[Federal Register Volume 85, Number 232 (Wednesday, December 2, 2020)]
[Notices]
[Pages 77463-77465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26569]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Transitions of Care 
From Pediatric to Adult Services for Children With Special Healthcare 
Needs

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 Transitions of 
Care from Pediatric to Adult Services for Children with Special 
Healthcare Needs, 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unpublished pertinent scientific information will improve the quality 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.

[[Page 77464]]


DATES: Submission Deadline on or before January 4, 2021.

ADDRESSES: 
    Email submissions: <a href="/cdn-cgi/l/email-protection#593c293a1938312b287731312a773e362f"><span class="__cf_email__" data-cfemail="fb9e8b98bb9a93898ad5939388d59c948d">[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: Jenae Benns, Telephone: 301-427-1496 
or Email: <a href="/cdn-cgi/l/email-protection#5134213211303923207f3939227f363e27"><span class="__cf_email__" data-cfemail="5431243714353c26257a3c3c277a333b22">[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 Transitions of Care 
from Pediatric to Adult Services for Children with Special Healthcare 
Needs. 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 Transitions of Care from Pediatric to Adult Services for 
Children with Special Healthcare Needs, including those that describe 
adverse events. The entire research protocol is available online at: 
https://effectivehealthcare.ahrq.gov/products/transitions-care-pediatric-adult/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Transitions of Care from Pediatric to Adult 
Services for Children with Special Healthcare Needs helpful:
    [squf] 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.
    [squf] 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.
    [squf] 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.
    [squf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your 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.

Key Questions (KQs)

    <bullet> KQ1: What are the effectiveness, comparative 
effectiveness, harms, and costs of care interventions for transition 
from pediatric to adult medical care services, including primary care, 
for children with special healthcare needs and their families/
caregivers?
    [cir] KQ1a: How do outcomes vary by intervention characteristics or 
components?
    [cir] KQ1b: How do outcomes vary by patient/caregiver or provider 
characteristics or setting?
    [cir] KQ1c: What are the barriers and facilitators to effective 
transitions?
    [cir] KQ1d: What are the gaps in evidence for the effectiveness of 
the interventions?
    <bullet> KQ2: What are the effectiveness, comparative 
effectiveness, harms, and costs of implementation strategies for care 
interventions for transition, including provider-related training?
    [cir] KQ2a: How do outcomes vary by intervention characteristics or 
components?
    [cir] KQ2b: How do outcomes vary by patient/caregiver or provider 
characteristics or setting?
    [cir] KQ2c: What are the barriers and facilitators to effective 
implementation?
    [cir] KQ2d: What are the gaps in evidence for the effectiveness of 
the interventions?
    <bullet> KQ3: What is the effectiveness, comparative effectiveness, 
harms, and costs of tools to facilitate communication between pediatric 
and adult providers for care transitions from pediatric to adult 
medical care for children with special healthcare needs and their 
families/caregivers?
    [cir] KQ3a: How do outcomes vary by intervention characteristics or 
components?
    [cir] KQ3b: How do outcomes vary by patient/caregiver or provider 
characteristics or setting?
    [cir] KQ3c: What are the barriers and facilitators to effective 
tools to facilitate communication?
    [cir] KQ3d: What are the gaps in evidence for the effectiveness of 
the interventions?

Contextual Questions

    In addition to the identified key questions, the report will 
include a mixed-methods evaluation of the contexts in which 
interventions for transitioning children with special healthcare needs 
from pediatric to adult services are developed and used. Contextual 
questions to be evaluated include:
    1. How is effectiveness defined and measured for transitions of 
care from pediatric to adult services for children with special 
healthcare needs?
    2. What transition care training and other implementation 
strategies are available to prepare pediatric medical providers (e.g., 
pediatricians and other specialists) and adult medical providers (e.g., 
primary care providers, nurse practitioners, physician assistants) for 
transitioning children with special healthcare needs to adult care?
    3. What training is available for linguistic- and culturally 
competent care?
    4. What transition care training and other implementation 
strategies are available to prepare pediatric patients and their 
families for transitioning children with special healthcare needs to 
adult care?

