[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published and unpublished pertinent scientific information will improve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: [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: Kelly Carper, Telephone: 301-427-1656
or Email: [email protected].
[[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)
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PICOTS elements Inclusion criteria Exclusion criteria
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Population........................... Adults aged 60 years or older with a Animals.
functional limitation, requiring assistance Children.
with activities of daily living, regardless of Adults without
payer source. disabilities.
Adults aged
<60 years,
exclusively.
Interventions........................ Person-centered HCBS, including the following None.
person-centered approach, used alone or in
combination:
Occupational, speech, and physical
therapy.
Durable medical equipment..............
Case management (in home or via phone).
Caregiver and client training (training
on skills to take care of a patient at home).
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).
Hospice care...........................
Senior centers and adult daycares......
[[Page 69188]]
Congregate meal sites and home-
delivered meal programs.
Personal assistance such as dressing,
bathing, toileting, eating, transferring to or
from a bed or chair, etc.
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).
Home repairs and modifications.........
Home safety assessments................
Homemaker and chore services...........
Information and referral services (to
clinical care or other community-based
services).
Community integration services and day
support.
Behavioral health services.............
Financial services.....................
Legal services, such as help preparing
a will.
Telephone reassurance..................
Comparators.......................... Institutional care (nursing care, long- None.
term care) without HCBS.
No HCBS while living in the home or
community.
Outcomes............................. Mortality.............................. None.
Time to nursing home placement.........
Patient satisfaction...................
Person-centered outcomes...............
Hospitalization, rehospitalization.....
Clinical outcomes (falls, disease-
related outcomes).
Social isolation.......................
Quality of life (see NQF HCBS Quality
Domains Report).
Harms of the intervention..............
Timing............................... All.................................... None.
Settings............................. Home settings.......................... Nursing home.
Independent living. Healthcare
setting.
Assisted living........................
Studies conducted in the United States.
Subgroup analysis.................... Geography.............................. None.
Race/ethnicity.........................
Sex....................................
Comorbidities..........................
Social situations (community, home)....
Clinical needs (includes activities of
daily living as well as other needs to care for
a person).
Study design......................... Guiding Question 1: In vitro
studies.
[cir] RCTs................................... Erratum.
[cir] Comparative observational studies...... Editorials.
[cir] Systematic reviews or meta-analyses.... Letters.
Guiding Questions 2-3: 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......................... Studies published in English as peer Foreign
reviewed full-text articles. language studies.
Studies published after Year 2000. Conference
abstracts.
Studies conducted outside of the United
States.
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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