Article Figures & Data
Figures
- Figure 1.
Study processes (letters reference the study elements in Table 1). IRB, institutional review board.
Tables
- Table 1. Challenges, Facilitators, and Recommendations from Initiating the First VA WH-PBRN Study
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 stepsB. 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to adapt its own process (eg, evening or weekend hours for site coordinator recruitment calls)C. Participant contact ∙ Outdated contact information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 proceduresD. 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 overburdenedF. 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 protocolG. 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 teamEMR, 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.
