[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]


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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

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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 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 Access to published and unpublished pertinent 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]
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               PICOTS                              Inclusion                              Exclusion
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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.
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    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