Protecting Identity in the New Digital Age

Now that HITECH has been able to increase the adoption of electronic medical records (EMRs), the focus is on interoperability. The market has been flooded with various EMR and PM (practice management) systems but how do they communicate? The challenge of interoperability is being addressed aggressively as we go into Meaningful Use Stage 2 and Health Information Exchanges. However, according Jitesh Chawla, MD the piece that might be forgotten is maintaining patient privacy in this new digital age.

As the nation progressively implements electronic healthcare records, stakeholders have uncovered an elephant in the room – how to implement patient identity and integrity solutions. Linking an individual’s electronic health records across disparate systems, many suggest, will more likely than not require a unique patient identifier. Yet from a policy perspective, implementing this identifier has been extremely difficult. Medical banking, or the convergence of banking and heath IT systems, is spawning new ideas that could impact this difficult area. New forms of efficiency in payment processing may yield a technology platform for managing digital identity by banks that could also be used for healthcare.

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Then please post comments and join Dr. Jitesh Chawla for an interesting discussion on this topic.

Dr. Jitesh Chawla reviews smoking cessation trials

Dr. Jitesh Chawla's clinical trial research shows that the first anti-nicotine vaccine to enter Phase 3 clinical trial, NicVax, was in it’s the last stage of testing before hitting the market. The product works by inciting the immune system to produce antibodies that bind to nicotine in the bloodstream, much as antibodies would attack an invading microorganism. Once bound, the nicotine cannot cross the blood-brain barrier to enter the brain. It is the neurotransmitters in the brain that cause chemical reactions leading to addictive behavior. The vaccine was therefore expected to diminish the pleasure of smoking and make it easier to quit. Unfortunately, the failure of the vaccine serves as major set-back to harness the immune system’s power to fight additions such as tobacco abuse.

Figure 1.
Trial paper posting by Dr. Chawla

Nevertheless, Micro-electric  current therapy shows a lot of promise. In one trial studied by Dr. Jitesh Chawla, 1,000 cigarette smokers treated between July 2006 and January 2008, 972 (97.2%) lost their craving for cigarettes within 1 to 5 minutes into a 20 minute session of CES. In those who were in the process of quitting and often at the height of their withdrawal symptoms, cravings started to diminish within 2 minutes of initiating CES and usually disappeared within 10 minutes. Several were 2 or 3 weeks into quitting and still experienced craving.

There may be many reasons for the difference between success and failure including the solidity of the product, trial design, lack of capital, tough FDA reviewers but clinical trials. Even after successful trials and FDA approval some smoking cessation products, like the Nicotrol Inhaler, are not adopted well, as the side-effects and limited efficacy with mediocre outcomes serves as a stumbling block. It is time to try something new. Micro-electrical current therapy has a different mechanism of action than any other therapeutic agent for smoking cessation, currently in the market, and is worth a shot. Next time you are searching for a new doctor make sure he or she keeps up with latest research regarding medical treatments for important common problems such as nicotine addition.

Also, keep following this blog for more exciting clinical trial news from Dr. Jitesh Chawla.

Medicaid Expansion Debate

Dr. Jitesh Chawla felt from the outset that the Medicaid Expansion effort part of the Affordable Care Act was going to be an uphill battle.

The 26 states have refused the are home to about half of the country’s population, but about 68 percent of poor, uninsured blacks and single mothers. About 60 percent of the country’s uninsured working poor are in those states.

Every state in the Deep South, with the exception of Arkansas, has rejected the expansion.Opponents of the expansion say they are against it on exclusively economic grounds, and that the demographics of the South — with its large share of poor blacks — make it easy to say race is an issue when it is not.

