Supplemental Evidence and Data Request on Strategies for Integrating Behavioral Health and Primary Care, 64043-64046 [2022-22843]
Download as PDF
<![CDATA[
Federal Register / Vol. 87, No. 203 / Friday, October 21, 2022 / Notices
President) 1 Memorial Drive, Kansas
City, Missouri 64198–0001:
1. WSB Financial, Inc., Leesburg,
Florida; to become a bank holding
company by acquiring J&M Bancshares,
Inc., and thereby indirectly acquiring
The Walton State Bank, both of Walton,
Kansas.
Board of Governors of the Federal Reserve
System.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2022–22897 Filed 10–20–22; 8:45 am]
BILLING CODE 6210–01–P
FEDERAL RESERVE SYSTEM
Board of Governors of the Federal Reserve
System.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
jspears on DSK121TN23PROD with NOTICES
Change in Bank Control Notices;
Acquisitions of Shares of a Bank or
Bank Holding Company
[FR Doc. 2022–22894 Filed 10–20–22; 8:45 am]
The notificants listed below have
applied under the Change in Bank
Control Act (Act) (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire shares of a bank
or bank holding company. The factors
that are considered in acting on the
applications are set forth in paragraph 7
of the Act (12 U.S.C. 1817(j)(7)).
The public portions of the
applications listed below, as well as
other related filings required by the
Board, if any, are available for
immediate inspection at the Federal
Reserve Bank(s) indicated below and at
the offices of the Board of Governors.
This information may also be obtained
on an expedited basis, upon request, by
contacting the appropriate Federal
Reserve Bank and from the Board’s
Freedom of Information Office at
https://www.federalreserve.gov/foia/
request.htm. Interested persons may
express their views in writing on the
standards enumerated in paragraph 7 of
the Act.
Comments regarding each of these
applications must be received at the
Reserve Bank indicated or the offices of
the Board of Governors, Ann E.
Misback, Secretary of the Board, 20th
Street and Constitution Avenue NW,
Washington, DC 20551–0001, not later
than November 4, 2022.
A. Federal Reserve Bank of St. Louis
(Holly A. Rieser, Senior Manager) P.O.
Box 442, St. Louis, Missouri 63166–
2034. Comments can also be sent
electronically to
Comments.applications@stls.frb.org:
1. Alberta Fleming, Michael F.
Fleming, and the MFF Trust, Michael F.
Fleming, as trustee, all of Litchfield,
Illinois; Susan K. Wetzel, and the SKW
Trust, Susan K. Wetzel, as trustee, all of
Hillsboro, Illinois; together as a family
control group, a group acting in concert,
VerDate Sep<11>2014
19:08 Oct 20, 2022
Jkt 259001
to retain voting shares of Litchfield
Bancshares Company, Inc., and thereby
indirectly retain voting shares of The
Litchfield National Bank, both of
Litchfield, Illinois.
B. Federal Reserve Bank of Dallas
(Karen Smith, Director, Applications)
2200 North Pearl Street, Dallas, Texas
75201–2272:
1. Cynthia S. Shaw, Austin, Texas; to
acquire additional voting shares of Big
Bend Bancshares Corporation, and
indirectly acquire additional voting
shares of Big Bend Banks, N.A. dba The
Marfa National Bank, both of Marfa,
Texas.
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Strategies for Integrating
Behavioral Health and Primary Care
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:
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
Strategies for Integrating Behavioral
Health and Primary Care, 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 21, 2022.
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
SUMMARY:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
64043
Coordinator, 5600 Fishers Lane, Mail
Stop 06E77D, Rockville, MD 20857.
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 Center (EPC)
Program to complete a review of the
evidence for Strategies for Integrating
Behavioral Health and Primary Care.
AHRQ is conducting this systematic
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 Strategies for Integrating
Behavioral Health and Primary Care,
including those that describe adverse
events. The entire research protocol is
available online at: https://
effectivehealthcare.ahrq.gov/products/
strategies-integrating-behavioral-health/
protocol. This is to notify the public that
the EPC Program would find the
following information on Strategies for
Integrating Behavioral Health and
Primary Care helpful:
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
E:\FR\FM\21OCN1.SGM
21OCN1
64044
Federal Register / Vol. 87, No. 203 / Friday, October 21, 2022 / Notices
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.
