|Submitted By: Andre Quina / MITRE|
|Data Element Information|
|Use Case Description(s)|
|Use Case Description||Information on functional status is becoming increasingly essential for fostering healthy people and a healthy population. Achieving optimal health and well-being for Americans requires an understanding across the life span of the effects of people’s health conditions on their ability to do basic activities and participate in life situations, in other words, their functional status. Functional status information can serve the management needs of health care providers and payers in such areas as financial management, utilization review and quality assurance.
CMMI is also requiring the collection of certain specific “clinical data elements” (CDEs) from participants in the mandatory Radiation Oncology (RO) model scheduled to begin in January 2021 and has issued an informal RFI soliciting public comment on the draft CDEs. Functional status (ECOG) is one of the proposed CDEs required for reporting in the RO model. See: https://innovation.cms.gov/media/document/ro-clin-data-elements-rfi-v2
Event for its collection and use: Functional status information is used, or could be used, to evaluate outcomes, compare treatment modalities, and predict costs. Changes in functional status is often one of the first signs of illness or exacerbation of a chronic condition.
Frequency of use: Functional status assessment is fundamental to geriatric care and cancer care and are regularly assessed throughout care.
Broader collection and use: Functional status information is routinely used to assess and care for patients, but the information is often not structured in medical records. This prevents a host of possible beneficial uses of the information for management, research, public health, and policy purposes.
|Estimated number of stakeholders capturing, accessing using or exchanging||Functional status assessment is fundamental to geriatric care and cancer care. As such, it is relevant to 50M seniors and 8M cancer patients.|
|Use Case Description||The Care Plan itself describes how one or more practitioners intend to deliver care for a particular patient, group or community for a period of time, possibly limited to care for a specific condition or set of conditions. The Care Plan tracks the progress of activities associated with the plan. Practitioners regularly review the care plan and make changes for a variety of reasons. Recording the date of review, whether the plan was changed, a coded reason for change, and a narrative describing the change is important for the understanding of the progression of care and associated outcomes of treatments in the care plan.
Through the ICAREdata study treatment plan change with rationale for change is being collected in the EHR for patients that are currently enrolled in a clinical trial that incorporates the ICAREdata protocol (currently 3 trials). The goal of the ICAREdata study is to evaluate the suitability of treatment change (among other patient outcomes) to drive a real-world data based research endpoints.
Event for its collection and use: Treatment change is recorded when a care plan is modified.
|Estimated number of stakeholders capturing, accessing using or exchanging||Treatment change is being evaluated as part of the ICAREdata study across 5 health systems and 3 clinical trials to assess the applicability of treatment change as a real world evidence based endpoint. The broader suitability of treatment change is still being evaluated.|
|Link to use case project page||https://confluence.hl7.org/display/COD/EHR+Endpoints+for+Cancer+Clinical+Trials|
|Maturity of Use and Technical Specifications for Data Element|
|Applicable Standard(s)||LOINC, SNOMED-CT, and FHIR
|Additional Specifications||HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE) Release 1 - US Realm | STU1
|Current Use||In limited use in production environments|
Functional status information for cancer is collected in most EHR systems. For cancer the representation of functional status is standardized through ECOG and Karnofsky. Beyond cancer there are a number of other functional status assessments across different specialties.
There are several initiatives developing FHIR use cases for the exchange of functional status between healthcare settings. See: https://www.healthit.gov/isa/representing-patient-functional-status-andor-disability
Collection and use of treatment change is being evaluated as part of the ICAREdata study across a number of health systems (currently 5 health systems being onboarded).
|Number of organizations/individuals with which this data element has been electronically exchanged||5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders.|
Functional status is frequently assessed and recorded for cancer and geriatric patients. There are a number of initiatives working on the exchange of functional status information. See: https://www.healthit.gov/isa/representing-patient-functional-status-andor-disability
Through the ICAREdata study treatment change is being collected at an increasing number of health systems (currently 5 health systems being onboarded). Treatment change is being exchanged between those health systems and the Alliance for Clinical Trials in Oncology using FHIR APIs for analysis against clinical trial data.
|Restrictions on Standardization (e.g. proprietary code)||none|
|Restrictions on Use (e.g. licensing, user fees)||none|
|Privacy and Security Concerns||Usual HIPAA restrictions apply|
|Estimate of Overall Burden||The IMPACT Act requires the reporting of standardized patient assessment data with regard to quality measures and standardized patient assessment data elements (SPADEs). The Act also requires the submission of data pertaining to measure domains pertaining to resource use, and other domains. In addition, the IMPACT Act requires assessment data to be standardized and interoperable to allow for exchange of the data among post-acute providers and other providers. The Act intends for standardized post-acute care data to improve Medicare beneficiary outcomes through shared-decision making, care coordination, and enhanced discharge planning. The requirement of assessment data as part of the impact act supports the inclusion of assessments in USCDI.
Conclusions and working assumptions that will guide treatment of the patient, and recommendations for future treatment.
Information from the submission form
Treatment Change documents the reason for changes to the plan of treatment plan. The options for this data element are, for example: no change (continue treatment), planned change, no response to treatment, adverse reaction, patient request for alternative treatment. The first option (no change in treatment plan) can document a review of the treatment plan that did not require in a change of treatment.