Supplemental Evidence and Data Request on Management of High-Need, High-Cost (HNHC) Patients: A Realist and Systematic Review, 68456-68458 [2019-26953]

Download as PDF 68456 Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices Notice and request for comments. ACTION: In accordance with the Paperwork Reduction Act of 1995, and the Office of Management and Budget (OMB) regulations, DoD, GSA, and NASA invite the public to comment on a revision and renewal concerning reporting purchases from sources outside the United States. DoD, GSA, and NASA invite comments on: Whether the proposed collection of information is necessary for the proper performance of the functions of Federal Government acquisitions, including whether the information will have practical utility; the accuracy of the estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. OMB has approved this information collection for use through March 31, 2020. DoD, GSA, and NASA propose that OMB extend its approval for use for three additional years beyond the current expiration date. DATES: DoD, GSA, and NASA will consider all comments received by February 14, 2020. ADDRESSES: DoD, GSA, and NASA invite interested persons to submit comments on this collection by either of the following methods: • Federal eRulemaking Portal: This website provides the ability to type short comments directly into the comment field or attach a file for lengthier comments. Go to http:// www.regulations.gov and follow the instructions on the site. • Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405. ATTN: Lois Mandell/IC 9000–0161, Reporting Purchases from Sources Outside the United States. Instructions: All items submitted must cite Information Collection 9000– 0161, Reporting Purchases from Sources Outside the United States. Comments received generally will be posted without change to http:// www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two-to-three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail). SUMMARY: lotter on DSKBCFDHB2PROD with NOTICES FOR FURTHER INFORMATION CONTACT: VerDate Sep<11>2014 19:21 Dec 13, 2019 Jkt 250001 Zenaida Delgado, Procurement Analyst, at telephone 202–969–7207, or zenaida.delgado@gsa.gov. SUPPLEMENTARY INFORMATION: A. OMB control number, Title, and any Associated Form(s): 9000–0161, Reporting Purchases from Sources Outside the United States. B. Need and Uses: This clearance covers the information that offerors must submit to comply with the Federal Acquisition Regulation (FAR) provision 52.225–18, Place of Manufacture. This provision requires offerors of manufactured end products to provide information as to whether the offered end products are predominantly manufactured in the United States or outside the United States. Contracting officers use the information as the basis for entry into the Federal Procurement Data System for further data on the rationale for purchasing foreign manufactured items. The data is necessary for analysis of the application of the Buy American statute and the trade agreements. C. Annual Burden: Respondents: 30,740. Total Annual Responses: 2,908,096. Total Burden Hours: 29,081. Obtaining Copies: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405, telephone 202–501–4755. Please cite OMB Control No. 9000– 0161, Reporting Purchases from Sources Outside the United States, in all correspondence. Dated: December 10, 2019. Janet Fry, Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy. [FR Doc. 2019–26998 Filed 12–13–19; 8:45 am] BILLING CODE 6820–EP–P 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 for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for supplemental evidence and data submissions AGENCY: PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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 Evidencebased 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: 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: 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 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 HighNeed, 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 HighNeed, High-Cost Patients: A Realist and Systematic Review helpful: E:\FR\FM\16DEN1.SGM 16DEN1 Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices 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 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 68457 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 lotter on DSKBCFDHB2PROD with NOTICES [Populations, Interventions, Comparators, Outcomes, Timing, Settings] PICOTS Inclusion Exclusion Population ....... KQs 1, 2, and 3: Noninstitutionalized adults, 18 years of age or older ..... Patients receiving a high level of 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. Intervention ..... 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. KQ 1: Not relevant, interventions not necessary for inclusion ................... Comparator ..... Outcomes ........ VerDate Sep<11>2014 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). KQ 1: Comparison population or no comparator ....................................... KQ 2: Any intervention, treatment as usual, or no comparator intervention. KQ 3: Any intervention or treatment as usual. KQ 1: Population characteristics described or predicted ........................... KQs 1, 2, and 3:. 19:21 Dec 13, 2019 Jkt 250001 PO 00000 Frm 00066 Fmt 4703 KQs 2 and 3: Interventions for which the relevance for and impact on HNHC patients cannot be determined. KQ 3: No comparator. All other outcomes, including behavioral health outcomes. Sfmt 4703 E:\FR\FM\16DEN1.SGM 16DEN1 68458 Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices PICOTS—Continued [Populations, Interventions, Comparators, Outcomes, Timing, Settings] PICOTS Time frame ...... Settings ........... Study design ... Language ........ Publication type Inclusion 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. Potentially preventable or modifiable 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. Health care and support services delivery settings, including outpatient, emergency department, the broader health care delivery 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. KQs 1 and 2: All study designs except 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. Studies published in English ...................................................................... All publications that allow abstraction and interpretation of findings ......... Dated: December 10, 2019. Virginia Mackay-Smith, Associate Director. BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket Number CDC–2019–0107, NIOSH– 331] NIOSH Center for Motor Vehicle Safety Strategic Plan, 2020–2029 National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Request for information and comment. AGENCY: The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft strategic plan titled NIOSH Center for Motor Vehicle Safety Strategic Plan, 2020–2029 now available for public comment. DATES: Electronic or written comments must be received by February 14, 2020. lotter on DSKBCFDHB2PROD with NOTICES SUMMARY: 19:21 Dec 13, 2019 Shorter time periods. Institutional care settings, such as hospitals, skilled nursing, long-term care facilities, and prisons or jails. KQ 3: All other designs. Studies published in languages other than English. KQ 3 only: Abstract-only publications. You may submit comments, identified by CDC–2019–0107 and docket number NIOSH–331, by any of the following methods: • Federal eRulemaking Portal: https://www.regulations.gov Follow the instructions for submitting comments. • Mail: National Institute for Occupational Safety and Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C–34, Cincinnati, Ohio 45226–1998. Instructions: All information received in response to this notice must include the agency name and docket number [CDC–2019–0107; NIOSH–331]. All relevant comments received will be posted without change to https:// www.regulations.gov, including any personal information provided. All electronic comments should be formatted as Microsoft Word. For access to the docket to read background documents or comments received, go to https://www.regulations.gov. All information received in response to this notice will also be available for public examination and copying at the NIOSH Docket Office, 1150 Tusculum Avenue, Room 155, Cincinnati, OH 45226–1998. FOR FURTHER INFORMATION CONTACT: Kyla Retzer, Western States Division, P.O. Box 25226, Denver, Colorado 80225– 0226, (303) 236–5934 (not a toll-free number), kretzer@cdc.gov OR Dr. Rosa Rodriguez-Acosta, Division of Safety Research, 1095 Willowdale Road, MS ADDRESSES: [FR Doc. 2019–26953 Filed 12–13–19; 8:45 am] VerDate Sep<11>2014 Exclusion Jkt 250001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 1808, Morgantown, West Virginia, 26505–2888, (304) 285–6299 (not a tollfree number), rer3@cdc.gov. SUPPLEMENTARY INFORMATION: Background: The National Institute for Occupational Safety and Health (NIOSH) is seeking input on the draft NIOSH Center for Motor Vehicle Safety Strategic Plan, 2020–2029. Motor vehicle crashes are the leading cause of work-related injury deaths in the United States. Millions of workers drive or ride in a motor vehicle as part of their jobs. The risk affects workers in all industries and occupations who drive as part of their job, whether they use a tractor-trailer or a passenger vehicle. NIOSH is the only part of the U.S. Federal Government whose mission includes prevention of work-related crashes and resulting injuries for workers who drive all types of vehicles (not just the commercial motor vehicles regulated by the U.S. Department of Transportation). NIOSH requests input on its strategic direction for research and communication to prevent work-related motor vehicle crashes and injuries. This plan aligns with the priority industry sectors (i.e., oil and gas extraction; public safety; transportation, warehousing, and utilities; and wholesale and retail trade) identified in E:\FR\FM\16DEN1.SGM 16DEN1

Agencies

[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