Table 2.

Key Recommendations for Planning Randomized Controlled Trials with Consented Patients in Primary Care PBRNs*

  • 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

  • * PBRN, practice-based research networks; IRB, Institutional Review Board.