Abstract
This column describes the collaboration among the American Psychiatric Association (APA), American Society of Addiction Medicine, Friends Research Institute, and the National Institute on Drug Abuse to create the Addiction Medicine Practice-based Research Network (AMNet) to address the opioid overdose epidemic in the United States. The collaboration leverages the APA’s patient registry (PsychPRO) and is recruiting office-based addiction medicine and psychiatry practices for AMNet. AMNet aims to address knowledge gaps regarding patient care in such practices, facilitate performance improvement efforts, and serve as a research platform.
I. Introduction
The United States is facing an unprecedented opioid epidemic. Despite the availability of FDA-approved medications to treat opioid use disorder (i.e., methadone, buprenorphine, and naltrexone), most individuals with opioid use disorder are not receiving care and many of those receiving care do not receive pharmacotherapy (1). Understanding the characteristics of individuals with opioid use disorder, improving the quality of their care, and discovering more effective treatments are important steps in addressing the country’s opioid overdose epidemic.
Many patients with opioid and other substance use disorders receive treatment in office-based practices beyond the bounds of specialty substance abuse treatment programs. Yet, relatively little is known about patient characteristics, services delivered, and treatment outcomes in such practices. This is a missed opportunity to gather important data on treatment in real-world practice settings, to organize data for performance improvement activities, and to study the effectiveness of novel treatments. The Addiction Medicine Practice-based Research Network (AMNet), a patient registry and practice-based research network focused on office-based practices by addiction psychiatrists, other addiction medicine physicians, and non-physician addiction medicine providers, aims to address this research gap.
This column describes the collaboration that led to the development of AMNet, which seeks to combine the features of a Practice-based Research Network (PBRN) and a registry to address the opioid epidemic. The challenges to conducting clinical research in office-based practices have been tackled in oncology and psychiatry through the creation of PBRNs and clinical data registries (2; 3). PBRNs are collaborations between researchers and community-based health care providers to design and implement studies aimed at improving patient outcomes (4). Registries, by contrast, are used to collect standardized process and outcomes data from clinicians and patients in a particular area of interest, thus providing a unique source of longitudinal data in large patient populations and a potentially robust research infrastructure, a key goal of AMNet (5).
II. Developing AMNet
Through a NIDA cooperative agreement which was supported by an interagency agreement between NIDA and the Office of the Secretary Patient-Centered Outcomes Research Trust Fund, the American Psychiatric Association (APA), American Society of Addiction Medicine (ASAM) and Friends Research Institute (FRI) launched the development of AMNet. Several years prior to this effort, FRI and ASAM had agreed to create an addiction medicine research network but lacked funding. Independently, the APA had developed its own plans to combine its previous experience in developing a PBRN and its recently launched Qualified Clinical Data Registry (PsychPRO), to develop a practice-based addiction medicine research network that would identify and inform quality care for patients with emerging symptoms of substance misuse through to substance use disorders. Identifying their shared vision, the partners met via a series of teleconferences and coordinated their efforts in a successful grant application to fund the development of AMNet. The partnership leveraged the distinct strengths of each organization (e.g., APA’s expertise in the developing data registry and PBRNs, FRI’s experience in conducting opioid use disorder treatment research, and ASAM’s expertise in clinical care and quality improvement).
Goals
AMNet’s goals are to capture timely clinician- and patient-reported data relevant to the opioid epidemic from routine practice; drive performance improvement efforts; and, develop a research network for community-based pharmacotherapy and service delivery intervention trials.
Governance
AMNet’s infrastructure consists of two main Committees that work to maintain a strong partnership through continued communication:
An Executive Committee comprising AMNet’s investigators from FRI, APA, ASAM, and a NIDA Science Officer. It meets weekly to oversee the development and implementation of AMNet. The Executive Committee members formed separate workgroups to address issues such as recruitment, data, research policy, and provider education. These workgroups report on their progress at the weekly Executive Committee meetings.
