Lessons learned from two randomized controlled trials: CITIES and STOP-DKD

Leah L Zullig; Megan M Oakes; Felicia McCant; Hayden B Bosworth

doi:10.1016/j.conctc.2020.100612

Lessons learned from two randomized controlled trials: CITIES and STOP-DKD

Contemp Clin Trials Commun. 2020 Jul 8:19:100612. doi: 10.1016/j.conctc.2020.100612. eCollection 2020 Sep.

Authors

Leah L Zullig^{1

2}, Megan M Oakes², Felicia McCant¹, Hayden B Bosworth^{1

2

3

4}

Affiliations

¹ Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, NC, USA.
² Department of Population Health Sciences, Duke University, Durham, NC, USA.
³ School of Nursing, Duke University, Durham, NC, USA.
⁴ Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.

Abstract

Background: Even well-designed, theoretically driven clinical trials can fall short of achieving the desired clinical outcomes. Our research team had an opportunity to conduct two randomized controlled trials that were enrolling patients in parallel. While both studies were targeting chronic disease management among patients with multiple comorbid conditions, the patient population and settings varied. The studies were the Cardiovascular Intervention Improvement Telemedicine Study (CITIES) and Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) studies. Both studies had null findings.

Objectives: Our goal is to discuss common design considerations across CITIES and STOP-DKD and potential implications for the design of future randomized controlled trials.

Methods: These were two 1:1 randomized controlled trials with attention control groups that recruited patients from various clinical practices in the Research Triangle area of North Carolina.

Conclusions: We make three recommendations for future studies. First, we assert that it is important to allow for piloting the enrollment process to ensure that it is possible to identify and recruit a patient population that is well aligned with the clinical outcomes of the intervention. Second, analysis plans should be more targeted in their approach and should consider heterogeneity of treatment effects. Third, in order to support the transition of evidence generated from randomized controlled trials into clinical practice, it is important to consider even early stage randomized controlled trials through an implementation science lens.

Trial registration: Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) NCT01829256; Cardiovascular Intervention Improvement Telemedicine Study NCT01142908.

Keywords: Cardiovascular disease; Clinical trials as a topic; Medication adherence; Pharmacists; Research design.

Associated data

ClinicalTrials.gov/NCT01829256
ClinicalTrials.gov/NCT01142908

Abstract

Associated data

Grants and funding