ULTRA is a five-year group randomized clinic trial of 60 primary care practices in New Jersey and Pennsylvania that use RAP to enhance the care delivery for multiple chronic conditions.
Three hundred twenty-one patients who needed fixed orthodontic therapy and were referred to the Orthodontic Clinic of Dental School at Shiraz University of Medical Sciences, Iran, were selected for this prospective double-blind randomized clinical trial investigation.
The 12-month, randomized, clinical trial enrolled 1,024 patients with noninsulin-treated type 2 diabetes (median baseline HbA1c, 7.3% [IQR, 6.9 7.8%]) at 39 diabetes clinics in Italy.
Because the intervention was delivered within the setting of routine clinical practice, we randomized the clinics rather than the individual participants to avoid contamination.
Participants randomized to clinic pap group (standard of care) were asked to follow up with their established clinic for a Pap test within 3 months of enrollment.
One cluster RCT was randomized at clinic [ 18], and the remaining four trials were randomized at a patient level [ 14- 17].
In this study, 577 adults with IGT were randomized by clinic site to one of three conditions or a no treatment control: a diet-only intervention, an exercise only intervention, or a combined diet and exercise intervention.
One limitation of the pilot study was that we were not able to randomize the clinics, which may have caused some baseline differences between the participants of the intervention and the control clinics [ 19, 20].
In future studies, this effect may be prevented by randomizing the clinics participating, whereby all physicians receive the same educational intervention rather than randomizing physicians into specific the study groups.
The most important reason for randomizing the clinics instead of individuals – i.e. public health nurses (PHN) or pregnant and postpartum women – is the likelihood of contamination of the PHNs' counselling practices.
