Notice2023-19272
Request for Information; Potential Changes to its Evidence-Based Practices Resource Center
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Published
September 7, 2023
Issuing agencies
Substance Abuse and Mental Health Services Administration
Abstract
SAMHSA is issuing this RFI to gather expert and public feedback to determine how to best satisfy Sec. 7002, subsections (b), (c), or (d) of the 21st Century Cures Act, which are explained below. Input from the public and experts will help SAMHSA identify the optimal ways to identify, evaluate, and disseminate programs and practices, based on their intended audiences, the nature of the evidence supporting the program or practice, and the type of product deemed best suited to the content. SAMHSA seeks input from members of the public on potential changes to its Evidence-Based Practices Resource Center (EBPRC), specifically regarding the possible introduction of three new domains for the EBPRC website (https://www.samhsa.gov/resource-search/ ebp). In addition to addressing four general questions about the EBPRC overall, SAMHSA encourages members of the public to comment on several questions pertaining to each of the domains described. SAMHSA believes that public and expert input on the new domains will help make the EBPRC more responsive to the needs of the public and the behavioral health field.
Full Text
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<title>Federal Register, Volume 88 Issue 172 (Thursday, September 7, 2023)</title>
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[Federal Register Volume 88, Number 172 (Thursday, September 7, 2023)]
[Notices]
[Pages 61608-61610]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-19272]
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SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION
Request for Information; Potential Changes to its Evidence-Based
Practices Resource Center
AGENCY: Substance Abuse and Mental Health Services Administration
(SAMHSA), Department of Health and Human Services (HHS).
ACTION: Notice of request for information (RFI).
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SUMMARY: SAMHSA is issuing this RFI to gather expert and public
feedback to determine how to best satisfy Sec. 7002, subsections (b),
(c), or (d) of the 21st Century Cures Act, which are explained below.
Input from the public and experts will help SAMHSA identify the optimal
ways to identify, evaluate, and disseminate programs and practices,
based on their intended audiences, the nature of the evidence
supporting the program or practice, and the type of product deemed best
suited to the content. SAMHSA seeks input from members of the public on
potential changes to its Evidence-Based Practices Resource Center
(EBPRC), specifically regarding the possible introduction of three new
domains for the EBPRC website (<a href="https://www.samhsa.gov/resource-search/ebp">https://www.samhsa.gov/resource-search/ebp</a>). In addition to addressing four general questions about the EBPRC
overall, SAMHSA encourages members of the public to comment on several
questions pertaining to each of the domains described. SAMHSA believes
that public and expert input on the new domains will help make the
EBPRC more responsive to the needs of the public and the behavioral
health field.
DATES: Comments on this notice must be received by October 13th, 2023.
ADDRESSES: Please submit all responses via email to
<a href="/cdn-cgi/l/email-protection#aaefe8faf8e9ead9cbc7c2d9cb84c2c2d984cdc5dc"><span class="__cf_email__" data-cfemail="aeebecfefcedeeddcfc3c6ddcf80c6c6dd80c9c1d8">[email protected]</span></a> as a Word document, Portable Document Format (PDF)
file, or in the body of the email message. Please include ``Request for
Information: Changes to SAMHSA's EBPRC'' in the subject line of the
message.
FOR FURTHER INFORMATION CONTACT: Carter A Roeber, Telephone: 240-276-
1488, Email: <a href="/cdn-cgi/l/email-protection#3b785a494f5e491569545e595e497b485a5653485a15535348155c544d"><span class="__cf_email__" data-cfemail="ecaf8d9e98899ec2be83898e899eac9f8d81849f8dc284849fc28b839a">[email protected]</span></a>, or <a href="/cdn-cgi/l/email-protection#d0959280829390a3b1bdb8a3b1feb8b8a3feb7bfa6"><span class="__cf_email__" data-cfemail="e1a4a3b1b3a2a192808c899280cf898992cf868e97">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The EBPRC was established in 2018 to fulfill
the statutory requirements of the 21st Century Cures Act (Pub. L. 144-
255). Specifically, section 7002 of the 21st Century Cures Act requires
that, as appropriate, SAMHSA shall ``improve access to reliable and
valid information on evidence-based programs and practices, including
information on the strength of evidence associated with such programs
and practices, related to mental and substance use disorders for
States, local communities, nonprofit entities, and other stakeholders,
by posting on the internet website of the Administration information on
evidence-based programs and practices that have been reviewed by the
Assistant Secretary in accordance with the requirements of this
section.'' SAMHSA has designated the EBPRC, managed by the agency's
National Mental Health and Substance Use Policy Laboratory (NMHSUPL),
to fulfill this charge.
