Successful program for recovery of dropouts to a clinical trial

This is a report of a successful program to return dropout participants to active participation at a single clinic of a multicenter long-term clinical trial, the Coronary Primary Prevention Trial of the Lipid Research Clinics Program. The specific objectives were to re-engage dropouts into active participation and to have them resume study medication. Thirty-six men had been absent from the Baylor-Methodist Clinic for 10 months to over four years. The program focused on resolving the presenting problems: psychosocial, somatic, and drug adherence. It was based on six general principles with corresponding goals and employed 13 activities and procedures in a specific operational sequence for reinstitution of the Coronary Primary Prevention Trial protocol. Counseling techniques were used to improve protocol adherence. The recovery program was monitored bi-weekly by computer. The dropout group did not appear to exhibit any biases and approximated the remainder of the Baylor-Methodist cohort demographically. At six months into the recovery program, 90 percent of the dropouts had been recovered. Seventy percent of the recovered participants re-established medication-taking behavior. The mean rate of adherence to medication for all of the recovered group was 35 percent of the prescribed dose, 8 g per day. Review of the data for the cholesterol differential between the two treatment groups demonstrated a favorable effect of the reinstitution of the study medication. The program's methods are applicable to clinical practice.