Supplemental Evidence and Data Request on Management of High-Need, High-Cost (HNHC) Patients: A Realist and Systematic Review, 68456-68458 [2019-26953]
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68456
Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices
Notice and request for
comments.
ACTION:
In accordance with the
Paperwork Reduction Act of 1995, and
the Office of Management and Budget
(OMB) regulations, DoD, GSA, and
NASA invite the public to comment on
a revision and renewal concerning
reporting purchases from sources
outside the United States. DoD, GSA,
and NASA invite comments on:
Whether the proposed collection of
information is necessary for the proper
performance of the functions of Federal
Government acquisitions, including
whether the information will have
practical utility; the accuracy of the
estimate of the burden of the proposed
information collection; ways to enhance
the quality, utility, and clarity of the
information to be collected; and ways to
minimize the burden of the information
collection on respondents, including the
use of automated collection techniques
or other forms of information
technology. OMB has approved this
information collection for use through
March 31, 2020. DoD, GSA, and NASA
propose that OMB extend its approval
for use for three additional years beyond
the current expiration date.
DATES: DoD, GSA, and NASA will
consider all comments received by
February 14, 2020.
ADDRESSES: DoD, GSA, and NASA
invite interested persons to submit
comments on this collection by either of
the following methods:
• Federal eRulemaking Portal: This
website provides the ability to type
short comments directly into the
comment field or attach a file for
lengthier comments. Go to https://
www.regulations.gov and follow the
instructions on the site.
• Mail: General Services
Administration, Regulatory Secretariat
Division (MVCB), 1800 F Street NW,
Washington, DC 20405. ATTN: Lois
Mandell/IC 9000–0161, Reporting
Purchases from Sources Outside the
United States.
Instructions: All items submitted
must cite Information Collection 9000–
0161, Reporting Purchases from Sources
Outside the United States. Comments
received generally will be posted
without change to https://
www.regulations.gov, including any
personal and/or business confidential
information provided. To confirm
receipt of your comment(s), please
check www.regulations.gov,
approximately two-to-three days after
submission to verify posting (except
allow 30 days for posting of comments
submitted by mail).
SUMMARY:
lotter on DSKBCFDHB2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
19:21 Dec 13, 2019
Jkt 250001
Zenaida Delgado, Procurement Analyst,
at telephone 202–969–7207, or
zenaida.delgado@gsa.gov.
SUPPLEMENTARY INFORMATION:
A. OMB control number, Title, and
any Associated Form(s): 9000–0161,
Reporting Purchases from Sources
Outside the United States.
B. Need and Uses: This clearance
covers the information that offerors
must submit to comply with the Federal
Acquisition Regulation (FAR) provision
52.225–18, Place of Manufacture. This
provision requires offerors of
manufactured end products to provide
information as to whether the offered
end products are predominantly
manufactured in the United States or
outside the United States.
Contracting officers use the
information as the basis for entry into
the Federal Procurement Data System
for further data on the rationale for
purchasing foreign manufactured items.
The data is necessary for analysis of the
application of the Buy American statute
and the trade agreements.
C. Annual Burden:
Respondents: 30,740.
Total Annual Responses: 2,908,096.
Total Burden Hours: 29,081.
Obtaining Copies: Requesters may
obtain a copy of the information
collection documents from the General
Services Administration, Regulatory
Secretariat Division (MVCB), 1800 F
Street NW, Washington, DC 20405,
telephone 202–501–4755.
Please cite OMB Control No. 9000–
0161, Reporting Purchases from Sources
Outside the United States, in all
correspondence.
Dated: December 10, 2019.
Janet Fry,
Director, Federal Acquisition Policy Division,
Office of Governmentwide Acquisition Policy,
Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2019–26998 Filed 12–13–19; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Management of High-Need,
High-Cost (HNHC) Patients: A Realist
and Systematic Review
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions
AGENCY:
PO 00000
Frm 00065
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Sfmt 4703
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
the public. Scientific information is
being solicited to inform our review on
Management of High-Need, High-Cost
Patients: A Realist and Systematic
Review, which is currently being
conducted by the AHRQ’s Evidencebased Practice Centers (EPC) Program.
Access to published and unpublished
pertinent scientific information will
improve the quality of this review.
DATES: Submission Deadline on or
before 30 days after date of publication.
ADDRESSES: Email submissions: epc@
ahrq.hhs.gov.
