Supplemental Evidence and Data Request on Management of High-Need, High-Cost (HNHC) Patients: A Realist and Systematic Review
| Published date | 16 December 2019 |
| Citation | 84 FR 68456 |
| Record Number | 2019-26953 |
| Section | Notices |
| Court | Agency For Healthcare Research And Quality |
Federal Register, Volume 84 Issue 241 (Monday, December 16, 2019)
[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 Access to published and unpublished pertinent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