Dr. Chawla found out the North Carolina practices who take Medicaid didn’t really even much of an opinion of the expansion in the first place. In Mississippi, Republican leaders note that a large share of people in the state are on Medicaid already, and that, with an expansion, about a third of the state would have been insured through the program. Even supporters of the health law say that eventually covering 10 percent of that cost would have been onerous for a predominantly rural state with a modest tax base.
“Any additional cost in Medicaid is going to be too much,” said State Senator Chris McDaniel, a Republican, who opposes expansion.
The law was written to require all Americans to have health coverage. For lower and middle-income earners, there are subsidies on the new health exchanges to help them afford insurance. An expanded Medicaid program was intended to cover the poorest. In all, about 30 million uninsured Americans were to have become eligible for financial help.
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Purchasing an EMR

     So you have decided that it is time to purchase an EMR for your practice.  You are tired of the paper charting process and are ready to step into the 21st century, but what EMR do you buy?  So many practices are hurt financially and become frustrated from buying into the wrong type of equipment.  It is imperative that you take several factors into consideration before buying this costly piece of equipment, and find the system that is best for you.

     The first option you have is to hire a consulting firm to help you pick and set up the EMR. Consultants are well versed on all kinds of EMR equipment and can help you decide what type will help your practice the most.  More importantly than the guidance through the purchasing process, is the fact that many firms will help you set up the system and set it up correctly the first time.  With any technology, there will be bugs that need to be fixed and many consulting firms provide around the clock diagnostic service to help fix any problems that may arise with the software. The most important advantage of hiring a consulting firm to set up your EMR is the fact that they will teach you how to use the technology and get the largest benefit for your practice.

    Maybe you've decided that hiring a firm is ludicrous and you want to take on the task yourself.  If you decide to go this route, you have to first analyze what problems you want EMR to solve for you.  Do you want to cut down on the number of employees? Do you want to increase the productivity in your practice and eliminate the large volume of paperwork that you use? EMR can solve these problems but you must read unbiased reviews and do the research on each product to find the smartest option for the practice.

     You have to realize that buying an EMR is all about increasing your productivity which leads to increased profits for your practice.  Take this into account before purchasing your equipment because that swanky technology that one EMR might have may not help you accomplish your goals as well as a more basic and no-frills system will. The main idea in the article is "DO YOUR HOMEWORK", the same idea that carried you through medical school and got you to the position that you are in today.

 

Viewpoints about Doctors' Salaries

Really, how many porsches do you need?" has been a popular motto among proponents of Obamacare in response to objections by physicians at the possible pay cut brought on by the bill. This is a fair statement as most anyone would agree that if you are wanting to become rich, a medical profession is not the best option. However, physicians do have a reason to gripe in this case. After 4 years of med school and the loans that one can accrue over this period and the gigantic liability that a practicing physician faces, one would expect to be compensated at least enough to be able to pay off these fees once their residency is completed.

There have been many politically slanted opinions about the effect that Obamacare will have on doctors' salaries. Many in the medical profession are left wondering, "Will I be able to pay off my student loans?...Will I be seeing twice as many patients for half the amount of money and provide a lesser quality of care?" No one an really say for certain what will happen until the bill is fully implemented.

Many people fear that pay cuts will dissuade potential physicians from attending medical school and cause a great shortage of doctors in our nation. I think the best way for us to navigate this topic is to look at what the bill will do in theory to your salaries, without a political slant. First of all, it is important to understand what the goal of Obamacare is. It's goal is to lower costs of the American Healthcare system without lowering the quality of care. It resembles a European style of healthcare, and in this type of system, physicians make less money on average. In an issue of the journal, Health Affairs, the amount that French primary care physician makes was compared to what an American one makes.

PCP's in the United States on average netted around $186,000 while a comparable French doctor made $95,000. How will Obamacare affect the American pay? Well it is widely stated that the bill will cause physicians to be reimbursed at a lower than market rate for Medicaid. In other words, lower than what they are being paid now. This could spell doom for specialists such as general surgeons, who see many Medicaid patients for surgery.

With the lower pay an inevitability many believe that physicians will have to see a larger volume of patients to make the same amount of money that they do now. Many comment that this will cause a large decrease in care as doctors will rush to see as many patients as they can in a shift. We will continue to look at this issue in the coming weeks with more specific examples of how the ACA will affect you.

Health Insurance Exchanges

The Affordable Healthcare Act may have not only changed the United State's  healthcare system forever, it also may have changed the insurance industry  forever.  The implementation of so called health insurance exchanges, or HIX for short, have helped change the industry forever.  The model is a consumer based  approach, where customers will be able to shop for the best insurance plan for  them.  President Obama focused on allowing states to set up the exchanges  instead of a blanket approach that would make one exchange for the whole  country.

