Supplemental Evidence and Data Request on Mixed Methods Review-Integrating Palliative Care With Chronic Disease Management in Ambulatory Care, 3691-3693 [2020-00903]
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Federal Register / Vol. 85, No. 14 / Wednesday, January 22, 2020 / Notices
Dated: December 27,2019.
David A. Shive,
Chief Information Officer.
[FR Doc. 2019–28347 Filed 1–21–20; 8:45 am]
BILLING CODE 6820–WY–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Mixed Methods Review—
Integrating Palliative Care With
Chronic Disease Management in
Ambulatory Care
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for Supplemental
Evidence and Data Submissions.
AGENCY:
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
Mixed Methods Review—Integrating
Palliative Care with Chronic Disease
Management in Ambulatory Care,
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published and unpublished pertinent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
in the Federal Register.
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:
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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 Mixed Methods Review—
Integrating Palliative Care with Chronic
VerDate Sep<11>2014
16:42 Jan 21, 2020
Jkt 250001
Disease Management in Ambulatory
Care. 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 Mixed Methods Review—
Integrating Palliative Care with Chronic
Disease Management in Ambulatory
Care, including those that describe
adverse events. The entire research
protocol is available online at: https://
effectivehealthcare.ahrq.gov/products/
palliative-care-integration/protocol.
This is to notify the public that the
EPC Program would find the following
information on Mixed Methods
Review—Integrating Palliative Care with
Chronic Disease Management in
Ambulatory Care helpful:
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
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3691
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.effective
healthcare.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)
Five questions about the integration of
palliative care in ambulatory care
will be addressed:
1. How can we identify those patients
who could benefit from palliative
care in ambulatory care settings?
2. What educational resources are
available for patients and caregivers
in ambulatory care about palliative
care?
3. What palliative care decision
making tools are available for
clinicians, patients and caregivers
in ambulatory care?
4. What educational resources are
available for non-palliative care
clinicians about palliative care in
ambulatory settings?
5. What are the models for integrating
palliative care into ambulatory
settings?
For each of these questions, three parts
will be addressed:
• What is available? (part a of
questions)
• What is the effectiveness? (part b of
questions)
• How is it implemented? (part c of
questions)
The following are the Key Questions
to be addressed in this mixed methods
review:
KQ 1:
KQ1a. What prediction models, tools,
triggers and guidelines and position
statements are available about how to
identify when and which patients with
serious life-threatening chronic illness
or conditions in ambulatory settings
could benefit from palliative care?
KQ1b. What is the effectiveness of
prediction models, tools and triggers for
identifying when and which patients
with serious life-threatening chronic
illness or conditions in ambulatory
settings could benefit from palliative
care?
KQ1c. How have prediction models,
tools and triggers for identifying when
E:\FR\FM\22JAN1.SGM
22JAN1
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3692
Federal Register / Vol. 85, No. 14 / Wednesday, January 22, 2020 / Notices
and which patients with serious lifethreatening chronic illness or conditions
in ambulatory settings could benefit
from palliative care been implemented?
What is the evidence for how, when and
for which patients they could best be
implemented in care?
KQ 2:
KQ2a. What educational materials
and resources are available about
palliative care and palliative care
options for patients with serious lifethreatening chronic illness or conditions
in ambulatory settings and their
caregivers?
KQ2b. What is the effectiveness of
educational materials and resources
about palliative care and palliative care
options for patients with serious lifethreatening chronic illness or conditions
and their caregivers in ambulatory
settings?
KQ2c. How have educational
materials and resources about palliative
care and palliative care options for
patients with serious life-threatening
chronic illness or conditions and their
caregivers in ambulatory settings been
implemented? What is the evidence for
how, when and for which patients and
caregivers they could best be
implemented in care?
KQ 3:
KQ3a. What palliative care shared
decision-making tools are available for
patients with serious life-threatening
chronic illness or conditions in
ambulatory settings and their
caregivers?
KQ3b. What is the effectiveness of
palliative care shared decision-making
tools for patients with serious lifethreatening chronic illness or conditions
in ambulatory settings and their
caregivers?
KQ3c. How have palliative care
shared decision-making tools been
implemented for patients with serious
life-threatening chronic illness or
conditions in ambulatory settings and
their caregivers? What is the evidence
for how, when and for which patients
and caregivers they could best be
implemented in care?
KQ 4:
KQ4a. What palliative care training
and educational materials are available
for non-palliative care clinicians caring
for patients with serious life-threatening
chronic illness or conditions in
ambulatory settings?
KQ4b. What is the effectiveness of
palliative care training and educational
materials (with or without other
intervention components) for nonpalliative care clinicians caring for
patients with serious life-threatening
chronic illness or conditions in
ambulatory settings?
