Notice of Intent to Publish for Effectiveness Trials to Optimize, Implement, Scale, and Sustain the Collaborative Care Model for Individuals with Opioid Use Disorders and Mental Health Conditions (U01 Clinical Trials Required)

Notice Number: NOT-MH-18-063

Key Dates

Release Date: October 29, 2018
Estimated Publication Date of Funding Opportunity Announcement: December 18, 2018
First Estimated Application Due Date: April 01, 2019
Earliest Estimated Award Date: September 01, 2019
Earliest Estimated Start Date: October 01, 2019

Related Announcements
None

Issued by
National Institute of Mental Health (NIMH)
National Center for Complementary and Integrative Health (NCCIH)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Nursing Research (NINR)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women’s Health (ORWH)

Purpose

In April 2018, the National Institutes of Health (NIH) launched the HEAL (Helping to End Addiction Long-term) Initiative, 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 and Offices, proposes research to adapt the Collaborative Care Model (referred to henceforth as collaborative care) – a specific service delivery model for treating mental/behavioral health conditions in primary care settings – to meet the needs of individuals with opioid use disorders (OUDs) and co-occurring mental health conditions. Effectiveness clinical trials are envisioned to develop, optimize, implement, scale, and sustain collaborative models that offer Medication Assisted Treatment (MAT) for OUD alongside indicated treatment for mental health conditions that commonly co-occur with OUD and are treatable in primary care.

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

The FOA is expected to be published in Winter 2018 with an expected application due date in Spring 2019.

This FOA will utilize the U01 activity code. Details of the planned FOA are provided below.

Research Initiative Details

Description

The planned request for applications (RFA) will support effectiveness clinical trials that develop, optimize, and test collaborative care models based in primary care to furnish indicated treatment for people with OUDs and co-occurring mental health conditions. In these collaborative care models, 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 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 (MAT . However, MAT remains underutilized. Only around one in five people with OUD receive any specific treatment, and only a minority of those receive MAT. 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. For example, approximately half of US counties lack even one practicing mental/behavioral health specialty clinician. 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. 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. 

The planned RFA 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.

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.

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 trade- offs 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?

Scale and Scope of Research

This planned RFA is intended to support clinical 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.

This planned RFA is intended to only fund strategies that optimize and test collaborative care for OUD and co-occurring mental health conditions. 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; 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.

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.

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.

Funding Information

Estimated Total Funding $10 million (total costs) per year
Expected Number of Awards 3
Estimated Award Ceiling TBD
Primary CFDA Numbers 93.242

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Michael C. Freed, Ph.D., EMT-B
National Institute of Mental Health (NIMH)
301-443-3747
michael.freed@nih.gov