With the directive to publish information on evidence-based
programs and practices (EBPs), the EBPRC relies on SAMHSA's
relationships with key behavioral health stakeholders, including
researchers, clinical and public health service providers, program
administrators, and people with lived experience to inform the content
it distributes. Further, SAMHSA's repository of EBPRC materials is
organized by topic area and made searchable to maximize navigability,
utility, and relevancy of content to those poised to implement EBPs. In
this way, the EBPRC aims to broaden the scale of EBP implementation and
provide support to improve behavioral health outcomes nationwide.
Recognizing the ever-changing nature of the evidence base, the
EBPRC seeks to take a dynamic and responsive approach to its curation
of resources. To date, however, the EBPRC has primarily posted
federally developed materials on practices. The programs and practices
mentioned in the posted materials are vetted through a review of the
evidence. However, unlike <a href="http://Crimesolutions.gov">Crimesolutions.gov</a> or the What Works
Clearinghouse (WWC), the EBPRC does not currently incorporate and
publish a systematic process for identifying, evaluating and rating
specific programs and practices across the behavioral health field and
related subspecialty fields for inclusion, as envisioned by section
7002, subsections (b), (c), or (d) of the 21st Century Cures Act. The
inclusion of reviews and ratings of particular programs would allow
users to search for and learn about specific programs that might meet
their population's needs.
To ensure that the EBPRC fulfills its roles in the analysis,
synthesis, and dissemination of behavioral health evidence, SAMHSA
requests that members of the public respond to the following questions,
the answers to which will help frame the agency's efforts to improve
the EBPRC's utility to the public.
Framing Questions
<bullet> Question A: How can SAMHSA improve the EBPRC to better
meet the needs of the behavioral health field?
<bullet> Question B: What strategies should the EBPRC use to ensure
its content is high-quality and supported by strong evidence?
<bullet> Question C: How can SAMHSA expand the reach of the EBPRC?
<bullet> Question D: How can SAMHSA solicit feedback on the use of
its resources and information?
In addition, SAMHSA requests that commenters consider the following
three domains of the EBPRC, upon which it seeks specific feedback, as
enumerated below.
Domain 1. Adding a program review and rating component to the
EBPRC.
SAMHSA's EBPRC provides communities, clinicians, policymakers, and
others with the information and tools needed to improve the quality of
care, by incorporating EBPs into their communities or clinical
settings. Evidence-based practices and programs (EBPs) are defined as
interventions that are guided by the best research evidence with
practice-based expertise, cultural competence, and the values of the
persons receiving the services that promote individual or population-
level outcomes. The distinction between
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programs and practice is important, however.
A Program is a specific set of activities carried out according to
guidelines to achieve a defined purpose. To determine whether
individual programs are effective, we rely on studies using randomized
experimental (i.e., controlled) evaluation designs and quasi-
experimental evaluation designs. Program profiles tell us whether a
specific program was found to achieve its goals when it was carefully
evaluated. The results apply to the exact set of activities and
procedures used for the program as implemented at the time of
evaluation. Thus, the program profile tells us that a program is likely
to produce the observed result if it is implemented in exactly the same
way. A program profile can answer: Did the ABC mentoring program in
Anytown, USA, achieve its goals?
A Practice is a general category of programs, strategies or
procedures that share similar characteristics with regard to the issues
they address and how they address them. We rely on meta-analyses
instead of evaluations of individual programs. Practice profiles tell
us about the average results from multiple evaluations of similar
programs, strategies, or procedures. The programs, strategies or
procedures within a practice are similar because they share certain
defining characteristics that are described for each practice profile.
