Using a Warm Hand-Off Approach to Enroll African American Caregivers in a Multi-Site Clinical Trial: The Handshake Protocol.

"Testing Tele-Savvy" was a three-arm randomized controlled trial that recruited participants from four National Institute on Aging (NIA)-funded Alzheimer's Disease Centers with Emory University serving as the coordinating center. The enrollment process involved each center providing a list of eligible caregivers to the coordinating center to consent. Initially, the site proposed to recruit primarily African American caregivers generated a significant amount of referrals to the coordinating center, but a gap occurred in translating them into enrolled participants. To increase the enrollment rate, a "Handshake Protocol" was established, which included a warm handoff approach. During preset phone calls each week, the research site coordinator introduced potential participants to a culturally congruent co-investigator from the coordinating center who then completed the consent process. Within the first month of implementation, the team was 97% effective in meeting its goals. This protocol is an example of a successful, innovative approach to enrolling minority participants in multi-site clinical trials.