Print submissions:
Mailing Address: Center for Evidence
and Practice Improvement, Agency for
Healthcare Research and Quality,
ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A,
Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.):
Center for Evidence and Practice
Improvement, Agency for Healthcare
Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane,
Mail Stop 06E77D, Rockville, MD
20857.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Jenae Benns, Telephone: 301–427–1496
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Management of High-Need,
High-Cost Patients: A Realist and
Systematic Review. AHRQ is
conducting this systematic review
pursuant to Section 902(a) of the Public
Health Service Act, 42 U.S.C. 299a(a).
The EPC Program is dedicated to
identifying as many studies as possible
that are relevant to the questions for
each of its reviews. In order to do so, we
are supplementing the usual manual
and electronic database searches of the
literature by requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Management of HighNeed, High-Cost Patients: A Realist and
Systematic Review, including those that
describe adverse events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
products/high-utilizers-health-care/
protocol.
This is to notify the public that the
EPC Program would find the following
information on Management of HighNeed, High-Cost Patients: A Realist and
Systematic Review helpful:
E:\FR\FM\16DEN1.SGM
16DEN1
Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices
D A list of completed studies that
your organization has sponsored for this
indication. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including the following
elements: Study number, study period,
design, methodology, indication and
diagnosis, proper use instructions,
inclusion and exclusion criteria,
primary and secondary outcomes,
baseline characteristics, number of
patients screened/eligible/enrolled/lost
to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
D A list of ongoing studies that your
organization has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, and primary and secondary
outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this indication and an
index outlining the relevant information
in each submitted file.
Your contribution is very beneficial to
the Program. Materials submitted must
be publicly available or able to be made
public. Materials that are considered
confidential; marketing materials; study
types not included in the review; or
information on indications not included
in the review cannot be used by the EPC
Program. This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EPC Program website and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://
www.effectivehealthcare.ahrq.gov/
email-updates.
The systematic review will answer the
following questions. This information is
provided as background. AHRQ is not
requesting that the public provide
answers to these questions.
Key Questions (KQ)
KQ 1. What criteria identify can be
used to predict that patients will be
HNHC and why?
KQ 1a. How do criteria incorporate
patient clinical characteristics?
KQ 1b. How do criteria incorporate
patient health behaviors and
68457
sociodemographic characteristics (e.g.,
age, social determinants of health,
insurance status and source of coverage,
and access to the health care system)?
KQ 1c. How do criteria incorporate
types, amount, duration, and patterns of
persistent use of potentially preventable
or modifiable health care use?
KQ 1d. Do criteria differ at the payer,
health care system, or provider levels?
KQ 1e. How can observed or predicted
potentially preventable or modifiable
high use of health care be differentiated
from necessary and appropriate use?
KQ 2. What are the mechanisms that
lead to reductions in potentially
preventable or modifiable health care
use and result in improved health
outcomes and cost savings in
interventions serving HNHC patients?
KQ 2a. What are the important
contexts, such as the characteristics of
the HNHC patients, the broader health
care delivery system, and the
community, that impact whether
mechanisms facilitate the desired
outcomes?
KQ 3. Overall, what is the
effectiveness and harms of
interventions, included in answering
KQ 2, in reducing potentially
preventable or modifiable health care
use and costs and improving health
outcomes among HNHC patients?
PICOTS
lotter on DSKBCFDHB2PROD with NOTICES
[Populations, Interventions, Comparators, Outcomes, Timing, Settings]
PICOTS
Inclusion
Exclusion
Population .......
KQs 1, 2, and 3: Noninstitutionalized adults, 18 years of age or older .....
Patients receiving a high level of health care services that are considered appropriate for their condition OR high level of health care services are measured for less than 1 year OR end-of-life care.
Intervention .....
KQ 1: One or more years of potentially preventable or modifiable high
health care cost and/or use.
KQs 2 and 3, two groups.
(a) HNHC patients with one or more years of potentially preventable or
modifiable high health care cost and/or use;.
(b) HNHC patients with one or more years of potentially preventable or
modifiable high health care cost and/use AND either 2 or more chronic physical health conditions, or a combination of 1 or more chronic
physical health conditions and 1 or more behavioral health conditions.
KQ 1: Not relevant, interventions not necessary for inclusion ...................
Comparator .....
Outcomes ........
VerDate Sep<11>2014
KQs 2 and 3;.
