| Submitted By: Andrea Fourquet
/ IHE USA
|
| Data Element Information |
| Rationale for Separate Consideration |
Submitting this data element for consideration at a higher level within the USCDI with use cases and supporting information. |
| Use Case Description(s) |
| Use Case Description |
Corrected Estimated Due Date is a commonly used term across maternal health. This data element is captured in EHRs, are defined and endorsed by the American College of Obstetricians and Gynecologists (ACOG), and represented in LOINC.
It is used across all areas of care provision for a pregnant patient. It is important that the Corrected Estimated Due Date data element is captured and exchanged.
According to the 2021 Aspen Health Strategy Group report on “Reversing the U.S. Maternal Mortality Crisis”, 700 women die each year as the result of pregnancy or delivery complications, and 50,000 more face short-term or long-term health consequences because of pregnancy or labor. The U.S. has the highest maternal mortality rate of any high-income nation in the world (17.4 maternal deaths per 100,000 live births) according to The Commonwealth Fund. While rates of maternal mortality have been decreasing in other countries, they have been rising in the United States since 1987. Maternal health data is not standardized, and data exchange is not interoperable across many settings, which impedes care and research on maternal morbidity, longitudinal maternal care, and associated impacts to infant and infant health.
The United States Congress S.796 - Protecting Moms Who Served Act of 2021 includes support by the Department of Veterans Affairs for Maternity Care Coordination by carrying out the maternity care coordination program described in the Veterans Health Administration Directive 1330.03. The Veterans Health Administration Directive includes required coordination of maternity care which include provision of care across settings.
Corrected Estimated Due Date is a necessary data element required to be exchanged in support of care provision and care coordination.
The following use cases demonstrate the exchange of information needed to support maternal care coordination and care provision.
Personal access and control over perinatal information
Frequency: Maintained and used Constantly by the person
Personal Health data owned by the person and shared with perinatal providers that interact with the person throughout their pregnancy, birth, postpartum, and newborn care.
The Person has the ability to share the following information as part their longitudinal record with providers with consent:
encounter data, labs, vital signs, birth directives and birth plans
SDOH assessments or screenings and associated interventions
Self Reported biometrics
Activities of daily living
This concept has been described by the 2006 Independent Health Record Bank Act https://www.congress.gov/bill/109th-congress/house-bill/5559?s=1&r=5
Outpatient Care
Frequency: Each Outpatient encounter
The first prenatal visit taking place in the first trimester is vitally important
Initial assessments, lab and documentation take place at this event
The person’s preferences, cultural, and family support are considered
Referral for routine or high-risk prenatal care
Performance of Preventative Care encounters whenever there is confirmation of pregnancy.
Completion of up to date relevant screenings.
Psychosocial-risk assessment to identify the presence of a broad range of social, economic, psychological, and emotional problems. Screening includes but is not limited to: an assessment of barriers to care, unstable housing, communication barriers, nutrition, tobacco use, substance use, depression or other psychiatric illness, employment or financial status, safety, domestic abuse, sexual abuse, and stress.
Performance of appropriate referrals based on screening results.
Ensuring effective coordination of care between varying care settings and care providers and specialists such as endocrinology, cardiology, rheumatology, neurology, gynecology, mental health, social services, etc.
The maternal patient is an active participant and is included as a key component of care provision use cases.
Inpatient Care
Frequency: Each Inpatient encounter
Required inpatient medical, surgical, psychiatric, or residential care services. Care must be coordinated with the patient’s care providers and specialists (such as endocrinology, cardiology, rheumatology, neurology, gynecology, mental health, social services, etc.).
Maternal patients need to be evaluated and referred or transferred from one inpatient setting to another based on consideration of the following factors: the stage of pregnancy, the patient’s health status, and the local resources available and needed to meet all of the patient’s medical and social needs.
The maternal patient is an active participant and is included as a key component of care provision use cases.
Obstetrical Emergencies
Frequency: Each emergency and/or urgent care encounter
The management of patients with obstetrical emergencies is normally directed toward the rapid evaluation, stabilization, and transfer to the nearest qualified facility. Mechanisms or processes need to be in place to initially triage obstetrics emergencies in the event this is necessary. It is imperative that the patient health information is available when the following occur:
Performance of timely (i.e., stat or point of care) testing to diagnose pregnancy is needed when necessary.
Timely access to diagnostic services, especially if this impacts the triaging of the patient’s care.
Pregnancy information must be provided when seeking emergency care at the closest Emergency Department, Urgent Care Center or at the hospital the patient will be using for delivery.
When a patient presents with a spontaneous abortion, the specialty provider may deem it medically necessary to provide care in the form of a procedure (i.e., dilation and curettage) or through medical management consistent with standard of care. Pregnancy information must be provided when seeking medically necessary procedures for the management of spontaneous abortion.