Questions for the Systematic Review
Question 1 (Scan). What approaches
have been used to integrate behavioral
health and primary care?
a. How do these approaches vary by:
(i) patient characteristics (e.g., clinical
focus/conditions/patient subgroups)
(ii) core components of the approach
(iii) practice/care delivery setting
characteristics such as the policy
environment, and geographic
location.
(iv) resources and infrastructure
required, such as staffing, payment
models, financing, and technology
(v) mechanisms of care integration
Question 2 (Key). How effective are
approaches to integrating behavioral
health and primary care?
a. Does effectiveness vary by:
(i) patient characteristics (e.g., clinical
focus/conditions/patient subgroups)
(ii) core components of the approach
(iii) practice/care delivery setting
characteristics, such as the policy
environment, and geographic
location.
(iv) resources and infrastructure
required, such as staffing, financing,
payment models, and technology
(v) mechanisms of care integration
b. How do interactions among the
components of integration approaches
impact effectiveness and maintenance of
the integration of behavioral health and
primary care?
Question 3 (Contextual). What are the
barriers to and facilitators of
implementing and sustaining different
approaches to integrating behavioral
health and primary care?
a. How do the barriers, facilitators,
and other factors involved in the
implementation of behavioral health
and primary care interact to affect
implementation and sustainability?
Question 4 (Contextual). What
reliable, valid, clinically meaningful,
and/or patient-centered measures and
metrics are available to monitor and
evaluate integration approaches?
a. How is measurement integrated
into clinical care and the ongoing
monitoring and evaluation of
integration?
b. Are the measures or metrics
specific to characteristics; level of
complexity; or the structure, process, or
outcomes of care integration?
c. Are there models or standards for
how frequently the effectiveness of
approaches to integration should be
reassessed?
d. What are the gaps in measurement
and what are the implications for our
current ability to measure and assess
integration?
Question 5 (Contextual). How are care
team member roles and their work flows
defined in different approaches to
integrating behavioral health and
primary care?
a. What training interventions (e.g.,
mode and content, trainee credentials,
dose and timing of training) are effective
in facilitating integrated care team
functioning?
POPULATION, INTERVENTIONS, COMPARATORS, OUTCOMES, AND SETTING (PICOS)
PICOS
Inclusion
Exclusion
Population .......................................
Children (aged 0–20 years) and adults (aged ≥21 years) with behavioral health needs.
Clinical focus/conditions including but not limited to patients with:
• Mental illness or mental health conditions
• Substance use disorders
• Stress-linked physical symptoms (e.g., insomnia, fatigue)
• Complex overlapping medical conditions and psychosocial risk
factors
• Experiences of trauma, adverse experiences, or stressful life
events
• Pregnant patients
• Geriatric patients
Different approaches to integrating behavioral health and primary
care services, including program/model components and strategies
to integrate care.
Examples of eligible programs/models for care integration include but
are not limited to:
• Collaborative Care Model
• Primary Care Behavioral Health Model
• Co-location models
• Models that use telehealth for integration
The baseline requirement is that the practice design of the approach
facilitates interaction among primary care and behavioral health
providers in the provision of care. Ongoing collaboration and coordination of care are required; activities may include screening
and diagnosis, acute and long-term interventions, and follow up
and maintenance.
• No exclusions for age or condition.
jspears on DSK121TN23PROD with NOTICES
Intervention ......................................
VerDate Sep<11>2014
19:08 Oct 20, 2022
Jkt 259001
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
E:\FR\FM\21OCN1.SGM
• Co-location without collaboration.
• Referral only (cold handoff).
• Warm handoff without plan for
continued communication and
coordination of care.
• Population level health promotion or prevention programs
that are not individualized, integrated care (e.g., Silver Sneakers).
• Interventions for chronic medical
conditions that do not include a
significant, explicit behavioral
health component.
21OCN1
64045
Federal Register / Vol. 87, No. 203 / Friday, October 21, 2022 / Notices
POPULATION, INTERVENTIONS, COMPARATORS, OUTCOMES, AND SETTING (PICOS)—Continued
PICOS
Inclusion
Exclusion
Comparator .....................................
• Care as usual (e.g., non-integrated behavioral health and primary
care services) in a different group or time period
• Alternative care integration strategy or strategies
• No care
Outcomes ........................................
