NIH – HEAL Initiative: Effectiveness Trials to Optimize, Implement, Scale, and Sustain the Collaborative Care Model for Individuals with Opioid Use Disorders and Mental Health Conditions (U01 Clinical Trial Required)

December 17, 2018 by kjt5j@virginia.edu

This funding opportunity announcement (FOA) is being offered as part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.

The current NIMH FOA will support effectiveness clinical trials that develop, optimize, and test collaborative care models based in primary care to furnish indicated treatment for people with opioid use disorders (OUDs) and co-occurring mental health conditions. In these collaborative care models, Medication Assisted Treatment (MAT) must be offered alongside indicated treatments for other mental health conditions that commonly co-occur with OUD (e.g., depression, anxiety, and/or PTSD).

Background

National survey data suggest around 2.1 million Americans ages 12 years and older had an opioid use disorder (OUD) in 2016; and that, among adults who misused opioids in the prior year, 15.6% also had a serious mental illness and 42.8% had any mental illness. OUDs are also associated with various serious co-occurring physical health conditions, as well as high risk of premature death via accidental overdose, other accident mortality, and suicide (via intentional self-poisoning, as well as by other means). In 2016, 42,000 people died from opioid overdoses in the US, which represents a five-fold increase since 1999.

Substantial evidence documents the effectiveness of certain medications, particularly buprenorphine and methadone, for treating OUDs, especially when such medications are combined with behavioral health counseling and delivered via coordinated Medication Assisted Treatment (MAT). MAT can significantly increase rates of recovery and reduce risk of fatal and non-fatal overdose. Despite a 2015 Practice Guideline from the American Society of Addiction Medicine that focuses on the use of medications in the treatment of substance use disorders involving opioid use, and a recommendation within the CDC Prescribing Guideline that clinicians offer MAT for patients with OUD, MAT remains underutilized. Only around one in five people with OUD receive any specific treatment, and only a minority of those receive MAT. Even among individuals who do receive indicated OUD treatments, effectiveness in current usual practice is limited.

Geographic availability of clinicians who provide MAT and other indicated OUD treatments is highly variable and is especially limited in rural and other areas where OUD morbidity and mortality rates have risen steeply.  The Substance Abuse and Mental Health Services Administration (SAMHSA) reports that approximately half of US counties lack even one practicing mental/behavioral health specialty clinician. Of counties that do have providers certified to prescribe buprenorphine for OUD, most providers practice well under the patient caps, with 40% of certified providers not prescribing any buprenorphine. Together, these factors identify an urgent need for better models of care for individuals with OUD, to improve access, quality, and clinical outcomes.

Over 80 randomized controlled trials demonstrate the effectiveness of collaborative care for improving clinical and service delivery outcomes among patients presenting in primary care with various common mental/behavioral health conditions, particularly mood and anxiety disorders, including those with co-occurring physical health problems. Collaborative care programs have been implemented and tested in diverse health care settings, including network and integrated systems, and private and public providers; different practice sizes; and different patient populations, including both insured and uninsured/safety-net populations. Compared to usual practice, collaborative care improves mental and physical health outcomes, functioning, and labor market outcomes; is associated with reductions in suicidality; increases access to care and improves quality of care; reduces disparities in quality and outcomes; and is relatively cost-effective and in some cases, is cost-saving. As such, collaborative care holds promise as an effective, scalable, sustainable, and readily implementable service delivery model for people with complex needs.

