Electronic Health Records and Clinical Trials: An Incentive to Integrate

By Chris Thorman
09:18 AM

As we wait for the federal government to finalize important sections of the Health Information Technology for Economic and Clinical Health Act (HITECH), there is a lot of talk about the financial incentives for implementing electronic health record software (EHR). And understandably so. Practices that implement an EHR under the federal government’s guidelines stand to gain nearly $50,000 in incentives over the next five years.

A topic that hasn’t been as hotly discussed is using information gleaned from EHR software to participate in clinical trials. We think this should play a larger role in deciding whether or not a practice should purchase EHR software. Why? Participation in clinical trials has the potential to net a profit of hundreds of thousands of dollars per year. Now that’s an incentive to purchase an EHR.

While there are many factors that go into an EHR software purchase, we think clinical trial participation should get more consideration because:

  • Participating in these trials is easier through an EHR than through traditional paper means;
  • Using EHR data solves many of the major problems that clinical trials face; and,
  • Purchasing an EHR creates a big ROI for physicians who decide to participate in clinical trials.

Using EHR data in clinical trials is a win for physicians, patients, the companies conducting clinical trials and the entire healthcare system.

Here’s why clinical trials should be a factor in purchasing EHR software.

EHR Software Facilitates Clinical Trial Participation
According to Synergyst Research, only 10% of licensed physicians participate in clinical trials. Why is participation so low?

Major reasons include the extra burden that research and information collection place on a practice’s time, staff and resources. Extra paperwork and onerous regulations are involved, not to mention training staff on how to properly complete forms and follow protocol. The average practice would find it difficult to find the time and resources to create a new department devoted to clinical trial participation.

Those using EHRs, however, stand a better chance of being able to adapt to the needs of a study. In the table below, we’ve identified ways that EHR software can make the clinical trial process faster, more efficient and more accurate.
 

Steps in the Clinical Trial EHR Software's Role
Identify potential opportunities EHR vendors whose software integrates with clinical trial providers will have access to trials, studies, and registries that your practice is eligible to participate in.
Identify number of potential trial subjects The search function in an EHR database allows a user to quickly identify how many of a practice's patients are potentially eligible for a clinical trial. From there, the clinical trial provider can determine if a practice would be a good partner.
Patient enrollment The EHR has the capability to implement trial-specific screening requirements into new patient records to determine their eligibility for a study. The EHR will also have the ability to identify patients who meet the exact requirements of a study.
Study execution During the trial, the EHR can create trial-specific data fields that can be populated during routine patient encounters. Conflict alerts can also be created to notify providers of actions that violate a study's protocol.
Data submission The EHR will be able to submit information to EDC software without having to convert the data. This eliminates redundant data entry and increases accuracy of the data.

Study execution During the trial, the EHR can create trial-specific data fields that can be populated during routine patient encounters. Conflict alerts can also be created to notify providers of actions that violate a study's protocol.
Data submission The EHR will be able to submit information to EDC software without having to convert the data. This eliminates redundant data entry and increases accuracy of the data.

By using an EHR to do much of the patient identification and information collection, many of the previously mentioned obstacles no longer exist. If a practice purchases EHR software that doubles as an electronic data capture (EDC) system for clinical trials, as we’ve described in the table above, then it’s way ahead of the curve in terms of efficiency and accuracy.

For years, there has been a growing push for EMR software to integrate with EDC systems. Greenway Medical Technologies is one company doing this through their PrimeResearch solution. In addition to designing their EHR software to natively submit data to EDC systems, Greenway is providing access to “a vast network of clinical studies, quality/safety initiatives, composite (clinical and financial) analytics that lead to more efficient processes, improved patient care and increased practice revenue.” Essentially, Greenway has created a turnkey solution to help practices participate in clinical trials.

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