Ideally, the concept will allow people with preexisting conditions to be denied  insurance.  Customers will have to satisfy a smaller amount of conditions in order  to receive insurance.  Lawmakers envisioned this change as a system in which citizens will be allowed to have the same type of variety that members of  Congress have in shopping for their health insurance.  At this point you may be saying, "Great, now how in the world will they  implement this and what does this mean for me?" Let's try to answer this  question! The exchanges can cover a whole state or be broken up in to smaller exchanges in one state.  For instance a state like California may have a Southern  California exchange and Northern California exchange.  As long as the exchange covers a certain geographic area they will be allowed to operate.

States can also partner with other bordering states to create an exchange. As for how the exchanges will be run and affect you, the consumer, lets look at the car insurance model. President Obama has repeatedly compared these  exchanges to car insurance purchasing.  People living in an area that has a HIX  will be able to compare plans online and buy which ever one fits them the best.

There will different levels of coverage, given a gold, silver, or bronze designation. Only companies meeting the standards set forth by ACA regulations will be able  to sell their insurance plans.  According to www.obamacarefacts.com, this alone  will lower insurance premiums 7-10 percent. 

Listed below are the criteria to be  an ACA-approved insurance plan.

All plans must include:

1. Ambulatory patient services

2. Emergency services

3. Hospitalization

4. Maternity and newborn care

5. Mental health and substance use disorder services, including behavioral health treatment

6. Prescription drugs

7. Rehabilitative and rehabilitative services and devices

8. Laboratory services

9. Preventive and wellness services and chronic disease management

10. Pediatric services, including oral and vision care

We have yet to see if these will in fact work in the United States.  In theory,  they sound like a great idea and that they will allow for variety in insurance  shopping.  The hope is that more people will be able to become insured in the  long run.

Role of EMRs in Accountable Care Organizations

As the final rule on ACOs ( Accountable Care Organization) has come out, it is apparent that that the value that EMRs (electronic medical records) bring is unprecedented.  Under the Medicare Shared Savings Program, ACO participants (which may include medical practices, hospitals and payers) are graded and paid based on 4 domains of care quality: 1) patient experience;  2) care coordination and safety;  3) preventative health; 4) at-risk populations.  The program consists of a 3 year performance period in which the performance of the ACO mapped against thresholds set by CMS. To reap financial benefits from this program, providers must report on 23 of 33 quality measures spanning these 4 domains during the second year and 33 out of 33 in the third. Some of the measures, like # 20, which asks for the percentage of providers that have received Meaningful Use money are easy to satisfy if you have a Certified EMR.

ACO participants are incented to work together and efficiently because if they don’t meet the CMS thresholds they must pay money back. Data is key when trying to coordinate care and the exchange of clinical data must be done properly to meet the quality measures set by CMS.

Now it must be apparent to medical providers that if they want to join an ACO it is very important that they are comfortable using an EMR. The good news is that there are certain features of the software that allow providers to capture the necessary data for ACO quality measures easily. For example, in the Preventative Health domain there are measures such as Adult weight screening and follow-up and Tobacco Use Assessment. Both of these are Meaningful Use criteria and any certified EMR has screens and buttons to record this information. 

In another example, the domain of at-risk population contains a diabetes composite measure in which the number of diabetics who BP is less than 140/90 must be recorded. To do this, it may necessary to setup a report in which there are fields to search for a patient’s diabetic status and their blood pressure level concurrently. For instance, in Patagonia Health’s EMR, there is a section called “My Reports” where users can fully customize search criteria for certain disease conditions, procedures and demographic characteristics.

Finally, the exchange of health information between providers and entities requires ability for the system to send and receive data securely and in a format that the receiving end would be able to decipher. Exchange of clinical data is a Meaningful Use criterion and is done through CCR (care of continuity record) which generates a summary of the usually about the patient’s medication, laboratory, immunizations, provider names, vital signs, alerts. Providers simply need to press the CCR button and it generates a file. This file can then be sent in encrypted format through email currently (and through Health Information Exchanges later) to the other provider’s EMR.