Patients with complications such as preeclampsia or severe hypertension may be seen outside of routine visits. Information from these visits should be made available if a referral to a specialist is needed. The information should also be available when the patient returns to their primary care provider or any other provider caring for existing chronic conditions.
The maternal patient is an active participant and is included as a key component of care provision use cases.
Pregnancy Care Provision
Frequency: Each care provision encounter
Regular encounters with the patient’s care team is required.
The maternal patient is an active participant and is included as a key component of care provision use cases.
Frequency: Each postpartum encounter
Postpartum visit with the patient’s maternity care provider at approximately 6-8 weeks following delivery (or earlier if recommended by that provider).
Follow-up with the patient’s routine care provider (e.g., PCP and other routine care providers) after postpartum visit within 3 months (or earlier if comorbid conditions, e.g.,cardiovascular disease, Human immunodeficiency virus, acquired immunodeficiency syndrome, mental health condition, etc.).
The maternal patient is an active participant and is included as a key component of care provision use cases.
Travel Use Case
Frequency: Each travel incidence that includes encounters with the health care system.
It is not uncommon for expecting mothers to travel. If acute clinical conditions arise, the mother may seek treatment at a care setting remote from her normal place of care. The Corrected Estimated Due Date element should be available to the new care team for the provision of safe and effective care. Additionally, A summary of the care provided by the remote provider should be available to the mother’s primary obstetrical provider for continuation and follow up care.
Community Care Services Use Case
Frequency: Each incidence where the barriers to care are identified and mitigated.
Community Clinical Integration (CCI) involves creating an infrastructure for community collaboration to improve perinatal outcomes. The infrastructure is used to address barriers to care such as antepartum or postpartum care by working collaboratively with community partners (doulas, community-based organizations, community health workers, home visitation programs, etc.). The majority of preventable maternal morbidity/mortality occurs in community settings. Medical care, dental care, behavioral health care, substance use disorder care, material support, social support are all key components of whole-person care. High-value care activities should be coordinated across multiple sectors to ensure smooth transitions and handoffs among care team partners in order to share resources and accountability.
Veterans Health Administration Directive 1330.03 https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4492813&FileName=36C24218R0013-006.pdf
https://www.healthit.gov/playbook/specialists/#section-11-2
https://www.aimcci.org/
IHE USA Maternal Health Project https://drive.google.com/drive/u/0/folders/1Y5_iBEDalbFUTn_MKYr4yCmqo61jSdMe
https://docs.google.com/document/d/1p0QS-O48Xcr1GZ1EFnz9S4gIvaL0cv8kkRv_RLOzgEQ/edit?usp=sharing
Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) https://www.nichd.nih.gov/about/advisory/PRGLAC#:~:text=Lactating%20Women%20(PRGLAC)-,Task%20Force%20on%20Research%20Specific%20to%20Pregnant%20Women%20and%20Lactating,pregnant%20women%20and%20lactating%20women.
The Gravity Consensus-driven Standards on Social Determinant of Health https://confluence.hl7.org/display/GRAV/The+Gravity+Project
Institute for Healthcare Improvement http://www.ihi.org/ includes -
Better Maternal Outcomes Rapid Improvement Network http://www.ihi.org/Engage/Initiatives/Better-Maternal-Outcomes-Rapid-Improvement-Network/Pages/default.aspx
Maternal and Infant Health http://www.ihi.org/Topics/Maternal-Infant-Health/Pages/default.aspx
Black Maternal Health: Reducing Inequities Through Community Collaboration http://www.ihi.org/resources/Pages/Publications/black-maternal-health-reducing-inequities-through-community-collaboration.aspx
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| Estimate the breadth of applicability of the use case(s) for this data element
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Maternal health data pertains to all maternal health patients, all providers providing care for maternal health patients and all requesters utilizing maternal health data to support applicable use cases such as research, public health and/or quality reporting.
Anticipated stakeholder examples are:
Patients
Newborns
Mothers
Providers
OB GYN
Birthing Centers
Doulas
Midwives
Community Health centers
Community Health workers
Fertility Clinics
Public Health
Insurance Providers
Military Health System
Veterans Administration
Home Visitation Programs
Dentists
This list is not exclusive to the stakeholders that will capture, access or use this data element.
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| Use Case Description |
Maternal Research Use Case
Supports mapping maternal data across health records from specialty care and linking mother and child data harmonized across a broad set of use cases. This supports researchers in identifying root causes of maternal mortality and pediatric developmental problems, including SDOH such as limited income, poor nutrition, lack of medical coverage, etc. The goal is to provide standardization of data capture for comparative analysis over time to improve health outcomes and to define a framework for studying additional research populations in the future.
