[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]


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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.

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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unpublished pertinent scientific information will improve the quality 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