EMRs have become a powerful tool that has empowered medical providers to collect the necessary data in order to provide medical care with a sense of accountability and level of quality in the form of an ACO. The Meaningful Use Program has further enabled different EMRs to have the standard features important for this data collection.

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Jitesh Chawla MD discusses the HIPPA Rule

Dr. Jitesh Chawla feels that in order to stay away from nasty trial lawyers and draining courtroom or legal cases or criminal charges, all providers should know the basics of the HIPPA (Health Insurance Portability and Accountability Act) rule.

Covered Entities

HIPPA contains the Privacy Rule whose goal is to protect healthcare information, especially in this age of health IT where information is exchanged frequently and easily. The first step in learing about HIPPA is  to understand who HIPPA applies towards –called “covered entities”..

• Health Plans
• Healthcare Providers (this includes both clinicians and organizations)
• Healthcare Clearinghouses (process non-standard health info to standardized versions –common in billing claims)

Business associates are entities or individuals, other than the covered entities, that provide services on their behalf and may have access to protected health information either by use or disclosure. The covered entity will need to use a Business Associate Agreement in this case in order to comply with the Privacy Rule. But the next question is what is protected health information.

PHI (Protected Health Information)

health information that is individually identifiable health information is one, including demographic data, that relates to:

• The provision of health care to the individual
• The individual’s past, present or future physical or mental health or condition,
• The past, present, or future payment for the provision of health care to the individual
• Anything that can be reasonably used to identify the individual

Common examples include full name, address, birth date, Social Security Number. Even photos can be included as such information.

Hypothetical Patient Jitesh Chawla’s Photo (unauthorized sharing of this could be a violation of HIPPA in some circumstances)

Penalties for non-compliance

These are classified into different degrees of offense.

1) Not more than $50,000, imprisoned greater than 1 year, or both;

(2) If done under false pretenses, fine shall not exceed $100,000, imprisoned not more than 5 years, or both

(3) If the intention is to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain, or to maliciously harm another, cannot be fine more $250,000, imprisoned not more than 10 years, or both.

Tips to stay out of trouble

1) Abstain from talking about patients in hallways, elevators or where others not involved in care are there

2) If using an electronic medical record, log off the software or the operating system when not using

3) Don’t share PHI in emails, on voicemails or jot down on notes/stickies which can be picked up by others

4) If an organization, make sure all new patients are given HIPPA paperwork, employees sign confidentiality agreements while being hired and 3^rd parties you enter with sign Business Associate Agreements.

You can never prevent all bad situations, particulary in Health Care, but with this knowledge and advice Dr. Jitesh Chawla hopes that meeting trial lawyers or courtrooms for violation of the Privacy Rule is nothing but a bad dream for you.

Please check out my new video on Patient Centered Medical Home at:
http://www.youtube.com/watch?v=FqLH7w9efqI

Review of Systems: Its importance in Medical Billing

Combining history of present illness and review of systems is possible when doing medical billing. Many medical billers think this practice is breaking a rule or impossible. However, documenting an element once to account for HPI (history of present illness) and ROS is acceptable medico-legally when done correctly.

CMS states that physicians absolutely do not need to document an element two times just so the person performing medical billing knows it is meant to be used both for review of systems and history of present illness. It is perfectly acceptable to use an element for both.

The only time an element cannot be used in duplication is when you attempt to use it in the same area. For example, the complaint of chest pain cannot be used in ROS (review of systems) for musculoskeletal systems and the cardiovascular system. It can be used only for one location in the medical billing.

A medical biller also cannot use a timing phrase such as "began a couple of days ago" to account for both the HPI (history of present illness) duration and timing. Direct medical documentation must be used.

According to Dr. Jitesh Chawla, healthcare expert, the most important thing to accomplish in medical billing is to make the bill match the service that was actually given. With the increasing adoption of EMRs and Health IT this becomes much easier.When this occurs, payment is made quicker. Medical billing companies can assist medical practices with this task. Outsourcing your medical billing be beneficial for your practice, however, better yet is to use an EMR that has an integrated PM (practice management )/ Billing system that can send statements directly to the payer. This takes the worry off correctly coding and billing by manual means and physicians will see reimbursements much more quickly.