Thus, practice profiles tell us about the average result across
multiple evaluations. A practice profile can answer: Does mentoring
usually achieve its goals?
It is well established that individuals, for-profit and non-profit
businesses, universities, and other groups develop and market
proprietary or copywritten interventions/programs, both as a source of
revenue, and as a means of improving the quality of behavioral health
services. Similarly, the development of a new pharmaceutical product
for a substance use or mental health condition is driven by both market
forces and health care needs. In the fields of substance use
prevention, mental health promotion, as well as treatment and recovery
for behavioral health conditions, organizations may charge fees for the
specific manualized program they developed or for additional consulting
services. These programs (i.e., manualized interventions) may or may
not be effective.
In its current form, the EBPRC posts relevant materials developed
by SAMHSA staff or on behalf of SAMHSA by contractors. These products
cover a wide range of topics and are generally in the format of a
comprehensive evidence-based guide, practical guide, or advisory.
Evidence-based guides are developed for topics on which the evidence is
well established, providing background information, a review of the
evidence, guidance on implementation and process improvement, and case
studies on specific evidence-based programs and practices. These guides
are targeted to the general public and various behavioral health
stakeholders across disciplines, including providers, researchers, and
administrators. Practical guides are developed when a topic is urgent
and for which there is an established evidence base, but uptake has
been slow due to various barriers. Practical guides address those
barriers through an environmental scan of up-to-date literature,
curated through the lens of implementation, with the aim of informing
end users. Using a similar methodology as practical guides, advisories
provide brief guidance on a given topic for a broad audience, focusing
on actionable steps to promote effective behavioral health practice and
mitigate immediate behavioral health risks.
SAMHSA also posts treatment improvement protocols, toolkits, fact
sheets, and systematic evidence reviews. Organizations and providers
can download these products at no cost. These products are one way of
disseminating information about EBPs in summarized form. However, there
may be other ways of disseminating information about EBPs.
The EBPRC does not currently seek applications for inclusion in its
website as envisioned by section 7002 (b) of the 21st Century Cures Act
and similarly has not established a review and rating system as
outlined in section 7002(c). Section 7002(b) suggests that the
Assistant Secretary for Mental Health and Substance Use Services (AS)
``may establish a period for the submission of applications for
evidence-based programs and practices to be posted publicly. . ..'' and
section 7002(c) states that the AS ``may establish minimum requirements
for the applications related to submission of research and
evaluation.'' In summary, the EBPRC may request that programs are
submitted for review and rating, requiring that minimum criteria be met
for inclusion on the EBPRC website. As such, this RFI seeks input on
the best ways to solicit program submissions as well as to review and
rate submitted programs.
Evidence-based practice registries, like CrimeSolutions.gov or What
Works in Education (<a href="https://ies.ed.gov/ncee/wwc/">https://ies.ed.gov/ncee/wwc/</a>), provide ratings of
individual programs. Similar to consumer group websites, these
registries' ratings provide useful information about a single program's
effectiveness, without going into detail about how the program should
be implemented, how much it may cost, or whether it is appropriate for
a particular organization or provider. This method has the advantage of
sharing critical information quickly. However, it may not provide
enough information to help an organization or provider make a final
decision regarding which program to select.
Relatedly, the impact of program selection on behavioral health
outcomes raises the question of how the EBPRC should consider and
select programs for review. The EBPRC has limited resources for
conducting program reviews and rating each submission.
Therefore, SAMHSA is interested in the following questions:
<bullet> Question 1a: Please describe the extent to which a new
EBPRC component that reviews the evidence for a manualized
intervention/program and publicly posts the results would be of use to
the behavioral health field.
<bullet> Question 1b: If SAMHSA chooses to add the program review
component, how should it decide which programs get reviewed and which
do not?
<bullet> Question 1c: Please describe the extent to which an
evaluation of a program's dissemination materials, costs, and other
issues associated with implementation would be of use to the behavioral
health field.
Domain 2. Including implementation science, process improvement,
capacity building and program evaluation resources.
Implementation science is defined as ``the scientific study of
methods to promote the systematic uptake of clinical research findings
and other evidence-based practices (EBPs) into routine practice and
hence improve the quality and effectiveness of health care.'' \i\ The
new field of study emerged with increased emphasis on EBPs and the
barriers that organizations faced in adopting them.
