Supplemental Evidence and Data Request on Mixed Methods Review-Integrating Palliative Care With Chronic Disease Management in Ambulatory Care
| Published date | 22 January 2020 |
| Citation | 85 FR 3691 |
| Record Number | 2020-00903 |
| Section | Notices |
| Court | Agency For Healthcare Research And Quality |
Federal Register, Volume 85 Issue 14 (Wednesday, January 22, 2020)
[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unpublished pertinent scientific information will improve the quality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