[[Page 77465]]

    5. What care interventions including primary care have been used 
for transition from pediatric to adult medical care for children with 
special healthcare needs?
    6. What strategies have been proposed to increase availability of 
adult care providers for people transitioning from pediatric to adult 
care?

   PICOTS (Populations, Interventions, Comparators, Outcomes, Timing,
                                Settings)
------------------------------------------------------------------------
                       KQ1: Benefits
                       and harms of          KQ2:              KQ3:
       PICOT               care         Implementation    Communication
                       intervention       strategies          tools
------------------------------------------------------------------------
Population.........  Adolescents and   Multi-            Multi-
                      young adults      disciplinary      disciplinary
                      (diagnosed with   care providers    care providers
                      cancer or other   (e.g., primary    (e.g., primary
                      special           care/family       care/family
                      healthcare        medicine          medicine
                      condition         physicians,       physicians,
                      before 21 years   specialty care    specialty care
                      old) with a       physicians,       physicians,
                      chronic           nurse             nurse
                      physical or       practitioners,    practitioners,
                      mental illness    physician         physician
                      or physical,      assistant,        assistant,
                      intellectual,     etc.) caring      etc.)
                      or                for adolescents   providers
                      developmental     and young         caring for
                      disability,       adults with a     adolescents
                      also including    special           and young
                      parents and/or    healthcare need.  adults with a
                      care givers.                        special need.
                     Patient           Patient           Patient
                      subgroups:        subgroups:        subgroups:
                      Disease           Disease           Disease
                      condition         condition         condition
                      (including        (including        (including
                      cancer), age of   cancer), age of   cancer), age
                      diagnosis, sex/   diagnosis, sex/   of diagnosis,
                      sexual            sexual            sex/sexual
                      orientation,      orientation,      orientation,
                      race/ethnicity,   race/ethnicity,   race/
                      religion,         religion,         ethnicity,
                      socioeconomic     socioeconomic     religion,
                      status, adverse   status, adverse   socioeconomic
                      childhood         childhood         status,
                      events.           events.           adverse
                     Provider          Provider           childhood
                      subgroups: Age,   subgroups: Age,   events.
                      sex, race/        sex, race/       Provider
                      ethnicity,        ethnicity,        subgroups:
                      education,        education,        Age, sex, race/
                      socioeconomic     socioeconomic     ethnicity,
                      status,           status,           education,
                      specialty, care   specialty, care   socioeconomic
                      setting.          setting.          status,
                                                          specialty,
                                                          care setting.
Intervention.......  Intervention      Implementation    Tools for
                      related to the    strategies,       provider
                      care transition   including         communication
                      from pediatric    training (e.g.,   (e.g., any
                      to adult          any single or     single or
                      medical care      multi-component   multi-
                      (e.g., any        intervention      component
                      single or multi-  that addresses    intervention
                      component         implementing      that addresses
                      intervention      the Six Core      communication
                      that addresses    Elements of       that supports
                      the Six Core      healthcare        the Six Core
                      Elements of       transition such   Elements of
                      healthcare        as trainings).    healthcare
                      transition such                     transition
                      as educational                      such as
                      materials,                          patient care
                      patient care                        documents).
                      documents,
                      processes, etc.
                      There are not
                      widely
                      established
                      neat packages
                      of intervention
                      components;
                      interventions
                      vary widely in
                      their
                      components,
                      structure, and
                      processes.). No
                      healthcare
                      transition
                      intervention is
                      explicitly
                      excluded.
                      However,
                      transition
                      interventions
                      that address
                      the full
                      spectrum of
                      transition to
                      adult life,
                      such as
                      transition to
                      independent
                      living from
                      foster care or
                      among people
                      with
                      developmental
                      disabilities,