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\i\ Wiltsey Stirman, S., Baumann, A. A., & Miller, C. J. (2019).
The FRAME: an expanded framework for reporting adaptations and
modifications to evidence-based interventions. Implementation
Science, 14, 1-10, <a href="https://doi.org/10.1186/s13012-019-0898-y">https://doi.org/10.1186/s13012-019-0898-y</a>.
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Improvement science draws heavily on process improvement
models.\ii\ Underlying most of these models is the Plan, Do, Study, Act
(PDSA) cycle, which involves systematically gaining
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learning and knowledge for the continual improvement of a product or
process through an iterative process of planning, making small changes,
and monitoring and responding to results.\iii\Like implementation
science, improvement science aims to improve population outcomes and
acknowledges the gap between current and ideal practice.\iv\
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\ii\ Pflager, D. (2022, August 2). Getting it right: Using
implementation research to improve outcomes in early care and
education. Foundation For Child Development. <a href="https://www.fcd-us.org/getting-it-right-using-implementation-research-to-improve-outcomes-in-early-care-and-education/">https://www.fcd-us.org/getting-it-right-using-implementation-research-to-improve-outcomes-in-early-care-and-education/</a>.
\iii\ Consumer assessment of healthcare providers and Systems
(CAHPS). AHRQ. (n.d.). <a href="https://www.ahrq.gov/cahps/">https://www.ahrq.gov/cahps/</a>.
\iv\ Nilsen, P., Thor, J., Bender, M., Leeman, J., Andersson-
G[auml]re, B., & Sevdalis, N. (2022). Bridging the silos: a
comparative analysis of implementation science and improvement
science. Frontiers in Health Services, 1, 18.
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For population outcomes to improve, the individuals, organizations,
systems, and communities implementing these processes must have
capacity to do so successfully. As such, in achieving population impact
goals, capacity building can be described as ``the ways to the means,''
and ``the process through which individuals, groups of people, and
organizations obtain, strengthen, and maintain the capabilities they
need to set and advance goals.'' \v\
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\v\ Early childhood systems building resource guide. Why
Capacity Building? <radical> Child Care Technical Assistance
Network. (n.d.). <a href="https://childcareta.acf.hhs.gov/systemsbuilding/systems-guides/capacity-building-self-assessment-tool/why-capacity-building">https://childcareta.acf.hhs.gov/systemsbuilding/systems-guides/capacity-building-self-assessment-tool/why-capacity-building</a>.
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Also, essential to improving population health is program
evaluation,\vi\ which can be defined as ``an assessment using
systematic data collection and analysis of one or more programs,
policies, and organizations intended to assess their effectiveness and
efficiency.'' \vii\
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\vi\ Edwards, B., Stickney, B., Milat, A., Campbell, D., &
Thackway, S. (2016). Building research and evaluation capacity in
population health: the NSW Health approach. Health promotion journal
of Australia: official journal of Australian Association of Health
Promotion Professionals, 27(3), 264-267. <a href="https://doi.org/10.1071/HE16045">https://doi.org/10.1071/HE16045</a>.
\vii\ Gao-21-404SP, program evaluation: Key terms and concepts.
Government Accountability Office. (2021, March). <a href="https://www.gao.gov/assets/gao-21-404sp.pdf">https://www.gao.gov/assets/gao-21-404sp.pdf</a>.
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<bullet> Question 2a: What types of implementation science, process
improvement, and capacity building resources should SAMHSA include in
the EBPRC to facilitate the adoption of EBPs?
<bullet> Question 2b: What additional resources on program
evaluation would be helpful to provide through the EBPRC?
Domain 3. Culturally informed and community-driven programs and
practices.
