Key Dates

RFA-MH-21-145 - HEAL Initiative: Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional)

NOT-DA-20-071 - Notice of Intent to Publish a HEAL Funding Opportunity Announcement for Consortium on Co-managing Chronic Pain and Opioid Use Disorder (C3PO) (RM1)

NOT-DA-20-077 - Notice of Intent to Publish a HEAL Funding Opportunity Announcement for Research on Related DSM-5 Diagnoses (R2D2) Coordination and Dissemination Center

National Institute of Mental Health (NIMH)

National Institute on Drug Abuse (NIDA)

National Center for Complementary and Integrative Health (NCCIH)

In April 2018, the National Institutes of Health (NIH) launched the Helping to End Addiction Long-term^SM Initiative or HEAL Initiative^SM, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. In response to this initiative, the National Institute of Mental Health (NIMH), in partnership with other NIH Institutes, Centers, and Offices, intends to invite research that will optimize multi-component service delivery interventions for people with opioid use disorder (OUD) and co-occurring conditions, to include suicide risk. The purpose of the initiative is to support studies that will test (1) overall effectiveness of multi-component interventions for OUD and co-occurring conditions and (2) examine the relative contribution of constituent components to overall effectiveness. This research will streamline service packages so they only include components that drive clinical improvements for complex conditions.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The content of this planned Funding Opportunity Announcement (FOA) is expected to complement research stemming from the initiatives referenced in NOT-DA-20-071 and NOT-DA-20-077.

The planned FOA is expected to be published in Fall 2020 with an expected application due date in Spring 2021.

This FOA will utilize the R01 activity code. Details of the planned FOA are provided below.

Background

In August 2019 and again in March 2020, the HEAL Multidisciplinary Working Group (MDWG) called for research that seeks to improve the provision of care for people with common co-occurring conditions associated with the opioid crisis (e.g., people with mental health disorders, suicide risk, alcohol misuse/alcohol use disorder, chronic pain, and/or other substance use disorders).

Results from national surveys and other recent sources demonstrate that rates of co-occurring conditions are high. For example, among the millions of people with OUD, 27% have a serious mental illness, 64% have any mental illness, and approximately 11% to 26% have alcohol use disorder or another substance use disorder. Among the those whose deaths are associated with opioid overdose (47,600 deaths in 2017 alone), up to 30% may be due to suicide. Additionally, nonfatal overdoses involving opioids are associated elevated suicide risk. Moreover, the 16% of Americans who have mental health disorders receive over half of all opioids prescribed in the United States.

Trial designs like parallel arm and stepped wedge yield high quality evidence to support a decision to implement a service delivery intervention as a bundled package. However, these designs often offer limited information about the relative contribution of intervention components, and include limited information about how to sequence treatments for patients with comorbidities. Trials are not necessarily powered or designed to detect the effects of constitute components of multi-component service delivery interventions. Findings from these trials therefore offer little direction to the practice community about how to identify the most important components and about how to optimize those components for the practice setting.

A review of primary care behavioral health services, for example, noted wide variation in outcomes associated with different bundled approaches to care integration used to treat and manage mental and behavioral health conditions. Findings from the review, along with findings from decades of NIH-funded research, challenge assumptions about the presumed effectiveness of face valid service delivery models. Unfortunately, the promotion and implementation of delivery models often outpaces evidence.

Research Objectives

Research from this initiative must seek to improve outcomes in people with OUD and common co-occurring conditions, to include suicide risk, by answering these questions about multi-component service delivery models:

• What are the high value components that drive clinical improvements and should be implemented?
• In what sequence should high value components be implemented, if simultaneously implementing all components of a service delivery model is untenable?
• What are the low value components to de-implement in practices where care integration is overly complex or noisy, and/or where exogenous factors (e.g., budget cuts or health system reorganization) force change?
• What are the effects of varying multiple practice relevant factors that would be too cumbersome to test together in a parallel arm or stepped wedge trial (e.g., factors like caseload size, job functions, frequency and content of outreach calls) but that are highly relevant to delivering effective care?
• When and how should treatments and services be efficiently selected, sequenced, and intensified?

