| Study Element | Challenges | Facilitators | Recommendations |
|---|---|---|---|
| A. Regulatory procedures | ∙ Tracking of complex IRB and R&D documents and multiple, sequenced regulatory steps ∙ Delays in turnaround time; across-site differences in review committee dates and processes ∙ Regulatory document version control across sites | ∙ Weekly calls with site coordinators, study team, and WH-PBRN program manager ∙ Availability of VA Central IRB (to streamline efforts and enhance cross-site consistency in regulatory processes) ∙ Strong relationship with VA Central IRB | ∙ Start early ∙ Inquire about availability of administrative pre-review of IRB submission documents ∙ Develop IRB tracking systems for each study site (eg, for review committee deadlines, document version control) ∙ Generate timeline of due dates for all sequential regulatory steps |
| B. Building the sampling frame | ∙ Pulling national data requires permissions and programming expertise ∙ Accessing clinic schedules is not a one-size-fits-all process for all sites | ∙ Centralized national EMR data can be converted to a recruitment mailing list ∙ Access to core data analysis staff who can process complex databases ∙ Local IT systems can generate clinic lists ∙ Stable cohort of site leads with long-term local relationships | ∙ Build relationship with local health care system's IT support, who can advise on the most efficient way to access and customize clinic lists ∙ Allow flexibility for each site to adapt its own process (eg, evening or weekend hours for site coordinator recruitment calls) |
| C. Participant contact | ∙ Outdated contact information ∙ Number of contact attempts limited by IRB protocol; failure to reach many participants by phone ∙ If reached, limited time to talk and poor recall of study mailing | ∙ Bulk mailing notifying eligible women that they might be contacted addressed prohibition against cold calls ∙ Approaching women directly in clinic (eg, women's health clinic) was often successful | ∙ Send rolling or multiple mailings to reduce problems with recall of the mailing ∙ Allow for flexibility in site coordinator hours ∙ Create flexible phone scripts ∙ Train site coordinators at all sites to ensure cross-site fidelity in content area and study procedures |
| D. Participant tracking systems | ∙ Variability in research staff knowledge of the software that was used to track participant contact ∙ Complexity of coordination around maintaining databases centrally vs locally | ∙ Access to existing tracking systems that were already in use | ∙ Provide cross-site training in database software ∙ Regularly back up databases at site and at coordinating center; standardize cross-site naming conventions for “live” versus “backup” database files ∙ Consider carefully what is essential to track (eg, for regulatory monitoring, for response rate calculations, or for recontacting participants) |
| E. Logistics of clinic-based recruitment | ∙ Clinic environments are dynamic ∙ Clinic appointments may start/run late, patients may be “no-shows,” or providers may have a day off ∙ Limited clinic space for interviews and limited private space for productive downtime for site coordinator ∙ Site coordinator travel time between clinic and research locations ∙ Logistics of securing paper data during transit ∙ Multiple studies recruiting from same clinic, competing for same pool of eligible participants and clinicians ∙ Research participant “burnout” or recruitment saturation due to special population with limited pool of eligible participants | ∙ Strong relationships with clinic staff ∙ Familiarity with clinic layout and flow ∙ Successful phone contact improved patient show rate for the clinic visit (thus benefitting the clinicians) | ∙ Coordinate efforts of site coordinators and clinic staff to avoid disruptions to clinic flow ∙ Provide flexible interview times/locations ∙ Locate computer workstations for site coordinator use between interviews ∙ Obtain locked bags for transporting sensitive documents between clinic and research office ∙ Seek communication among researchers when studies recruiting from the same pool of patients may coincide ∙ Stagger studies so clinicians are not overburdened |
| F. Participant enrollment | ∙ Participants sometimes intimidated by HIPAA language ∙ Participant time constraints (eg, VA shuttle schedule, travel time, caregiving responsibilities) | ∙ Strong perception that women wanted to help other women veterans | ∙ Simplify HIPAA language/train site coordinator to address participant concerns around HIPAA ∙ Provide incentives when possible ∙ Describe policies about children attending research visits in protocol |
| G. Ensuring effective clinic partnerships | ∙ Clinic environments are busy, and, appropriately, research is not the top clinic priority ∙ Clinic staff heavily committed to clinical duties | ∙ Strong relationships between site lead and clinic leadership ∙ Clinic staff accepted role of assisting with scheduling, identifying participants, finding clinic space | ∙ Garner leadership support (at the facility and clinic levels) ∙ Provide study in-service to clinic staff ∙ Introduce site coordinators to clinic staff ∙ Have site leads and site coordinators regularly attend clinic team meetings ∙ Be visible: build relationship with clinic staff during slow times; attend events and meetings ∙ Recognize added demands imposed by research and express gratitude to clinic team |
EMR, electronic medical record; HIPAA, Health Insurance Portability and Accountability Act; IRB, institutional review board; IT, information technology; R&D, research and development; VA, Veterans Health Administration; WH-PBRN, VA Women's Health Practice-Based Research Network.