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Abstract: There is an urgent need within the substance-use-disorders (SUD) treatment field to develop and implement consensus-based common core data elements (CDEs) with standardized vocabularies relevant to drug addiction treatment that could be incorporated and widely adopted into harmonized electronic medical record systems (EMRs). This will benefit patients by improving the quality of care and will assist in integration of specialty addiction treatment into disciplines of mainstream medicine. To achieve these aims, the NIDA Clinical Trials Network (CTN) has collected and collated dozens of treatment-form-related information and standardized instruments to develop a treatment-relevant set of CDEs. These CDEs were refined following a consensus-based meeting of federal, state, and community-based treatment stakeholders and providers. This poster describes the collaborative “Mind Map” used for developing and implementing core questions as CDEs for EMRs on SUD in primary care and SUD specialty treatment settings. Current progress in developing EMR core questions as CDEs for use in those settings is also provided, as well as implications of this project for the future of drug abuse treatment. NIDA is especially interested in input from College on Problems of Drug Dependence (CPDD) members on data collection hierarchy and core data elements and on the overall strategy in regards to other sources of input, other stakeholders who should be consulted, and other “next steps” as this project moves forward.

Abstract:

The goal of Project CODE-PRO (Capturing Opioid Use Disorder Electronically and Patient Reported Outcomes) was to build clinical data research infrastructure that will begin to enhance capacity to use electronic health record (EHR) data and patient reported outcomes measures (PROs) to conduct opioid related research in emergency departments (EDs). The project builds data capacity for research in four main areas, including standardized collection of standardized clinical data, collection of participant provided information, linking of clinical and other data for research, and use of clinical data for research in ED settings. As such, the project included three distinct tasks and objectives, including:

1. Identifying existing or potential common data elements (CDEs) for OUD that are relevant to the ED setting (Task 1)
2. Demonstrating that CDEs from the EHRs can be transmitted or integrated into the American College of Emergency Physicians (ACEP) Clinical Emergency Data Registry (CEDR) (Task 2)
3. Exploring the feasibility and acceptability of collecting PRO measures electronically in patients with non-medical opioid use in the ED setting (Task 3)

Together, these tasks were designed to improve interoperability and linkages between EHRs, research networks and registries for research relevant to the opioid epidemic. Enhanced clinical data research infrastructure in ED settings has the potential to facilitate research to address key strategic priorities, such, as improving access to treatment and recovery services, promoting use of overdose-reversing drugs, providing support for cutting edge research on addiction and pain, and advancing better practices for management of OUD and pain.

Related protocols: CTN-0081

Abstract:

The emergency department (ED) offers an important opportunity to identify patients with opioid use disorder (OUD) and initiate treatment. However, post-ED follow-up is challenging, and novel approaches to enhance care transitions are urgently needed. Outcomes following ED visits have traditionally focused on overdose, treatment engagement, and mortality with an absence of patient reported outcomes (PROs), for example patient ability to schedule follow-up OUD treatment appointments or pick up a prescription medication, that may better inform evaluation of treatment pathways and near-term outcomes after acute events. In the context of increasing novel secure mobile health (mHealth) platforms, researchers explored the feasibility and acceptability of electronically collecting PROs from ED patients with non-medical opioid use to enhance care in the ED and transitions of care.

ED patients with non-medical opioid use or opioid overdose who endorsed willingness and ability to complete electronic surveys after discharge were enrolled from a tertiary, urban academic ED. Participants were enrolled in an mHealth platform, shared electronic health records with researchers, and completed electronic surveys of PROs at baseline, three- and thirty-days post discharge from the hospital, including questions about ability to schedule a follow-up appointment, pick up a prescription medication and overdose risk behaviors. Primary outcomes were measures of feasibility and acceptability of electronic PRO collection among ED patients with non-medical opioid use.

Among 1,808 patients assessed for eligibility between June-December 2019, 101 of 130 (78%) eligible adult patients consented to participate. Ninety-six (95%) of 101 patients completed registration in the mHealth platform, and 77/96 (80%) were successful in sharing their electronic health data. Completion rates for the baseline, three-day and thirty-day surveys were 97% (93/96), 49% (47/96) and 42% (40/96). Implementation challenges included short engagement window during ED visit, limited access to smartphones/computers, insufficient battery life of participant phone to access email and password, forgotten emails and passwords, multi-step verification processes for account set-up, and complaints about hospital care, most of which were effectively addressed by study personnel.

Conclusions: ED patients with OUD were willing to share electronic health information and PROs, although implementation challenges were common, and more than half of participants were lost-to-follow-up after hospital discharge at 30 days. Efforts to streamline communication and remove barriers to engagement are needed to improve the collection of PROs and pathways of care in ED patients with OUD.

