[Federal Register Volume 87, Number 203 (Friday, October 21, 2022)]
[Notices]
[Pages 64043-64046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 Access to published and unpublished pertinent scientific 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: [email protected].
    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: [email protected].

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: 
https://effectivehealthcare.ahrq.gov/products/strategies-integrating-behavioral-health/protocol. 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 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: 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 
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.
    [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: 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.

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