Increasing Access to Medication-Assisted Treatment (MAT) in Rural

Primary Care Practices (R18)

Technical Assistance Conference CallJanuary 13, 2016

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Conference Call Overview

• Introductions• Background• Review of the R18 Request for Application• Frequently asked questions• Open Q&A

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Brief Background

• MAT in Primary Care• Federal Initiatives on Opioid Addiction• Demonstration Research at AHRQ (R18)

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Purpose

• This initiative will fund demonstration research projects that implement Medication-Assisted Treatment (MAT) for opioid use disorder in primary care practices in rural areas of the U.S.

• AHRQ’s intent is to discover and test solutions to overcoming known barriers to implementation of MAT in primary care, and create training and implementation resources to support future efforts to expand access to this evidence-based therapy, especially in underserved communities.

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Definition of important terms

• Primary care• Primary care practice• Opioid Use Disorder• Medication-Assisted Treatment (MAT)• Buprenorphine• Naltrexone• Rural

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Primary care

• AHRQ defines primary care as the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, including prevention and health promotion, developing a sustained partnership with patients, and practicing in the context of family and community.

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Primary care practices

• Primary care practices are health care organizations that are dedicated to the provision of primary care utilizing lead clinicians such as family medicine physicians, general internal medicine physicians, general practice physicians, general pediatric physicians, geriatrician physicians, and primary care nurse practitioners and physician assistants.

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Opioid Use Disorder

• Opioid Use disorder (OUD) is a substance use disorder defined as a problematic pattern of opioid use leading to clinically significant impairment or distress occurring within a 12 month period. It can involve misuse of prescribed opioid medications, use of diverted opioid medications, or use of illicitly obtained heroin.

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Medication-Assisted Treatment (MAT)

• Medication-assisted treatment (MAT) is the use of FDA-approved opioid agonist and antagonists medications, in combination with counseling and behavioral therapies, to provide a whole-patient approach to the treatment of substance use disorders. MAT includes screening, assessment (which includes determination of severity of opioid use disorder, including presence of physical dependence and appropriateness for MAT), initiation, maintenance, and on-going support for recovery. Research shows that when treating substance-use disorders, a combination of medication and behavioral therapies, as provided in MAT, is most successful.

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Buprenorphine

• This medication is a partial opioid agonist approved by the FDA in 2002. It has a lower risk of abuse, dependence, and side effects compared with other drugs. It can be prescribed by a certified physician, thus eliminating the need to visit specialized treatment clinics. Buprenorphine often is offered as a combination medication with naloxone, which reduces its potential for abuse.

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Naltrexone

• This medication is used for the treatment of opioid dependence and alcohol use disorders. As an opioid antagonist, naltrexone blocks the effects of opioids and has demonstrated effectiveness in reducing alcohol consumption, the effects of alcohol, and cravings for alcohol. Because patient compliance can be an issue with naltrexone, the FDA has approved Vivitrol, an injectable form of naltrexone that is administered monthly.

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Rural(NOT-HS-16-003 )

• For the purposes of this FOA, applicants that use the National Center for Health Statics (NCHS) 2013 Urban-Rural Classification System to document that the proposed area(s) are rural will be considered responsive.  ► Using this system counties that are micropolitan or noncore are

considered rural. 

• Applicants may, however, utilize other definitions of rural within their applications.  ► Applicants who use other definitions must clearly demonstrate how their

definition is consistent with the intention of the FOA. 

• Additionally, AHRQ reminds applicants that they must demonstrate that the area(s) selected for the project are both rural and lack adequate access to substance abuse treatment services. 

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Guidance for Applicants (I)

Applicants should:

• Define a rural region or set of rural communities and describe current available treatment for OUD.

• Describe a comprehensive model(s) for delivery of MAT in primary care in the region/communities. ► Must include provision of medications and behavioral support

services.

• Describe detailed plan for practice recruitment and engagement.

