Notice2022-22843

Supplemental Evidence and Data Request on Strategies for Integrating Behavioral Health and Primary Care

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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
October 21, 2022

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 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.

Full Text

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<title>Federal Register, Volume 87 Issue 203 (Friday, October 21, 2022)</title>
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[Federal Register Volume 87, Number 203 (Friday, October 21, 2022)]
[Notices]
[Pages 64043-64046]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-22843]


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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.

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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 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 Access to published and unpublished pertinent scientific 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: <a href="/cdn-cgi/l/email-protection#c8adb8ab88a9a0bab9e6a0a0bbe6afa7be"><span class="__cf_email__" data-cfemail="eb8e9b88ab8a83999ac5838398c58c849d">[email&#160;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#0c697c6f4c6d647e7d2264647f226b637a"><span class="__cf_email__" data-cfemail="d1b4a1b291b0b9a3a0ffb9b9a2ffb6bea7">[email&#160;protected]</span></a>.

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: 
<a href="https://effectivehealthcare.ahrq.gov/products/strategies-integrating-behavioral-health/protocol">https://effectivehealthcare.ahrq.gov/products/strategies-integrating-behavioral-health/protocol</a>. 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 <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: 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 
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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: <a href="https://www.effectivehealthcare.ahrq.gov/email-updates">https://www.effectivehealthcare.ahrq.gov/email-updates</a>.
    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)
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                 PICOS                                     Inclusion                           Exclusion
----------------------------------------------------------------------------------------------------------------
Population.............................  Children (aged 0-20 years) and adults (aged   <bullet> No exclusions
                                          >=21 years) with behavioral health needs.     for age or condition.
                                         Clinical focus/conditions including but not
                                          limited to patients with:
                                            <bullet> Mental illness or mental health
                                             conditions
                                         <bullet> Substance use disorders
                                         <bullet> Stress-linked physical symptoms
                                          (e.g., insomnia, fatigue)
                                         <bullet> Complex overlapping medical
                                          conditions and psychosocial risk factors
                                         <bullet> Experiences of trauma, adverse
                                          experiences, or stressful life events
                                         <bullet> Pregnant patients
                                         <bullet> Geriatric patients
Intervention...........................  Different approaches to integrating           <bullet> Co-location
                                          behavioral health and primary care            without collaboration.
                                          services, including program/model            <bullet> Referral only
                                          components and strategies to integrate        (cold handoff).
                                          care.                                        <bullet> Warm handoff
                                         Examples of eligible programs/models for       without plan for
                                          care integration include but are not          continued communication
                                          limited to:                                   and coordination of
                                         <bullet> Collaborative Care Model              care.
                                         <bullet> Primary Care Behavioral Health       <bullet> Population level
                                          Model                                         health promotion or
                                         <bullet> Co-location models                    prevention programs that
                                         <bullet> 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  <bullet> 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.............................  <bullet> Care as usual (e.g., non-integrated  <bullet> No comparator
                                          behavioral health and primary care            for KQ 2 (descriptive
                                          services) in a different group or time        studies; such as case
                                          period                                        studies).
                                         <bullet> Alternative care integration         <bullet> Comparators not
                                          strategy or strategies                        applicable to other
                                         <bullet> 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.
                                         <bullet> Morbidity
                                            <bullet> Mortality
                                         <bullet> Improved symptoms
                                         <bullet> Guideline concordant screening and
                                          diagnosis
                                         <bullet> Remission/recovery
                                         <bullet> Adherence to treatment
                                         Patient Reported Outcomes:
                                            <bullet> Health related quality of life
                                         <bullet> Functional status (including social
                                          and adaptive functioning)
                                         <bullet> Satisfaction with care
                                         Measures of care utilization:
                                         <bullet> Avoidable emergency care or
                                          inpatient care for behavioral health crises
                                         <bullet> Total health care utilization
                                         Measures of access to care:
                                         <bullet> Patients receive routine care as
                                          soon as wanted
                                         <bullet> Patients receive acute care when
                                          needed
                                         <bullet> Average wait time for BH
                                         <bullet> Patients experiencing difficulties
                                          or delays in obtaining BH care
                                         <bullet> Patients with mental health
                                          condition received treatment
                                         <bullet> Patients with SUDs received
                                          treatment
                                         CLINICIAN AND PRACTICE LEVEL
                                         Clinician Outcomes:
                                         <bullet> Clinician retention/turnover rates
                                         <bullet> Burnout
                                         <bullet> Professional satisfaction
                                         <bullet> Efficiency of clinician time use
                                         Population/community/clinic panel health
                                          outcomes:
                                         <bullet> BH-related preventive care measures
                                         <bullet> BH screening services
                                         Cost outcomes:
                                         <bullet> Cost per patient per year
                                         <bullet> Cost per service
                                         <bullet> Costs associated with care delays,
                                          fragmentation, poor coordination,
                                          redundancy, requested but not completed
                                          patient referrals
                                         Implementation Outcomes:
                                         <bullet> Adoption of intervention approaches
                                         <bullet> Fidelity
                                         <bullet> Systemic Change/Sustainment
                                         HARMS
                                         <bullet> Missed diagnoses
                                         <bullet> Delays in care
                                         <bullet> Overutilization of resources
                                         <bullet> Redundant or inappropriate care
Setting................................  <bullet> Health systems/hospitals and         <bullet> Hospitals.
                                          community-based primary care practices in    <bullet> Prehospital/EMS/
                                          the United States (physical or virtual) or    crisis care.
                                          in countries with similar healthcare         <bullet> Prisons.
                                          systems                                      <bullet> Countries with
                                         <bullet> Non-healthcare settings providing     healthcare systems that
                                          outpatient BH/PC (school-based clinics,       do not provide
                                          community centers, churches, shelters)        information relevant to
                                         <bullet> Nursing homes, group homes and        the U.S.
                                          other long-term residential settings
Study Designs..........................  <bullet> Experimental and observational       <bullet> Articles that do
                                          studies that describe and evaluate            not include any data.
                                          integration approach.                        <bullet> Proposals for
                                         <bullet> For Scan Question 1 and Contextual    approaches that have not
                                          Questions 3 and 5: Survey and Qualitative     been implemented.
                                          Studies.                                     <bullet> Descriptions of
                                         <bullet> For Contextual Question 4:            approaches that have not
                                          Psychometric Studies                          been evaluated (for
                                         <bullet> Systematic reviews that directly      KQ2).
                                          address one of the review questions          <bullet> 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


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