BACKGROUND:

Clinical trials conducted in real world settings can improve the translation of research into practice. Although many experts have outlined strategies to conduct effectiveness research in primary care practices, there are few case studies describing how decisions and trade-offs influence the design and implementation of practical clinical trials.

METHODS:

This paper outlines the IDEALL (Improving Diabetes Efforts Across Language and Literacy) Project, a study of self-management support strategies for diabetes. We present a case study about translational diabetes research. We explore patient, clinician, and practice recruitment; which interventions to study; and decisions about the level of integration of interventions into practices.

RESULTS:

Recruitment strategies needed to take into account Institutional Review Board restrictions not allowing direct patient contact outside of the clinic. Patient diversity was increased by using a population-based database to identify eligible patients; clinic diversity was increased by including neighborhood and hospital-based clinics. An adjunctive model of care to provide interventions was used to avoid burdening clinics with integrating the interventions into clinical practice, but did not address the importance of sustainability in primary care settings.

CONCLUSION:

Practical clinical trials involve complex strategies, decisions, and trade-offs. Researchers engaging in translational research should continue to describe how design decisions may influence the interpretation of results.