|Submitted By: Matt Elrod on behalf of ADVault, Inc. / ADVault, Inc.|
|Data Element Information|
|Use Case Description(s)|
|Use Case Description||Use Case: Patient has an advance directive but provides episodic patient instructions prior to a high-risk medical procedure
Steven is a 34 year old man who has had Cystic Fibrosis all his life. He created his advance directives a few years ago when his condition sharply worsened and became so critical that he became eligible for a lung transplant. The advance directive states that he wants no life-sustaining treatments provided if he is unable to communicate for himself due to his condition. Steven knows the wait for new lungs can be lengthy and he worries that if he has a health crisis while waiting, he does not wish to be resuscitated only to wait for a lung transplant that may never happen.
He gets the call one night that he has been matched with a donor and goes immediately to the hospital for his lung transplant. His surgeon meets with him before the transplant procedure and asks if he wants to provide episodic patient instructions related to the transplant he is about to undergo surgery for, should something happen that requires life-sustaining treatment decisions be made during surgery. Steven creates an episodic patient instruction that he is to be resuscitated and receive life-sustaining treatment during the present episode of care because he has a chance at a long life with new lungs that he hasn’t been able to consider until now. Steven’s instructions are reflected in the clinical record so the entire medical team knows what Steven expects from the medical team during his surgical episode.
His surgery and recovery goes well, and 30 days after his surgery Steven updates his advance directive to reflect the changes in his advance medical goals, preferences, and priorities for care in the event that he is unable to communicate for himself during a future health crisis or emergency.
|Estimated number of stakeholders capturing, accessing using or exchanging||In 2014, 17.2 million hospital visits (ambulatory or inpatient) included invasive, therapeutic surgeries.1
There are over 5,000 hospitals and 231,000 small practices, long-term post-acute care centers, skilled nursing facilities and other healthcare providers who have clinical record technologies which are suitable for the capture, access, use or exchange of this data element. In addition, there are over 190 million Americans over the age of 18 who should be creating, digitally storing and exchanging advance directives data with their healthcare providers. Currently, there are over 200 health systems, four federal agencies, 59 state and regional Health Information Networks, and other healthcare organizations using a wide variety of vendor platforms who have the ability to capture, access, use or exchange this data element.
|Maturity of Use and Technical Specifications for Data Element|
|Applicable Standard(s)||HL7 CDA® R2 Implementation Guide: C-CDA R2.1; Advance Directives Templates, Release 1 - US Realm
2.4 Obligation Instruction
[act: identifier urn:hl7ii:2.16.840.1.1138188.8.131.52.4.205:2018-01-01 (open)]
Draft as part of Advance Directives - Template Revisions
The Obligation Instruction template is designed to be used within the Advance Directives Section. However, this information also may be relevant within an Interventions Section or a Plan of Treatment Section.
It is an adaptation of the Instruction V2 template. It follows the structure of an instruction template, but modifies the semantics in two ways. First, the code element comes from a value set containing concepts that are types of Obligation Instructions that a patient, or a patient's healthcare agent or other type of surrogate decision-maker may decide to make when the patient is unable to communicate. Second, the author of this template is the person who made the decision documented in the Obligation Instruction.
The Obligation Instruction template and Prohibition Instruction template are designed as a "matched pair" to permit either prohibitions or obligations to be clearly expressed in an unambiguous way. The use of negation is explicitly expressed, and the semantic design of the recommended value sets takes into consideration the logical meaning of an obligation versus a prohibition. The Obligation Instruction template explicitly prohibits the use of negationInd. It always expresses activities that care providers have been instructed to perform. Coded concepts used in this template express activities in the positive. For decisions that establish prohibition instructions, refer to the Prohibition Instruction template. For decisions that establish prohibition instructions, refer to the Prohibition Instruction template.
2.5 Prohibition Instruction
[act: identifier urn:hl7ii:2.16.840.1.1138184.108.40.206.4.206:2018-01-01 (open)]
Draft as part of Advance Directives - Template Revisions
The Prohibition Instruction template is designed to be used within the Advance Directives Section. However, this information also may be relevant within an Interventions Section or a Plan of Treatment Section.
It is an adaptation of the Instruction V2 template. It follows the structure of an instruction template, but modifies the semantics in several ways. First, the code element comes from a value set containing concepts that are types of care instructions about activities that a patient, or a patient's healthcare agent or other type of surrogate decision-maker (when the patient is unable to communicate) does not want care providers to perform. Second, the author of this template is the person who made the decision documented in the Prohibition Instruction.