Alternative delivery models (e.g., Accountable Care Organizations, coordinated care organizations, health homes, home-based primary
care, behavioral health integration).
System- or practice-level interventions (e.g., emergency department
alerts, hotspotting).
Patient supportive services (e.g., community health workers, social
workers, patient navigators, care coordinators, case and care managers, intensive primary care support, medication management, health
reliance specialists, self-management instruction, and peer-to-peer
support).
Social determinants of health-related interventions (e.g., transportation,
health literacy, housing support, caregiver support).
KQ 1: Comparison population or no comparator .......................................
KQ 2: Any intervention, treatment as usual, or no comparator intervention.
KQ 3: Any intervention or treatment as usual.
KQ 1: Population characteristics described or predicted ...........................
KQs 1, 2, and 3:.
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KQs 2 and 3: Interventions for which the relevance for and impact on
HNHC patients cannot be determined.
KQ 3: No comparator.
All other outcomes, including behavioral health outcomes.
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Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices
PICOTS—Continued
[Populations, Interventions, Comparators, Outcomes, Timing, Settings]
PICOTS
Time frame ......
Settings ...........
Study design ...
Language ........
Publication type
Inclusion
Health care use: Decreases in emergency department visits, emergency
management services use, and hospitalizations; changes in primary
care or specialist visits or other necessary and appropriate types of
care (e.g., care manager visits, telephone followup) and use of support services.
Patient health behavior (e.g., treatment adherence, empowerment,
knowledge, self-care).
Patient health outcomes: All-cause mortality, disease and condition-specific outcomes, health indicators, quality of life.
Patient satisfaction with care.
Physicians’ and health professionals’ satisfaction with clinical practice.
Costs.
Patient and health professional harms such as increased barriers to necessary care, clinician time, and/or resource trade-offs of other duties.
Potentially preventable or modifiable high cost health care use measured for 1 year or more.
KQ 3: Measurement of outcomes at 1 year or more after implementation
of the intervention.
Health care and support services delivery settings, including outpatient,
emergency department, the broader health care delivery environment,
community characteristics related to social determinants of health.
KQ 1: United States.
KQs 2 and 3: Patient-level interventions: very high human development
index countries; Health system or payer-level interventions: United
States.
KQs 1 and 2: All study designs except reviews summarizing across
original studies or interventions.
KQ 3: Randomized controlled trials, cluster randomized trials, cohort
studies, case-control studies, quasi-experimental designs with a comparison group.
Studies published in English ......................................................................
All publications that allow abstraction and interpretation of findings .........
Dated: December 10, 2019.
Virginia Mackay-Smith,
Associate Director.
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number CDC–2019–0107, NIOSH–
331]
NIOSH Center for Motor Vehicle Safety
Strategic Plan, 2020–2029
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Request for information and
comment.
AGENCY:
The National Institute for
Occupational Safety and Health of the
Centers for Disease Control and
Prevention announces the availability of
a draft strategic plan titled NIOSH
Center for Motor Vehicle Safety
Strategic Plan, 2020–2029 now available
for public comment.
DATES: Electronic or written comments
must be received by February 14, 2020.
lotter on DSKBCFDHB2PROD with NOTICES
SUMMARY:
19:21 Dec 13, 2019
Shorter time periods.
Institutional care settings, such as hospitals, skilled nursing, long-term
care facilities, and prisons or jails.
KQ 3: All other designs.
Studies published in languages other than English.
KQ 3 only: Abstract-only publications.
You may submit comments,
identified by CDC–2019–0107 and
docket number NIOSH–331, by any of
the following methods:
• Federal eRulemaking Portal:
https://www.regulations.gov Follow the
instructions for submitting comments.
• Mail: National Institute for
Occupational Safety and Health, NIOSH
Docket Office, 1090 Tusculum Avenue,
MS C–34, Cincinnati, Ohio 45226–1998.
Instructions: All information received
in response to this notice must include
the agency name and docket number
[CDC–2019–0107; NIOSH–331]. All
relevant comments received will be
posted without change to https://
www.regulations.gov, including any
personal information provided. All
electronic comments should be
formatted as Microsoft Word. For access
to the docket to read background
documents or comments received, go to
https://www.regulations.gov. All
information received in response to this
notice will also be available for public
examination and copying at the NIOSH
Docket Office, 1150 Tusculum Avenue,
Room 155, Cincinnati, OH 45226–1998.
