[Federal Register Volume 88, Number 211 (Thursday, November 2, 2023)]
[Notices]
[Pages 75285-75286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 Access to published and unpublished 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: https://effectivehealthcare.ahrq.gov/products/trauma-informed-care/protocol.
    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 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.

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)
------------------------------------------------------------------------
           PICOTS                      KQ1                   KQ2
------------------------------------------------------------------------
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).
------------------------------------------------------------------------


    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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