A Steering Committee that includes external addiction medicine and addiction psychiatry clinicians and researchers, a patient advocate, and two federal representatives. It holds annual in-person meetings and bimonthly conference calls with the Executive Committee to help guide selection of patient assessment tools and quality measures, recruitment strategies, research policies and procedures, and prioritization of research questions.
Registry Platform
AMNet is being built on PsychPRO, a robust Quality Improvement tool developed in partnership between APA and Featherstone Informatics Group (FIGmd), a HIPAA-compliant, U.S. Department of Health and Human Services Office of the National Coordinator for Health Information Technology-certified health information technology firm. PsychPRO’s flexible data collection methods allow for integration with electronic health records to obtain patient- and provider-level data. PsychPRO’s portals gather patient-reported (PROMs) and clinician-rated outcome measures. The patient portal provides real-time and historical feedback of PROM summary scores to enable clinicians, via the clinician portal, to conveniently screen patients, track progress, and monitor treatment effectiveness over time. Also, PsychPRO’s online dashboards provide timely feedback of performance data.
Practice Recruitment
The APA’s experience in recruiting PsychPRO users, and FRI and ASAM’s access to office-based practices, guided parameters for practice inclusion. Lessons learned from previous experiences informed the development of effective recruitment strategies and materials such as: a webpage with links to program reference guides and publications, educational resources for grant participants, and prioritized mail outreach to generate a greater response to meet recruitment goals. The goal over the next 2 years is to recruit 120 eligible providers/practices that offer addiction treatment. These practices can vary in sizes (solo or group), provider types (primary care clinicians such as physicians, physician assistants, and nurse practitioners; psychiatrists; addiction psychiatrists; and addiction medicine specialists) and geographic locations. Providers are being recruited through APA, ASAM, and American Academy of Addiction Psychiatry memberships, publications, conference presentations, social media, and listserv outreach. Providers are not required to be members of these organizations.
Assessments
AMNet offers standardized patient-reported and clinician-rated baseline and follow-up assessments and quality measures. The AMNet partners used their registry, clinical, and research experience to employ a multi-staged approach to identify and finalize the domains of interest and the associated assessments and quality measures for inclusion in the PsychPRO portal. First, a Measures Subcommittee was formed to conduct an environmental scan to identify the domains of interest and associated candidate assessments that are brief; clinically useful; in the public domain; and possess sound psychometric properties. Next, Executive Committee members had an open review and discussion of the results before a final review and approval by the Steering Committee.
Quality Measures
The Executive Committee also conducted an environmental scan of quality measures for opioid use disorder treatment. Inclusion criteria for AMNet quality measures were: being extractable from electronic health records of typical practices; used in the field; and associated with favorable treatment outcomes. Meeting all of these criteria, the Center for Care Innovations Quality Measures were adopted for use in AMNet (https://www.careinnovations.org/).
Common Data Elements and Research Database
AMNet common data elements, collected via PsychPRO’s portals and extracted from electronic health records, will comprise de-identified patient demographics; medications; drug testing results; and patient-reported and clinician-rated outcomes.
Feasibility and Validation Testing
The feasibility of AMNet data elements in PsychPRO and their validation will be assessed in the early phase of the network’s development using a combination of quantitative and qualitative methods. Continued feasibility testing will assess the workflow impacts and will consist of a clinical utility questionnaire and provider debrief interviews.
III. Discussion
The partner organizations bring a combination of strengths, experience, and resources to bear to create AMNet. APA and ASAM have large and active provider networks and extensive experience in reaching their respective memberships via websites, listservs, strategic email cascades, social media, and conferences. APA is applying its experience in recruiting providers for PsychPRO to the recruitment of AMNet providers. APA, through its Council on Addiction Psychiatry, NIDA, ASAM, and FRI used their knowledge of addiction treatment and research to inform selection of measures, and all partners used their extensive professional networks to form an expert Steering Committee. AMNet’s providers will be invited to take part in educational webinars led by the partners covering such topics as human research protection, research methods, cutting-edge research findings, and clinical care relevant to opioid use disorder treatment. Thus, the partners’ complementary strengths enhance the development and future success of AMNet.