In collaborative care, care is provided to a panel of patients by a treatment team. Team members include the primary care provider, a care manager, and a behavioral health specialty consultant. The care manager supports the patient and the primary care provider through a variety of treatment coordination activities. These activities include proactive follow-up of treatment adherence, tolerance, and response, alerting treatment team members when the patient is not improving; supporting medication management; facilitating communication among the treatment team; and delivering brief interventions like motivational interviewing, behavioral activation, and problem-solving therapy. The behavioral health specialty consultant, who has expertise and authority to prescribe medications, advises the primary care treatment team regarding patients who present diagnostic challenges or who are not adequately adhering, tolerating, or responding to treatment. Such consultation can be provided in person, or via tele- or web/video-conference to help address geographic scarcity. Teams may be augmented to include clinicians who furnish psychotherapy or other indicated treatments, or such treatments can be furnished via referral. Collaborative care programs follow the principles of measurement-based care, treatment-to-target, stepped care, and shared patient-provider decision making. In collaborative care, new cases are identified thorough routine screening, and patients’ progress is closely tracked using validated instruments. Treatment is adjusted – stepped up – if patients are not improving as expected.

Evidence supporting collaborative care is strongest for common mental disorders but is less robust for OUD and other substance use disorders. While collaborative care trials focusing on common mental disorders have typically included patients with co-occurring substance use disorders, research has typically not examined effectiveness separately for those with and without such co-occurring conditions.

This FOA will support research to address unanswered questions regarding the adaptation, effectiveness, and implementation of collaborative care for individuals with OUD and co-occurring mental health conditions. This research will complement studies conducted within OUD specialty care clinics by testing integrated treatment models appropriate for diverse primary care settings, where many patients with OUDs and mental health conditions already seek care, and that are more plausibly available in areas where behavioral health specialty providers are – and are likely to remain – scarce.

The anticipated effectiveness trials will channel the efforts of the scientific community to develop and implement pragmatic, effective, scalable, and sustainable solutions to the formidable public health challenges of OUD, which affect the lives and welfare of millions of Americans.

Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed March 23, 2018) includes a requirement that grantees from for-profit applicant organizations must provide a 50% match and/or in-kind contribution of all federally awarded dollars under the grant award (direct costs, as well as facilities and administrative costs) for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment.

Matching Requirement: A grantee from a for-profit organization funded under this funding opportunity announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.The applicant will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applications must identify the source and amount of funds proposed to meet the matching requirement and how the value for in-kind contributions was determined. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award.  NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement.  See 45 CFR 75.306 for additional details.

Research Objectives

NIH is interested in supporting effectiveness trials that develop, optimize, and test collaborative care models based in primary care to furnish indicated treatment for people with OUD and co-occurring mental health conditions. The collaborative care model must include MAT for OUD–specifically including indicated medications such as buprenorphine and/or methadone–as a component of care.  The comparative effectiveness trials should be designed to support rapid implementation, scalability, and sustainability of collaborative care approaches, should findings be positive.

Two categories of patients would be the primary foci for enhancing quality of care and improving clinical outcomes via the collaborative care model:

  • Individuals presenting or referred to primary care who are identified with an OUD and one or more co-occurring mental health conditions and who, based on shared patient-provider decision-making, choose to receive treatment for these conditions in primary care;
  • Individuals with an OUD and one or more co-occurring mental health condition presenting to a hospital emergency department or other acute care setting with non-fatal overdose, intentional self-harm, or other OUD-related emergent risk, and who prefer to receive follow-up outpatient care after discharge in primary care (including because they lack access to specialty care).

To meet the needs of people with OUD and mental health conditions, applicants should seek to answer these important primary research questions:

  • When integrating MAT and indicated treatment for mental health conditions, and when compared to standard care or other adaptions of collaborative care, how effective is collaborative care for improving patient outcomes with respect to (1) OUD, i.e., reducing or eliminating opioid use; (2) co-occurring mental health conditions, i.e., symptom response or remission; (3) functioning; and (4) risk for premature mortality, via accidental overdose, suicide, or other manner?
  • How can routine screening practices in primary care and as part of collaborative care be improved to identify new patients with OUD and mental health conditions?
  • When compared to standard care, how much does collaborative care improve access to and engagement with evidence-based services? That is, what is the reach of collaborative care into the target population?
  • How can collaborative care be optimized to introduce MAT to existing primary care practices already offering collaborative care for depression, anxiety, or other mental health conditions?
  • How can collaborative care for MAT and mental health conditions be introduced to primary care practices not providing collaborative care?
  • What patient, provider, and health system-level strategies are most effective to implement, bring to scale, and sustain collaborative care in diverse primary care practice settings for people with OUD and mental health conditions?

