Electronic Health Record (EHR) and use in clinical trials

Electronic Health Record (EHR) and its use in clinical trials

An electronic health record (EHR) is a digital record of patient’s health information. EHRs are the real-time patient-centered records which makes information available instantly and securely to authorized users. While an EHR contains all the medical and treatment histories of the patients, an EHR makes health information instantly accessible to authorized providers and health organizations, helping to inform clinical decisions and coordinate patient’s care.

What information does an EHR contain?

EHRs are a vital part of health IT and can contain:

     Patient’s medical history, demographic information, vital signs, diagnoses, progress notes, medications, immunization dates, allergies, laboratory tests and results, treatment plans, insurance information, data imported from personal wellness devices and radiology images and allow access to evidence-based tools, which the providers can use to make decisions about the patient’s care.

The main key features of an EHR is that the health information can be created and managed by the authorized providers in the form of a digital record and that can be shared with other providers across more than one health care organizations, and also one can share the information with other health care providers and organizations –such as specialists, laboratories, pharmacies, emergency facilities, schools and other workplace clinics-so they can have the updated information about the patient’s care

EHR functions:

  ·        Health info and data

   ·        Result management

   ·        Order management

   ·        Decision support

   ·        Electronic communication

  ·        Patient support

  ·        Administrative reporting

  ·        Population health and health statistics reportin

Benefits of Electronic Health Records:

A single EHR can bring information together from:

Online patient’s information - Where patients information is readily available in online and a patient can log on to his/her own health records and see the lab results over the last year which can help motivate him/her to take his/her medications and keep up with the lifestyle changes that have improved the numbers and as the data is available online, can be accessed anywhere from the computer

Patient medical record- Where physician an access complete patient record, so that the physician can provide better and quality patient care

Cloud-based EHR software- Physicians can use cloud-based EHRs, which does not require any hardware installation or software licences

Nursing benefits-Decreases redundant data collection, allows data comparison from prior visits, on-going access, updation of records at bedside, improved documentation and quality of care and supporting in timely decision making

Healthcare provider benefits- Better/faster/simultaneous data access, improved documentation, reporting, prompts to ensure administration of treatments and medication, improves efficiency of care

Advantages of EHR:

EHR’s and the ability to exchange health information electronically can help to provide higher quality and safer care for patients. EHRs help to provide better management of care to the patients and better health care time to time. Electronic health records have several benefits for health care professionals. These are as follows:

·        Providing accurate, up-to-date, and complete information about the patients at time of care

·        Document sharing - able to share information quickly and easily between themselves, healthcare practitioners are able to treat patients more efficiently and effectively

·        Easy access- by having data to hand at all times, healthcare professionals can deal with patients efficiently, without having to spend time trawling through paper record

·        Easy to update- as records are updated on computer, there is no delay in changing patient data, such as changes of address or phone number, new medication, and all other aspects that could change and all the electronic patient records are always accurate

·        Easy to store- because the records are held on a computer, a lot less physical space is needed to store records and takes as much physical space to store 2 records, as it does two million records. This makes information held at doctors surgeries, hospitals and other medical and dental establishments much easier to use

·        Speed of use , enabling safer, more reliable prescribing, multiple users can view a chart, lab and x-ray results returned automatically, drug to drug/ allergy interactions checking, improved patient communications and services

·        Security- having an electronic copy of patient’s medical record can help to improve security and firstly it means that only authorized personnel will be able to access the records on a computer system which will usually be protected by password and secondly having a backup of the records will mean that in the event of the data being destroyed in any natural occurrence etc.

·        Reducing costs through decreased paperwork, improved safety, reduced duplication of testing and improved health

Disadvantages of EHR

·        Upgrade problems, including lack of internal or external IT or support resources

·        Inadequate EHR templates that are difficult to use or update

·        Hidden or unexpected EHR expenses

·        Inefficient

·        Costly storage and retrieval

·        Information not readily available

·        Discrepancies between charts

·        Cannot report off information (unstructured data)

How EHR’s are useful in clinical trials:

®Describes the responsibilities and processes for how we assess the validity, reliability, and integrity of EHR source data

®Evaluate best practices for using EHRs in clinical research

®Describes the inter-operability in EHR use

®EHRs can be used by health care institutions to integrate real time electronic health care information from medical devices and different health care providers involved in the care of patients

®Ensures the quality and the integrity of EHR data that are collected and used as electronic source data in clinical investigations

®Ensures the use of EHR data collected and used as electronic source data in clinical investigations which meets the regulatory inspections, recordkeeping, record retention requirements

Difference between a EMR(electronic medical record) and EHR(electronic health record):

Often the terms “electronic medical record” and “electronic health record” are very similar, however they are not the same thing. Both EMRs and EHRs make healthcare more efficient than paper, however it is safe to consider an HER, which is the next generation to an EMR.

EMR	EHR
Electronic medical record (EMR) is a digital replacement for a patient’s paper chart to store the entire data of each patient in an electronic format.	An electronic health record includes all of the information contained in an electronic medical record and more.
An EMR is accessible by a single practice and is primarily used for diagnosis and treatment; this would include a patient’s medical history previous and current medications, diagnoses, allergies and more.	The primary benefit of an EHR is the collaborative nature; they are designed to be shared with other health care providers.
EMR aren’t designed to be shared with other practices, hospitals, pharmacies etc	EHR is also aid in the level of care provided across the care continuum and it also present the ability to track additional information about patients including prior off insurance, lab results and more.
Provides more in-depth data tracking over time and gives reminders for patient screenings and checkups, improves patient care from the individual provider	EHRs also plays a significant role in the rollout of meaningful use the medicare Medicaid program that helps to use of EHR to improve patient outcomes and subsequently performance-based compensation
It is usually limited to one practice and the information doesn’t travel out easily.	While EHR allows patient information to be shared care facilities.

 

Standards of EHR:

To create inter- operable EHR’s, standards are needed for:

ü  Clinical vocabularies

ü  Healthcare message exchanges, in which one system exchanges messages, with one another

ü  EHR ontologies ( i.e., content and structure of the data entries in relation to each other)

ü  EHR systems should follow appropriate privacy and security standards, especially as they relate to HIPAA regulations.

Three main organizations create standards related to EHRs:

ü  Health Level Seven (HL7)

ü  Committee European de Normalization- Technical Committee (CEN TC-215)

ü  American society for Testing and Materials (ASTM) E31

NAME	STANDARDS
HITSP	Health information technology standards panel
HIPAA	Health Insurance Portability Accountability Act
CDC	HL7 Continuity of Care Document
NDC	National Drug Code
SYOMED	Systemic Nomenclature of Medicine
ICD-9-CM	International  Classification of Diseases

Conclusion:

Eventually, the overall vision is that the electronic health information from EHRs will hold big data science to conduct surveillance and make conclusion about health determinants, implementing traditional population-level interventions and individual clinical intervention and improves access to aggregated data which included in the trial which is compared to paper-based manual processes and enhanced availability technologies implies more timely analysis and opportunities for innovation.

There was clear support for EHR which can reduce the workloads and improve the conduct and quality of trials.

 

I pay my sincere thanks to the mentor and our core trainer, Mujeebuddin sir, Founder and CEO of Clinosol Research Pvt. Ltd., for driving me throughout the entirety of this blog and the management of Clinosol for supporting me to post this free and for helping me spread the knowledge I have gained to all my friends and to the society.

 

By:

D.Yamini Sai Nikitha

B. Pharmacy (Srinivasrao College of Pharmacy, Visakhapatnam)

Intern at Clinosol Research Pvt. Ltd.