Large trial proposed to compare HCTZ, chlorthalidone
(HealthDay)—A large randomized trial is being developed to compare the effectiveness of hydrochlorothiazide with chlorthalidone in Veterans Affairs (VA) patients, according to an Ideas and Opinions piece published online Aug. 16 in the Annals of Internal Medicine.
To develop efficient, less expensive clinically integrated trials, Frank A. Lederle, M.D., from the Minneapolis Veterans Affairs Health Care System, and colleagues established a trial by embedding processes within the VA electronic medical record (EMR). They plan to randomize veterans older than 65 years currently prescribed uncombined hydrochlorothiazide to continue on hydrochlorothiazide or receive open-label chlorthalidone. The trial will enroll 13,500 patients over three years and follow them for three years in order to detect a 17.5 percent relative reduction in the composite cardiovascular outcome.
The researchers note that key aspects of the design that make the study feasible are use of centralized study processes and relying on the patient's usual primary care physician instead of on-site personnel. This involves identification of eligible patients using the VA EMR. Several processes are unique to this study, including a new method for trackable order dialogue with primary care clinicians using remote order placement on the VA EMR. Use of a phone bank to enroll and obtain patient consent completes the centralization of study functions.
"The principal purpose of our design innovations was to reduce the infrastructure and cost of a large randomized trial," the authors write.
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