The Prohibition Instruction template and Obligation Instruction template are designed as a "matched pair" to permit either prohibitions or obligations to be clearly expressed in an unambiguous way. The use of negation is explicitly expressed, and the semantic design of the recommended value sets takes into consideration the logical meaning of an obligation versus a prohibition. . The Prohibition Instruction template explicitly requires the use of negationInd=”true”. It always expresses activities that care providers have been instructed not to perform. Coded concepts used in this template express activities in the positive and add sematics for negation through the structural negationInd attribute. For decisions that establish prohibition instructions, refer to the Prohibition Instruction template. For decisions that establish prohibition instructions, refer to the Prohibition Instruction.
|Current Use||In limited use in production environments|
Previous unsolicited proposal "ISA and USCDI Recommendations: Advance Directives Data Class Recommendations" submitted on June 4, 2020 by ADVault, Inc. L. Scott Brown and MaxMD Lisa R Nelson, MS, MBA and updated on October 20, 2020.
USCDI Proposal for Advance Directives Data Class 20201022.pdf
|Number of organizations/individuals with which this data element has been electronically exchanged||1|
While we are not able to provide specific information about the electronic exchange of episodic patient instructions, capturing patient obligation or prohibition instructions is standard practice prior to medical procedures and during episodes of care.
|Restrictions on Standardization (e.g. proprietary code)||There are no restrictions on the standardization of this data element.|
The value sets used for the data element are all recorded with the National Library of Medicine Value Set Authority Center (VSAC) and freely available for use under the Unified Medical Language System® Metathesaurus License (UMLS).
Finally, all of the OIDs are registered with HL7. Everything required to standardize this data element is freely and universally accessible.
|Privacy and Security Concerns||The use and exchange of this data element raises concerns associated with data provenance and authentication. However, HL7 standards addressing patient consent and digital signature offer potential solutions to these concerns.
|Estimate of Overall Burden||Implementation of the data element is not burdensome. All of the LOINC codes, value sets and data transport standards exist and are widely and freely accessible.|
|Other Implementation Challenges||Any challenges to implementation of the data element are related to existing paper and non-interoperable electronic documentation processes and are not technological. Natural resistance to process change and a perceived associated risk, combined with a historical culture of “a clinician has to document it for it to be correct,” result in a refusal by healthcare providers to permit patients to insert information related to their personal goals, preferences, and priorities for care into the electronic medical record.
Paper documents, unstructured chart notes, and silo’d EMR attempts to address the capture of episodic patient instructions have created fast paths that give the illusion of accommodating the patient’s obligations or prohibitions for medical interventions related to a specific episode of care but do not provide a path forward for moving to a digital solution for patient-generated guidance that informs care and puts the patient at the center of their own healthcare experience.
Information from the submission form
|Obligation or Prohibition Instruction for Life Sustaining Treatment||
The 2020 Interoperability Standards Advisory (ISA) includes the concept of “patient preference/consent” in the content and structure section. (https://www.healthit.gov/isa/section/patient-preferenceconsent) The proposed data element, Obligation or Prohibition Instruction for Life-Sustaining Treatment, is loosely related to both the data class of “patient instructions” and the data element of “care experience preference”. A patient preference regarding a treatment for which the patient has provided consent to perform (obligation) or not to perform (prohibition) is aligned with the notion of a Patient Instruction. Episodic patient instruction records a patient’s consent to have or not have a particular medical treatment under certain circumstances during an episode of care. These consents provide the patient’s care team with information needed to establish the patient’s plan of care. When a person is about to undergo a medical procedure where he or she will be sedated, or about to have an inpatient stay, or a stay at a nursing or rehab care facility, care providers may ask the patient to make episode-of-care-specific decisions about medical treatments he or she does or does not want should a circumstance arise when this choice would need to be taken into consideration. A patient may make these decisions for himself or herself, or if the patient cannot make these decisions, the surrogate decision-maker may decide. These consents are made in the present and apply to the current episode of care. They are instructions provided by the patient or a surrogate decision-maker. The patient makes these decisions by himself or herself and communicates them to the care team. There is no requirement for the patient to make decisions which are consistent with the goals, preferences, and priorities they may have previously documented in advance directives or their PACP, but it is possible their prior thoughts may influence their current choices. If the patient is unable to communicate, then a patients previously appointed healthcare agent or a surrogate decision-maker if a healthcare agent was not appointed may make these decisions on the patient’s behalf. Ideally, these decisions are informed by the values, beliefs, and quality of life priorities documented previously by the patient as advance directives or PACP. Episodic patient instructions are closely related to advance directives, in that they say, for this episode of care if x happens, then do y. Or, if x happens, do not do y. For this reason, episodic patient instructions are often recorded in the clinical record along with a person’s advance directives. However, episodic patient instructions are not advance directives because they represent actual treatment decisions not input to inform potential treatment decisions. A set of recognized obligation or prohibition instructions that a patient or his or her surrogate decision-maker may make is documented in the value set Obligation or Prohibition Instruction Type urn:oid:2.16.840.1.1138220.127.116.11.69.17. This value set is openly available for reference in the National Library of Medicine’s Value Set Authority Center. It can be referenced using this url: • https://vsac.nlm.nih.gov/valueset/2.16.840.1.113818.104.22.168.69.17/expansion/Latest