Patients, Practices, and Relationships: Challenges and Lessons Learned from the Kentucky Ambulatory Network (KAN) CaRESS Clinical Trial

Build and nurture long-term relationships with practices

Make physician-to-physician contact for practice recruitment

Make nurse-to-nurse contact to prepare to implement study

Minimize burden on practices

Emphasize patient safety and satisfaction in research processes

Provide ongoing and timely support for practice participation

Adapt feasible processes for each practice’s participation

Budget generously in terms of project funding and timeline

Bring lunch for practice orientation and instruction

Faculty time for practice recruitment and ongoing problem-solving is significant

Project staff time is extensive for patient recruitment and follow-up, as well as for repeated visits to practices

Reimburse practices for the time their staff members contribute

Anticipate mileage costs and staff time for extra practice visits (eg, for rescheduled patient visits)

Sophisticated statistical support is needed throughout the design, implementation, and analysis of the study, in addition to research assistance, data entry, and data management

Use pilot projects to help estimate likely patient eligibility across multiple practices

Ensure more than adequate power (>80%, eg, 90%) in the sample size calculations to protect against unanticipated problems with patient recruitment or retention

Identify institutional issues, such as parent company policies about fees for conducting research

Facilitate successful study implementation in the practices through careful planning, training, and ongoing support

Assure adherence to the protocol through standardized procedures and training, and ongoing checking of these systems

Evaluate practice resources when deciding to involve each practice (ie, staff availability, space availability)

Control the data collection processes when possible

Maintain timeline integrity by avoiding lengthy extensions of the patient recruitment period at any given site

Proactively address IRB issues in depth, promoting understanding of PBRN research issues