FOR FURTHER INFORMATION CONTACT: Kyla
Retzer, Western States Division, P.O.
Box 25226, Denver, Colorado 80225–
0226, (303) 236–5934 (not a toll-free
number), kretzer@cdc.gov OR Dr. Rosa
Rodriguez-Acosta, Division of Safety
Research, 1095 Willowdale Road, MS
ADDRESSES:
[FR Doc. 2019–26953 Filed 12–13–19; 8:45 am]
VerDate Sep<11>2014
Exclusion
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1808, Morgantown, West Virginia,
26505–2888, (304) 285–6299 (not a tollfree number), rer3@cdc.gov.
SUPPLEMENTARY INFORMATION:
Background: The National Institute
for Occupational Safety and Health
(NIOSH) is seeking input on the draft
NIOSH Center for Motor Vehicle Safety
Strategic Plan, 2020–2029.
Motor vehicle crashes are the leading
cause of work-related injury deaths in
the United States. Millions of workers
drive or ride in a motor vehicle as part
of their jobs. The risk affects workers in
all industries and occupations who
drive as part of their job, whether they
use a tractor-trailer or a passenger
vehicle.
NIOSH is the only part of the U.S.
Federal Government whose mission
includes prevention of work-related
crashes and resulting injuries for
workers who drive all types of vehicles
(not just the commercial motor vehicles
regulated by the U.S. Department of
Transportation).
NIOSH requests input on its strategic
direction for research and
communication to prevent work-related
motor vehicle crashes and injuries. This
plan aligns with the priority industry
sectors (i.e., oil and gas extraction;
public safety; transportation,
warehousing, and utilities; and
wholesale and retail trade) identified in
E:\FR\FM\16DEN1.SGM
16DEN1
Agencies
[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Pages 68456-68458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26953]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Management of High-
Need, High-Cost (HNHC) Patients: A Realist and Systematic Review
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions
-----------------------------------------------------------------------
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on Management of
High-Need, High-Cost Patients: A Realist and Systematic Review, which
is currently being conducted by the AHRQ's Evidence-based Practice
Centers (EPC) Program. Access to published and unpublished pertinent
scientific information will improve the quality of this review.
DATES: Submission Deadline on or before 30 days after date of
publication.
ADDRESSES: Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement,
Agency for Healthcare Research and Quality, ATTN: EPC SEADs
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.): Center for Evidence and
Practice Improvement, Agency for Healthcare Research and Quality, ATTN:
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Management of High-
Need, High-Cost Patients: A Realist and Systematic Review. AHRQ is
conducting this systematic review pursuant to Section 902(a) of the
Public Health Service Act, 42 U.S.C. 299a(a).
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Management of High-Need, High-Cost Patients: A Realist
and Systematic Review, including those that describe adverse events.
The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/high-utilizers-health-care/protocol.
This is to notify the public that the EPC Program would find the
following information on Management of High-Need, High-Cost Patients: A
Realist and Systematic Review helpful:
[[Page 68457]]
[ssquf] A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements: Study
number, study period, design, methodology, indication and diagnosis,
proper use instructions, inclusion and exclusion criteria, primary and
secondary outcomes, baseline characteristics, number of patients
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including a study number, the study period,
design, methodology, indication and diagnosis, proper use instructions,
inclusion and exclusion criteria, and primary and secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this indication and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on indications not
included in the review cannot be used by the EPC Program. This is a
voluntary request for information, and all costs for complying with
this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
The systematic review will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions.
Key Questions (KQ)
KQ 1. What criteria identify can be used to predict that patients
will be HNHC and why?
KQ 1a. How do criteria incorporate patient clinical
characteristics?
KQ 1b. How do criteria incorporate patient health behaviors and
sociodemographic characteristics (e.g., age, social determinants of
health, insurance status and source of coverage, and access to the
health care system)?
KQ 1c. How do criteria incorporate types, amount, duration, and
patterns of persistent use of potentially preventable or modifiable
health care use?
KQ 1d. Do criteria differ at the payer, health care system, or
provider levels?
KQ 1e. How can observed or predicted potentially preventable or
modifiable high use of health care be differentiated from necessary and
appropriate use?
KQ 2. What are the mechanisms that lead to reductions in
potentially preventable or modifiable health care use and result in
improved health outcomes and cost savings in interventions serving HNHC
patients?