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Guidance for Applicants (II)

Applicants should (cont.):

• Identify at least 5 major barriers to providing MAT and how the proposed MAT model and implementation intervention will address and overcome them.

• Propose a robust intervention evaluation focused on:► Effect of the initiative on expanding access of MAT,► Experience of primary care providers and staff in implementing

the model,► Effectiveness of addressing the barriers to implementation.

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Guidance for Applicants (III)

Applicants should (cont.):

• Provide a detailed, comprehensive dissemination plan to ensure that stakeholders are informed of the initiative’s progress and findings in an on-going and timely manner.► Remember, this is an R18 mechanism

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FOA Basics

• AHRQ is utilizing the R18 mechanism• AHRQ anticipates making 3 awards

► Note: This is a change reflecting FY2016 AHRQ budget

• Grants are limited to $1 million total costs per year► Total costs = Direct costs + Indirect Costs

• The project period may not exceed 3 years

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Eligible Organizations

• Grants are made to organizations, not individuals• Eligible organizations that may submit and lead

applications include:► Public and non-profit private institutions ► Units of local or State government; ► Eligible agencies of the Federal government. ► Indian/Native American Tribal Governments and

Designated Organizations

• For-profit organizations and foreign institutions are not eligible to lead applications

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Program Director/Principal Investigator

• Any individual with the knowledge, skills, and experience required to carry out the proposed research is eligible to serve as the project’s PD/PI► There are no degree requirements► The PD/PI must be accountable to the organization

submitting the application

• AHRQ requires that there be one and only one PD/PI per application

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The Application (I)

• The Research Strategy section is limited to 25 pages• The Research Strategy section must contain the following

sections:1. The Region (~2 pages)2. Model for Delivery of MAT in Rural Primary Care Practices

(~4 pages)3. Plan for Supporting Rural Primary Care Practices in Implementing MAT

(~8 pages)4. Barriers to Implementing MAT in Rural Communities and How the

Proposed Model and Implementation Plan Will Address These Barriers (~4 pages)

5. Evaluation Plan (~4 pages)6. Project Timeline (~1 page)7. Dissemination (~2 pages)

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The Application (II)

• Each section includes details of what should be included in the application

• Read the entire FOA carefully

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A few reminders on budget

• AHRQ does not accept modular budgets► AHRQ only uses the detailed Research & Related

Budget

• The budget ceiling is for total costs► Total costs = Direct + Indirect costs

• Matching funds are welcomed and encouraged, but not required

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Review Criteria (I)

• The review criteria provide an outline of both what AHRQ is seeking and the questions peer reviewers will be asked to consider► Review these carefully!

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Significance

• How likely is it that the proposed plan for supporting rural primary care practices will be successful?

• How likely is it that the proposed project will produce information useful to primary care practices who plan to deliver MAT in the future?

• How likely is that the proposed project will produce information useful to other stakeholders about how to support primary care practices in rural or other communities in expanding access to MAT?

• Does the proposed project target rural communities with high rates of opioid use disorder and/or opioid overdose deaths that currently have limited access to MAT treatment services?

• Does the project’s implementation plan propose meaningful responses to recognized barriers to the implementation of MAT in primary care practice?

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Investigators

• Are the PD/PI, collaborators, and other researchers well suited to the project?

• Is the work proposed appropriate to the experience level of the PD/PI and other researchers?

• Do the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)?

• Do investigators and other team members have appropriate skills and experience for their roles in the project?

• Is the leadership approach, governance and organizational structure appropriate for the project?

• Does the team have substantial experience with the proposed approach and relations with primary care practices that ensure that the project can recruit and engage primary care practices and deliver the proposed approach within the proposed timeline?

• Is it likely that the proposed project and team will be able to develop the necessary partnerships for an effective MAT program, including community-based service organizations and specialty providers?

