Study Structure Models Comprehensive Interventions in Diabetes

Kidney disease occurs along a continuum, and for people who have diabetes, the risk of developing kidney disease is significantly elevated. In the United States, diabetic kidney disease (DKD) is the leading cause of end-stage kidney disease.

A new publication in the journal Contemporary Clinical Trials acknowledges that DKD has multiple risk factors, but to date, researchers have designed interventions that tend to target 1 risk factor at a time. This publication describes the study protocol, recruitment, and baseline participant characteristics for a randomized controlled trial that looks at several simultaneous interventions.

The Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study, in addition to looking at multifactorial behavioral interventions, examines medication management, comparing this intense approach to usual care. The goal is to determine if intense intervention mitigates kidney function decline at 3 years. Target participants were drawn from 7 primary care clinics in North Carolina who have diabetes and uncontrolled hypertension, and evidence of kidney dysfunction.

Practicing clinicians can learn from clinical trial structure. For example in this clinical trial, study pharmacists provide up to 36 monthly educational modules by telephone, and encourage home blood pressure monitoring. They also deliver medication management recommendations electronically to primary care physicians.

The STOP-DKD study emphasizes patient engagement; it is structured to ensure that the same study pharmacist calls the patient, promoting continuity of care and building trust. They decided to use a standard voice telephone, technology that was unlikely to intimidate participants.

In addition, they encouraged pharmacists to take the role of clinical champions and promote evidence-based DKD treatment strategies. Pharmacists communicated with treating primary care providers at times and in ways designed to lessen workflow interruptions.

The researchers have not yet evaluated their study results, but they report 1 observation: patient engagement with phone calls varied. Many participants were happy to spend more than the allotted time speaking with study pharmacists; others were more businesslike. The researchers reported that just a few patients ignored the calls. The researchers plan to examine differences in the way that pharmacists approach the calls or delivered scripted intervention materials to see if it affected patient response.

This study's importance is related to a national movement toward remote monitoring, and use of telehealth. We look forward with interest to the researchers final report, and encourage practicing pharmacists to model some of these interventions in their communities.

Reference

Diamantidis CJ, Bosworth HB, Oakes MM, et al. Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study: Protocol and baseline characteristics of a randomized controlled trial. Contemp Clin Trials. 2018;69:28-39.