Related protocols: CTN-0081

Abstract:

This guide was developed by investigators at Yale University as part of a project designed to build data capacity for patient-centered outcomes research (CTN-0081).

It provides an overview of the collection of patient reported outcomes (PROs) from emergency department (ED) patients with nonmedical opioid use using a novel mobile health (mHealth) platform and is designed to aid in the design and conduct of similar projects at other institutions.

Related protocols: CTN-0081

Abstract:

This is the primary outcomes paper for CTN-0081. Gaps in electronic health record (EHR) data collection and the paucity of standardized clinical data elements (CDEs) captured from electronic and digital data sources have impeded research efforts aimed at understanding the epidemiology and quality of care for opioid use disorder (OUD). As part of CTN-0081, researchers aimed to identify existing CDEs and evaluate their validity and usability, which is required prior to infrastructure implementation within EHRs.

Investigators conducted (a) a systematic literature review of publications in Medline, Embase and the Web of Science using a combination of at least one term related to OUD and EHR and (b) an environmental scan of publicly available data systems and dictionaries used in national informatics and quality measurement of policy initiatives. Opioid-related data elements identified within the environmental scan were compared with related data elements contained within nine common health data code systems and each element was graded for alignment with match results categorized as “exact”, “partial”, or “none.”

The literature review identified 5186 articles for title search, of which 75 abstracts were included for review and 38 articles were selected for full-text review. Full-text articles yielded 237 CDEs, only 12 (5.06%) of which were opioid-specific. The environmental scan identified 379 potential data elements and value sets across 9 data systems and libraries, among which only 84 (22%) were opioid-specific. We found substantial variability in the types of clinical data elements with limited overlap and no single data system included CDEs across all major data element types such as substance use disorder, OUD, medication and mental health. Relative to common health data code systems, few data elements had an exact match (<1%), while 61% had a partial match and 38% had no matches.

Conclusions: Despite the increasing ubiquity of EHR data standards and national attention placed on the opioid epidemic, we found substantial fragmentation in the design and construction of OUD related CDEs and little OUD specific CDEs in existing data dictionaries, systems and literature. Given the significant gaps in data collection and reporting, future work should leverage existing structured data elements to create standard workflow processes to improve OUD data capture in EHR systems.

Related protocols: CTN-0081

Abstract:

Healthcare data from electronic health records (EHRs) and related health information technology (IT) tools are critical data sources for pragmatic clinical trials and observational studies aimed at producing real-world evidence. To unlock the full potential of such data to advance science, the data must be complete and in structured formats to facilitate research use.

A Health IT survey was conducted within the National Drug Abuse Treatment Clinical Trials Network (CTN) to explore information related to data completeness and presence of unstructured data (e.g., clinical notes, free text) for conducting the EHR-based research for substance use disorders (SUDs). The analysis was based on 36 participants from 36 facilities located in 14 states and affiliated with the CTN.

The mean age of the participants (n = 34) was 48.0 years (SD = 9.8). Of the participants enrolled, 50.0% were female and 82.4% were white. Participants’ facilities were from four census-defined regions (South 35.3%, Northeast 29.4%, West 20.6%, Midwest 11.8%, Missing 2.9%) and represented diverse settings. The EHR was used by all surveyed facilities including 17 different kinds of EHR platforms or vendors, and 17.6% (n = 6) of surveyed facilities also used a separate EHR for behavioral health care (e.g., SUD care). Paper records were also used by 76.5% of surveyed facilities for clinical care (e.g., for health risk appraisal questionnaires, substance use screening or assessment, check-in screening, substance use specific intervention/treatment or referral, or labs/testing). The prevalence of using a patient portal, practice management system, and mHealth for patient care was 76.5%, 50.0%, and 29.4%, respectively.

Conclusions: While results are descriptive in nature, they reveal the heterogeneity in the existing EHRs and frequent use of paper records to document patient care tasks, especially for SUD care. The use of a separate EHR for behavioral healthcare also suggests the challenge of obtaining complete EHR data to support research for SUDs. Much EHR development, integration, and standardization needs to be done especially in regard to SUD treatment to facilitate research across disparate healthcare systems.

Related protocols: CTN-0071-Ot

Abstract:

Tobacco, alcohol, and drug use are leading causes of preventable death in the U.S. and screening for alcohol and drug use in primary care is recommended. However, such screening has not become part of routine health care, and substance use information is not systematically collected in electronic health records. This presentation describes the objectives, methods, and outcomes of CTN-0062-Ot, a phased feasibility and proof-of-concept study seeking to incorporate addiction-specific screening and assessment common data elements into a widely used EHR.