During the grant period, AMNet will work with NIDA to explore creating collaborations between AMNet providers and extramural researchers to enhance the reach of practice-based addiction research. Following the end of the three-year grant award, the network could be sustained through funding obtained from extramural agencies, industry, and foundations.
IV. Conclusion
AMNet strives to help address the opioid epidemic as well as the nation’s other current and future substance use disorder challenges. Its success will depend on continued strong collaboration between its founding partner organizations.
Highlights.
The Addiction Medicine Practice-based Research Network (AMNet) is a collaboration among the American Psychiatric Association (APA), the American Society of Addiction Medicine, Friends Research Institute, and the National Institute on Drug Abuse.
AMNet leverages APA’s patient registry (PsychPRO) to develop a repository for a novel practice-based research network to collect information on treatment and outcomes in office-based addiction medicine and addiction psychiatry practices.
AMNet will facilitate performance improvement efforts and serve as a research platform for future studies.
Acknowledgments
The authors would like to thank the external Steering Committee members Drs. Karen Drexler, Walter Ling, Brian Hurley, Emily Jones, Anita Everett, and Mr. Vikram Chiruvolu for their guidance.
This project was made possible by grant number 3U01DA046910-02S2 from the National Institute on Drug Abuse at the National Institutes of Health, with funding from the Office of the Secretary Patient Centered Outcomes Research Trust Fund (Interagency Agreement Number 750120PE080047). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health or the US Department of Health and Human Services.
Disclosures
Dr. Schwartz reports serving as a consultant for a Verily Life Sciences project on substance use disorder treatment that is not related to the present paper. Dr. Vocci reports consulting fees from Nirsum Laboratories and Reckitt Benckiser. Dr. Vocci also reports consultant fees and meals and travel reimbursements from Insys Therapeutics, Lyndra Pharmaceuticals, Takeda Pharmaceuticals, and Intratab Labs (meals and lodging only). Dr. Vocci has also received medication for a clinical study from Alkermes and meals and medication for a clinical study from Braeburn Pharmaceuticals. Finally, Dr. Vocci has also participated on an advisory panel for generic buprenorphine manufacturers. Dr. Vocci’s consulting are related to opioid use disorder treatment and are not directly related to the present paper Drs. Pagano and Doty have no potential conflicts of interest to disclose. Ms. Gibson, Ms. Patel, and Ms. Ibrahim have no potential conflicts of interest to disclose. Dr. Clarke serves on the Mental Health Landscape Project Advisory Panel for RAND Corporation: a project funded by Otsuka Pharmaceuticals that is not related to the present paper. Dr. Goldstein is the NIDA Science Officer; NIDA has funded the project.
References
- 1.National Academies of Science, Engineering, and Medicine: Medications for Opioid Use Disorder Save Lives. Washington, DC, National Academies Press, March 2019 [PubMed] [Google Scholar]
- 2.Minasian LM, Carpenter WR, Weiner BJ, et al. : Translating research into evidence-based practice: The National Cancer Institute Community Clinical Oncology Program. Cancer 2010; 116: 4440–4449 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Kelly EL, Kiger H, Gaba R, et al. : The Recovery-Oriented Care Collaborative: A practice-based research network to improve care for people with serious mental illness. Psychiatr Serv 2015; 66: 1132–1134 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4.West J, Moscicki E, Duffy F, et al. : APIRE Practice Research Network: Accomplishments, challenges, and lessons learned. Psychother Res 2015; 25: 152–165 [DOI] [PubMed] [Google Scholar]
- 5.Gliklich R, Dreyer N, Leavy M (eds): Registries for Evaluating Patient Outcomes: A User’s Guide. Third edition, Rockville, MD, Agency for Healthcare Research and Quality, 2014 [PubMed] [Google Scholar]