NIH is particularly interested in clinical trial designs which can secondarily answer the following questions:

  • Does treatment of mental health conditions also improve outcomes for people with OUDs?
  • What are the clinical and treatment engagement tradeoffs associated with sequencing mental health treatment ahead of treatment for OUD? How can designs that study treatment sequencing inform clinical practice guidelines for co-occurring disorders and inform shared patient-provider decision making during initial treatment planning?
  • Can improved collaborative care for OUD and mental disorders be considered “primary prevention” for acute overdose, suicide behaviors, and/or accidental death – catastrophic outcomes for which individuals with OUD have very elevated risk?
  • Can collaborative care be part of a care pathway for individuals with OUD who have been identified via presentation to a hospital emergency department or other acute care setting with non-fatal overdose or suicide attempt? And if so, under what conditions would this pathway be reasonable and effective in the context of other alternatives (e.g., immediate inpatient hospitalization if beds are available, emergency department boarding followed by inpatient hospitalization, telehealth consultation with a behavioral health specialist, warm handoff to an outpatient behavioral health specialist, usual care discharge home)?
  • Given the public health urgency to furnish high value services that are effective, scalable, and sustainable in real-world practice, NIH is additionally interested in answering these questions:
  • How well do existing financing models support the implementation of collaborative care models for treating individuals with OUD and co-occurring mental health conditions? What are the major barriers to wider implementation of collaborative care for these purposes, and practical options for addressing them?
  • What are the best strategies to ensure collaborative care models are implemented, adopted, scaled, and sustained in routine practice, to include rural and Native American settings, and other settings of high need which may be under resourced?

Institute Interests

NCCIH.  The mission of NCCIH is to define, through rigorous scientific investigation, the usefulness and safety of complementary and integrative health interventions and their roles in improving health and health care. in the context of this FOA, NCCIH is interested in studies that will evaluate the impact of adding evidence-based complementary approaches for mental health conditions that are commonly co-occurring with OUD, such as mood disorders, anxiety, or sleep disorders, to determine if they have a measurable impact on improving OUD outcomes. Applicants are encouraged to discuss applications the NCCIH contact listed in Section VII. Agency Contacts.

NIAAA.  Given the substantial co-occurrence of OUD, mental health issues, and alcohol use disorder, service delivery models that emphasize integration of care for behavioral health in general medical settings are of particular importance.  In the context of this FOA, NIAAA is interested in studies that will assess whether and how the benefits of collaborative care models extend beyond patients’ OUD and mental health outcomes to other co-occurring behavioral health conditions, particularly heavy drinking and alcohol use disorder. In addition, NIAAA encourages studies that will examine the influence of alcohol drinking history and current drinking on the efficacy of collaborative care models as applied to OUD and co-occurring mental health conditions.  Applicants are encouraged to discuss applications with the NIAAA contact listed in Section VII. Agency Contacts.

OBSSR.  Although OBSSR does not accept assignment of applications or manage awards that are funded through this announcement, OBSSR does encourage applications relevant to the OBSSR mission and may provide co-funding support to ICs that do manage the awards. OBSSR is specifically interested in studies that apply evidence-based approaches for behavioral change (e.g., provider prescribing practices, adherence to treatment and management recommendations for both the practitioner and patients, provider/patient communications, resilience and other topics) to improve outcomes within the collaborative care model.

ORWH.  The Office of Research on Women’s Health (ORWH) is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women’s health research is part of the scientific framework at the NIH, and throughout the scientific community. In general, ORWH is interested in research that considers the influence of sex and gender on health and disease, and the total health of women across the full spectrum of research. ORWH encourages interdisciplinary approaches and would be interested in partnering to support research that examines ways to integrate evidence-based practices, interventions, and policies into practice settings to improve the health of women.  The Trans-NIH Strategic Plan for the Health of Women covering FY 2019 – 2023 is available on the ORWH website (https://orwh.od.nih.gov) for additional guidance.