Related protocols: CTN-0062-Ot

Abstract:

Alcohol and drug use are leading causes of morbidity and mortality that frequently go unidentified in medical settings. As part of a multi-phase study to implement electronic health record-integrated substance use screening in primary care clinics (the CTN-EHR-PC study, CTN-0062-Ot), researchers interviewed key clinical stakeholders to identify current substance use screening practices, barriers to screening, and recommendations for its implementation. Focus groups and individual interviews were conducted with 67 stakeholders, including patients, primary care providers (faculty and resident physicians), nurses, and medical assistants, in two urban academic health systems affiliated with the NIDA Clinical Trials Network. Themes were identified using an inductive approach, revised through an iterative process, and mapped to the Knowledge to Action (KTA) framework, which guides the implementation of new clinical practices.

Factors affecting implementation based on KTA elements were identified from participant narratives:

• Identifying the problem: Participants consistently agreed that having knowledge of a patient’s substance use is important because of its impacts on health and medical care, that substance use is not properly identified in medical settings currently, and that universal screening is the best approach.
• Assessing barriers: Patients expressed concerns about consequences of disclosing substance use, confidentiality, and the individual’s own reluctance to acknowledge a substance use problem. Barriers identified by providers included individual-level factors such as lack of clinical knowledge and training, as well as systems-level factors including time pressure, resources, lack of space, and difficulty accessing addiction treatment.
• Adapting to the local context: Most patients and providers stated that the primary care provider should play a key role in substance use screening and interventions. Opinions diverged regarding the optimal approach to delivering screening, although most preferred a patient self-administered approach. Many providers reported that taking effective action once unhealthy substance use is identified is crucial.

Conclusions: Participants expressed support for substance use screening as a valuable part of medical care, and identified individual-level as well as systems-level barriers to its implementation. These findings suggest that screening programs should clearly communicate the goals of screening to patients and proactively counteract stigma, address staff concerns regarding time and workflow, and provide education as well as treatment resources to primary care providers.

Related protocols: CTN-0062-Ot

Abstract:

Tobacco, alcohol, and drug use are leading causes of preventable death in the U.S., but screening for alcohol and drug use is not part of routine health care and substance use information is not systematically collected in electronic health records.

This presentation described two protocols in the CTN that aimed to address this issue: CTN-0059, in which the TAPS Tool for screening and brief assessment was developed and validated, and CTN-0062, a feasibility and proof-of-concept study to assess incorporating the NIDA CTN Common Data Elements into electronic health records in large primary care settings.

Related protocols: CTN-0059, CTN-0062-Ot

Abstract:

Alcohol and drug use are significant drivers of preventable morbidity and mortality that are not routinely identified or treated in medical settings. Screening, brief intervention, and referral to treatment (SBIRT) to address substance use in primary care is widely promoted, but has proven challenging to implement. Validated screening tools that can quickly and accurately identify substance use have been designated common data elements (CDEs), but are not widely integrated into electronic health records (EHRs). As part of a study of the NIDA Clinical Trials Network (CTN-0062-Ot), a clinical decision support system (CDSS) was developed to support the delivery of substance use screening and interventions in primary care.

This presentation reports on usability testing performed to address the challenges of developing the CDSS. Usability testing identified important issues related to workflow and content, as well as human-computer interactions problems. An iterative process of usability testing and content adaptation allowed researchers to successfully modify a commercial EHR for delivery of a complex behavioral intervention, though some limitations to its functionality remain. Future phases of this study will examine adoption of this CDSS in multiple primary care clinics.

Related protocols: CTN-0062-Ot

Abstract:

This webinar provided an update on CTN-0062-Ot, a phased feasibility and proof-of-concept study seeking to incorporate addiction-specific screening and assessment of common data elements (CDEs) into a widely used electronic health record (EHR), explore the logistics and time required to do this, and assess impacts on the frequency of identification, diagnosis, and referral to treatment in large healthcare organizations.

The webinar included these components (click each title for the individual slides):

• A Phased-Implementation Feasibility and Proof-of-Concept Study to Assess Incorporating the NIDA CTN Common Data Elements into the Electronic Health Record in Large Primary Care Settings (CDE-EHR-PC Study, CTN-0062-Ot). Jennifer McNeely, MD, MS, New York University School of Medicine
• Usability: An Introduction. Joseph Kannry, MD, Mount Sinai Health System
• Usability in Healthcare IT: Data Collection and Analysis Approaches. Andrew Kushniruk, PhD, School of Health Information Science, University of Victoria
• Lessons Learned and Conclusion.

Related protocols: CTN-0062-Ot

Abstract:

Electronic Medical Records (eMedical Records/EMR) and Electronic Health Records (EHR) are becoming more and more significant in the delivery of quality healthcare.

