The Infectious Disease Clinical Research Program (IDCRP), a military drug trials group, is using a tablet solution to eliminate errors and inefficiencies in studies aimed at improving healthcare of military personnel overseas.
Formed in 2005 through an interagency agreement between the National Institute of Allergy and Infectious Diseases (NIAID) and the Uniformed Services University (USU), IDCRP’s current study would have involved 20,000 paper-forms before the adoption of tablets. The workflow also would have entailed double-key data entry that may have resulted in errors and delays.
With three remote sites, all outside the U.S., the IDCRP needed a solution that would allow clinical research coordinators and investigators to enter data, as well as enroll new subjects and review existing subjects, all offline. In addition, an audit trail was mandatory to remain compliant.
Offline a Must
The organization reviewed numerous solutions during a months-long procurement process, with the primary driver being the need for offline data capture and a way to maximize mobility. The IDCRP decided on the Mi-Forms Tablet-forms app, running on Sahara i500 Tablet PC.
The devices, operating on Windows 7, were chosen for their battery life, weight and ruggedness, said Josh Kumpf, Mobile Technology Specialist, IDCRP, in an interview with Mobile Enterprise.
As a result of implementing the solution, with its offline data-entry capabilities, a time savings of 50% was realized. Query resolution was also immediate, rather than weeks or months, and compliance by coordinators increased. (Eighty percent of the coordinators say the solution is more efficient than paper.)
“Doctors’ and nurses’ time is very valuable,” Kumpft said. By capturing data where it originates, in real-time, as opposed to the previous paper process, gives time back to the practitioners. In addition, “the cleaner the data off the bat, the better it is.”
Doctors and nurses, whether online or offline, can program numerous logic checks so that data is captured accurately. Take temperature for example. The vital sign must be in an acceptable range, or something is seriously wrong — 72 degrees Fahrenheit is not possible. If a user accidentally enters this, or another alarming amount, a validation rule will issue an alert, a pop up message similar to “Are you sure you want to type in 72 degrees Fahrenheit? Normal range is 96 and 104.”
Logic checks can either be critical — meaning a user can’t upload data until the information is correction —or non-critical, which allows the user to continue but still receives a reminder. The IDCRP uses a combination of Mi-Forms logic check scripting, which can be programmed for complex functionality, as well as a helpful validation rules wizard which allows if/then statements, Kumpft explained.
One to two hours is all it takes to train new users on the system. “It is a testament to how intuitive the software is,” Kumpft said.
With minimal training required, and immediate results, it is no surprise that feedback has been positive. The handwriting recognition feature, in particular, is great for a clinical setting, Kumpft noted. “It allows us to teach doctors and nurses who are used to filling out case study report forms, to capture digital data very easily.” (Clinicians employ a stylus on a digital form.)
Based on preference, a user can switch views from horizontal to vertical, with the push of a button. Data entry itself also mimics a paper form, but of course, offers much more: backend functionality.
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