Table 1.
Instrument | Primary Data Collected | Completed by | Time Point |
---|---|---|---|
Specialty Clinic GIS Information |
Population percentages within 30 miles of specialty clinic, minority, foreign born, non-English speaking; other socio- economic and healthcare access markers |
RECRUIT Team from Census Data | Before determination of eligibility |
Specialist Investigator Demographics Form |
Demographics, clinical trial experience, Average number of patients on protocol for any trial at a specialty clinic |
Specialist Investigator | Baseline, consenting specialty clinics |
Coordinator Demographics Form |
Demographics, education, clinical trial experience |
Coordinator | Baseline, consenting specialty clinics |
Self-Efficacy and Outcome Expectations Questionnaires36 |
Confidence in planning effective recruitment, implementing a plan to recruit minorities, communicating with patients, communicating with recruitment sources |
Specialist Investigators and Coordinators (separate forms) |
Kick Off End of modules End of intervention |
Enrollment Logs | Patient age category, gender, ethnicity, and date of enrollment |
Parent Trial Coordinating Center | Monthly |
Screening Logs** | Race/Ethnicity, age category, gender referral source, reason for refusal |
Coordinator or Parent Trial Coordinating Center |
Monthly |
Recruitment Activity Checklists** |
Frequency of common recruitment activity types |
Coordinator | Monthly |
Patient Satisfaction Survey78,79 ** |
Anonymous satisfaction rating on interactions with clinic staff, convenience of visit, and comfort level |
All screened potential participants and enrolled parent trial participants (voluntary) |
Every Screening and Study Visit |
Key Informant Interview67 |
Semi-structured open-ended questions about minority recruitment strategies and intervention components |
Interviewer independent of RECRUIT Team interviewing Specialist investigators’ and coordinators’ from consenting specialty clinics |
End of the RECRUIT intervention |
Specialty clinics are followed for two years from enrollment in RECRUIT or until the end of recruitment for their parent trial, whichever occurs first.