Outcomes of interest include but not limited to:
PATIENT LEVEL
Health outcomes:
• Morbidity
• Mortality
• Improved symptoms
• Guideline concordant screening and diagnosis
• Remission/recovery
• Adherence to treatment
Patient Reported Outcomes:
• Health related quality of life
• Functional status (including social and adaptive functioning)
• Satisfaction with care
Measures of care utilization:
• Avoidable emergency care or inpatient care for behavioral
health crises
• Total health care utilization
Measures of access to care:
• Patients receive routine care as soon as wanted
• Patients receive acute care when needed
• Average wait time for BH
• Patients experiencing difficulties or delays in obtaining BH care
• Patients with mental health condition received treatment
• Patients with SUDs received treatment
CLINICIAN AND PRACTICE LEVEL
Clinician Outcomes:
• Clinician retention/turnover rates
• Burnout
• Professional satisfaction
• Efficiency of clinician time use
Population/community/clinic panel health outcomes:
• BH-related preventive care measures
• BH screening services
Cost outcomes:
• Cost per patient per year
• Cost per service
• Costs associated with care delays, fragmentation, poor coordination, redundancy, requested but not completed patient referrals
Implementation Outcomes:
• Adoption of intervention approaches
• Fidelity
• Systemic Change/Sustainment
HARMS
• Missed diagnoses
• Delays in care
• Overutilization of resources
• Redundant or inappropriate care
• Health systems/hospitals and community-based primary care practices in the United States (physical or virtual) or in countries with
similar healthcare systems
• Non-healthcare settings providing outpatient BH/PC (school-based
clinics, community centers, churches, shelters)
• Nursing homes, group homes and other long-term residential settings
• Experimental and observational studies that describe and evaluate
integration approach.
• For Scan Question 1 and Contextual Questions 3 and 5: Survey
and Qualitative Studies.
• For Contextual Question 4: Psychometric Studies
• Systematic reviews that directly address one of the review questions
• No comparator for KQ 2 (descriptive studies; such as case
studies).
• Comparators not applicable to
other questions.
Simulated results or responses to
hypothetical scenarios or questions.
Setting .............................................
jspears on DSK121TN23PROD with NOTICES
Study Designs .................................
•
•
•
•
Hospitals.
Prehospital/EMS/crisis care.
Prisons.
Countries with healthcare systems that do not provide information relevant to the U.S.
• Articles that do not include any
data.
• Proposals for approaches that
have not been implemented.
• Descriptions of approaches that
have not been evaluated (for
KQ2).
• Articles reporting simulation or
speculation.
Abbreviations: BH = behavioral health; EMS = emergency medical services; KQ = key question; PC = primary care.
VerDate Sep<11>2014
19:08 Oct 20, 2022
Jkt 259001
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
E:\FR\FM\21OCN1.SGM
21OCN1
64046
Federal Register / Vol. 87, No. 203 / Friday, October 21, 2022 / Notices
Dated: October 17, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022–22843 Filed 10–20–22; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–23–23AH; Docket No. CDC–2022–
0125]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other federal
agencies the opportunity to comment on
a proposed information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled Community
Health Workers for COVID Response
and Resilient Communities (CCR)
National Evaluation. This data
collection will assess the activities
implemented by the 68 recipients of the
CDC–RFA–DP21–2109 CCR NOFO (CCR
award recipients).
DATES: CDC must receive written
comments on or before December 20,
2022.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2022–
0125 by either of the following methods:
• Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
www.regulations.gov.
jspears on DSK121TN23PROD with NOTICES
SUMMARY:
Please note: Submit all comments through
the Federal eRulemaking portal
(www.regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT:
To
request more information on the
VerDate Sep<11>2014
19:08 Oct 20, 2022
Jkt 259001
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road, NE, MS
H21–8, Atlanta, Georgia 30329;
Telephone: 404–639–7118; Email: omb@
cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Proposed Project
Community Health Workers for
COVID Response and Resilient
Communities (CCR) National
Evaluation—New—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC is requesting a New Information
Collection Request titled Community
Health Workers for COVID Response
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
and Resilient Communities (CCR)
National Evaluation. In 2021, CDC
funded DP21–2109, ‘‘Community Health
Workers for COVID Response and
Resilient Communities (CCR)’’. DP21–
2109 funds 68 CCR recipients across the
United States to train and deploy
community health workers (CHWs) to
support COVID–19 response efforts and
to build and strengthen community
resilience to fight COVID–19 through
addressing existing health disparities.
Thirty-two of the 68 recipients were
funded for Component A, Capacity
Building, which focuses on building
capacity among CHWs, and 36
recipients are funded for Component B,
Implementation Ready, which focuses
on enhancing and expanding existing
CHW efforts. DP21–2109 is funded for a
three-year period, from September 2021
through August 2024.
