiple
data collection tools, each of which has
a specific purpose and set of
respondents.
1. Partner Hospital Champion Survey.
Each Partner Hospital will designate a
‘‘Champion,’’ who will coordinate
activities associated with implementing
Automatic Referral with Care
Coordination at the hospital, and
provide the Champion’s name and email
address. The Champion may have any
role in the hospital, although they are
expected in relevant positions, such as
cardiologists or quality improvement
managers. We will conduct online
surveys of 125 Champions (one
Champion per hospital). We will use the
email addresses to send the Champion
a survey at two points: Seven months
after the start of dissemination and
implementation to the Partner Hospitals
and at the end of the 12-month
dissemination and implementation
period. The first survey will focus on
four constructs. First, it will capture
data about the hospital context, such as
whether it had prior experience
customizing an electronic medical
record (EMR) or is a safety net hospital.
Second, it will address the hospital’s
decision to participate in TAKEheart.
Third, it will capture data on the CR
programs the hospital refers to, whether
the number or type has changed, and
why. Fourth, it will collect feedback on
the training and technical assistance
received. The second survey will focus
on three constructs. First, it will collect
feedback on the TAKEheart
components, including training,
technical assistance, and use of the
website. Second, we will ask about the
hospitals’ response to participating in
TAKEheart, such as changes to referral
workflow or CR programs. Third, we
will ask those Partner Hospitals which
have not completed the process of
implementing Automatic Referral with
Care Coordination whether they
anticipate continuing to work towards
that goal and their confidence in
succeeding.
2. Partner Hospital Interviews.
a. Interviews with Partner Hospital
Champions. We will select, from each
cohort, eight Partner Hospitals that
demonstrated a strong interest in
addressing underserved populations or
reducing disparities in participation in
cardiac rehabilitation. We will conduct
a key informant interview with the
Champion of each selected Partner
Hospital to delve into their response to
the information and guidance that was
disseminated to them and to describe
how they are addressing the needs of
underserved populations by
implementing Automatic Referral with
Care Coordination.
b. Interviews with Partner Hospital
cardiologists. We will select, from each
cohort, eight hospitals based on criteria
such as hospitals which serve specific
populations, or have the same EMRs,
which will inform their experience
customizing the EMR. We will conduct
semi-structured interviews with one
cardiologist at each of the selected
hospitals twice. In the second month of
the cohort for dissemination and
implementation, we will ask about their
needs, concerns, and expectations of the
program. In the 11th month of the
cohort implementation, we will
determine whether their concerns were
addressed appropriately and adequately.
c. Interviews with Partner Hospitals
that withdraw. We expect that a small
number of Partner Hospitals may
withdraw from the cohort. We will
identify these hospitals by their lack of
participation in training and technical
assistance events; technical assistance
providers will confirm their withdrawal.
We will interview up to nine
withdrawing hospitals to better
understand the reason for withdrawal
(e.g., a merger resulted in a loss of
support for the intervention, Champion
left), as well as facilitators of, and
barriers to, each hospital’s approach to
implementing Automatic Referral with
Care Coordination. If more than nine
hospitals withdraw, we will cease
interviewing.
3. Learning Community Participant
Survey. We will conduct online surveys
of 250 currently active Learning
Community participants at two points
in time, in months 18 and 31 of the
project. We will administer the survey
by sending a link to an online survey to
email addresses entered by virtual
meeting participants during registration.
The email will describe the purpose of
the survey.
4. Learning Community Follow-up
Survey. We will conduct a brief online
survey with up to 15 Learning
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Community participants following the
final virtual meeting for each of 10
Affinity Groups, to ascertain whether
the hospitals were able to act on what
they learned during the session. The
total sample will be 150 Learning
Community participants.
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 and what
can reasonably be requested of
participating health care organizations.
The number of respondents listed in
column A, Exhibit 1 reflects a projected
90% response rate for data collection
effort 1, and an 80% response rate for
efforts 3 and 4 below.