Scale and Scope of Research Covered Under This Announcement

This FOA is intended to support trials that are statistically powered to provide a definitive answer regarding the effectiveness of collaborative care for people with OUD and co-occurring mental health conditions in comparison to usual care practices or alternative intervention/services approaches. The study should also be designed to address hypotheses regarding predictors and moderators of effectiveness and questions regarding the action of mediators and mechanisms that underlie improvements to service delivery, implementation, scalability, and sustainability of collaborative care.

This FOA is intended to only fund strategies that optimize and test collaborative care for OUD and co-occurring mental health conditions. This FOA is not intended to test other models of integration (e.g., co-location of a behavioral health provider into primary care in the absence other elements like care management services or application of measurement-based care).  It is also not intended to support other efforts like the development of treatment guidelines and education of primary care providers, in the absence of collaborative care.

Core elements of collaborative care include 1) a prepared primary care practice (e.g., routine screening for indicated conditions; real-time availability and use of a disease registry for measurement-based care and treat-to-target practices); 2) care management services (in-person and/or telehealth); 3) a behavioral health consultant (in-person and/or telehealth) with prescription privileges and who has collaborative care expertise; 4) delivery of indicated treatments for common mental health conditions encountered in primary care settings (e.g., depression, anxiety, and/or PTSD) that are integrated within a collaborative care model; and 5) shared patient-provider decision making.

NIH envisions an intervention arm that integrates both MAT for OUDs and treatment for indicated mental health conditions within a collaborative care model of service delivery. Here, the behavioral health consultant must also advise directly on MAT services (or ensure regular expert consultation is available to the care team about MAT). Workflows, decision support tools, principles of measurement-based care and treatment-to-target, strategies to engage patients in care, etc. that are used in collaborative care for patients with mental health conditions should also be adapted (if necessary) and used as part of MAT services that are integrated with collaborative care.

Comparison conditions could include the following: 1) usual care for OUD plus usual care for mental health conditions, 2) MAT for OUD plus usual care for mental health conditions, 3) usual care for OUD plus collaborative care for mental health conditions, 4) MAT for OUD that is separate from collaborative care for mental health conditions plus collaborative care for mental health conditions, and/or 5) usual care where MAT for OUD plus indicated treatment for mental health conditions is integrated within a collaborative care framework and where manipulations in the intervention arm might include specific components of treatment, service delivery, and/or strategies for implementation.

Study sites should be representative and in areas of high need. The proposed projects should be multi-site and potentially include entire states like New Hampshire, West Virginia, New Mexico, Kentucky, or Ohio.

Projects must specify the patient outcomes that will be the focus of treatment; provide detailed rationale for the choice of outcomes; and describe valid and standardized methods for how those outcomes will be measured. Wherever possible, projects should utilize existing validated, standardized instruments of patient outcomes, which are available for many mental disorders and for functioning.

Given the urgency for rapid implementation of pragmatic and effective interventions to stem the opioid crisis, projects must demonstrate a deployment-focused model of design and testing. That is, studies should take into account key characteristics of the settings, providers, and intervention elements (e.g., training, supervision, infrastructure, and capacity to pursue measurement-based care) and factors related to implementation (reach, effectiveness, adoption, and maintenance). Designs should be pragmatic, and procedures and infrastructure unique to research (e.g., recruitment and follow-up strategies) should have minimal impact on clinical care and should not confound the interpretation of intervention effects or the generalizability of findings to non-research settings. A deployment focus is crucial to ensure that clinical trials that test collaborative care for people with OUDs and co-occurring mental health conditions have sufficient external validity to support broad implementation of evidence-based practices outside of a clinical trial context.