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16:42 Jan 21, 2020
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KQ4c. How have palliative care
training and educational materials (with
or without other intervention
components) for non-palliative care
clinicians caring for patients with
serious life-threatening chronic illness
or conditions in ambulatory settings
been implemented? What is the
evidence for how, when and for which
clinicians they could best be
implemented in care?
KQ 5:
KQ5a. What models (i.e., stepped
care, consultative care, shared care,
collaborative care, coaching, integrating
social workers into practice, and
palliative care approaches provided by
non-palliative care specialists) for
integrating palliative care have been
developed for patients with serious lifethreatening chronic illness or conditions
in ambulatory settings?
KQ5b. What is the effectiveness of
models (i.e., stepped care, consultative
care, shared care, collaborative care,
coaching, integrating social workers into
practice, and palliative care approaches
provided by non-palliative care
specialists) or multimodal interventions
for integrating palliative care for
patients with serious life-threatening
chronic illness or conditions in
ambulatory settings?
KQ5c. What are components of
models for integrating palliative care in
ambulatory settings? What models have
been implemented for key
subpopulations? What components and
characteristics of these models
contribute to their effective
implementation? What is the evidence
for how, when and for which patients
they could best be implemented in care?
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing,
Settings)
• Population(s):
Æ Adults age 18 or older with serious
life-threatening chronic illness or
conditions (other than those adults
only with cancer) and their
caregivers, being seen in
ambulatory settings (KQ 1,2,3,5)
Æ Clinicians practicing in ambulatory
settings listed below (KQ 4)
• Interventions:
Æ KQ1: Prediction models, tools or
triggers to identify patients for
palliative care in ambulatory
settings
Æ KQ2: Educational materials and
resources for patients and/or
caregivers about palliative care in
ambulatory settings
Æ KQ3: Palliative care shared
decision-making tools and
resources for clinicians and patients
and/or caregivers in ambulatory
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Fmt 4703
Sfmt 4703
settings
Æ KQ4: Palliative care training or
educational materials for nonpalliative care clinicians in
ambulatory settings
Æ KQ5: Models for integrating
palliative care in ambulatory
settings
• Comparators (for part (b) KQ):
Comparators between:
Æ KQ1: Prediction models, tools or
triggers to identify patients for
palliative care in ambulatory
settings
Æ KQ2: Educational materials and
resources for patients and/or
caregivers about palliative care in
ambulatory settings
Æ KQ3: Palliative care shared
decision-making tools and
resources for clinicians and patients
and/or caregivers in ambulatory
settings
Æ KQ4: Palliative care training or
educational materials for clinicians
in ambulatory settings
Æ KQ5: Models for integrating
palliative care or multimodal
interventions in ambulatory settings
Æ As well as with usual care for all
KQs
• Outcomes (for part (b) KQ):
Æ Intermediate (Excludes clinician selfreport):
D Knowledge (clinicians, patients,
caregivers) (KQ2, KQ4)
D Awareness (clinicians, patients,
caregivers) (KQ2, KQ4)
D Skills (clinicians) (KQ4)
Æ Final (All apply to all KQ) (In
hierarchy from patient-centered to
clinician to health system. All
patient or caregiver-reported
outcomes must be measured by a
validated instrument. All outcomes
must relate to components of care
relevant to serious, life-threatening
chronic illness or conditions.)
D Patient or caregiver satisfaction
D Patient or caregiver health-related
quality of life
D Patient or caregiver symptoms of
depression or anxiety or
psychological well-being
D Caregiver burden, caregiver impact
or caregiver strain
D Patient symptoms or symptom
burden (includes multidimensional
symptom tools and key symptoms
of pain, dyspnea, fatigue). This
must include patient-reported
symptom measurement (or
caregiver-reported for patients
unable to report).
D Concordance between patient
preferences for care and care
received
D Clinician job satisfaction or
burnout, perceptions of teamwork
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Federal Register / Vol. 85, No. 14 / Wednesday, January 22, 2020 / Notices
D Healthcare utilization (use and
length of hospice care,
hospitalizations, advance directive
documentation) and costs and
resource use (use of outpatient
clinician services, including
palliative care)
Æ Adverse effects
D Medication side effects
D Dropouts
• Timing
Æ Any timing
• Settings
Æ Ambulatory primary and specialty
care, including geriatrics,
nephrology, pulmonology,
cardiology, and neurology
Æ U.S.-based studies, as systems of
care differ in other countries
Dated: January 15, 2020.
Virginia L. Mackay-Smith,
Associate Director, Office of the Director,
AHRQ.
[FR Doc. 2020–00903 Filed 1–21–20; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[0Day–20–0006; Docket No. CDC–2019–
0118]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on
Statements in Support of Application of
Waiver of Inadmissibility (0920–0006).
