[Federal Register Volume 88, Number 192 (Thursday, October 5, 2023)]
[Notices]
[Pages 69186-69188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22131]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Evidence Map on Home 
and Community Based Services

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 Evidence Map on 
Home and Community Based Services, 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published and unpublished pertinent scientific information will improve 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 November 6, 2023.

ADDRESSES: 
    Email submissions: <a href="/cdn-cgi/l/email-protection#4421342704252c36356a2c2c376a232b32"><span class="__cf_email__" data-cfemail="bcd9ccdffcddd4cecd92d4d4cf92dbd3ca">[email protected]</span></a>.
    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: Kelly Carper, Telephone: 301-427-1656 
or Email: <a href="/cdn-cgi/l/email-protection#bcd9ccdffcddd4cecd92d4d4cf92dbd3ca"><span class="__cf_email__" data-cfemail="9affeaf9dafbf2e8ebb4f2f2e9b4fdf5ec">[email protected]</span></a>.

[[Page 69187]]


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 Evidence Map on Home 
and Community Based Services. AHRQ is conducting this review pursuant 
to Section 902 of the Public Health Service Act, 42 U.S.C. 299a.
    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 Evidence Map on Home and Community Based Services. The 
entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/evidence-map/protocol. This is to 
notify the public that the EPC Program would find the following 
information on Evidence Map on Home and Community Based Services 
helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this topic. 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, if 
relevant: 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 topic. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including, if relevant, 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 topic 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 topics 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 review will answer the following questions. This information is 
provided as background. AHRQ is not requesting that the public provide 
answers to these questions.

Guiding Questions

    1. Describe the available research on the effectiveness of person-
centered HCBS interventions, for adults aged 60 or older with a 
functional limitation in home and community-based settings.
    a. What HCBS interventions have been studied in relation to person-
centered approaches?
    1. For which person-centered HCBS interventions are systematic 
reviews available?
    2. For which person-centered HCBS interventions are sufficient 
primary research studies available to justify a new systematic review?
    b. What populations have been studied with person-centered HCBS 
interventions?
    c. What primary outcomes of person-centered HCBS interventions have 
been studied?
    d. What mediating factors have been identified in the literature 
that could affect outcomes such as the presence of unpaid family 
caregivers as part of the overall care team?
    e. What study designs have been used to evaluate the effectiveness 
of person-centered approaches to HCBS interventions?
    2. What quality measures related to person-centered HCBS 
interventions exist or are under development (See NCQA measures of 
person-centered outcomes (https://www.ncqa.org/hedis/reports-and-research/pco-measures/) under development, including the University of 
Minnesota's efforts (https://acl.gov/sites/default/files/news%202022-11/ACL%20HCBS%20Outcome%20Measurement%20Webinar%20Slides%2005.26.22_AR%20%28002%29.pdf))?
    3. Describe the gaps that exist in the current research.
    a. Which person-centered HCBS interventions identified by experts 
as currently relevant have no or inadequate evidence?
    b. Which patient populations and outcome measures have no or 
inadequate evidence?
    c. Are there gaps in evidence related to taking person-centered 
planning approaches to these interventions?

                PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Settings)
----------------------------------------------------------------------------------------------------------------
           PICOTS elements                            Inclusion criteria                    Exclusion criteria
----------------------------------------------------------------------------------------------------------------
Population...........................  <bullet> Adults aged 60 years or older with a     <bullet> Animals.
                                        functional limitation, requiring assistance      <bullet> Children.
                                        with activities of daily living, regardless of   <bullet> Adults without
                                        payer source.                                     disabilities.
                                                                                         <bullet> Adults aged
                                                                                          <60 years,
                                                                                          exclusively.
Interventions........................  Person-centered HCBS, including the following     <bullet> None.
                                        person-centered approach, used alone or in
                                        combination:
                                       <bullet> Occupational, speech, and physical
                                        therapy.
                                       <bullet> Durable medical equipment..............
                                       <bullet> Case management (in home or via phone).
                                       <bullet> Caregiver and client training (training
                                        on skills to take care of a patient at home).
                                       <bullet> Health promotion and disease prevention
                                        (training to enabling people to increase
                                        control over, and to improve, their health like
                                        cook a healthier meal, or doing stretches to
                                        maintain flexibility again to prevent falls).
                                       <bullet> Hospice care...........................
                                       <bullet> Senior centers and adult daycares......