CDC also funded CDC–RFA–DP21–
2110, ‘‘Community Health Workers for
COVID Response and Resilient
Communities (CCR)—Evaluation and
Technical Assistance’’ (CCR–ETA
recipients) at the same time the agency
funded DP21–2109. Two recipients
were funded to design and conduct the
national evaluation of DP21–2109 CCR
and will lead the information collection
described in this request.
The CCR National Evaluation aims to
collect consistent, systematic
information from the 68 CDC–RFA–
DP21–2109 award recipients through
two primary data collection efforts: (1)
a CCR recipient survey; and (2) a survey
of Community Health Workers (CHWs)
funded through CCR. The CCR recipient
survey will collect information about
program management, organizational
infrastructure, CHW implementation
practices, populations of focus served
by CCR funded efforts, non-CDC
resources supporting the program, and
other aspects of program
implementation. The CHW survey will
collect information about CHW roles,
integration into community-based and
care COVID response teams, core
competency training, supervision,
implementation activities, and
compensation. The surveys will be
administered by the CCR–ETA award
recipients. Both surveys will be
available in English and Spanish.
The goal of this data collection is to
assess the activities implemented by the
68 recipients of the CDC–RFA–DP21–
2109 CCR NOFO (CCR award
recipients), as part of the three CCR core
strategies (i.e., CHW training,
deployment, and engagement with
COVID–19 response teams) and the
intended outcomes of these activities on
the CCR populations of focus. CDC will
use resulting information to describe the
E:\FR\FM\21OCN1.SGM
21OCN1
]]>Agencies
[Federal Register Volume 87, Number 203 (Friday, October 21, 2022)]
[Notices]
[Pages 64043-64046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22843]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Strategies for
Integrating Behavioral Health and Primary Care
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 Strategies for
Integrating Behavioral Health and Primary Care, 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 21, 2022.
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 Center (EPC)
Program to complete a review of the evidence for Strategies for
Integrating Behavioral Health and Primary Care. AHRQ is conducting this
systematic 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 Strategies for Integrating
Behavioral Health and Primary Care, including those that describe
adverse events. The entire research protocol is available online at:
https://effectivehealthcare.ahrq.gov/products/strategies-integrating-behavioral-health/protocol. This is to notify the public that the EPC
Program would find the following information on Strategies for
Integrating Behavioral Health and Primary Care helpful:
[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
[[Page 64044]]
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.
Questions for the Systematic Review
Question 1 (Scan). What approaches have been used to integrate
behavioral health and primary care?
a. How do these approaches vary by:
(i) patient characteristics (e.g., clinical focus/conditions/patient
subgroups)
(ii) core components of the approach
(iii) practice/care delivery setting characteristics such as the policy
environment, and geographic location.
(iv) resources and infrastructure required, such as staffing, payment
models, financing, and technology
(v) mechanisms of care integration
Question 2 (Key). How effective are approaches to integrating
behavioral health and primary care?
a. Does effectiveness vary by:
(i) patient characteristics (e.g., clinical focus/conditions/patient
subgroups)
(ii) core components of the approach
(iii) practice/care delivery setting characteristics, such as the
policy environment, and geographic location.
(iv) resources and infrastructure required, such as staffing,
financing, payment models, and technology
(v) mechanisms of care integration
b. How do interactions among the components of integration
approaches impact effectiveness and maintenance of the integration of
behavioral health and primary care?
Question 3 (Contextual). What are the barriers to and facilitators
of implementing and sustaining different approaches to integrating
behavioral health and primary care?
a. How do the barriers, facilitators, and other factors involved in
the implementation of behavioral health and primary care interact to
affect implementation and sustainability?
Question 4 (Contextual). What reliable, valid, clinically
meaningful, and/or patient-centered measures and metrics are available
to monitor and evaluate integration approaches?
a. How is measurement integrated into clinical care and the ongoing
monitoring and evaluation of integration?
b. Are the measures or metrics specific to characteristics; level
of complexity; or the structure, process, or outcomes of care
integration?
c. Are there models or standards for how frequently the
effectiveness of approaches to integration should be reassessed?
d. What are the gaps in measurement and what are the implications
for our current ability to measure and assess integration?
Question 5 (Contextual). How are care team member roles and their
work flows defined in different approaches to integrating behavioral
health and primary care?
a. What training interventions (e.g., mode and content, trainee
credentials, dose and timing of training) are effective in facilitating
integrated care team functioning?