These EMR and EHR systems are designed based on critical data elements commonly used for collection of medical history and made available in clinical care as well as in research. This one-hour webinar, presented by Robert Gore-Langton, PhD, of the EMMES Corporation and Betty Tai, PhD, Director of the CTN at NIDA, will discussed the differences between EMRs and EHRs, Common Data Elements (CDEs), and implications for use in research projects on Substance Use Disorders.

Additional Resources:

• Download slides (pdf)
• Download handout (pdf)

Abstract:

The National Drug Abuse Treatment Clinical Trials Network (CTN) of the National Institute on Drug Abuse (NIDA) recently launched a public portal which provides a single-source repository for CTN-recommended common data elements (CDEs) for substance use disorders (SUD) for use in electronic health record systems (EHRs) and clinical research. A CDE in this context is a data element consisting of a question and enumerated set of possible values for responses precisely defined by standardized metadata descriptors. CDEs consisting of individual question/answer pairs can be combined into more complex questionnaires and case report forms or used when gathering medical information in the context of providing clinical care. Thus, CDEs describe semantic characteristics for a discrete piece of data, which will be collected, stored, or exchanged during the course of a study or health examination. This will facilitate exchange of standardized data because of the use of CDEs. In this manner, NIDA CDEs can be commonly applied to multiple data collection systems whether in research or clinical care and across different institutions, such that their intentional commonality with use of common data standards can improve data quality, facilitate data repurposing, and promote data sharing.

This paper describes objectives and importance of the CTN CDEs initiative and portal to translational psychiatric research: To support harmonized use of EHR-compatible common data elements to enable exchange and integration of data to answer clinical meaningful questions of broad interest to SUD treatment research, thereby facilitating big-data biomedical science crossing boundaries between research and clinical care.

Abstract:

Electronic health records (EHR) are essential in improving quality and enhancing efficiency of health-care delivery. By 2015, medical care receiving service reimbursement from US Centers for Medicare and Medicaid Services (CMS) must show “meaningful use” of EHRs. Substance use disorders (SUD) are grossly under-detected and under-treated in current US medical care settings. Hence, an urgent need exists for improved identification of and clinical intervention for SUD in medical settings. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) has leveraged its infrastructure and expertise and brought relevant stakeholders together to develop consensus on brief screening and initial assessment tools for SUD in general medical settings, with the objective of incorporation into US EHRs. Stakeholders were identified and queried for input and consensus on validated screening and assessment for SUD in general medical settings to develop common data elements to serve as shared resources for EHRs on screening, brief intervention, and referral to treatment (SBIRT), with the intent of supporting interoperability and data exchange in a developing Nationwide Health Information Network. Through consensus of input from stakeholders, a validated screening and brief assessment instrument, supported by Clinical Decision Support tools, was chosen to be used at out-patient and general medical settings. The screening instrument consists of a single question, “How many times in the past year have you used an illegal drug or used a prescription medication for non-medical reasons?” (developed and validated by Smith et al, Arch Intern Med 2010:170:1155-60), and the 10-item version of the Drug Abuse Screening Test (DAST) serves as the assessment tool for those who screen positive for potential SUD.

Conclusions: The creation and adoption of a core set of validated common data elements and the inclusion of such consensus-based data elements for general medical settings will enable the integration of SUD treatment within mainstream health care, and support the adoption and “meaningful use” of the US Office of the National Coordinator for Health Information Technology (ONC)-certified EHRs, as well as CMS reimbursement.

Abstract:

While substance use problems are considered to be common in medical settings, they are not systematically assessed and diagnosed for treatment management. Research data suggest that the majority of individuals with a substance use disorder do not use treatment or delay treatment-seeking for over a decade. The separation of substance abuse services from mainstream medical care and a lack of preventive services for substance abuse in primary care can contribute to under-detection of substance use problems. When fully enacted in 2014, the Patient Protection and Affordable Care Act 2010 will address these barriers by supporting preventive services for substance abuse (screening, counseling) and integration of substance abuse care with primary care. One key factor that can help to achieve this goal is to incorporate the standardized screeners or common data elements for substance use and related disorders into the electronic health records (EHR) system in the health care setting. NIDA has asked its Clinical Trials Network (CTN) to lead the effort to develop a set of such data elements for drug abuse research that could also be used in EHRs for patient care.

This commentary focuses on recent evidence about routine screening and intervention for alcohol/drug use and related disorders in primary care. Federal efforts in developing common data elements for use as screeners for substance use and related disorders are described. A pressing need for empirical data on screening, brief intervention, and referral to treatment (SBIRT) for drug-related disorders to inform SBIRT and related EHR efforts is highlighted.

Supported by the Duke Clinical Research Institute (CTN DSC 1).