[[Page 69188]]

 
                                       <bullet> Congregate meal sites and home-
                                        delivered meal programs.
                                       <bullet> Personal assistance such as dressing,
                                        bathing, toileting, eating, transferring to or
                                        from a bed or chair, etc.
                                       <bullet> Transportation and access including
                                        physical access to their homes (ramps, rails,
                                        etc.) or access to places (doctor's offices,
                                        etc.) or could also be access to healthcare
                                        setting (ride to the doctor's office).
                                       <bullet> Home repairs and modifications.........
                                       <bullet> Home safety assessments................
                                       <bullet> Homemaker and chore services...........
                                       <bullet> Information and referral services (to
                                        clinical care or other community-based
                                        services).
                                       <bullet> Community integration services and day
                                        support.
                                       <bullet> Behavioral health services.............
                                       <bullet> Financial services.....................
                                       <bullet> Legal services, such as help preparing
                                        a will.
                                       <bullet> Telephone reassurance..................
Comparators..........................  <bullet> Institutional care (nursing care, long-  <bullet> None.
                                        term care) without HCBS.
                                       <bullet> No HCBS while living in the home or
                                        community.
Outcomes.............................  <bullet> Mortality..............................  <bullet> None.
                                       <bullet> Time to nursing home placement.........
                                       <bullet> Patient satisfaction...................
                                       <bullet> Person-centered outcomes...............
                                       <bullet> Hospitalization, rehospitalization.....
                                       <bullet> Clinical outcomes (falls, disease-
                                        related outcomes).
                                       <bullet> Social isolation.......................
                                       <bullet> Quality of life (see NQF HCBS Quality
                                        Domains Report).
                                       <bullet> Harms of the intervention..............
Timing...............................  <bullet> All....................................  <bullet> None.
Settings.............................  <bullet> Home settings..........................  <bullet> Nursing home.
                                       <bullet> Independent living.                      <bullet> Healthcare
                                                                                          setting.
                                       <bullet> Assisted living........................
                                       <bullet> Studies conducted in the United States.
Subgroup analysis....................  <bullet> Geography..............................  <bullet> None.
                                       <bullet> Race/ethnicity.........................
                                       <bullet> Sex....................................
                                       <bullet> Comorbidities..........................
                                       <bullet> Social situations (community, home)....
                                       <bullet> Clinical needs (includes activities of
                                        daily living as well as other needs to care for
                                        a person).
Study design.........................  <bullet> Guiding Question 1:                      <bullet> In vitro
                                                                                          studies.
                                          [cir] RCTs...................................  <bullet> Erratum.
                                          [cir] Comparative observational studies......  <bullet> Editorials.
                                          [cir] Systematic reviews or meta-analyses....  <bullet> Letters.
                                       <bullet> Guiding Questions 2-3:                   <bullet> Case reports/
                                                                                          series.
                                          [cir] RCTs...................................
                                          [cir] Comparative observational studies......
                                          [cir] Surveys................................
                                          [cir] Qualitative studies....................
                                          [cir] Mixed-method studies...................
                                          [cir] Narrative reviews......................
                                          [cir] Systematic review or meta-analysis.....
Publications.........................  <bullet> Studies published in English as peer     <bullet> Foreign
                                        reviewed full-text articles.                      language studies.
                                       <bullet> Studies published after Year 2000.       <bullet> Conference
                                                                                          abstracts.
                                       <bullet> Studies conducted outside of the United
                                        States.
----------------------------------------------------------------------------------------------------------------
Abbreviations: HCBS = Home and Community Based Services; NQF = National Quality Forum; RCT = randomized clinical
  trials.


    Dated: September 29, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-22131 Filed 10-4-23; 8:45 am]
BILLING CODE 4160-90-P


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