Notice of Intent to Publish a Funding Opportunity Announcement for Research Site for the HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis (UM1)

Notice Number: NOT-DA-18-026

Key Dates

Release Date: July 18, 2018
Estimated Publication Date of Funding Opportunity Announcement: September 17, 2018
First Estimated Application Due Date: December 04, 2018
Earliest Estimated Award Date: February 01, 2019
Earliest Estimated Start Date: February 01, 2019

Related Announcements
NOT-DA-18-025
RFA-DA-19-016
RFA-DA-19-017

Issued by
National Institute on Drug Abuse (NIDA)

Purpose

The National Institute on Drug Abuse(NIDA), in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA), intends to publish a Funding Opportunity Announcement (FOA) to solicit cooperative agreement applications and ultimately fund up to three research sites and one data coordinating center to participate in the: HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis (HEALing Communities Study).

The HEALing Communities Study will test the immediate impact of implementing an integrated set of evidence-based interventions across healthcare, behavioral health, justice, and other community-based settings to prevent and treat opioid misuse and Opioid Use Disorders (OUD) within highly affected communities. Highly affected communities of interest could include counties, neighborhoods, or some other justifiable geographic areas, within states that are burdened with higher than average rates of overdose mortality and opioid-related morbidity, and other complications. 

The integrated set of evidence-based prevention and treatment interventions should be designed to achieve the following goals: reduce overdose fatalities, and events; decrease the incidence of OUD; and increase the number of individuals receiving medication-assisted treatment, retained in treatment beyond 6 months, and receiving recovery support services compared to baseline. 

As background, on June 18, 2018, NIH held a planning meeting with scientific experts and stakeholders to discuss questions related to the design and outcomes for the HEALing Communities Study.  A summary of meeting proceedings is available at: https://www.drugabuse.gov/drugs-abuse/opioids/nih-heal-initiative.  To solicit additional input on the study from interested stakeholders a Request for Information (RFI) was developed.  The RFI can be found at:  https://grants.nih.gov/grants/guide/notice-files/NOT-DA-18-023.html

Research site applicants will be expected to leverage federal, state, local, foundation, and other resources and infrastructure deployed to provide prevention and treatment services and collect data to address the opioid crisis (e.g. SAMHSA, Centers for Disease Control and Prevention, Department of Justice, Health Resources and Services Administration and Federally Qualified Health Centers, etc.)  Cluster, rather than individual, trial designs will be sought through this FOA in line with the goal of testing the immediate impact of implementing an integrated set of existing evidence-based interventions.  The development of novel individual-level prevention and treatment interventions will not be considered responsive.  

This study will be part of the 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

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.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations at the state, local government, and community level across multiple systems including healthcare, behavioral health, criminal justice, and other key stakeholders, and develop responsive applications.   

The FOA is expected to be published in September 2018, with an expected application due date in December 2018.   

This FOA is expected to utilize the UM1 activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with a wide range of expertise to consider applying for this FOA.  The areas of research expertise encouraged in this initiative are epidemiology and modeling, public health and healthcare data systems, data harmonization and integration, health services research, drug abuse prevention, OUD and treatment, systems science, community-based participatory research, implementation science, and health economics.  In addition to these listed areas of expertise, each research site must include a highly involved co-investigator who is a governmental official with the documented ability to influence the type, quality, and integration of multiple systems across all communities involved with the research site to develop a systematic approach to opioid overdose fatalities, opioid misuse, OUD treatment, and prevention and answer research questions described below.  This person is expected to be included among the key personnel on the research study and to be involved in all aspects of study design and implementation.  In addition, since cluster trial designs (e.g. group or cluster-randomized trial, stepped wedge design, etc.) will be used to test "intervention" effects at the "community site" level researchers should partner with multiple counties, neighborhoods, or other geo-political units who will be willing to collaborate in delivering an integrated evidence-based prevention and treatment system to meet the needs of their population.   These sites will be expected to adapt, change, and integrate efforts across multiple sectors: health care (including behavioral health), criminal justice, community support (e.g. police, fire department, faith based organizations, schools) etc. to meet the needs of the study. 

As a multi-site cooperative agreement, grantees will be expected to work collaboratively with NIDA and SAMHSA, other grantees, and the data coordinating center on the study design, implementation, outcome and instrument development, data integration and harmonization, analyses, publications, dissemination of findings, etc.  All grantees will be required to implement common data elements, instruments, approaches to data collection, outcomes, baseline, and follow-up data collection.  Investigators are encouraged to use new and existing resources provided to communities to pay for prevention and treatment services from federal, state, and local sources including SAMHSA.  They are also encouraged, if present in their state, to take advantage of NIDA's clinical trials network and the Clinical and Translational Science Award Program funded by the National Center for Advancing Translational Sciences. 

Objectives and Scope

Overarching research questions include:

1) What evidence-based integrated prevention and treatment system of care is needed to reduce overdose fatalities by at least 40% and improve other related individual, public health, process, and structural outcomes?

2)  What factors (structural, organizational, community, and policy-level) contribute to successfully implementing and sustaining an integrated evidence-based prevention and treatment system that takes advantage of healthcare, justice and community settings? 

3)  What analytic tools, resources, and strategies are most useful in helping communities respond rapidly and effectively to the opioid crisis? 

