- National Institutes of Health's National Institute on Drug Abuse (NIH/NIDA)
- Standardized Collection of Standardized Clinical Data
- Collection of Patient-Provided Information
- Linking of Clinical and Other Data for Research
STATUS: Completed Project
EHR data are often used in research to improve patient outcomes in the field. The quality of this research could be improved by including opioid relevant common data elements (CDEs) in clinical data registries and EHRs. EHR vendors have been slow to incorporate CDEs related to opioid use disorders (OUDs), and clinical data on OUDs are not collected in a uniform format. There are also inconsistencies in terminology used and types of information recorded about OUD patients. The American College of Emergency Physicians (ACEP) developed the first emergency medicine registry called the Clinical Emergency Data Registry (CEDR). CEDR has the functionality to measure emergency medicine outcomes, identify practice patterns and trends, improve the quality of acute care, exceed quality reporting standards, and eliminate and/or increase payer revenue.
Electronic health record (EHR) data are often used in research to improve patient outcomes in the field. The quality of this research could be improved by including opioid relevant common data elements (CDEs) in clinical data registries and EHRs. EHR vendors have been slow to incorporate CDEs related to opioid use disorders (OUDs), and clinical data on OUDs are not collected in a uniform format. There are also inconsistencies in terminology used and types of information recorded about OUD patients. The American College of Emergency Physicians (ACEP) developed the first emergency medicine registry called the Clinical Emergency Data Registry (CEDR). CEDR has the functionality to measure emergency medicine outcomes, identify practice patterns and trends, improve the quality of acute care, exceed quality reporting standards, and eliminate and/or increase payer revenue.
This project facilitated standardized measurement through use of OUD-specific CDEs in order to track and improve the quality of care at the point of contact with persons with OUD. In recent years, there has been an increased focus on patient-reported outcomes (PROs). PROs place patients at the center of health care research and ensure that research is of maximum value for both clinicians and patients. This project also explored the feasibility of collecting PRO measures in Emergency Department (ED) setting and after an ED visit, and identified PROs most appropriate for inclusion in ED settings. Improved measurement and enhanced EHR infrastructure could provide benchmarking data such as how many providers provide naloxone for OUD, and can facilitate tracking of quality improvement efforts.
Improving clinical data infrastructure in ED settings addresses key areas of the HHS 5-point strategy to combat the opioids crisis by 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.
PROJECT PURPOSE & GOALS
The goal of this project was to build clinical data research infrastructure that will begin to enhance capacity to use EHR data and PROs to conduct opioid-related research in EDs. The project aimed to improve interoperability and linkages between EHRs, research networks, and registries for research relevant to the opioid epidemic.
Identify existing OUD CDEs relevant to the ED setting by conducting an environmental scan of current, publicly available data systems, data elements, and quality measures.
Test the integration of opioid relevant data elements from test site EHRs into the ACEP CEDR and translate and map electronic OUD data elements to the National Library of Medicine (NLM) Value Set Authority Center (VSAC).
Explore feasibility of collecting electronic PROs such as PROMIS and other measures (e.g., pain intensity, substance use disorder treatment/status) at one or more of the NIDA’s Clinical Trial Network’s (CTNs) sites.
PROJECT ACHIEVEMENTS & HIGHLIGHTS
The project team completed a literature review and environmental scan to assess the use of OUD-specific CDEs that could improve the quality of care captured in the emergency department setting. The resulting compendium of CDEs and PROs, technical report, and manuscript examined current publicly available data systems, data elements, and quality measures to identify OUD data elements suitable for capture in the EHR or use in the ED setting of existing OUD CDEs. The team found substantial variability in both the types of CDEs used and data elements captured (e.g., substance use disorder, mental health), and few OUD-specific CDEs in existing data dictionaries.
The team developed an OUD Data Dictionary and tested the integration of opioid relevant data elements into the ACEP CEDR in order to facilitate harmonized measurement of OUD in emergency department EHRs.
The project team developed and pilot tested a prototype mobile app. The pilot study was conducted among ED patients with non-medical opioid use or opioid overdose to complete electronic surveys after discharge from a tertiary, urban academic ED.
PUBLICATIONS, PRESENTATIONS, AND OTHER PUBLICALLY AVAILABLE RESOURCES
The project team released a comprehensive final report, “Project CODE-PRO: Capturing Opioid Use Disorder Electronically and Patient Reported Outcomes.” The report is available here: https://aspe.hhs.gov/sites/default/files/private/pdf/259016/ctn-0081-final-report.pdf
The project team established a public website contextualizing project goals and relevancy to patient-centered outcomes research: https://www.drugabuse.gov/about-nida/organization/cctn/ctn/research-studies/emergency-medicine-opioid-data-infrastructure-key-venue-to-address-opioid-morbidity-mortality
Final project products including a compendium and data dictionary are available on the NIH/NIDA CTN Dissemination Library here: http://ctndisseminationlibrary.org/protocols/ctn0081.htm
The team released an Implementation Guide, “Electronic administration of patient reported outcomes using mHealth platform in emergency department patients with nonmedical opioid use,” to assist researchers with the management of electronic data on PROs for emergency department patients with nonmedical opioid use. The guide is available here: http://ctndisseminationlibrary.org/PDF/1436.pdf
- A technical report identifying existing CDEs for OUD relevant to the emergency department setting was adapted for a manuscript, “Assessing the readiness of digital data infrastructure for opioid use disorder research.” The manuscript was published July 2020 in Addiction Science & Clinical Practice and is available here: https://ascpjournal.biomedcentral.com/articles/10.1186/s13722-020-00198-3
Below is a list of ASPE-funded PCORTF projects that are related to this project
Enhancing Data Resources for Researching Patterns of Mortality in Patient Centered Outcomes Research - Through collaboration between the Centers for Disease Control (CDC), Centers for Medicare and Medicaid (CMS), and Food and Drug Administration (FDA), the overall goal of this project is to increase the availability of information on the cause of death by linking NDI data to other sources. Enabling linkages will allow researchers to develop national estimates of cause-specific death rates following ED visits and/or hospital stays for specific conditions.
Conceptualizing a Data Infrastructure for the Capture and Use of Patient-Generated Health Data – This project was initiated to identify challenges and opportunities that support the capture, use, and sharing of Patient-Generated Health Data (PGHD). This project developed a white paper that describes the current policy landscape, challenges and opportunities for the use of PGHD in research and care delivery through 2024. The white paper addresses seven topics areas including: patient recruitment for research studies and trials; collection and validation of data and tools; data donation; ability to combine PGHD with medical record data in multiple ways; data interoperability; big data analysis; regulatory overview. Additionally, the project conducted pilots that tested the concepts discussed in the white paper. The insights from the white paper can be used to inform future policies and guidance that promote standardized data collection of PGHD, increase its consistency and utility for research, clinical uses, and other analytic activities.