                      will be
                      excluded.
Comparators........  Comparator        Comparator        Comparator
                      required, but     required, but     required, but
                      no exclusion      no exclusion      no exclusion
                      based on          based on          based on
                      comparator type.  comparator type.  comparator
                                                          type.
Outcomes...........  [cir] Transition  [cir]             [cir]
                      readiness         Intervention.     Transition
                      (e.g., patient,   [ssquf]           readiness.
                      family,           Adoption..       [cir] Quality
                      provider, and     [ssquf]           of life.
                      system level).    Fidelity..       [cir]
                     [cir] Quality of   [ssquf]           Mortality.
                      life..            Sustainability.. [cir]
                     [cir] Mortality.   [ssquf]           Morbidity.
                     [cir] Morbidity.   Feasibility..    [cir] Disease-
                     [cir] Disease-     [ssquf]           specific
                      specific          Acceptability..   clinical
                      clinical         [cir]              outcomes.
                      outcomes..        Satisfaction     [cir] Treatment
                     [cir] Wellness     (physician and    or care
                      visits/           other formal      adherence.
                      screenings        caregiver)..     [cir]
                      (e.g.,           [cir] Quality of   Engagement in
                      depression,       life..            care (e.g., no
                      anxiety, STIs,   [cir] Mortality.   shows, time
                      other risk and   [cir] Morbidity.   between
                      resiliency       [cir] Disease-     providers,
                      factors such as   specific          satisfaction,
                      alcohol use,      clinical          loss to follow-
                      substance         outcomes..        up, time
                      abuse,           [cir] Family       between
                      violence)..       Caregiver         leaving
                     [cir] Treatment    outcomes..        pediatric
                      or care          [cir] Harms.....   setting to
                      adherence..      [cir] Unintended   going to
                     [cir] Engagement   consequences      adult).
                      in care (e.g.,    (e.g., ethics    [cir]
                      no shows, time    of transition..   Satisfaction
                      between          [cir] Cost of      (patient and
                      provider,         implementation..  family).
                      satisfaction,    [cir] Insurance.  [cir] Family
                      loss to follow-                     Caregiver
                      up, time                            outcomes.
                      between leaving                    [cir] Harms.
                      pediatric                          [cir]
                      setting to                          Unintended
                      going to                            consequences
                      adult)..                            (e.g., ethics
                     [cir]                                of
                      Satisfaction                        transition).
                      (patient and                       [cir]
                      family).;.                          Insurance.
                     [cir] Family                        [cir] Cost.
                      caregiver                          [cir] Resource
                      outcomes..                          utilization
                     [cir] Harms.....                     (ER visit,
                     [cir] Unintended                     hospitalizatio
                      consequences                        n, length of
                      (e.g., ethics                       stay).
                      of transition)..
                     [cir]
                      Psychosocial
                      (e.g., social-
                      emotional,
                      mental health,
                      etc.)..
                     [cir] Insurance.
                     [cir] Cost......
                     [cir] Resource
                      utilization (ER
                      visit,
                      hospitalization
                      , length of
                      stay)..
Timing.............  At least 6        At least 6        At least 6
                      months post       months for        months for
                      transition for    tests of          tests of
                      tests of          interventions.    interventions.
                      interventions.    No exclusions     No exclusions
                      No exclusions     for qualitative   for
                      for qualitative   or mixed          qualitative or
                      or mixed          studies for       mixed studies
                      studies for       barriers and      for barriers
                      barriers and      facilitators      and
                      facilitators      subquestion.      facilitators
                      subquestion.                        subquestion.
Setting............  All settings      All settings      All settings
                      (e.g., primary    (e.g., primary    (e.g., primary
                      care, specialty   care, specialty   care,
                      care, schools,    care, schools,    specialty
                      rural, resource   rural, resource   care, schools,
                      limited           limited           rural,
                      settings, and     settings, and     resource
                      telehealth).      telehealth).      limited
                                                          settings, and
                                                          telehealth).
------------------------------------------------------------------------


    Dated: November 27, 2020.
Marquita Cullom,
Associate Director.
[FR Doc. 2020-26569 Filed 12-1-20; 8:45 am]
BILLING CODE 4160-90-P


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