4)  What are the incremental costs and cost-effectiveness of a coordinated integrated evidence-based prevention and treatment system compared to standard care in the community with respect to reducing overdose fatalities by at least 40%? 

The primary objective and outcome of this program is to support the design and conduct of a multi-site cooperative study that measurably reduces overdose fatalities by at least 40% compared to baseline.

Secondary outcomes may include (but are not limited to):

  • decreasing rates of non-fatal overdose events,
  • decreasing the misuse of opioids, incidence of OUD, and progression in severity to OUD or injection drug use, 
  • increasing the number of individuals receiving medication and behavioral treatment for OUD,
  • increasing the number of individuals retained in treatment beyond 6 months,
  • increasing the number of individuals receiving recovery support services. 

The list of structural changes and outcomes might include but is not limited to the following:

  • changing prescribing patterns to reduce the supply of prescription opioids
  • community-level expansion of prevention and treatment in healthcare, behavior health and justice settings
  • increasing the number of specialized treatment programs that provide medications for OUD
  • increasing the number of providers (doctors, nurses, nurse practitioners, physician assistants) prescribing and monitoring the use medications for OUD
  • increasing the availability of naloxone across a community to reduce fatal overdoses
  • creating programs to support connect to and provision of treatment following an opioid overdose
  • increasing the use of screening and brief intervention to address opioid misuse within healthcare settings
  • increasing collaboration and coordination of efforts by the healthcare, behavioral health, and justice systems to address opioid misuse and OUD during incarceration and following release to the community (e.g. the number of incarceration and community release settings providing medication to address OUD)

Research Strategy:  The HEALing Communities Study research sites applications must consist of the functional and structural units clearly marked in sub-sections A-H described below. 

Sub-section A: Research Plan (required). The research plan must describe the approach to understanding the nature and scope of the opioid crisis within communities and development of a response strategy, which must be ready for implementation within 10-12 months of the award.  The Research Plan must include: a) data sources and use of epidemiological and modeling methodologies to determine the nature of the opioid crisis in geographic area of study, collect baseline measures and follow-up data for primary outcome of overdose fatalities and other secondary outcomes, and track factors outside of the study (e.g. changing drug markets, clinician prescribing patters, etc.) that could affect the primary outcome; b) a model to organize communities and integrate systems across multiple settings to address opioid overdose fatalities, misuse and OUD including community coalition  building; c) development of an integrated  set of evidence-based prevention and treatment interventions; d) rigorous cluster study design with power analysis, recruitment plan, and intervention implementation; d) secondary outcomes; e) measures, use of existing datasets, and de novo data collection; f) approach and timing of baseline and follow-up data collection; g) analysis plan; h) data harmonization, integration, and sharing across sites.

Sub-section B: Infrastructure, Partnerships and Collaborations subsection (required): Describe the academic, government, community, and other partnerships needed to achieve the goals of the research and experience in developing and maintaining successful research collaborations.  Describe current partnerships, and the role and contribution of partners to the program, any existing infrastructure support provided by the partners for delivery of prevention and/or treatment services or data collection.

Sub-section C:  Community Engagement and Outreach subsection (required):  Must include experience and track record of working collaboratively with communities, an evidence-based approach to community engagement and community coalition building (e.g. Communities that Care Model), and application of principles from community-based participatory research paradigms.  Letters of participation from partners and the establishment and regular meetings of a Community Advisory Board will be required.

Sub-section D:  Data Collection, Management, and Harmonization (required):  Describe the plan for data collection, management, integration and harmonization across common data elements, between research sites, and collaboration with the data coordinating center including data sharing.

Sub-section E:  Systems Science, Implementation and Sustainability Research (required): Describe the plan for integrating systems science to create a learning healthcare system for opioid misuse and OUD.  Describe how implementation and sustainability research will help understand factors that contribute to the successful implementation and sustainability of an integrated evidence-based prevention and treatment system.

Sub-section F:  Health Economics subsection (required):  Describe how the research site will interface with the coordinating center (responsible for designing and implementing the health economics study) to develop and collect data needed to address health economics questions related to cost, cost effectiveness, economic modeling, and sustainability.

Sub-section G:  Research site Overview, Management, and Operations subsection (required):  Each application must propose a plan for the leadership, coordination, administration of the research site.  An organization chart must be included.  This section should also include: a) overall programmatic structure to effectively promote interactions with communities involved with the research, other research sites, the Coordinating Center, NIDA, SAMHSA, and other key stakeholders; b) administrative organization with roles, responsibilities, and clear lines of authority for personnel involved in the center; c) project management plans and processes for establishing, tracking, reviewing, and managing milestones and productivity; d) quality control to ensure rapid problem identification and resolution, prioritization of resources, high quality data and publications; e) clear communication plan across the research site and their partners, NIDA, SAMHSA, other research sites, and the data coordinating center. 

Sub-section H:  Scientific Research Support Unit(s): (optional):  This section includes any other SRS necessary to support the research agenda.  A full description with strong justification will be needed. 

Funding Information

Estimated Total Funding TBD
Expected Number of Awards TBD
Estimated Award Ceiling TBD
Primary CFDA Numbers 93.279

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)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Redonna K. Chandler, Ph.D.
National Institute on Drug Abuse (NIDA)
301-443-1470
redonna.chandler@nih.gov