VA, Stanford test point-of-care diabetes research

A team from the Department of Veterans Affairs (VA) and Stanford University is exploring a new approach to clinical trials that may be easier to translate into practice. An online article 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.

The approach was developed by a team led by informatics expert Louis Fiore, MD, of the VA Boston Healthcare System and Boston University; and Stanford University biostatistician Philip Lavori. Co-authors include researchers at the VA Boston Healthcare System’s Massachusetts Epidemiology Research and Information Center.

Features of the VA-Stanford trial include:
  • Enrollment and randomization of study volunteers occurs during regular care—within the framework of a patient’s visit to his or her usual healthcare provider.
  • Providers draw on data from EMRs—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.

The pilot study 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 EMR system includes electronic ordering and protocols for both methods, which are used with equal frequency at the Boston-area VA medical facilities where the study has been taking place, according to the agency.

As the study progresses, the EMR system will track which approach is associated with the best outcome. Eventually, software in VA’s EMRs 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 VA stated. 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.

Funding for the study came from VA’s Cooperative Studies Program and the National Institutes of Health.

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