Developing a clinical decision support for opioid use disorders: a NIDA center for the clinical trials network working group report.

There is an urgent need for strategies to address the US epidemic of prescription opioid, heroin and fentanyl-related overdoses, misuse, addiction, and diversion. Evidence-based treatment such as medications for opioid use disorder (MOUD) are available but lack numbers of providers offering these services to meet the demands. Availability of electronic health record (EHR) systems has greatly increased and led to innovative quality improvement initiatives but this has not yet been optimized to address the opioid epidemic or to treat opioid use disorder (OUD). This report from a clinical decision support (CDS) working group convened by the NIDA Center for the Clinical Trials Network aims to converge electronic technology in the EHR with the urgent need to improve screening, identification, and treatment of OUD in primary care settings through the development of a CDS algorithm that could be implemented as a tool in the EHR. This aim is consistent with federal, state and local government and private sector efforts to improve access and quality of MOUD treatment for OUD, existing clinical quality and HEDIS measures for OUD or drug and alcohol use disorders, and with a recent draft grade B recommendation from the US Preventative Services Task Force (USPSTF) for screening for illicit drug use in adults when appropriate diagnosis, treatment and care services can be offered or referred. Through a face-to-face expert panel meeting and multiple follow-up conference calls, the working group drafted CDS algorithms for clinical care felt to be essential for screening, diagnosis, and management of OUD in primary care. The CDS algorithm was reviewed by addiction specialists and primary care providers and revised based on their input. A clinical decision support tool for OUD screening, assessment, and treatment within primary care systems may help improve healthcare delivery to help address the current epidemic of opioid misuse and overdose that has outpaced the capacity of specialized treatment settings. A semi-structured outline of clinical decision support for OUD was developed to facilitate implementation within the EHR. Further work for adaptation at specific sites and for testing is needed.

The globalization of addiction research: capacity-building mechanisms and selected examples.

Over the past decade, the amount and variety of addiction research around the world has increased substantially. Researchers in Australia, Canada, United Kingdom, United States, and western Europe have significantly contributed to knowledge about addiction and its treatment. However, the nature and context of substance use disorders and the populations using drugs are far more diverse than is reflected in studies done in Western cultures. To stimulate new research from a diverse set of cultural perspectives, the National Institute on Drug Abuse (NIDA) has promoted the development of addiction research capacity and skills around the world for over 25 years. This review will describe the programs NIDA has developed to sponsor international research and research fellows and will provide some examples of the work NIDA has supported. NIDA fellowships have allowed 496 individuals from 96 countries to be trained in addiction research. The United Arab Emirates and Saudi Arabia have recently developed funding to support addiction research to study, with advice from NIDA, the substance use disorder problems that affect their societies. Examples from Malaysia, Tanzania, Brazil, Russian Federation, Ukraine, Republic of Georgia, Iceland, China, and Vietnam are used to illustrate research being conducted with NIDA support. Health services research, collaboratively funded by the U.S. National Institutes of Health and Department of State, addresses a range of addiction service development questions in low- and middle-income countries. Findings have expanded the understanding of addiction and its treatment, and are enhancing the ability of practitioners and policy makers to address substance use disorders.

Overview of the Consortium of Hospitals Advancing Research on Tobacco (CHART).

BACKGROUND: The Consortium of Hospitals Advancing Research on Tobacco (CHART) is a network of six projects and a research coordinating unit funded by the National Heart, Lung, and Blood Institute, the National Cancer Institute, the National Institute on Drug Abuse, and the National Institutes of Health (NIH) Office of Behavioral and Social Science Research. The CHART projects will assess the effectiveness and cost-effectiveness of smoking cessation interventions initiated during hospitalization and continued post-discharge. METHODS/DESIGN: Along with a seventh project funded previously under the NIH Challenge grants, the CHART projects will assess smoking cessation strategies delivered to approximately 10,000 hospitalized smokers across a geographically diverse group of nearly 20 private, public, academic, and community hospitals. The CHART research coordinating unit at Kaiser Permanente Center for Health Research provides organizational and data coordination support, facilitating the development of common measures for combining data from multiple CHART projects. DISCUSSION: The targeted enrollment in CHART, if achieved, will represent the largest, most diverse pooled dataset of hospitalized smokers receiving smoking cessation assistance, and is designed to contribute to the dissemination and implementation of smoking cessation interventions provided by hospital systems.

