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

---
identifier: "/us/fr/2022-22843"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Supplemental Evidence and Data Request on Strategies for Integrating Behavioral Health and Primary Care"
title_number: 0
title_name: "Federal Register"
section_number: "2022-22843"
section_name: "Supplemental Evidence and Data Request on Strategies for Integrating Behavioral Health and Primary Care"
positive_law: false
currency: "2022-10-21"
last_updated: "2022-10-21"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2022-22843"
document_type: "notice"
publication_date: "2022-10-21"
agencies:
  - "Health and Human Services Department"
  - "Agency for Healthcare Research and Quality"
fr_citation: "87 FR 64043"
fr_volume: 87
fr_action: "Request for supplemental evidence and data submissions."
---

#  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.

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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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

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.*

*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.

*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.

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.*

**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?

| PICOS | Inclusion | Exclusion |
| --- | --- | --- |
| Population | Children (aged 0-20 years) and adults (aged ≥21 years) with behavioral health needs. | • No exclusions for age or condition. |
|  | • Mental illness or mental health conditions |  |
| Intervention | Different approaches to integrating behavioral health and primary care services, including program/model components and strategies to integrate care. | • Co-location without collaboration. |
| Comparator | • Care as usual (
                            
                             non-integrated behavioral health and primary care services) in a different group or time period | • No comparator for KQ 2 (descriptive studies; such as case studies). |
| Outcomes | Outcomes of interest include but not limited to: | Simulated results or responses to hypothetical scenarios or questions. |
|  | • Mortality |  |
|  |  |  |
|  | • Health related quality of life |  |
|  |  |  |
|  |  |  |
|  |  |  |
|  |  |  |
|  |  |  |
|  |  |  |
|  |  |  |
|  |  |  |
| Setting | • Health systems/hospitals and community-based primary care practices in the United States (physical or virtual) or in countries with similar healthcare systems | • Hospitals. |
| Study Designs | • Experimental and observational studies that describe and evaluate integration approach. | • Articles that do not include any data. |

Dated: October 17, 2022.

Marquita Cullom,

Associate Director.