CDC uses the information collected in
0920–0006 to review Class A medical
waiver applications for prospective
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SUMMARY:
VerDate Sep<11>2014
16:42 Jan 21, 2020
Jkt 250001
immigrants to the United States. CDC
assists DHS/USCIS in determining
whether or not a prospective immigrant
with a Class A mental health
designation may be admitted into the
United States.
DATES: CDC must receive written
comments on or before March 23, 2020.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0118 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS–D74, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger, of
the Information Collection Review
Office, Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
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3693
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.
Proposed Project
Statements in Support of Application
of Waiver of Inadmissibility (OMB
Control No. 0920–0006 Exp. 6/30/
2020)—Revision—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
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with specific health related conditions
are ineligible for admission into the
United States. The Attorney General
may waive application of this
inadmissibility on health-related
grounds if an application for waiver is
filed and approved by the consular
office considering the application for
visa. CDC uses this application
primarily to collect information to
establish and maintain records of waiver
applicants in order to notify the U.S.
Citizenship and Immigration Services
when terms, conditions and controls
imposed by waiver are not met.
The purpose of this Revision is to
remove information collections for form
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information about the evaluation report
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This results in a reduction of 67 burden
hours. CDC requests approval for 33
annual burden hours.
E:\FR\FM\22JAN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 14 (Wednesday, January 22, 2020)]
[Notices]
[Pages 3691-3693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00903]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Mixed Methods Review--
Integrating Palliative Care With Chronic Disease Management in
Ambulatory Care
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 Mixed Methods
Review--Integrating Palliative Care with Chronic Disease Management in
Ambulatory Care, 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 in the Federal Register.
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 Mixed Methods Review--
Integrating Palliative Care with Chronic Disease Management in
Ambulatory Care. 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 Mixed Methods Review--Integrating Palliative Care with
Chronic Disease Management in Ambulatory Care, including those that
describe adverse events. The entire research protocol is available
online at: https://effectivehealthcare.ahrq.gov/products/palliative-care-integration/protocol.
This is to notify the public that the EPC Program would find the
following information on Mixed Methods Review--Integrating Palliative
Care with Chronic Disease Management in Ambulatory Care helpful:
[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)
Five questions about the integration of palliative care in ambulatory
care will be addressed:
1. How can we identify those patients who could benefit from
palliative care in ambulatory care settings?
2. What educational resources are available for patients and
caregivers in ambulatory care about palliative care?
3. What palliative care decision making tools are available for
clinicians, patients and caregivers in ambulatory care?
4. What educational resources are available for non-palliative care
clinicians about palliative care in ambulatory settings?
5. What are the models for integrating palliative care into
ambulatory settings?
For each of these questions, three parts will be addressed:
What is available? (part a of questions)
What is the effectiveness? (part b of questions)
How is it implemented? (part c of questions)
The following are the Key Questions to be addressed in this mixed
methods review:
KQ 1:
KQ1a. What prediction models, tools, triggers and guidelines and
position statements are available about how to identify when and which
patients with serious life-threatening chronic illness or conditions in
ambulatory settings could benefit from palliative care?
KQ1b. What is the effectiveness of prediction models, tools and
triggers for identifying when and which patients with serious life-
threatening chronic illness or conditions in ambulatory settings could
benefit from palliative care?
KQ1c. How have prediction models, tools and triggers for
identifying when
[[Page 3692]]
and which patients with serious life-threatening chronic illness or
conditions in ambulatory settings could benefit from palliative care
been implemented? What is the evidence for how, when and for which
patients they could best be implemented in care?
KQ 2:
KQ2a. What educational materials and resources are available about
palliative care and palliative care options for patients with serious
life-threatening chronic illness or conditions in ambulatory settings
and their caregivers?
KQ2b. What is the effectiveness of educational materials and
resources about palliative care and palliative care options for
patients with serious life-threatening chronic illness or conditions
and their caregivers in ambulatory settings?
KQ2c. How have educational materials and resources about palliative
care and palliative care options for patients with serious life-
threatening chronic illness or conditions and their caregivers in
ambulatory settings been implemented? What is the evidence for how,
when and for which patients and caregivers they could best be
implemented in care?
KQ 3:
KQ3a. What palliative care shared decision-making tools are
available for patients with serious life-threatening chronic illness or
conditions in ambulatory settings and their caregivers?
KQ3b. What is the effectiveness of palliative care shared decision-
making tools for patients with serious life-threatening chronic illness
or conditions in ambulatory settings and their caregivers?
KQ3c. How have palliative care shared decision-making tools been
implemented for patients with serious life-threatening chronic illness
or conditions in ambulatory settings and their caregivers? What is the
evidence for how, when and for which patients and caregivers they could
best be implemented in care?
KQ 4:
KQ4a. What palliative care training and educational materials are
available for non-palliative care clinicians caring for patients with
serious life-threatening chronic illness or conditions in ambulatory
settings?