Should the reorganization of addiction-related research across all the National Institutes of Health be structural?--The devil is truly in the details.

The recent proposal to dissolve the National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse and create a new institute for substance use, abuse, and addiction will require significant effort by the staff of both institutes, the Advisory Councils, and outside experts to overcome complex challenges that could threaten its success. Although integration of the grants portfolios can be achieved, harmonization of goals and policies related to legal use of alcohol versus illegal consumption of drugs will present serious challenges. Consolidating the infrastructure of the 2 existing institutes would entail avoiding encroachment on grant funding. A new institute for substance use, abuse, and addiction would require an enormous amount of cooperation from other institutes as the portfolios of research on alcohol, tobacco, and other drug abuse should logically be transferred to the new institute. In the near term, a structural reorganization would be less efficient and more costly than the individual institutes are currently. Increasing efficiency and reducing costs over time will necessitate careful strategic planning. Success in this difficult task would be made easier and less costly by first implementing carefully placed building blocks of increasing functional reorganization. The newly created institute should increase opportunities for specialization within disorders of addiction, attract new leadership, and build a novel strategic plan that will energize scientists and staff and incorporate ideas of stakeholders to advance the public good in preventing and treating alcohol, tobacco, and all addictions. Attention must be paid to the devil in the details.

Sun-downing and integration for the advancement of science and therapeutics: the National Institute on Substance Use Disorders (NISUD).

The National Institutes of Health (NIH) is the most prominent funding source for scientific research in the world. It is also a complex and diverse organization, having multiple institutes, centers and offices. NIH emphasizes the need for innovation and collaboration in research to discover critical knowledge, enhance health and prevent disease. Advancement in science requires not only sophisticated methods, but also logical organization. Here, an overview of 'behavioral research' (writ large) at NIH is presented, focusing upon the common trinity of 'alcohol, tobacco/nicotine and other drugs' and programmatic overlap across entities. Consideration is also given to the origins of institutes and their historical movement across organizational boundaries. Specific issues, concerns and advantages of integration of the National Institute on Drug Abuse and National Institute on Alcoholism and Alcohol Abuse are addressed. It is concluded that advances in understanding, treating and preventing substance use disorders would best be served by (1)review and integration of all related research throughout NIH, (2) logical placement of leadership for this activity in a single institute, here entitled the National Institute on Substance Use Disorders, and (3) close collaboration of this institute with its complementary partner, the National Institute on Mental Health. Thus, NIH can establish an organizational structure and collaborations reflecting the realities of the scientific and disease/health domains. This would make a prominent statement to the world scientific and health communities regarding NIH recognition of the need for innovation (scientific and organizational) and focus upon these myriad interrelated and costly problems.

A centralized informatics infrastructure for the National Institute on Drug Abuse Clinical Trials Network.

BACKGROUND: Clinical trial networks (CTNs) were created to provide a sustaining infrastructure for the conduct of multisite clinical trials. As such, they must withstand changes in membership. Centralization of infrastructure including knowledge management, portfolio management, information management, process automation, work policies, and procedures in clinical research networks facilitates consistency and ultimately research. PURPOSE: In 2005, the National Institute on Drug Abuse (NIDA) CTN transitioned from a distributed data management model to a centralized informatics infrastructure to support the network's trial activities and administration. We describe the centralized informatics infrastructure and discuss our challenges to inform others considering such an endeavor. METHODS: During the migration of a clinical trial network from a decentralized to a centralized data center model, descriptive data were captured and are presented here to assess the impact of centralization. RESULTS: We present the framework for the informatics infrastructure and evaluative metrics. The network has decreased the time from last patient-last visit to database lock from an average of 7.6 months to 2.8 months. The average database error rate decreased from 0.8% to 0.2%, with a corresponding decrease in the interquartile range from 0.04%-1.0% before centralization to 0.01-0.27% after centralization. Centralization has provided the CTN with integrated trial status reporting and the first standards-based public data share. A preliminary cost-benefit analysis showed a 50% reduction in data management cost per study participant over the life of a trial. LIMITATIONS: A single clinical trial network comprising addiction researchers and community treatment programs was assessed. The findings may not be applicable to other research settings. CONCLUSIONS: The identified informatics components provide the information and infrastructure needed for our clinical trial network. Post centralization data management operations are more efficient and less costly, with higher data quality.