The unique EMR needs of Public Health

With the passage of the HITECH Act there is been an ever increasing push towards the use of electronic medical records (EMR). However, public health agencies have generally been slower to adopt for a variety of reasons. Also, their Health IT systems are often more outdated then the ones in the private, non-public sector. However, certain meaningful use rules, such as conducting syndromic surveillance and reporting to immunization registries, ask providers to communicate with public health agencies. Consequently, public health departments are under pressure to re-structure their technology platforms.

Public health has unique workflows which can have major implications for EMR vendors. To understand this it is important to explore how public health is different from medical care in doctors' offices or in hospitals.

1)      There is greater emphasis on population screening and treatment, resulting in separate clinics focusing on specific aspects of care provision – providing immunizations, conducting STD screenings, etc. Also, there may be many more staff involved, some of which play roles that are not present in outpatient practice.

2)      As part of their mission these organizations normally perform a community assessment at regular intervals. This helps to identify the rates of certain diseases in the community and can guide the deployment of conditions that are more prevalent. As a result the type of visits and demographic make-up of the patient panels can vary greatly over time.

3)      The type of data that needs to be tracked is such that epidemiological studies can be readily done on it (ie. incidence, prevalence, etc.).  

4)      There are certain forms that mandatory to use. One example is the use of Healthy Futures Pediatrics for pediatric physicals.

5)      There are unique situations where patients are seen in settings that are not typical for a doctor’s office. For example, a patient that has tuberculosis will be placed on home quarantine. The nurse will go there and obtain sputum samples and treat the patient with none of the interaction taking place in the clinic.

6)      Finally, there are specific reporting requirements by the State and Federal Government. This has implications on the type of and amount of data that needs to be collected. Also, there

As a result, the EMR vendor has to:

1)      Understand various different workflows, each specific to a particular clinic.

2)      Be able to work with a large number of users, some of which play unorthodox roles

3)      Incorporate data fields and a format to capture information that can be used for population reporting. The databases that are used should be able to store a large number of data points.

4)      Provide access to the EMR through a variety of mobile portals – phones, tablets, etc.

5)      Incorporation of or access to certain specific forms.

6)      Design reporting engines that can produce reports in a pre-defined format acceptable to the State and Federal Government requirements

7)      Ensure their product is highly interoperable and can regularly pass data back and forth from providers and to State Registries and between other organizations.

The EMRs that can successfully support public health needs have an architecture that allows need new programming code to be inserted readily without having to create a new. New features can be added through widgets that make it easier for the user to locate and utilize them.

The revolutionizing of Public Health IT infrastructure is a long-awaited milestone that is soon to pass and will improve the management of population health.   Dr. Chawla feels that this a trial period for these organizations.The Meaningful Use initiative has really started the ball rolling. The key is to use the right electronic medical record.

Stage 2 Final Rules: Implications for Providers

Dr Jitesh Chawla feels that for the longest time, the fate of health IT was on trial.

Finally, on August 23rd, CMS released Meaningful Use Final Rules for Stage 2 of the EHR Incentive Program. For those of you that are knowledgeable about Meaningful Use and saw the proposed Stage 2 Rules there are major changes that were made based on feedback from the medical community.

Nevertheless, since the final version is now out, it is important for medical providers and hospitals to understand what is expected of them and how the criteria differ from Stage 1. This article is a quick overview of the additions and changes in Stage 2 Rules and will present some tips to how clinicians can be ready. We will not cover hospital requirements here.

 Stage 2 Requirements

Stage 2 represents “Advanced Care Processes” according to the Meaningful Use stages plan as explained by ONC. A central theme is “connectivity” where different EMRs or EHRs can exchange data with each other. Also, the first stage allowed providers to get a certified EHR and  learn how to use it to collect some meaningful data. Now the goal is to have them use more advanced functions of the EHR and collect some of the same data for a larger pool of patients.

Some of these measures are new and others represent higher thresholds from Stage 1 (latter marked by *). Examples of few of these measures are highlighted below.

·         At least 5% of patients must access have access to their online health information

·         Providers must engage in secure messaging with at least 5 % of their patients

To be sensitive to practices in rural areas CMS is granting exclusion to providers without access to broadband internet. Both measures will require internet connectivity to communicate to patients regardless of whether the EHR is web-based or not.

