WASHINGTON –  A team from the Department of Veterans Affairs (VA) and Stanford University is exploring a new approach to clinical trials that experts say will cost less and be easier to translate into practice.
“It demonstrates an effective way to use electronic medical records to improve health care at a local level.”

A paper just released online in the journal Clinical Trials describes a “point-of-care” study now under way that will involve more than 3,000 Veterans with diabetes. The trial will compare two methods of treatment like many randomized clinical trials, but the approach embeds research into routine clinical care. It compares treatments that doctors are already using, and collects data on which treatments work best within the context of real-world, everyday practice.

“Point-of-care studies allow us to make randomized comparisons within the health care system, instead of ‘extracting’ patients and placing them in a special setting and protocol that are not part of everyday care,” said Dr. Joel Kupersmith, VA’s chief research and development officer.
 
The new approach was developed by a team led by informatics expert Dr. Louis Fiore of the VA Boston Healthcare System and Boston University; and Stanford University biostatistician Philip Lavori.

Key features of the new model include:

• Enrollment and randomization of study volunteers occurs during regular care – within the framework of a patient’s visit to their usual health care provider.
• Providers draw on data from electronic medical records -- or receive electronic alerts, delivered at the point-of-care -- to determine if a patient is right for a study.
• Patients who agree to take part are randomized into one of the study’s treatment arms and continue to receive care from their regular providers, with little or no deviation from routine care.

According to the Clinical Trials paper, a point-of-care trial shifts away from the asynchronous, distinct and separate environments of research and clinical care, toward a real-time integrated system of research-based care. The goal of the trial is to deliver the best care to patients while learning from each experience and redefining that care.

The pilot study now being conducted in VA compares two methods of administering insulin to hospitalized Veterans. In the sliding-scale regimen, short-acting insulin is given three to four times a day according to an algorithm that factors in blood sugar levels, planned activities and sugar consumption. In the weight-based protocol, patients receive longer-acting insulin throughout the day in doses based on their weight.
 
VA’s electronic medical records system includes electronic ordering and protocols for both methods, and they are used with equal frequency at the Boston-area VA medical facilities where the study has been taking place.
“The idea of embedding research into clinical care has been around for quite a while, but to my knowledge this is the first time that a randomized trial has been fully integrated into a hospital’s informatics system,” said Fiore. “It demonstrates an effective way to use electronic medical records to improve health care at a local level.”
 
He added, “The pilot study has been so successful that we plan on rolling it out to other VA hospitals over the coming months.” VA’s electronic medical record system -- the nation’s largest and most sophisticated -- makes for an ideal environment in which to conduct this type of research.

As the study progresses, the health record system is tracking which of the two approaches is associated with the best outcome. Eventually software in VA’s electronic medical records will begin to direct more patients to the treatment that has proven more effective. The research process will continue until the estimated probability that one treatment is better than the other tops 99 percent.

The ideal result is that the evidence gained from the trial is incorporated quickly and inexpensively into everyday practice, overcoming the need for costly and often disruptive large-scale implementation.

Fiore’s and Lavori’s co-authors on the Clinical Trials paper are researchers at the VA Boston Healthcare System’s Massachusetts Epidemiology Research and Information Center. Funding for the study came from VA’s Cooperative Studies Program and the National Institutes of Health.