NIH will give priority to studies that leverage existing equities (e.g., practice networks, clinical trial networks, research-practice partnerships) rather than those that need to create research and clinical infrastructure de novo. Collaborations between academic researchers and clinical or community practice partners or networks are expected. When possible, studies should capitalize on existing infrastructure. Examples include practice-based research networks such as the NIMH-sponsored Mental Health Research Network (MHRN), the NIDA supported Clinical Trials Network, the NCATS Trial Innovations Network, the AHRQ Clinical Directors Network, and other clinical infrastructure (e.g., federal qualified health centers, rural health clinics, other integrated care settings supported by federal partners like HRSA or SAMHSA. Other examples may include leveraging electronic medical records, administrative data bases, and patient registries to increase the efficiency of participant recruitment (i.e., more rapid identification and enrollment) and to facilitate the collection of moderator data (e.g., patient, provider, and setting characteristics), longer-term follow-up data, and broader, stakeholder-relevant outcomes (e.g., mental health and general health care utilization, value and efficiency of intervention approaches).

Effective prevention, treatment, and management of OUD and mental health conditions have the potential to reduce morbidity and mortality associated with intentional injury (i.e., suicide attempts and deaths, see: www.suicide-research-agenda.org) and accidental overdose. Lack of attention to the assessment of these outcomes has limited our understanding regarding the degree to which MAT and indicated mental health treatment might offer prophylaxis. Accordingly, NIMH encourages effectiveness research that includes assessment of suicidal behavior to advance understanding of how effective prevention and treatment of mental disorders might impact suicide-relevant outcomes.

For multi-site trials, use of single IRBs is expected.

This funding announcement is intended to invite single applications that will use subcontracts to fund research being conducted at multiple clinical sites and/or fund investigators at multiple research institutions.

This RFA is not intended to support the development and testing of novel treatment modalities for the conditions being targeted here, i.e., new psychotherapies, medications, devices, or other treatments that are not yet indicated for OUD or relevant mental health conditions. Rather, this RFA is intended to support innovations in the delivery of existing efficacious treatment, when integrated as part of an optimized collaborative care model. Similarly, this RFA is also not intended to support the development and testing of new screening or patient outcome instruments. Wherever feasible and appropriate, projects should utilize existing validated and standardized instruments to screen for OUD and other substance use, as well as for common mental health conditions, as well as existing validated and standardized instruments to assess patient outcomes related to OUD, specific mental health conditions, functioning, and other relevant patient outcomes.

Examples of studies that are considered low priority to this FOA include the following:

  • Studies that do not include these core elements of the collaborative care model to be tested:1) A prepared primary care practice (e.g., routine screening for indicated conditions; real-time availability and use of a disease registry for measurement-based care and treat-to-target practices for a panel of patients); 2) Care management services (in-person and/or via telehealth); 3) A behavioral health consultant with prescription privileges, with collaborative care expertise and with MAT expertise (if the behavioral health consultant does not have the prerequisite expertise, applicants must provide a plan for how that expertise will be obtained and provided to the care team); 4) Integration of MAT for OUD within the collaborative care model; 5) Indicated treatment for mental health conditions commonly seen in primary care settings (e.g., depression, anxiety, and/or PTSD); and 6) Shared patient-provider decision making.
  • Projects that do not demonstrate a deployment-focused model of design and testing. That is, studies that do not take into account key characteristics of the settings, providers, and intervention elements.
  • Designs that are not pragmatic, and/or do not have procedures and infrastructure unique to research (e.g., recruitment and follow-up strategies) that have minimal impact on clinical care and minimal impact on trial results.
  • Projects that do not explicitly inform understanding regarding whether collaborative care engages putative change mechanisms (i.e., targets) related to service delivery that are presumed to account for improved outcomes.

Deadline:  March 1, 2019 (letters of intent); April 1, 2019 (full proposals)

URL:  https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-19-525.html

Filed Under: Funding Opportunities