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Innovation

• The goal of this FOA, to increase access to MAT, is not in and of itself innovative. Successful projects may in fact propose the use of multiple best practices in supporting rural primary care practices in initiating and sustaining the delivery of MAT. The FOA also requires a multi-level evaluation, but does not specifically require innovation.► Does the application propose an implementation strategy that is likely

to be successful in engaging primary care practices in delivering MAT?

► Is the proposed implementation strategy likely to overcome barriers to the delivery of MAT in rural primary are practices?

► Does the application bring together resources from across various organizations and stakeholders to improve the chances of project success?

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Approach

• Pay special attention to theses criteria!• Reviewers will be considering three areas:

► Approach to implementation► Approach to evaluation► Approach to dissemination

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Environment

• How extensive are the capacities, experience, expertise and other resources of the applicant institution and participating organizations, institutions, and other entities? How well-aligned are they with the needs and aims of the project? How likely are they to contribute to the project’s success?

• Does the application effectively leverage regional and local expertise?• Is there sufficient evidence of suitable arrangements and agreements for

collaboration among all members of the project and other partners? • Do partnering organizations have a history of successfully working together and a

commitment to supporting MAT in primary care?• Is there a strong management plan? • Is there evidence of institutional commitment and support from all proposed

organizations?• Is the region and/or rural communities clearly defined and logical? • Does the proposed project benefit from features of the region such as recent or on-

going health and health care initiatives, health information exchanges, clinical environments, community settings, and patient populations?

• Have potential environmental obstacles (e.g., political/interest group opposition; regulations) and the means for avoiding or mitigating their effects been identified?

• Has the applicant provided clear evidence of no overlap or intersection with other federal MAT and OUD treatment initiatives? 1/13/16 27

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AHRQ Selection Criteria

• AHRQ will consider the following in making award decisions: ► Scientific and technical merit of the proposed project

as determined by peer review.► Availability of funds. ► Responsiveness to goals and objectives of the FOA. ► Relevance and fit within AHRQ research priorities, as

well as overall programmatic and geographic balance.

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Important Dates

• Letters of intent are due February 1, 2016• Applications are due date is March 4, 2016• Peer review will be in summer 2016• Grants award/start date is estimated to be

September 2016

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Letter of Intent

• Highly encouraged, non-binding, not required• Allows AHRQ to provide you with the highest quality grant

review

• Letter of intent should include:► Number and title of this funding opportunity ► Descriptive title of proposed activity ► Name, address, and telephone number of the PD/PI ► Names and institutions of other key personnel ► Participating institution(s)

• The letter of intent can be sent electronically to: ► Phillip Jordan

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Additional Help

• Scientific and research issues:► Mr. Phillip Jordan► Email: Phillip.Jordan@ahrq.hhs.gov

• Grant peer review:► Dr. Nghia Vo ► Email: Nghia.Vo@ahrq.hhs.gov

• Financial matters:► Ms. Kathyrn Carr:► Email: Kathryn.Carr@ahrq.hhs.gov

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Frequently Asked Questions (FAQs)

• Q: If a clinic cares for patients from rural communities, but is itself not in a rural area, may an application focus an initiative around it?

• A: No. The intention of the FOA is to support the delivery of MAT in rural communities through engagement of primary care practices within these rural communities.

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FAQs

• Q: Since naloxone is an evidence-based tool for the prevention of overdose deaths, may an applicant propose a project to expand distribution of naloxone in rural communities?

• A: Such an application would not be considered responsive to this FOA. Researchers and implementers, however, may be interested in opportunities from the HRSA Office on Rural Health.

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FAQs

• Q: May an applicant propose to incorporate virtual behavioral support that is provided by nurses outside of the rural community if it linked to MAT provided in rural primary care practice offices?

• A: Yes.

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FAQs

• Q: May an applicant propose to provide MAT services in a rural area that crosses state borders?

• A: Yes. Applications may propose to work in multiple contiguous or non-contiguous states as long as the defined service areas are all rural.

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Open Forum

• The operator will assist in queuing questions from participants.

• If time does not allow for all questions to be answered, please submit your questions via email after the call.

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Thank you

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