Specific examples of topics may include but are not limited to the following:

• Identifying the high value components of the collaborative care model to implement and/or informing how to prioritize the implementation of multiple components (e.g., components like routine screening for depression and anxiety, training/hiring a psychiatric consultant, training/hiring care managers, the disease registry) in resource constrained environments.
• Optimizing the primary care-based Massachusetts Model to address to assess and treat not only OUD but also other co-occurring problems and suicide risk.
• Optimizing components of the Screening, Brief Intervention, and Referral to Treatment (SBIRT) framework, to include adding Medication for Opioid Use Disorder (MOUD), and intensifying referral to treatment where most patients are lost to follow up, in efforts to improve outcomes in people with OUD and co-occurring problems.
• Identifying the relative value of behavioral counseling (to include the specific content of the behavioral counseling) as part of MOUD, to improve clinical outcomes for mental health conditions and suicide risk and promote initial and sustained engagement with MOUD.
• Identifying optimal functions or composition of integrated care teams (e.g., value of a psychiatric consultant who is a psychiatrist versus a nurse practitioner, physician's assistant, or psychologist with prescription privileges).
• Assessing the value of adding, de-implementing, or varying psychosocial treatment modules (e.g., motivational interviewing delivered by a care manger to promote engagement versus problem solving therapy, the brief negotiated interview, or behavioral activation) delivered as part of a multicomponent integrated care model.
• Evaluating the relative contribution and tradeoffs of optimizing service provisions, as part of a system of care for high risk patients in the emergency department (proactive suicide screening and assessment, referral processes, intervention and aftercare strategies) given the high proportion of patients with comorbid pain, opioid use, and mental health conditions.

Applications need not address all possible co-occurring conditions, but to be considered for funding, they must have clear and direct relevance to HEAL priority areas which include OUD and/or pain.

Design Considerations

Studies are to be highly pragmatic and practice relevant, with designs that balance rigor with time-to-practice urgency. Projects will seek to a) identify high value constitute components that drive improvements in access, continuity, quality, value, and outcomes of care, for service delivery interventions with previously demonstrated effectiveness as a bundled package; and b) simultaneously test overall effectiveness of the package and its subcomponents, for popular (widely implemented) service delivery packages without previously demonstrated effectiveness.

Projects must be designed to unbundle and test the unique contributions of components in multicomponent service delivery interventions. This planned FOA calls for the use of innovative designs that efficiently and simultaneously test the main effects and interactions of several intervention components. Approaches could include the following: factorial designs and their derivatives (e.g., fractional factorial); Multiphase Optimization STrategy (MOST); Sequential, Multiple Assignment, Randomized Trials (SMART); randomized encouragement; and interrupted time series designs or other quasi-experimental approaches, where randomization may not be possible.

Study designs should take into account practical aspects of service delivery (e.g., use of technologies, telehealth, clinical workflows, screening, and assessment of patient outcomes). NIH encourages assessment and manipulation of patient-, provider-, and setting- factors that facilitate or impede the delivery of intervention components.

NIMH encourages a deployment-focused model of intervention refinement and testing that considers the perspectives of relevant stakeholders (e.g., patients, providers, administrators, or payors) and the key characteristics of the settings that are intended to deliver optimized service delivery interventions. This attention to end-user perspectives and characteristics is intended to ensure that the resultant service delivery interventions and evidence standards to implement such interventions are acceptable to patients and providers, to ensure that the approaches are feasible and scalable in the settings where individuals are typically served, and to ensure that the research results will have utility for end users. Meritorious projects will leverage strong and clearly defined research practice partnerships.

Multicomponent service delivery interventions should be tested as naturalistically as possible in order to increase the generalizability of research findings as well as to minimize barriers to translating any positive research findings into real-world practice. NIMH encourages studies that furnish services through existing providers/vendors of such services, versus developing services specifically for this research. Similarly, NIMH encourages studies to rely as much as possible on existing financing mechanisms. Regardless, studies under this announcement should assess the adequacy of existing financing models to support the service delivery models being tested.

Study teams will be required to collaborate with one another as well as with teams from projects stemming from the initiatives referenced in NOT-DA-20-071 and NOT-DA-20-077. The purpose of these collaborations is to a) develop or harmonize common data elements, standard measures, and uniform data collection procedures; b) participate in a bidirectional pipeline to facilitate practice-based research and improve early identification, diagnosis, clinical assessment, intervention effectiveness, service delivery, and health outcomes in people affected by the opioid epidemic; and c) identify innovative assessment, intervention, and quality improvement practices for broad dissemination.

Applications are not being solicited at this time.

Please direct all inquiries to:

Michael C. Freed, Ph.D., EMT

National Institute of Mental Health

301-443-3747

[email protected]