·         Summary of care record for more than 50% of transitions of care and referrals*

·         Transmit summary of care for more than 10% of transitions and referrals to provider even if

       they  have vendor or organizational affiliation*. However, the 2 providers that conduct the

        exchange must be using EHRs from different vendors

·         Eligible providers must select and  report on 9 out of 64 total clinical quality measures (CQMs)

·         Tobacco screening for patients 13 or older is required for 80% or more of patients

In addition, all providers must select Clinical Quality Measures (CQMs) from at least 3 of the 6 key health care policy domains from the Department of Health and Human Services’ National Quality Strategy:

 •Population and Public Health

 •Efficient Use of Healthcare Resources

 •Clinical Processes/Effectiveness

 •Patient and Family Engagement

 •Patient Safety

 •Care Coordination

  

Compared to Stage 1, EPs (eligible providers) must satisfy 20 measures 17 core and 3 / 6 for menu. Reporting will be allowed such so that batches of EPs in the same group can attest together in 1 file. For a full report of Stage 2 measures and requirements visit the CMS website.

Getting Ready

1.The patient portal is likely the medium by which patients will access online information and use email (secure messaging) to communicate with their providers. Make sure to check with your vendor if the patient portal is set-up to support all these features. PP is included as part of all certified EMRs.

Dr. Jitesh Chawla posts a trial version of a patient portal screen

 

(reference: cliniclogo)

2.Ensure policies, procedures and workflow allows collection of data in at least 3 of the 6 domains part of the National Quality Strategy. There should be a logical approach to choosing the 3. Health departments may include Population/Public Health, behavioral health practices include care coordination and practices recognized for Patient Centered Medical Home may include Clinical Processes and Effectiveness. In all 3 examples, the CQM topic represents an area that practice or clinic may focused on as part of their daily operations and so the data is being collected anyways.

3.Adopt the practice of motivational interviewing as patient engagement is bigger theme in this stage of meaningful use. Motivational Interviewing has been becoming a more widely tool in health care, as it has been used in other industries or years.

4.Keep track of the Health Information Exchanges (HIEs) in your area and make sure your HER connects with them. The good part is that Stage 1, required you to test the CCD/CCR function a which is medium by which patient information is summarized and can be submitted in exchange through a standardized format.

Concluding thoughts

The step-wise government push towards the adoption and use of EHRs is not to advocate the use of technology, help vendors with EHR sales or to create some hurdles to jump though just to get free money. But, providers and practices that streamline their work processes, capture the right patient data consistently, strive for increased quality and safety will find that EHRs are actually enablers for those goals and achieving Meaningful Use, though time consuming, is just a little more than a formality.

This certainly feels like a painful trial period for many providers, but Dr. Jitesh Chawla would encourage practices to stay persistent.

Micro-electric therapy for smoking cessation??

Dr. Jitesh Chawla discuss smoking cessation clinical trials-failures and successes

 

The first anti-nicotine vaccine to enter Phase 3 clinical trial, NicVax, was in it’s the last stage of testing before hitting the market. The product works by inciting the immune system to produce antibodies that bind to nicotine in the bloodstream, much as antibodies would attack an invading microorganism. Once bound, the nicotine cannot cross the blood-brain barrier to enter the brain. It is the neurotransmitters in the brain that cause chemical reactions leading to addictive behavior. The vaccine was therefore expected to diminish the pleasure of smoking and make it easier to quit. Unfortunately, the failure of the vaccine serves as major set-back to harness the immune system’s power to fight additions such as tobacco abuse.

Nevertheless, Micro-electric  current therapy shows a lot of promise. In one trial, 1,000 cigarette smokers treated between July 2006 and January 2008, 972 (97.2%) lost their craving for cigarettes within 1 to 5 minutes into a 20 minute session of CES. In those who were in the process of quitting and often at the height of their withdrawal symptoms, cravings started to diminish within 2 minutes of initiating CES and usually disappeared within 10 minutes. Several were 2 or 3 weeks into quitting and still experienced craving.