Population, Interventions, Comparators, Outcomes, and Setting (PICOS)
----------------------------------------------------------------------------------------------------------------
PICOS Inclusion Exclusion
----------------------------------------------------------------------------------------------------------------
Population............................. Children (aged 0-20 years) and adults (aged No exclusions
>=21 years) with behavioral health needs. for age or condition.
Clinical focus/conditions including but not
limited to patients with:
Mental illness or mental health
conditions
Substance use disorders
Stress-linked physical symptoms
(e.g., insomnia, fatigue)
Complex overlapping medical
conditions and psychosocial risk factors
Experiences of trauma, adverse
experiences, or stressful life events
Pregnant patients
Geriatric patients
Intervention........................... Different approaches to integrating Co-location
behavioral health and primary care without collaboration.
services, including program/model Referral only
components and strategies to integrate (cold handoff).
care. Warm handoff
Examples of eligible programs/models for without plan for
care integration include but are not continued communication
limited to: and coordination of
Collaborative Care Model care.
Primary Care Behavioral Health Population level
Model health promotion or
Co-location models prevention programs that
Models that use telehealth for are not individualized,
integration integrated care (e.g.,
The baseline requirement is that the Silver Sneakers).
practice design of the approach facilitates Interventions
interaction among primary care and for chronic medical
behavioral health providers in the conditions that do not
provision of care. Ongoing collaboration include a significant,
and coordination of care are required; explicit behavioral
activities may include screening and health component.
diagnosis, acute and long-term
interventions, and follow up and
maintenance.
[[Page 64045]]
Comparator............................. Care as usual (e.g., non-integrated No comparator
behavioral health and primary care for KQ 2 (descriptive
services) in a different group or time studies; such as case
period studies).
Alternative care integration Comparators not
strategy or strategies applicable to other
No care questions.
Outcomes............................... Outcomes of interest include but not limited Simulated results or
to: responses to
PATIENT LEVEL hypothetical scenarios
Health outcomes: or questions.
Morbidity
Mortality
Improved symptoms
Guideline concordant screening and
diagnosis
Remission/recovery
Adherence to treatment
Patient Reported Outcomes:
Health related quality of life
Functional status (including social
and adaptive functioning)
Satisfaction with care
Measures of care utilization:
Avoidable emergency care or
inpatient care for behavioral health crises
Total health care utilization
Measures of access to care:
Patients receive routine care as
soon as wanted
Patients receive acute care when
needed
Average wait time for BH
Patients experiencing difficulties
or delays in obtaining BH care
Patients with mental health
condition received treatment
Patients with SUDs received
treatment
CLINICIAN AND PRACTICE LEVEL
Clinician Outcomes:
Clinician retention/turnover rates
Burnout
Professional satisfaction
Efficiency of clinician time use
Population/community/clinic panel health
outcomes:
BH-related preventive care measures
BH screening services
Cost outcomes:
Cost per patient per year
Cost per service
Costs associated with care delays,
fragmentation, poor coordination,
redundancy, requested but not completed
patient referrals
Implementation Outcomes:
Adoption of intervention approaches
Fidelity
Systemic Change/Sustainment
HARMS
Missed diagnoses
Delays in care
Overutilization of resources
Redundant or inappropriate care
Setting................................ Health systems/hospitals and Hospitals.
community-based primary care practices in Prehospital/EMS/
the United States (physical or virtual) or crisis care.
in countries with similar healthcare Prisons.
systems Countries with
Non-healthcare settings providing healthcare systems that
outpatient BH/PC (school-based clinics, do not provide
community centers, churches, shelters) information relevant to
Nursing homes, group homes and the U.S.
other long-term residential settings
Study Designs.......................... Experimental and observational Articles that do
studies that describe and evaluate not include any data.
integration approach. Proposals for
For Scan Question 1 and Contextual approaches that have not
Questions 3 and 5: Survey and Qualitative been implemented.
Studies. Descriptions of
For Contextual Question 4: approaches that have not
Psychometric Studies been evaluated (for
Systematic reviews that directly KQ2).
address one of the review questions Articles
reporting simulation or
speculation.
----------------------------------------------------------------------------------------------------------------
Abbreviations: BH = behavioral health; EMS = emergency medical services; KQ = key question; PC = primary care.
[[Page 64046]]
Dated: October 17, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022-22843 Filed 10-20-22; 8:45 am]
BILLING CODE 4160-90-P
