- Agency for Health Research and Quality (AHRQ)
- Office of the National Coordinator for Health Information Technology (ONC)
- Collection of Patient-Provided Information
- Use of Clinical Data for Research
STATUS: Completed Project
The patient’s perspective is central to healthcare decisions affecting prevention, diagnosis, treatment, and long-term care. Patient Reported Outcomes (PROs) critically inform patient-centered outcomes research (PCOR) and can inform clinical management of individuals, shared decision making, patient self-management support, care planning, goal setting, and goal attainment. PROs offer a complementary perspective to that of clinician assessments, and may provide greater insights into health status, function, symptom burden, adherence, health behaviors, and quality of life. Therefore, while the focus of this project was to develop research infrastructure for PCOR, it simultaneously provided data needed to improve care delivery and patient experiences. Altogether, this supported a learning health system where research routinely enables and contributes to improved patient-centered outcomes.
While some electronic health records (EHRs) are currently able to capture some structured PRO data, this information is not commonly collected at the point of care. Thus, these data are not routinely available for both clinical care and research. Moreover, standards do not exist for collecting and integrating PRO data into health information technology (health IT) systems, thereby limiting the ability to easily share these data across health systems for research or other purposes such as benchmarking for quality improvement.
PROJECT PURPOSE & GOALS
This project aimed to standardize the integration of PRO data in EHRs and other health IT solutions to support the sharing of this information. This standardized integration and the resulting consistency across products was achieved by using data element and data capture standards. This allowed for PRO assessments to be conducted and easily shared regardless of what EHR or health IT solution is being used. It also allowed for consistency in interpretation and would clarify the meaning of results for patient-provider communication and shared decision-making. This effort supported the use of APIs (application programming interface), defined as a set of protocols and tools for building software applications for data exchange. Finally, the project incentivized the development of user-friendly applications for PRO collection that made use of the refined/developed standards and implementation specifications.
- Develop technical tools for collecting and integrating PRO assessments into EHRs or other health IT products.
- Refine and/or harmonize health IT standards and implementation specifications that can be used to support sharing of PRO data through APIs and relevant health IT products for research.
- Support the development of user-friendly, PRO-collection applications that utilize the health IT standards, implementation specifications, or APIs.
- Implement private/public partnerships for pilot-testing these technical tools in a health system that supports both healthcare delivery and research.
PROJECT ACHIEVEMENTS & HIGHLIGHTS
- The ONC team conducted key informant interviews and summarized findings about: 1) PROs used for functional status assessments; 2) standards for electronic capture and use of PROs; and 3) research programs and networks that use functional status to study patient outcomes. The team also prepared a report on the technical specifications needed to standardize the collection of PROs and to easily integrate PRO data into an EHR. The report detailed the technical approach for pilot sites.
- The ONC team developed and pilot-tested a Health Level Seven International (HL7) Fast Healthcare Interoperability Resources (FHIR®)-based implementation specification in REACHnet and pSCANNER. As a result, ONC developed a PRO FHIR implementation guide (IG). The IG has gone through several rounds of ballot comments through HL7.
- The AHRQ team launched the “Step-Up App Challenge” where participants developed user-friendly apps able to collect standardized PRO data. PRISM, the PROMIS Reporting and Insight System from Minnesota, won the challenge.
- AHRQ worked with MedStar to modify an existing application used to collect PROs called OBERD by incorporating ONC’s PRO FHIR IG to demonstrate that developers could utilize the PRO FHIR IG on existing apps.
- The AHRQ team worked with MedStar Health to pilot-test the PRISM and OBERD apps. The team identified several lessons learned: 1) EHR vendors are moving towards adopting FHIR standards as an efficient and secure way to integrate PRO data; 2) to secure organizational commitment, it is essential to understand the needs of the industry, and the needs of sites that plan to collect PROs; 3) leveraging existing resources and using PRO instruments that align with organizational priorities will help mitigate compatibility issues.
PUBLICATIONS, PRESENTATIONS, AND OTHER PUBLICALLY AVAILABLE RESOURCES
- ONC published a final project report, “Advancing the Collection and Use of Patient-Reported Outcomes through Health Information Technology,” in March 2020. The report is available here: https://aspe.hhs.gov/sites/default/files/private/pdf/259016/ONCPROFinalReportFinal.pdf
- AHRQ published a final project report for the work conducted by MedStar Health. The report is available here: https://digital.ahrq.gov/sites/default/files/docs/citation/advancing-collection-use-pro-through-hit-final-report-2020.pdf
- In September 2019, AHRQ released the report on the Step-Up App Challenge that details the winners and how the app can be applied in PCOR research: https://healthit.ahrq.gov/sites/default/files/docs/citation/ahrq-step-up-app-challenge-summary-2019.pdf
- Two versions of the PRO FHIR IG are available:
- The last balloted version is available here: http://hl7.org/fhir/us/patient-reported-outcomes/2019May/
- The continuous-build version (updated as comments are reconciled) is available here: http://build.fhir.org/ig/HL7/patient-reported-outcomes/
- The PRISM: PROMIS Reporting and Insight System from Minnesota app is available here: https://apps.apple.com/us/app/prism-for-minnesota/id1454714605 and https://play.google.com/store/apps/details?id=com.perkmotivation.PrismForMedstar
- The project team published a study on patient and healthcare provider perspectives on facilitators and barriers to use of PRO apps and PRO data in ambulatory care settings in the Journal of Biomedical Informatics. The publication is available here: https://www.sciencedirect.com/science/article/pii/S2590177X19300472
- The ONC team presented a webinar on the project and IG, available here: https://www.healthit.gov/sites/default/files/page/2019-09/ONC_PRO_Webinar_Slides_FINAL.PDF
Below is a list of ASPE-funded PCORTF projects that are related to this project
Conceptualizing a Data Infrastructure for the Capture and Use of Patient Generated Health Data (PGHD) – This ONC project was a multi-pronged effort to combine PGHD data with medical record data across multiple health information systems and devices. This began with an assessment of the necessary data collection tools, technical barriers, data donation policies, and regulatory gaps. It then demonstrated successful capture and use of PGHD in two pilot sites. One site focused on app-driven capture of PGHD and its integration into physician workflow to achieve better care coordination and population management for diabetes patients. The other site tested a technical platform capturing PGHD to support care for orthopedic surgery, behavioral health, bariatric surgery, and stroke.
Use of the ADAPTABLE Trail to Strengthen Methods to Collect and Integrate Patient-Reported Information with Other Data Sets and Assess its Validity – This NIH project generated tools and data standards that could be broadly deployed to support PCOR by leveraging the infrastructure of the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) trial. This trial is the first major randomized comparative effectiveness trial to be conducted by PCORnet. The ADAPTABLE trial encompassed several key features, including enrollment of 20,000 patients across six large health care systems; an internet portal to consent patients and collect patient reported information regarding risk factors, medications, and experiences; and reliance on existing electronic health record (EHR) data sources for baseline characteristics and outcomes follow up.