Picture of Micro-electrical current device- as proposed by Dr. Chawla for smoking cessation clincal trials

 

There may be many reasons for the difference between success and failure including the solidity of the product, trial design, lack of capital, tough FDA reviewers but clinical trials. Even after successful trials and FDA approval some smoking cessation products, like the Nicotrol Inhaler, are not adopted well, as the side-effects and limited efficacy with mediocre outcomes serves as a stumbling block. It is time to try something new. Micro-electrical current therapy has a different mechanism of action than any other therapeutic agent for smoking cessation, currently in the market, and is worth a shot.

 If you interested in gaining access to new treatments to help your long-time smoking habit, when you go look for a doctor who conducst such studies. Dr. Chawla suggests the best way to find out if something works for sure is to conduct a small controlled trial .

The Use of Electronic Medical Records for Clinical Trial Recruitment

By Jitesh Chawla, MD.

About EMRs

With the advent of  the HITECH Act and Meaningful Use, EMRs (electronic medical records) have become very popular among practicing clinicians. The technology enables medical providers to chart patient data into structured fields. This allows information to be easily retrieved for analysis and reporting. Another major advantage of the EMR is the ability to provide clinical decision support  (CDS). Rules can be set to alert or inform about patient clinical information that would affect treatment at the point of care. Rule parameters are configured on a settings screen and the rule is run on patient data captured in those structured fields. One example of CDS in action is an OB/GYN clinic that set for an alert to come up for every woman that was overdue on her PAP smear based on age, prior history of PAP abnormalities and family history of cervical cancer. EMRs and CDS can play a vital role in clinical trials.

Clinical Trial Enrollment

Clinical trials are divided into the following phases: 1) using healthy subjects to test for drug safety 2) using a larger group healthly subjects tested for drug efficacy 3) treatment and control groups involved in a randomized control trial 4) post marketing surveillance.  The enrollment requirements significantly increase in each phase (see table below).

Table 1. Typical Enrollment Estimates of Clinical Trials¹

Phase	Subjects Needed
1	20-100
2	100-300
3	300-3000

  Since clinical trials can account for at least 50% drug development costs, which may run up to 1 billion dollars per product, delay or cancellation of a trial due to inadequate or late enrollment is very costly². Once source cites a company lose from $600,000 to 8 million per each day a trial is delay³. Furthermore, with increased government regulations of the pharmaceutical industries and fierce competition, many drug companies cannot afford any major delays or a cancellation.

Challenges and Possible EMR Solutions for Trial Recruitment

Some reasons why recruitment and retention of subjects for clinical trials presents a challenge include:

1)Finding patients that meet the criteria and finding them quickly. The study design specifies very clearly who does and does not quality for trial participation. Also, requirements change based on the phase of study. These inclusion and exclusion criteria are very strict and need several levels of approval (ie. IRB, sponsor, investigator) before any exceptions  are made.

2)   Patient interest. Many patients may not elect to be part of a trial when they otherwise had there been better explanation about the drug being tested or condition being treated. Furthermore, some patients are just too scared to be part of an “experiment” and are not convinced by all the precautionary measures that trial staff explains they have taken.

The beauty of the CDS feature in the EMR is that each inclusion/exclusion criteria can be put as a separate rule. Furthermore, the patient reminders feature can cause a pop-up window to appear every time that rule is satisfied. Secondly, there is no better person than the patient’s provider to convince them that trying an experimental treatment might be the best option and that the benefits outweigh the risks. The relationship between provider and his or her patient is a unique one and cannot be replaced by any clinical trial staff member. EMRs have a patient education button that contains information about disease conditions and can be customized such that details about the clinical trial can be included.  Providers can go through the education sheet with their patients.

Conclusion

It is true that not all patients are suited for participating in clinical trials. Also, despite all the information and intelligence available at the point of care, some providers may choose not to use the EMR to help with trial recruitment. Nevertheless, the fact remains that clinical trial enrollment is a big issue and the EMR with its CDS and other features can help in this endeavor.

In the next article, I will go through an example of how a rule is set up in the CDS module of a typical EMR and give some real-life case study examples of organizations that have leveraged this technology to help them successfully recruit for their clinical trials.

References:

1) wikepedia

2) http://www.promodel.com/solutions/pharma/clinicaltrials.asp

3)  http://www.pdpipeline.org/2011/clinicaltrials/recruitretention.htm