August 1, 2023
- August 3, 2022 - HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional). See NOFO RFA-DA-23-053
- August 3, 2022 - HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R33 Clinical Trial Optional). See NOFO RFA-DA-23-054
- July 14, 2022- HEAL Initiative: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K01 - Clinical Trial Required). See NOFO PAS-22-206
- July 14, 2022- HEAL Initiative: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K23 - Clinical Trial Required). See NOFO PAS-22-207
National Institute on Drug Abuse (NIDA)
Background
This notice of special interest (NOSI) is part of the NIH's Helping to End Addiction Long-term (HEAL) initiative to speed the development and implementation of scientific solutions to the national opioid public health crisis by bolstering research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information and periodic updates about the HEAL Initiative are available at: https://heal.nih.gov/.
In the United States, a relatively small number of high-need patients account for a disproportionately high level of healthcare utilization, including hospital admissions and costs. Having a substance use disorder (SUD) increases the risk of an individual falling into this high-risk, high-need population. Furthermore, the co-occurrence of general medical conditions and SUD, including opioid use disorder (OUD) complicates the treatment and can worsen the outcomes of both. Screening for SUD and OUD is not routine for most medical or surgical admissions. Even when identified, individuals can experience worse outcomes for their medical or surgical conditions because of stigma or because their SUD may complicate their hospitalization in other ways (e.g., poor venous access in people who inject drugs). At the same time, individuals being treated in medical or surgical wards may not receive evidence-based treatment or linkage to outpatient OUD/SUD treatment upon discharge.
There are existing models for initiation of treatment for OUD during general inpatient hospital medical stays, some of which involve linkage to care post-discharge (e.g., addiction consult services, consultation liaison psychiatry referrals, care coordinators, patient navigators, bridge clinics). Some of these have been studied formally for short time periods and/or at limited scale. Others may have both emergency department (ED) and inpatient treatment initiation and linkage, but far more evaluation has been done on the ED initiation and linkage than the inpatient components. These models have not been scaled up and used widely to date, indicating possible limitations with the models, additional barriers to implementation, or limited experience with the models in varied health systems.
In addition, there is literature to support the idea the hospital may be an appropriate place to screen for and assess SUDs including OUD, that OUD may complicate or extend the hospital stay and increase costs, and that initiation of treatment during hospitalization and linkage to continued outpatient care can be beneficial in reducing hospital re-admissions.
Research Objectives
The goal of this initiative would be to test models of care longitudinally and across sites to address gaps in knowledge related to inpatient screening and treatment initiation for OUD and linkage to continuing care on discharge. Specifically, this initiative would support awards to test inpatient initiation and linkage models using multi-site clinical trials in order to:
- Identify the most effective inpatient screening, treatment initiation, and linkage models for different hospital and service systems, such as rural vs urban, large vs small hospitals, and safety net systems, including cost impacts and economic evaluations
- Evaluate the impact of inpatient-to-outpatient linkage of substance use disorder care on hospital readmission and long-term patient outcomes including morbidity, mortality, and substance use outcomes
- Identify systemic strategies to support the successful implementation, sustainability, and scalability of effective and cost-effective inpatient initiation and linkage interventions
Studies must include OUD relevant outcomes but may propose interventions to treat stimulant use disorder in combination with OUD. All projects must include a multi-site clinical trial for the model or multi-component intervention being tested.
A key element of this initiative is a focus on scalability, sustainability, and dissemination across the healthcare ecosystem. To that end, high priority applications will include:
- Evaluation of rates of readmission and hospitalization (including SUD related admissions) over a sufficiently long follow-up period
- Economic evaluations, which could include but are not limited to cost, cost-effectiveness, and cost-utility analyses of the treatment model
- The perspectives and feedback of patients, treatment providers, and other clinical, community and organizational stakeholders
- Plans to identify sources of stigma and approaches to reducing their impact on the intervention outcomes
This initiative is seeking information on a range of hospital-to-community settings, including rural, urban, academic, community, and safety net hospital systems. High priority applications will address issues of treatment equity as well as the translation of research to practice.
Special Considerations:
- Budget requests should reflect costs that are necessary and reasonable to complete the work described in the application.
- Rather than the creation of new measurement tools, applicants are strongly encouraged to use existing psychometrically validated measures where possible (See also the NIH HEAL initiative Common Data Elements Program https://heal.nih.gov/data/common-data-elements)
- Letters of support from all sites and organizations should be included, even for applications intending to further develop those relationships in an R61 phase.
Engaging People with Lived Experience and Other Collaborators:
People with lived experience (e.g., patients, patient advocates, caregivers, families, community leaders) have important insights that can improve meaningful outcomes, uptake of research findings, and health equity across the continuum of research from basic through implementation studies. The perspectives of other relevant collaborators (e.g., health service providers, payors, public health agencies, community-based organizations, biotech, Pharma) can further improve research impact. The NIH HEAL initiative strongly encourages applicants to specify their plan for meaningful engagement of people with lived experience and other collaborators in the research process. Meaningful engagement will vary with the focus of the research but should at minimum ensure that researchers are connecting with relevant collaborators and incorporating their perspectives throughout the conception, implementation, and dissemination of the research. Meaningful engagement should address what the researchers will learn and how the people with lived experience and/or collaborators will benefit from the partnership. To promote health equity, as is relevant for the research proposed, it is recommended that at least two people with lived experience from populations who experience health disparities should be meaningfully engaged in these efforts (see NIH’s Notice of Interest in Diversity for more information: NOT-OD-20-031).
See this resource for more information in engaging people with lived experience: https://aspe.hhs.gov/lived-experience).
Application and Submission Information
This notice applies to due dates on or after November 15, 2023 and subsequent receipt dates through November 13, 2025.
Submit applications for this initiative using one of the following notice of funding opportunity (NOFO) or any reissues of these announcements through the expiration date of this notice.
- August 3, 2022 - HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional). See NOFO RFA-DA-23-053
- August 3, 2022 - HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R33 Clinical Trial Optional). See NOFO RFA-DA-23-054
- July 14, 2022- HEAL Initiative: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K01 - Clinical Trial Required). See NOFO PAS-22-206
- July 14, 2022- HEAL Initiative: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K23 - Clinical Trial Required). See NOFO PAS-22-207
All instructions in the SF424 (R&R) Application Guide and the NOFO used for submission must be followed, with the following additions:
- For funding consideration, applicants must include “NOT-DA-24-011” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.
Please direct all inquiries to the contacts in Section VII of the listed notice of funding opportunity with the following additions/substitutions:
Scientific/Research Contact(s)
Marcy Fitz-Randolph, DO MPH
National Institute on Drug Abuse (NIDA)
Phone: 301-443-9800
Email: marcy.fitz-randolph@nih.gov
and Human Services (HHS)