1. Partner Hospital Champion Survey.
We assumed 113 hospital champions
will complete the survey based on a
90% response rate. It is expected to take
up to 45 minutes to complete for a total
of 169.5 hours to complete.
2. Partner Hospital Interviews. In-
depth interviews will occur with select
Partner Hospital staff.
a. Interviews with Partner Hospital
Champions. We will have a single, 90
minute interview with eight Partner
Hospital Champions, in each cohort,
from Partner Hospitals that have a
common characteristic of particular
interest, for a total of 24 hours.
b. Interviews with Partner Hospital
cardiologists. We will hold individual,
up-to-30 minute interviews with eight
cardiologists, twice in each cohort, for a
total of 16 hours.
c. Interviews with Partner Hospitals
that withdraw. We will interview up to
nine withdrawing hospitals for no more
than 20 minutes to better understand
the reason for withdrawal as well as
facilitators and barriers, for a total of 2.7
hours.
3. Learning Community Participant
Survey. We assumed 200 Learning
Community participants will complete
the survey based on an 80% response
rate. It is expected to take up to 15
minutes to complete each survey for a
total of 100 hours.
4. Learning Community Follow-up
Survey. We will conduct a brief, up to
10 minute, online survey of participants
of each of just ten selected Affinity
Groups at two months after the virtual
meeting. We assumed 120 Learning
Community participants will complete
the survey based on an 80% response
rate. It is expected to take up to 15
minutes to complete each survey for a
total of 20.4 hours.
E
XHIBIT
1—E
STIMATED
A
NNUALIZED
B
URDEN
H
OURS
Data collection method or project activity A.
Number of
respondents
B.
Number of
responses per
respondent
C.
Hours per
response
D.
Total
burden
hours
1. Partner Hospital Champion Survey * ........................................................... 113 2 0.75 169.5
2a. Interviews with Partner Hospital Champions ............................................. 16 1 1.5 24.0
2b. Interviews with Partner Hospital Cardiologists .......................................... 16 2 0.5 16.0
2c. Interviews with Partner Hospitals that withdraw ........................................ 9 1 0.3 2.7
3. Learning Community Survey ** .................................................................... 200 2 0.25 100.0
4. Learning Community Follow-up Survey ** ................................................... 120 1 0.17 20.4
Total .......................................................................................................... 474 ........................ ........................ 332.6
* Number of respondents (Column A) reflects a sample size assuming a 90% response rate for this data collection effort.
** Number of respondents (Column A) reflects a sample size assuming an 80% response rate for this data collection effort.
Exhibit 2, below, presents the
estimated annualized cost burden
associated with the respondents’ time to
participate in this research. We obtained
median hourly wage rates for relevant
occupations from the Bureau of Labor &
Statistics on ‘‘Occupational
Employment Statistics, May 2018
Occupation Profiles’’ found at the
following URL on October 1, 2019:
https://www.bls.gov/oes/current/oes_
stru.htm#15-0000. We assumed that half
the Partner Hospital Champions will be
cardiologists and half will be Quality
Improvement managers. We calculated
the hourly rate of $72.27 by averaging
the median hourly wage rate for
cardiologists ($96.58, occupation code
29–1069) and medical and health
services managers ($47.95, occupation
code 11–1141). The occupation of
medical and health services managers
has been used for quality improvement
staff in other AHRQ projects. The total
cost burden is estimated to be about
$21,497.
E
XHIBIT
2—E
STIMATED
A
NNUALIZED
C
OST
B
URDEN
Data collection method or project activity A.
Number of
respondents
B.
Total burden
hours
Average
hourly
wage rate
Total cost
burden
1. Partner Hospital Champion Survey * ........................................................... 113 169.5 $72.27 $12,250
2a. Interviews with Partner Hospital Champions ............................................. 16 24.0 72.27 1,734
2b. Interviews with Partner Hospital Cardiologists .......................................... 16 16.0 96.58 1,545
2c. Interviews with Partner Hospitals that withdraw ........................................ 9 2.7 72.27 195
3. Learning Community Survey ** .................................................................... 200 100.0 47.95 4,795
4. Learning Community Follow-up Survey ** ................................................... 120 20.4 47.95 978
Total .......................................................................................................... 474 332.6 ........................ 21,497
* Number of respondents (Column A) reflects a sample size assuming a 90% response rate for this data collection effort.
