Clinical Research, Public Health and Quality use of EHR Data

Scope

In this paper, we are looking for several things. First, for each of our stakeholders, we would like them to describe each of their problem stakeholders, and the tasks and workflows that are executed under the current state of affairs.

Secondly, we will review both the similaries and differences between stakeholders, tasks and workflows from each of the three communititees. This will help define the scope of the problems that we want to solve.

Lastly, we will put forth a proposed plan of work, not just for the PCC domain, but also to other domains, including IT Infrastructure, Laboratory, and the newly formed Quality domain.

Clinical Trials

The initial interest of the CDISC community -- the biopharmaceutical companies who sponsor clinical trials -- was to insert a research protocol into an EHR as an executable piece of workflow. While this bears semblance to other 'case management' use cases, the phrase will not make sense to the clinical trial community.

The embedded image (also included as a Powerpoint link) shows how protocol insertion might work.

Media:Media-ProcessDiagramClinicalTrial_CaseMgt_14Mar07_lb.ppt

Public Health Reporting

Use Case

Example use cases

Disease Management – a aggregate analysis of care delivery for a disease entity

Chronic Diseases Management (Asthma , Diabetes , COPD, Heart, obesity)

Decision Support

1. Community Record

Bioterrorism Preparedness/surveillance

Direct Care providers

1. Case Management

2. Scheduled public care

3. Health Education

Environmental health (abatement, asbestos)

Preventive care services

1. Maternal and Child Health

a. Prenatal (nutrition, WIC, genetic testing), Newborn (e.g. pku, a1c), hearing, immunization, birth defects, vital registration, lead screening, school, vision, developmental assessment (mental, physical), nutrition (Early Periodic Screening Diagnostic Tests EPSDT)

2. Physicians A1C's law to order testing on annual physicals (EGFR), not required to report results – Public Act to perform mandatory testing as part of the physical. Educational component may be needed.

3. School Health

a. Healthy Child (communicable disease reporting, lead, TB, chronic care Asthma/Diabetic, immunization)

b. Sick

i. Walkins

ii. Medication administration

iii. Participation/non-participation in physical activities

iv. Assistive devices (e.g. insulin pump, wheelchair)

v. Special education (developmental disabilities)

c. Security/Privacy

i. Parent consent to share sensitive data

ii. Minimum data set

iii. Consent

iv. Audit

v. Access Control (DOE vs DPH employed nurses)

vi. FERPA

vii. COPPA

d. Surveillance

i. Absentee

ii. Vitals on walkin (e.g. fever, viral infections, rashes, diahrea, injuries, obesity)

Quality Reporting

Definition of Quality (Safe, Effective, Efficient, Patient-Centered, Timely and Equitable)

Five key areas in which information technology could contribute to an improved health care delivery system:<ref>Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. 2001. p 31.</ref>

Enhanced patient and clinician communication

As summary, the Quality Domain includes aggregate measures of performance as well as individual case reporting of adverse events (including but not limited to Hospital Acquired Infections <HAIs>, adverse drug events <ADEs>, sentinel events, and others).

Quality Vision as defined by AHIC (see Appendix A)

Enablers and Barriers

Enablers

• Clear value proposition supports the use of HIT capabilities for quality assessment, quality improvement and informed decision making
• Collaboration between providers, purchasers, consumers and accreditors/oversight bodies and professional certification entities produce uniform standards for sharing and aggregating health data and for public reporting
• Collaboration between regional quality measurement initiatives and RHIOs or NHIN service providers
• Standard approach for EHRs to routinely produce quality data based on approved measures that span care delivery
• Designation of a national health data stewardship entity to oversee appropriate use of data
• Comprehensive medical record across points of care obtained via health information exchange networks to enable intelligent alerts to providers
• Measure developers identify data and HIT requirements in order to implement measures into clinical care and software
• Certification of HIT based on criteria to enable reporting of an expanded set of AQA and HQA quality measurement in EHRs
• Education of consumers on how to obtain data and assess quality of care along with sharing of data with patients' PHRs will increase consumer stake in quality measurement
• Overall payment system that provides incentives for quality and safe care
• Cultural change that encourages performance reporting
• Certification of clinical decision support capabilities in EHRs
• Additional pilot projects that provide leadership for a national framework and act as learning laboratories to link public and private data sets and assess clinical quality, cost of care and patient experience
• Personal Health Records

Barriers

• Lack of a clear business model for health information exchange
• Lack of a clear business model for quality
• Limited set of national consensus measures; robust measures not yet developed for all physician specialties
• Lack of standards for data collection and aggregation
• Lack of standardized mechanisms for external reporting including data stewardship
• Lack of alignment of payment with quality performance
• Gaps in regulations and practices relating to privacy/security and secondary use of data
• Slow translation of research into practice at the point of care
• Quality assessment tightly linked with site of care or individual clinicians; few integrated or episode-based metrics
• Lack of coordination in quality measurement
• Gaps in quality management capabilities of EHRs
• Clinical documentation unstructured using non-standardized nomenclature
• HIE operational in few regions
• Poor provider economics- higher costs of doing business, declining reimbursement and the expectation of implementing information technology solutions
• Lack of a complete medical record to support CDS (Clinical Decision Support)
• Reluctance to share data
• PHR adoption
• EHR adoption

Organization of Quality (local, state and federal)[May be adequately defined in the components above]

Today

credentialing and accrediting organizations (responsible for selecting measures).

There are multiple concurrent credentialing and accrediting activities for the same practitioners. (e.g. Payor accreditation, state licensing requirements for physician groups include quality measures that could be conflicting or have multiple reporting requirements)

Quality Reporting Consumer

[May be informed by or replaced by the content in the Stakeholder section from the AHIC table as indicated above.]

Credentialing and accrediting organizations (responsible for selecting measures)

Measured developing organizations work with these bodied to create the measures (e.g. 3M that sells sw to manage performance measures, demanders of healthcare measures-payers, facilities that want to benchmark themselves regarding quality of care.

Provider Organization

Decision support

This section encompasses internal decision support capabilities for concurrent (or interactive) decision support which may be managed through multiple means, e.g., order sets, protocols, care plans, aggregated alerts and reminders, individual alerts and reminders. Management of concurrent decision support should be enabled by quality measurement and reporting elements defined externally or locally. Methodologies for attaining successful quality outcomes require careful attention to local practice and workflow and therefore such methodologies should not be proscriptive.

Continuous Quality Improvement (CQI)

This section refers to capability to compare dynamically, in near real-time, and retrospectively, performance with respect to structural, process and outcome measures of quality, whether defined and transmitted from an external stakeholder or identified locally. Methodologies for attaining quality outcomes require alignment with local workflow and practice and therefore such methodologies should not be proscriptive. The site for aggregation of data for such CQI practices can be inherent within the EHR or external to the EHR either at the practice location or managed by a third party data warehouse organization or vendor. Such data management tactics must be determined by the healthcare organization, yet enabled by the input and export for the quality domain.

Quality considerations in a RHIO – vision statement

Filter Data

Exclusions

Numerator

1.1.1.1.1.1 Retrospective removal from denominator

1.1.1.1.1.2 E.g. patient compliance

1.1.1.1.1.3 Patient leaves practice (death, move, change doctors)

Denominator

1.1.1.1.1.4 E.g. allergy to medication class

1.1.1.1.1.5 Failure of therapy trial

1.1.1.1.1.6 Contra-indicated conditions

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Glossary of Terms

Public Health

(derive definition from Anna Orlova's presentation)