Notice2023-24214
Supplemental Evidence and Data Request on Trauma Informed Care
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 2, 2023
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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 Trauma Informed 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 88 Issue 211 (Thursday, November 2, 2023)</title>
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[Federal Register Volume 88, Number 211 (Thursday, November 2, 2023)]
[Notices]
[Pages 75285-75286]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-24214]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Trauma Informed Care
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submission.
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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 Trauma Informed
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 Access to published and unpublished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 December 4, 2023.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#1376637053727b61623d7b7b603d747c65"><span class="__cf_email__" data-cfemail="f7928794b7969f8586d99f9f84d9909881">[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#781d081b3819100a095610100b561f170e"><span class="__cf_email__" data-cfemail="dfbaafbc9fbeb7adaef1b7b7acf1b8b0a9">[email protected]</span></a>.
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 Trauma Informed Care.
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 Trauma Informed Care. The entire research protocol is
available online at: <a href="https://effectivehealthcare.ahrq.gov/products/trauma-informed-care/protocol">https://effectivehealthcare.ahrq.gov/products/trauma-informed-care/protocol</a>.
This is to notify the public that the EPC Program would find the
following information on Trauma Informed Care 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 <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>
trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, 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
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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: <a href="https://www.effectivehealthcare.ahrq.gov/email-updates">https://www.effectivehealthcare.ahrq.gov/email-updates</a>.
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.
Key Questions (KQ)
TIC for Adult Patients/Clients
<bullet> KQ 1. What is the evidence of benefits and/or harms of TIC
on outcomes for patients/clients?
[cir] KQ 1a. Which components (e.g., education and training of
providers about trauma, screening patients, delivering point-of-care
interventions [note this is not meant to include established
evidence-based treatments for trauma-related disorders], referring
patients/clients for various forms of additional assessment and
treatment for indicated needs) of TIC models, and organizational and
practice characteristics, are associated with benefits and/or harms?
[cir] KQ 1b. Do outcomes vary by patient/client or clinical or
organizational characteristics, including the nature, extent and
timing of exposure (e.g., recent or ongoing vs. prior exposure in
childhood)?
TIC for Child and Adolescent Patients/Clients
<bullet> KQ 2. What is the evidence of benefits and/or harms of TIC
on outcomes for patients/clients?
[cir] KQ 2a. Which components (e.g., education and training of
providers about trauma, screening patients, delivering point-of-care
interventions [note this is not meant to include indicated evidence-
based treatments for trauma-related disorders], referring clients
for various forms of additional assessment and treatment for
indicated needs) of TIC models, organizational and practice
characteristics, are associated with benefits and/or harms?
[[Page 75286]]
[cir] KQ 2b. Do outcomes vary by patient/client (as well as
parent) or clinical or organizational characteristics including the
nature, extent, and timing of exposure (e.g., recent or ongoing vs.
prior exposure)?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting)
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PICOTS KQ1 KQ2
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Population.................. Adults 18 years and Youth <18 years,
older, regardless regardless of
of trauma exposure. trauma exposure.
1b. Patient/client 2b. Patient/client
and clinical and clinical
characteristics characteristics
including type, including type,
time since, and time since, and
duration of trauma duration of trauma
exposure; gender; exposure; gender;
race/ethnicity; race/ethnicity;
age; clinical age; clinical
condition; or condition; or
disorder (e.g., disorder, (e.g.,
anxiety, anxiety,
depression, depression, ADHD,
substance use). conduct disorder,
substance use).
Intervention................ TIC models/ TIC models/
components of care components of care
(e.g., education (e.g., education
and training of and training of
providers about providers about
trauma, screening trauma, screening
patients/clients patients/clients
for trauma exposure for trauma exposure
using ACEs or other using ACEs or other
tools, screening tools, screening
for symptoms, for symptoms,
delivering point-of- delivering point of
care interventions, care interventions,
referring patients/ referring patients/
clients for various clients for various
forms of additional forms of additional
assessment and assessment and
treatment for treatment for
indicated needs). indicated needs).
1a. single or multi- 2a. single or multi-
component, component,
individual or individual or
group, targeting group, targeting
organizations, organizations,
providers, patients/ providers, patients/
clients, clients,
caregivers, or a caregivers, or a
combination, combination,
training, screening. training,
screening.
Comparator.................. No TIC model of care/ No TIC model of care/
usual or routine usual or routine
care (CAU). care (CAU).
Other TIC model or Other TIC model or
component(s) of component(s) of
care, evidence- care, evidence-
based therapies for based therapies for
trauma-related trauma-related
conditions (e.g., conditions (e.g.,
prolonged exposure, trauma-focused CBT)
cognitive or approaches
processing therapy) (e.g.,
or approaches Collaborative
(e.g., Care).
Collaborative Care).
Outcome..................... Trauma-Specific: Trauma-Specific:
Additional or Additional or
repeat trauma repeat trauma
exposure from the exposure from the
point-of-care in point-of-care in
the course of care/ the course of care/
service delivery service delivery
(e.g., (e.g.,
retraumatization). retraumatization).
Process outcomes: Process outcomes:
Health care Healthcare outcomes/
outcomes/ utilization/
utilization/ referral, provider
referral, provider outcomes burnout/
burnout/mental mental health.
health.
Organizational/ Organizational/
practice/systems practice/systems
outcomes: Intake outcomes: Intake
and referral and referral
processes (e.g., processes (e.g.,
wait times), wait times),
disseminated disseminated
policies, policies,
trainings, staffing trainings, staffing
(e.g., scribes), (e.g., scribes),
administrative administrative
requirements, requirements,
access to access to
treatment, treatment,
workforce diversity. workforce
diversity, anti-
racism principles.
Patient/client- Patient/client-
centered outcomes: centered outcomes:
Physical and mental Physical and mental
health outcomes, health outcomes,
functioning, functioning,
clinical clinical
improvement, improvement,
patient/client patient/client
engagement, trust, engagement, trust,
comfort or comfort or
satisfaction, and satisfaction, and
strengths-based strengths-based
outcomes (e.g., outcomes (e.g.,
quality of life). quality of life).
Harms: Includes Harms: Includes
displacement of displacement of
evidence based care evidence based care
(e.g., screening (e.g., screening
for anxiety, for developmental
depression, milestones, ADHD,
substance use, depression,
suicide risk), anxiety, suicide
increase in patient/ risk, substance
client aggression use), increase in
or other behavioral patient/client
misconduct. aggression or other
behavioral
misconduct.
Timing...................... Any................. Any.
Setting..................... Routine or emergency Routine or emergency
healthcare in any healthcare in any
setting that setting that
provides human or provides human or
social services, social services,
including in including in
nontraditional nontraditional
settings (e.g., HIV settings (e.g.,
clinics providing school-based
behavioral health clinics providing
care). behavioral health
care).
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Dated: October 27, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-24214 Filed 11-1-23; 8:45 am]
BILLING CODE 4160-90-P
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