SAMHSA's mission covers the entire continuum of care, from
substance use prevention and mental health promotion to treatment and
services fostering recovery.\viii\ Furthermore, as a federal agency,
SAMHSA serves all Americans, with a special emphasis on equity for
under-resourced communities. For the purpose of this RFI, under-
resourced communities are defined as ``population groups that
experience greater obstacles to health, based on characteristics such
as, but not limited to, race, ethnicity, religion, income, geography,
gender identity, sexual orientation, and disability.'' \ix\ Steps
toward fulfilling that mission include listening to and collaborating
with under-resourced communities to address the barriers that limit
access to behavioral health services and to support community
development through culturally informed interventions. SAMHSA has a
long history of promoting and disseminating community-based and
culturally based programs that are developed in collaboration with
under-resourced populations. Yet, for several reasons, many community-
and culturally-based programs are excluded from evidence-based
registries or clearinghouses. The way these programs are developed and
implemented means that they cannot ethically or logistically be
evaluated using randomized controlled trial or quasi-experimental
designs that registries require for consideration. The programs can
also be small in scale and geographically specific, making it even more
difficult to randomly select participants or develop matching control
groups.
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\viii\ White House (2023, May 18). Biden-Harris Administration
Announces New Actions to Tackle Nation's Mental Health Crisis [Fact
sheet]. <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2023/05/18/fact-sheet-biden-harris-administration-announces-new-actions-to-tackle-nations-mental-health-crisis/">https://www.whitehouse.gov/briefing-room/statements-releases/2023/05/18/fact-sheet-biden-harris-administration-announces-new-actions-to-tackle-nations-mental-health-crisis/</a>.
\ix\ Substance Abuse and Mental Health Services Administration
(SAMHSA): Adapting Evidence-Based Practices for Under-Resourced
Populations. SAMHSA Publication No. PEP22-06-02-004. Rockville, MD:
National Mental Health and Substance Use Policy Laboratory.
Substance Abuse and Mental Health Services Administration, 2022.
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Taking these factors into account, please answer the following
questions:
<bullet> Question 3a: In what ways, if any, would an EBPRC
component that assesses and shares findings from research on community-
based and/or culturally driven behavioral health programs be of use to
the behavioral health field?
<bullet> Question 3b: What methods should SAMHSA use to assess
community- or culturally-based behavioral health programs and present
them on the EBPRC?
<bullet> Question 3c: If SAMHSA convenes a technical expert panel,
what areas of expertise should be included?
Responses from the public will inform SAMHSA's efforts to improve
the EBPRC and better disseminate programs and practices to our partners
and collaborators. Responses from the public are one of the best ways
for SAMHSA to hear from people and organizations who are directly
affected by SAMHSA's work. Thank you for your consideration.
How To Submit a Response
Responses will be accepted through October 13th, 2023. Responses
must be emailed to <a href="/cdn-cgi/l/email-protection#b5f0f7e5e7f6f5c6d4d8ddc6d49bddddc69bd2dac3"><span class="__cf_email__" data-cfemail="c98c8b999b8a89baa8a4a1baa8e7a1a1bae7aea6bf">[email protected]</span></a>. Please include ``Request for
Information: Changes to SAMHSA's EBPRC'' in the subject line.
Responders are free to address any or all the questions listed
above. Please identify the question or question(s) to which you are
responding. Responses also may address concerns or issues not
identified above.
The submitted information will be reviewed by SAMHSA and HHS staff.
However, individual comments may not be acknowledged by SAMHSA due to
the volume of comments received.
Responses to this RFI are entirely voluntary and may be submitted
anonymously. Please do not include any personally identifiable
information or any information that you do not wish to make public.
Proprietary, classified, confidential, or sensitive information should
not be included in your response.
SAMHSA will use the information submitted in response to this RFI
at its discretion. SAMHSA reserves the right to use any submitted
information on public websites, in reports, in summaries of the state
of the science, in any possible resultant solicitation(s), grant(s),
contract(s) or cooperative agreement(s), or in the development of
future funding opportunity announcements.
This RFI is for informational and planning purposes only and is not
a solicitation for applications or an obligation on the part of the
Government to provide support for any ideas identified in response to
it. Please note that the Government will not pay for the preparation of
any information submitted or for use of that information.
Dated: August 31, 2023.
Carlos Castillo,
Committee Management Officer.
[FR Doc. 2023-19272 Filed 9-6-23; 8:45 am]
BILLING CODE 4162-20-P
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