Patients, practices, and relationships: challenges and lessons learned from the Kentucky Ambulatory Network (KAN) CaRESS clinical trial.

The Cardiovascular Risk Education and Social Support (CaRESS) study is a randomized controlled trial that evaluates a social support intervention toward reducing cardiovascular risk in type 2 diabetic patients. It involves multiple community-based practice sites from the Kentucky Ambulatory Network (KAN), which is a regional primary care practice-based research network (PBRN). CaRESS also implements multiple modes of data collection. The purpose of this methods article is to share lessons learned that might be useful to others developing or implementing complex studies that consent patients in PBRNs. Key points include building long-term relationships with the clinicians, adaptability when integrating into practice sites, adequate funding to support consistent data management and statistical support during all phases of the study, and creativity and perseverance for recruiting patients and practices while maintaining the integrity of the protocol.