Quality Improvement Use Case
The Quality Improvement Ecosystem begins with information such as maternal care provision needs, information to support maternal care coordination, etc. Such information indicates existing status and knowledge about a given clinical topic. Stakeholders, such as professional societies, public health agencies, and governmental bodies, publish such information to assure awareness among consumers, healthcare practitioners, and healthcare organizations about what is known and suggested methods for managing the clinical topic as clinical guidelines. These clinical guidelines are translated into clinical decision support (CDS) artifacts to incorporate relevant, evidence based, and patient-specific clinical recommendations and actions directly within clinical workflow. To close the loop and enable continuous improvement, the results of such measurement analytics must be reported for aggregate review. “Reporting” serves the purpose of evaluating clinical performance and outcomes, whether it be internally for health care organizations, or for third parties such as public health or for payers.
Public Health Reporting
An expectant mother’s pregnancy attributes are crucial for providing the best possible prenatal care. As well, after delivery, Public Health needs to capture this data as part of birth certification, fetal death reporting and birth defect reporting. In particular, birth certification forms the basis of the patient census required by a large number of other Public Health programs including newborn screening, birth defect reporting and immunization registries making it critical that birth certification is as automated, timely and accurate as possible
Longitudinal Maternal & Infant Health Information for Research https://build.fhir.org/ig/HL7/fhir-mmm-ig/
Vital Records Birth and Fetal Death Reporting https://build.fhir.org/ig/HL7/fhir-bfdr/
Birth and Fetal Death Reporting https://www.ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_BFDR-E.pdf
WHO Antenatal Care Guideline Implementation Guide https://build.fhir.org/ig/WorldHealthOrganization/smart-anc/index.html
https://www.healthit.gov/playbook/specialists/#section-11-2
MATERNAL MORTALITY Factsheet https://docs.google.com/document/d/1p0QS-O48Xcr1GZ1EFnz9S4gIvaL0cv8kkRv_RLOzgEQ/edit
https://www.aimcci.org/
https://hl7.org/fhir/us/ecr/2018sep/StructureDefinition-pregnancy-status.html
https://www.ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_Suppl_IPS.pdf
https://www.healthit.gov/playbook/specialists/#section-11-2
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| Estimate the breadth of applicability of the use case(s) for this data element
|
Maternal health data pertains to all maternal health patients, all providers providing care for maternal health patients and all requesters utilizing maternal health data to support applicable use cases such as public health and/or quality reporting.
Anticipated stakeholder examples are:
Patients
Newborns
Mothers
Providers
OB GYN
Birthing Centers
Doulas
Midwives
Community Health centers
Community Health workers
Fertility Clinics
Public Health
Insurance Providers
Military Health System
Veterans Administration
Home Visitation Programs
Dentists
This list is not exclusive to the stakeholders that will capture, access or use this data element.
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| Healthcare Aims |
- Improving patient experience of care (quality and/or satisfaction)
- Improving the health of populations
- Reducing the cost of care
- Improving provider experience of care
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| Maturity of Use and Technical Specifications for Data Element |
| Applicable Standard(s) |
LOINC
57060-6 Estimated date of delivery Narrative
11778-8 Delivery date Estimated
53692-0 Delivery date Estimated from conception date
11780-4 Delivery date Estimated from ovulation date
57063-0 Delivery date Estimated from quickening date
90368-2 Delivery date Estimated from physical exam
57064-8 Delivery date Estimated from date fundal height reaches umb
11779-6 Delivery date Estimated from last menstrual period
53694-6 Delivery date Estimated from prior gestational age assessment
SNOMED CT
161714006 | Estimated date of delivery (observable entity)
289206005 | Estimated date of delivery from last period (observable entity)
33714007 | Corrected (qualifier value)
https://loinc.org/ https://www.ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_TF_Vol2.pdf https://www.healthit.gov/isa/sites/isa/files/webform/uscid_webform/1966/CDAR2_IG_PREGNANCY_R1_DSTU_2019JAN.pdf
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| Additional Specifications |
Birth and Fetal Death Reporting-Enhanced (BFDR-E) - https://www.ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_BFDR-E.pdf
https://www.hl7.org/implement/standards/product_brief.cfm?product_id=494
Labor and Delivery Summary (LDS) - https://www.ihe.net/uploadedFiles/Documents/PCC/IHE_PCC_Suppl_Labor_and_Delivery_Profiles.pdf
Birth Defect Reporting FHIR IG - https://build.fhir.org/ig/HL7/fhir-birthdefectsreporting-ig/index.html
Postpartum Visit Summary (PVS) - https://www.ihe.net/Technical_Framework/upload/IHE_PCC_Suppl_PPVS_Rev1-2_TI_2011-09-09.pdf
Newborn Discharge Summary (NDS) - https://www.ihe.net/Technical_Framework/upload/IHE_PCC_Suppl_NDS_Rev1-2_TI_2011-09-09.pdf
Family Planning Version 2 (FPv2) - https://www.ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_FPv2.pdf
Healthy Weight (HW) - https://www.ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_HW.pdf