KQ4b. What is the effectiveness of palliative care training and
educational materials (with or without other intervention components)
for non-palliative care clinicians caring for patients with serious
life-threatening chronic illness or conditions in ambulatory settings?
KQ4c. How have palliative care training and educational materials
(with or without other intervention components) for non-palliative care
clinicians caring for patients with serious life-threatening chronic
illness or conditions in ambulatory settings been implemented? What is
the evidence for how, when and for which clinicians they could best be
implemented in care?
KQ 5:
KQ5a. What models (i.e., stepped care, consultative care, shared
care, collaborative care, coaching, integrating social workers into
practice, and palliative care approaches provided by non-palliative
care specialists) for integrating palliative care have been developed
for patients with serious life-threatening chronic illness or
conditions in ambulatory settings?
KQ5b. What is the effectiveness of models (i.e., stepped care,
consultative care, shared care, collaborative care, coaching,
integrating social workers into practice, and palliative care
approaches provided by non-palliative care specialists) or multimodal
interventions for integrating palliative care for patients with serious
life-threatening chronic illness or conditions in ambulatory settings?
KQ5c. What are components of models for integrating palliative care
in ambulatory settings? What models have been implemented for key
subpopulations? What components and characteristics of these models
contribute to their effective implementation? What is the evidence for
how, when and for which patients they could best be implemented in
care?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing,
Settings)
Population(s):
[cir] Adults age 18 or older with serious life-threatening chronic
illness or conditions (other than those adults only with cancer) and
their caregivers, being seen in ambulatory settings (KQ 1,2,3,5)
[cir] Clinicians practicing in ambulatory settings listed below (KQ
4)
Interventions:
[cir] KQ1: Prediction models, tools or triggers to identify
patients for palliative care in ambulatory settings
[cir] KQ2: Educational materials and resources for patients and/or
caregivers about palliative care in ambulatory settings
[cir] KQ3: Palliative care shared decision-making tools and
resources for clinicians and patients and/or caregivers in ambulatory
settings
[cir] KQ4: Palliative care training or educational materials for
non-palliative care clinicians in ambulatory settings
[cir] KQ5: Models for integrating palliative care in ambulatory
settings
Comparators (for part (b) KQ):
Comparators between:
[cir] KQ1: Prediction models, tools or triggers to identify
patients for palliative care in ambulatory settings
[cir] KQ2: Educational materials and resources for patients and/or
caregivers about palliative care in ambulatory settings
[cir] KQ3: Palliative care shared decision-making tools and
resources for clinicians and patients and/or caregivers in ambulatory
settings
[cir] KQ4: Palliative care training or educational materials for
clinicians in ambulatory settings
[cir] KQ5: Models for integrating palliative care or multimodal
interventions in ambulatory settings
[cir] As well as with usual care for all KQs
Outcomes (for part (b) KQ):
[cir] Intermediate (Excludes clinician self-report):
[ssquf] Knowledge (clinicians, patients, caregivers) (KQ2, KQ4)
[ssquf] Awareness (clinicians, patients, caregivers) (KQ2, KQ4)
[ssquf] Skills (clinicians) (KQ4)
[cir] Final (All apply to all KQ) (In hierarchy from patient-centered
to clinician to health system. All patient or caregiver-reported
outcomes must be measured by a validated instrument. All outcomes must
relate to components of care relevant to serious, life-threatening
chronic illness or conditions.)
[ssquf] Patient or caregiver satisfaction
[ssquf] Patient or caregiver health-related quality of life
[ssquf] Patient or caregiver symptoms of depression or anxiety or
psychological well-being
[ssquf] Caregiver burden, caregiver impact or caregiver strain
[ssquf] Patient symptoms or symptom burden (includes
multidimensional symptom tools and key symptoms of pain, dyspnea,
fatigue). This must include patient-reported symptom measurement (or
caregiver-reported for patients unable to report).
[ssquf] Concordance between patient preferences for care and care
received
[ssquf] Clinician job satisfaction or burnout, perceptions of
teamwork
[[Page 3693]]
[ssquf] Healthcare utilization (use and length of hospice care,
hospitalizations, advance directive documentation) and costs and
resource use (use of outpatient clinician services, including
palliative care)
[cir] Adverse effects
[ssquf] Medication side effects
[ssquf] Dropouts
Timing
[cir] Any timing
Settings
[cir] Ambulatory primary and specialty care, including geriatrics,
nephrology, pulmonology, cardiology, and neurology
[cir] U.S.-based studies, as systems of care differ in other
countries
Dated: January 15, 2020.
Virginia L. Mackay-Smith,
Associate Director, Office of the Director, AHRQ.
[FR Doc. 2020-00903 Filed 1-21-20; 8:45 am]
BILLING CODE 4160-90-P
