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Improving Management of Opioids and Opioid Use Disorder (OUD) in Older Adults (R18) Technical Assistance Conference Call For RFA-HS-20-001 January 21, 2020 1
Improving Management of Opioids and Opioid Use Disorder (OUD) in Older
Adults (R18)
Technical Assistance Conference CallFor RFA-HS-20-001January 21, 2020
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Introductions
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Background and Overview
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Background
• Between 2010 and 2015, the rate of opioid-related inpatient stays and Emergency Department (ED) visits increased for people 65 years old or older by 34% and 74% respectively.
• Managing opioids in older adults is especially complex and challenging. Older adults have a high prevalence of chronic pain and are especially vulnerable to adverse events from opioids. Furthermore, substance use disorders may be overlooked or misdiagnosed in older adults.
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https://www.hcup-us.ahrq.gov/reports/statbriefs/sb244-Opioid-Inpatient-Stays-ED-Visits-Older-Adults.jsp
Purpose of RFA-HS-20-001
• Develop, implement, evaluate, and disseminate strategies to improve the management of opioid use and opioid use disorder (OUD) in older adults
• AHRQ is seeking applications that ► are based in primary care settings► include socially at-risk older adults ► use evidence-based interventions and quality
improvement strategies ► implement and evaluate intervention effectiveness
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RFA Basics
• R18 mechanism• AHRQ anticipates making up to 3 awards• $2.5 million total costs for entire project period
► total costs = direct + indirect costs► AHRQ only uses detailed Research & Related budget
• Project period may not exceed 3 years
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Important Dates
• Application due date is February 20, 2020
• Anticipated project start date expected no later than September 30, 2020
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Application Requirements and Related FAQs
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Applicants Must…
1. Convene a team with the expertise and experience to achieve the goals of this FOA
AHRQ encourages:► building on existing strong relationships with primary care
practices► expertise in pain management, OUD, and geriatrics► experience with implementing quality improvement in primary
care practices► experience in disseminating and implementing findings from
patient centered outcome research
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Applicants Must …
2. Identify either a health system which provides primary care, or a network of primary care practices which care for older adults, and provide preliminary data to suggest that pain and opioid management in this population is suboptimal.
AHRQ encourages:► including other settings as long as the intervention is
centered in primary care► selecting practices that include diverse populations in
terms of socio-economic status, gender, race/ethnicity, and geography (including rurality)
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Applicants Must …
3. Provide a preliminary assessment of the extent to which current efforts to improve pain management and optimize opioid use in the study practices specifically address older adults.
► Applicants should provide a description of any federal or state (SUD/OUD) funding that they currently receive and a description of how they will avoid duplication/overlap
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Applicants Must …
4. Develop a comprehensive model or models for improving the management of pain, opioid use and OUD for older adults in those primary care practices.
► Care should be provided in the context of person-centered management that acknowledges multiple chronic conditions as well as social risk factors
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Applicants Must …
5. Consider the use of innovative methods and study designs in answering the intended research questions that advance our understanding of implementation.
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Applicants Must …
6. Plan to recruit and engage at least 25 primary care practices, and provide necessary training and support to clinicians and practices in implementing the model. The practices selected must serve a sufficient number of relevant patients (i.e. older adults, older adults with chronic pain, and older adults using opioids) for interpretable evaluation results.
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Applicants Must …
7. Plan for a robust, multi-level intervention evaluation that will examine the effectiveness of the implemented model to improve opioid-related outcomes and pain outcomes among older adults while maintaining or improving other important measures of health and well-being
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Applicants Must …
8. Propose a dissemination plan.
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Applicants Must …
9. Provide a project timeline showing the major scheduled activities and milestones for the project, including:
► Start-up activities (e.g., hiring and training staff)► Recruitment of primary care practices► Implementation initiation and completion► Evaluation plan► Dissemination and Sustainability Plan
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Selected Guidance from FOA
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Eligible Organizations
• Grants are made to organizations, not individuals
• Please see the FOA for complete list of eligible organizations
• For-profit organizations and foreign institutions are not eligible to lead applications
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Scored Review Criteria
See section V.1 of FOA• Significance• Investigator• Innovation• Approach• Environment
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Guidance on Approach
• “If the cohort of practices to be recruited does not meet the criteria in the FOA (e.g., data demonstrating suboptimal pain and opioid management), does the application adequately explain how the proposed intervention would lead to additional improvements?” (RFA-HS-20-001, Section V)
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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 of the proposed project to program priorities
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FAQs
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Definition of Management of Opioids Use
Q: What does “management of opioid use” mean?A: Processes or activities to support the spectrum
of care needed to: prevent potentially inappropriate prescribing and opioid misuse while ensuring the need for effective pain management is addressed; appropriately prescribe opioids when indicated; manage the care of opioid users to prevent adverse events and misuse; treat OUD when present.
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Definition of a Primary Care Practice
Q: How is a primary care practice defined?A: Primary care practices are health care
organizations that are dedicated to providing primary care and where care is delivered by clinicians such as family medicine physicians, general internal medicine physicians, general practice physicians, geriatrician physicians, nurse practitioners, and physician assistants.
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PI/PD
Q: Who qualifies as a PI/PD?A: The PI/PD must have the appropriate training,
skills, experience, and resources to carry out the work successfully.