C-CDA R2.1 Supplemental Templates for Pregnancy Status - HL7 CDA® R2 Implementation Guide: C-CDA R2.1 Supplemental Templates for Pregnancy Status, Release 1 - US Realm
Pregnancy Outcome List - https://nhsconnect.github.io/FHIR-Maternity-Record/explore_pregnancy_outcome.html
NIH - https://www.nationalacademies.org/documents/embed/link/LF2255DA3DD1C41C0A42D3BEF0989ACAECE3053A6A9B/file/DD9D34E3DC420E58DE0011417F4073B95E45E1C3F1FC
HL7 CHOICE Project - Pregnancy History Model
https://confluence.hl7.org/x/ptM7Bg
Longitudinal Maternal & Infant Health Information for Research IG - https://hl7.org/fhir/us/mihr/2022may/index.html |
| Current Use |
This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders |
| Supporting Artifacts |
ISA:
https://www.healthit.gov/isa/representing-patient-pregnancy-status
Blue Cross BLue Shield Pregnancy Risk assessment form:
https://about.bcbstx.com/provider/pdf/3rd_trimester.pdf
UnitedHealthcare Pregnancy Risk assessment form:
https://www.uhcprovider.com/content/dam/provider/docs/public/commplan/multi/UHC-UHCCP-Obstetrics-Pregnancy-Risk-Assessment-Form.pdf
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| Extent of exchange
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5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders. |
| Supporting Artifacts |
This data is exchanged routinely as part of care provision and care coordination across multiple care settings and for informing patients.
The preconception office visit https://www.uptodate.com/contents/the-preconception-office-visit?topicRef=446&source=see_link
Prenatal care: Initial assessment https://www.uptodate.com/contents/prenatal-care-initial-assessment?topicRef=448&source=see_link
Prenatal care: Second and third trimesters https://www.uptodate.com/contents/prenatal-care-second-and-third-trimesters?topicRef=112420&source=see_link
Prenatal care: Patient education, health promotion, and safety of commonly used drugs https://www.uptodate.com/contents/prenatal-care-patient-education-health-promotion-and-safety-of-commonly-used-drugs?topicRef=446&source=see_link
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| Potential Challenges |
| Restrictions on Standardization (e.g. proprietary code) |
None |
| Restrictions on Use (e.g. licensing, user fees) |
None |
| Privacy and Security Concerns |
Pregnancy-related data, particularly pregnancy outcome, is sensitive and private information. It will be important to safeguard identifying information of individuals using current HIPAA policies and other relevant standards. Privacy and security should include statutes, regulations, and guiding principles to protect patient specific maternal health data because it is sensitive and private information. Privacy and security considerations associated with any health-related data should take appropriate action to mitigate the risk of compromise. The use of the following is highly encouraged: Security and Implementation Guidance; Security/Privacy Related Technologies Including Explicit Consent and Security Labels; Exchange Security; Additionally Protected Information. |
| Estimate of Overall Burden |
These data elements are straightforward in nature and should not present a large burden to implement provided the EHR system is capturing the data as a component of care provision.
Corrected Estimated Due Date is pregnancy information. It is essential to capture this information across care settings when a person is assessed for pregnancy planning information to reduce the risk of adverse health effects for the woman, fetus, and neonate by working with the woman to optimize health, address modifiable risk factors, provide education and interventions.
It should not be a considerable burden to implement this data element because it has minimal implementation lift and will have an enormous benefit for care provision and improving health outcomes for pregnant patients.
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| Other Implementation Challenges |
N/A |
ONC Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
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Criterion #1
Maturity - Current Standards |
Level 2
- Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
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Criterion #2
Maturity - Current Use
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Level 2
- Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
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Criterion #3
Maturity - Current Exchange |
Level 0
- Data element is electronically exchanged in limited environments, such as connectathons or pilots.
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Criterion #4
Use Case(s) - Breadth of Applicability |
Level 0
- Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.
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| Evaluation Comment |
This data element is a specialized use of the Observation data elements in the Observation data class. |
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Submitted by nedragarrett_CDC on
CDC's comment on behalf of CSTE for USCDI v5
CSTE strongly urges ONC to include Estimated due date and not just gestational age as an element in USCDI since data are exchanged at points in time and gestational age at the time of recording may differ from gestational age at the time of the data transmission or receipt. Including estimated due date fixes the maturity of the pregnancy in time, as opposed to gestational age. If gestational age is favored as a variable to use, then it must be accompanied by a date of recording of the gestational age which requires additional data capture.