KQ 2a. What are the important contexts, such as the characteristics
of the HNHC patients, the broader health care delivery system, and the
community, that impact whether mechanisms facilitate the desired
outcomes?
KQ 3. Overall, what is the effectiveness and harms of
interventions, included in answering KQ 2, in reducing potentially
preventable or modifiable health care use and costs and improving
health outcomes among HNHC patients?
PICOTS
[Populations, Interventions, Comparators, Outcomes, Timing, Settings]
----------------------------------------------------------------------------------------------------------------
PICOTS Inclusion Exclusion
----------------------------------------------------------------------------------------------------------------
Population......................... KQs 1, 2, and 3: Noninstitutionalized Patients receiving a high level of
adults, 18 years of age or older. health care services that are
considered appropriate for their
condition OR high level of health
care services are measured for less
than 1 year OR end-of-life care.
KQ 1: One or more years of
potentially preventable or
modifiable high health care cost and/
or use.
KQs 2 and 3, two groups..............
(a) HNHC patients with one or more
years of potentially preventable or
modifiable high health care cost and/
or use;.
(b) HNHC patients with one or more
years of potentially preventable or
modifiable high health care cost and/
use AND either 2 or more chronic
physical health conditions, or a
combination of 1 or more chronic
physical health conditions and 1 or
more behavioral health conditions.
Intervention....................... KQ 1: Not relevant, interventions not KQs 2 and 3: Interventions for which
necessary for inclusion. the relevance for and impact on
HNHC patients cannot be determined.
KQs 2 and 3;.........................
Alternative delivery models (e.g.,
Accountable Care Organizations,
coordinated care organizations,
health homes, home-based primary
care, behavioral health integration).
System- or practice-level
interventions (e.g., emergency
department alerts, hotspotting).
Patient supportive services (e.g.,
community health workers, social
workers, patient navigators, care
coordinators, case and care
managers, intensive primary care
support, medication management,
health reliance specialists, self-
management instruction, and peer-to-
peer support).
Social determinants of health-related
interventions (e.g., transportation,
health literacy, housing support,
caregiver support).
Comparator......................... KQ 1: Comparison population or no KQ 3: No comparator.
comparator.
KQ 2: Any intervention, treatment as
usual, or no comparator intervention.
KQ 3: Any intervention or treatment
as usual.
Outcomes........................... KQ 1: Population characteristics All other outcomes, including
described or predicted. behavioral health outcomes.
KQs 1, 2, and 3:.....................
[[Page 68458]]
Health care use: Decreases in
emergency department visits,
emergency management services use,
and hospitalizations; changes in
primary care or specialist visits or
other necessary and appropriate
types of care (e.g., care manager
visits, telephone followup) and use
of support services.
Patient health behavior (e.g.,
treatment adherence, empowerment,
knowledge, self-care).
Patient health outcomes: All-cause
mortality, disease and condition-
specific outcomes, health
indicators, quality of life.
Patient satisfaction with care.......
Physicians' and health professionals'
satisfaction with clinical practice.
Costs................................
Patient and health professional harms
such as increased barriers to
necessary care, clinician time, and/
or resource trade-offs of other
duties.
Time frame......................... Potentially preventable or modifiable Shorter time periods.
high cost health care use measured
for 1 year or more.
KQ 3: Measurement of outcomes at 1
year or more after implementation of
the intervention.
Settings........................... Health care and support services Institutional care settings, such as
delivery settings, including hospitals, skilled nursing, long-
outpatient, emergency department, term care facilities, and prisons
the broader health care delivery or jails.
environment, community
characteristics related to social
determinants of health.
KQ 1: United States..................
KQs 2 and 3: Patient-level
interventions: very high human
development index countries; Health
system or payer-level interventions:
United States.
Study design....................... KQs 1 and 2: All study designs except KQ 3: All other designs.
reviews summarizing across original
studies or interventions.
KQ 3: Randomized controlled trials,
cluster randomized trials, cohort
studies, case-control studies, quasi-
experimental designs with a
comparison group.
Language........................... Studies published in English......... Studies published in languages other
than English.
Publication type................... All publications that allow KQ 3 only: Abstract-only
abstraction and interpretation of publications.
findings.
----------------------------------------------------------------------------------------------------------------
Dated: December 10, 2019.
Virginia Mackay-Smith,
Associate Director.
[FR Doc. 2019-26953 Filed 12-13-19; 8:45 am]
BILLING CODE 4160-90-P