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Additional questions covered on the call
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Questions about the number/size of clinics.
A: It is up to the prospective grantee to justify the size of the practices included. Refer to Section 7-Approach for guidance on deviations: “If the cohort of practices to be recruited does not meet the criteria in the FOA (e.g., data demonstrating suboptimal pain and opioid management), does the application adequately explain how the proposed intervention would lead to additional improvements?”
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Does the entire range of care need to be provided within the grant or can specific parts be referred out?
A: The key is management – as long as the model identifies and manages the needs of older adults related to opioids, not all aspects of treatment need to be provided within the grant (i.e. referring out can be part of a management model).
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What is the definition of socially at-risk?
A: Factors that have been shown to impact health outcomes. These could include SES, racial/ethnic/cultural context, gender, social relationships, residential and community context. National Academies of Sciences, Engineering, and Medicine 2016. Accounting for Social Risk Factors in Medicare Payment: Identifying Social Risk Factors. Washington, DC: The National Academies Press. https://doi.org/10.17226/21858.
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Is AHRQ is less interested in models that are solely intervening in the primary care setting?
A: It is up to the prospective grantee to make the case that their design is the best approach to improve opioid related outcomes in older adults, but it must be centered in primary care.
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Does AHRQ anticipate three separate research teams developing and testing three different models in parallel? If so, does AHRQ expect the research teams to communicate and/or coordinate their project work in some way?
A: Yes, AHRQ anticipates three research teams developing and testing three different models in parallel. AHRQ strongly encourages communication and coordination among the grantees.
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AHRQ recently awarded a contract for "Identifying and Testing Strategies for Management of Opioid Use and Misuse In Older Adults in Primary Care Practices". How does the work specified in the present funding opportunity relate to this recently awarded contract?
A: The contract is to conduct an environmental scan and to help clinics identify and pilot potential interventions to improve outcomes related to opioids in older adults. The intended product is a description of current practice and a compendium of promising interventions. The FOA is intended to develop and test integrated models to improve management of opioids in older adults. The intended product is evidence on effective models of care.
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Does AHRQ have any preference on which tool practices use to support shared decision-making?A: No.
Can there be a variety of tools used within a project?A: Yes.
Are there any limitations on the type of Community Based Organizations to involve in the project?A: None other than the usual government requirements.
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Agency Contacts
• Scientific and research content:► Elisabeth Kato, MD, MRP
• Peer review process: • Ying Tian, MD, PhD
• Financial/Grants management issues► Nicole Williams
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Definitions of Key Terms
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Older Adults
Older Adults: While older adults are typically defined to be persons aged 65 or older, AHRQ recognizes the potential limitations with this arbitrary definition. Applicants who define the term “older adults” differently should provide a clear and convincing reason for why the different definition will be more effective for meeting the objectives of the FOA.
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Opioid Misuse and Opioid Use Disorder (OUD)
• Opioid misuse: Taking prescription opioids in a manner or for a purpose other than what they were prescribed for.
• Opioid Use Disorder (OUD): Problematic pattern of opioid use leading to clinically significant impairment or distress. It may be characterized by physical effects; difficulty reducing use; risky use behaviors; failure to fulfill obligations; and social problems. OUD occurs when the recurrent use of illegal or prescription opioids causes clinically significant impairment, including health problems, disability, and failure to meet major responsibilities at work, school, or home. Physical dependence alone is not opioid use disorder.
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Medication-Assisted Treatment
• Medication-Assisted Treatment: (MAT; also referred to as Medications for Opioid Use Disorder, or MOUD) is the use of FDA-approved medications in combination with counseling and behavioral therapies to provide a whole-patient approach to the treatment of OUD.
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Opioid Related Outcomes
• Opioid related outcomes: Patient outcomes affected by opioid use. These include mortality, hospitalization or emergency care due to illegal or prescription opioids, rates of potentially inappropriate opioid prescribing, adverse events from opioid use, rates of opioid misuse, OUD, and rates of co-occurring mental disorders (e.g. depression, suicidal ideation).
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Primary Care and Primary Care Practices
• 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.
• Primary care practices: Primary care practices are health care organizations that are dedicated to providing primary care and where care is delivered by clinicians such as family medicine physicians, general internal medicine physicians, general practice physicians, general pediatric physicians, geriatrician physicians, nurse practitioners, and physician assistants. 41
Quality Improvement
• Quality improvement: Quality improvement (QI) is the action of systematically improving the process by which care is delivered to patients. Processes have characteristics that can be measured, analyzed, improved, and controlled. QI entails continuous efforts to achieve stable and predictable process results, that is, to reduce process variation and improve the outcomes of these processes both for patients and the health care organization and system. Achieving sustained QI requires commitment from the entire organization, particularly from top-level management.
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Dissemination
• Dissemination is defined as the spread of findings from research to a target audience, such as patients, families, providers and health care teams, healthcare systems, and payers. The intent is to make stakeholders aware of the research findings.
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Implementation
• Implementation is defined as the use of strategies and processes to adopt and integrate research findings and evidence-based interventions into day-to-day practice. Implementation often requires the need to change practice patterns. In essence, implementation is putting the evidence-based interventions to use within the setting and population of interest.
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