** Number of respondents (Column A) reflects a sample size assuming an 80% response rate for this data collection effort.
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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: January 29, 2020.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2020–02112 Filed 2–3–20; 8:45 am]
BILLING CODE 4160–90–P
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
‘‘Evaluation of the SHARE Approach
Model.’’
DATES
: Comments on this notice must be
received by 60 days after date of
publication.
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
Evaluation of the SHARE Approach
Model
Shared decision making (SDM) occurs
when a health care provider and a
patient work together to make a health
care decision that is best for the patient.
Implementing SDM involves effective
communication between providers and
patients to take into account evidence-
based information about available
options, the provider’s knowledge and
experience, and the patient’s values and
preferences in reaching the best health
care decision for a patient. To facilitate
SDM in all care delivery settings, AHRQ
developed the five-step SHARE
Approach, which includes exploring
and comparing the benefits, harms, and
risks of each option through meaningful
dialogue about what matters most to the
patient. Using the SHARE Approach
also builds a trusting and lasting
relationship between health care
professionals and patients.
SDM is increasingly included in
clinical care guidelines, and in some
cases is even mandated. While there is
considerable interest in improving SDM
across broad health care settings, less is
known about how to effectively
implement SDM. There is evidence that
SDM is often not conducted effectively
in practice, and identifying ways to
improve SDM has therefore become an
imperative. Lack of clinician support
and education have been identified as
important barriers to SDM.
The SHARE Approach was released in
2015 by AHRQ as a clinician-facing
toolkit that teaches clinicians skills to
facilitate SDM across a broad range of
clinical contexts. While several
implementation success stories have
been shared with AHRQ, to date there
has been no formal evaluation of the
effectiveness of the SHARE Approach
materials for improving SDM in primary
and specialty care settings for which it
was designed. As a result, challenges
that may be faced by practices who wish
to implement the SHARE Approach are
currently unknown. Without research to
identify and address these issues,
practices and organization may be
unable to effectively implement the
SHARE Approach and may be unwilling
to do so absent evidence of its
effectiveness at improving SDM
outcomes.
The Evaluation of the SHARE
Approach Model project aims to revise
the SHARE Approach toolkit to remove
outdated references and increase
applicability for SDM in contexts
involving problem solving, evaluate the
implementation of the SHARE
Approach model in eight primary care
and four cardiology clinics, and
evaluate the effectiveness of the SHARE
Approach model at improving SDM.
Method of Collection
The purpose of this clearance request
is to collect the information needed to
evaluate the implementation and
effectiveness of the modified SHARE
Approach materials. Specifically, the
data collection activities requested in
this clearance are:
1. Brief surveys of physicians,
advanced practice providers, other
clinicians, nurses and other staff in 12
clinics immediately following the
SHARE Approach training in each
clinic.
2. A brief survey of physicians,
advanced practice providers, other
clinicians, nurses and other staff in 12
clinics one month following the SHARE
Approach training in each clinic.
3. A short card survey completed by
patients in the 12 clinics immediately
following a clinic visit with a physician
or advanced practice provider.
4. A short card survey completed by
physicians or advanced practice
providers in the 12 clinics immediately
following a clinic visit with a patient.
5. Audio recordings of patient-
provider (physician or advanced
practice provider) encounters in clinic
examination rooms in the 12 clinics.
This study is being conducted by
AHRQ through its contractor, the
University of Colorado, 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
clinical practice, including primary care
and practice-oriented research. 42 U.S.C
299a(a)(4).
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated burden
hours over the full 3 years of this
clearance for the respondents’ time to
participate in the research activities that
will be conducted under this clearance.
Brief card surveys will be completed by
both patients and clinicians. The
physician/advanced practice provider
card survey will require a maximum of
60 seconds. The patient card survey will
take a maximum of 2 minutes. Number
of observations will include a maximum
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