U24DA058673

Multilevel interventions to reduce harm and improve quality of life for patients on long-term opioid therapy - Yale Resource Center (MIRHIQL-YRC) - even after significant reductions in long-term opioid therapy (LTOT) prescribing for chronic pain nationally, approximately 13 million US adults receive LTOT, putting them at risk for an array of harms often without adequate benefit.

Due to the often unfavorable risk-benefit profile of LTOT, current consensus guidelines promote 1) continuous re-assessment of risk and benefit of LTOT and 2) reduction or discontinuation of LTOT while supporting pain self-management strategies and non-opioid pain care when benefit no longer outweighs harm. However, the guidelines lack crucial details--such as how to assess risk vs. benefit--hampering quality improvement efforts.

Clinical research has been slowed by lack of consensus related to important questions such as: what is the threshold for determining that harm outweighs benefit in LTOT? Should there be a new diagnostic entity to characterize the clinical scenario of harm outweighing benefit? And, if so, what are its distinguishing characteristics? These research and clinical gaps translate into potentially poor quality pain care for patients on LTOT, including low efficacy and heightened risk in a vulnerable population.

In accordance with RFA-DA-23-042, we propose the establishment of the Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy – Yale Resource Center (MIRHIQL-YRC) to address the national opioid public health crisis via a focus on the oft-overlooked population of patients on LTOT for whom risk may outweigh benefit but who do not have opioid use disorder.

We propose an integrated, multi-level structure of the MIRHIQL-YRC modeled after our high-functioning IMPOWR-YOU Research Center, with a community steering committee (CSC) at the hub and several smaller, agile workgroups focusing on specific tasks but moving forward in a highly inter-related fashion. The CSC's impact will be bolstered by the presence of partners historically left out of consensus-building projects: persons with lived experience and frontline clinicians, groups for whom it is crucial the tools and other products developed are patient-centered, non-stigmatizing, feasible and practical.

Via this structure, the MIRHIQL-YRC, governed by the CSC, will pursue four objectives: (1) facilitating, through a variety of mechanisms detailed herein, the successful execution of the companion MIRHIQL Network R01 clinical trials; (2) creating a risk-benefit decision tool to assist providers in determining when opioids should be continued as prescribed, tapered, or tapered and discontinued; (3) creating a clinical definition, identifying associated symptoms/behaviors, and generating a screening assessment for individuals on LTOT for whom harms outweigh the benefits; and (4) validating the clinical definition, associated symptoms/behaviors, and screening assessment in an independent prospective cohort study.

Our multi-disciplinary team with a long track record of successful collaboration and deep and broad expertise in chronic pain and opioid management is exceptionally well-positioned to meet these objectives.

Yale Univ

TO SUPPORT BASIC AND CLINICAL NEUROSCIENCE, BIOMEDICAL, BEHAVIORAL AND SOCIAL SCIENCE, EPIDEMIOLOGIC, HEALTH SERVICES AND HEALTH DISPARITY RESEARCH. TO DEVELOP NEW KNOWLEDGE AND APPROACHES RELATED TO THE PREVENTION, DIAGNOSIS, TREATMENT, ETIOLOGY, AND CONSEQUENCES OF DRUG ABUSE AND ADDICTION, INCLUDING HIV/AIDS. TO SUPPORT RESEARCH TRAINING AND RESEARCH SCIENTIST DEVELOPMENT. TO SUPPORT DISSEMINATION OF RESEARCH FINDINGS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) LEGISLATION IS INTENDED TO EXPAND AND IMPROVE THE SBIR PROGRAMS TO EMPHASIZE AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF TECHNOLOGY DEVELOPED THROUGH FEDERAL SBIR RESEARCH AND DEVELOPMENT, INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN THE SBIR PROGRAM. THE LEGISLATION INTENDS THAT THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.279 - Drug Abuse and Addiction Research Programs

National Institute on Drug Abuse (NIDA) [HHS - NIH]

Connecticut United States

State-Wide

HEAL Initiative: Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL): Resource Center (U24- Clinical Trial Optional) (RFA-DA-23-042)