The University of Michigan Spinal Cord Injury Research Registry Registries for patient recruitment

1. The University of Michigan Spinal Cord Injury Research RegistryRegistries for patient recruitment Claire Z. Kalpakjian, Ph.D., M.S. Rachel Hartwig, B.S. September 21, 2012

2. Research Registries &Recruitment • A Registry developed specifically for recruitment focuses on connecting researchers with potential participants • Creates a bridge between the person and a researcher that allows for connection, but protects confidentiality of the potential participant • Makes explicit to the participant how information is shared (by the Registry) and how contact with researchers will occur; no cold calls • Allows the person to say “no” before contact is attempted; avoids putting them on the spot; the Registry is a neutral “middle man” • Makes recruitment efficient for researchers; usually one of several ways to recruit participants

3. Spinal Cord Injury (SCI) & Research Registries • SCI is a relatively rare, but devastating, injury – 40 cases/million; ~270,000 living with SCI in the US • The SCI Model Systems is a national registry of over 27,000 persons with traumatic SCI (largest in the world) • BUT…it is limited for facilitating other research • Only includes those who have traumatic injuries • Only includes those seen at the UMHS • Which leaves out a lot of people in a rare population • And so a Registry was born!

4. Characteristic of SCI Registry Participants • SCI Registry open to anyone who has a spinal cord injury • Not just “patients” from the medical center, but people with SCI in the community (friends tell friends) • Injury characteristics of the Registry • Leading cause: motor vehicle accident (42%) • Most common level of injury: C5 (tetraplegia) • Time since injury: 14 years on average • Basic demographics • Average age: 48 years old • Gender: 239 males (73%)/88 females (27%) • Race: 280 Caucasian (78%)/40 African American (11%)/5 Hispanic/Latino (1.4%) • Preferences • 61% provided an email address • 28% are willing to travel (mostly limited due to mobility and finances)

5. Flow of Enrollment to Engagement

6. Ideal Registry Coordinator Qualities • Broad knowledge-base • A coordinator must act as both a gateway for resources and a possible entry point to the health system • Commitment • Invested in the Registry, its success and its participants • Cultural competence • A diverse pool of potential participants requires a strong cultural competence and special attention to the demographics of the target population • Patient-centered approach • Recruitment may occur in a medical model but its vital to maintain a compassionate approach that acknowledges the patient as an individual with their own life story

7. Getting the Word Out for Recruitment • Where? • Inpatient, Outpatient and Community • How? • Flyer • Website • Personal visit • Professional referral • Community integration • Continual process! • Finding what works for you and focusing on that strategy

8. Screening for Enrollment • When screening participants… • Ask the right questions to get the information you need • Identify common conditions to exclude • Refer ineligibles to other possible registries in your department or at large (e.g., www.umclinicaltrials.org ) • Be aware of recruitment bias in Registries • These are people who want to do research and lots of it! • Informed Consent and HIPAA Waivers • Streamline the process and ease the burden on participant and recruiter alike • Increase the chances of successful transition from screening to enrollment

9. Getting to “Yes!” • Time your entry • Ask for a second opinion; make it a team effort • Highlight the main reasons to participate • Its all about the money! In fact, its not at all about the money • Address and break down possible barriers • Stereotypes of the recruiter that may influence the decision to join or not (e.g., age, race, gender, etc.) • Preemptive and structured responses • Encourage input from other health professionals • Take precautions to avoid coercion, but don’t underestimate the power of a few words • Be flexible!

10. Setting Expectations for Participants • Joining for one reason or a specific study • In SCI, likely to be stem cell or “cure” research BUT stem cell research still in very early phases for SCI • Wide variety of possible studies • From over the phone to in the lab; two minutes to two days; medical testing to survey response • Frequency of contact from the Registry and potential studies • Possibility for extended lag or clusters of invitations • Opt in/opt out response structure • What that really means for participants

11. Retention of Participants • Initial transparency • Tailored contact • Preferred method and time of day • Updating contact information • Especially vital in patient populations that may move or enter nursing homes frequently • Continuous contact • Birthday/holiday/thank-you cards • Newsletters • Alternate contacts • Prompt and courteous communication

12. Investigator Access • The Application for Investigators must be • Concise but thorough, with clear requirements for use • Easy to access and retrieve information (e.g., Qualtrics) • Be prepared for pressure • Study coordinators may press for immediate additional contact information, but its your job to stick to the protocol • Be prepared to pressure • Study coordinators may need a few reminders to return progress reports and end-of-study update • Clarify how to handle participants who wish to withdraw from the Registry • Refer these individuals to the Registry coordinator

13. Feedback from Participants • Annual surveys • A short, anonymous online survey completed via Qualtrics to ascertain participant satisfaction and suggestions • The 2012 survey had 21 respondents out of 198 total (11%) • Participants felt they had enough time to opt-out and would appreciate receiving a Registry newsletter update. • Personal feedback • “I would like to hear the outcome of these studies.” • “I never seem to get contacted after getting an initial letter stating that I would be contacted…” • “I participated in a survey two years ago and have very little since…” • “I would like to help in many ways the best I can… It gives me something to look forward to...”

14. Trouble-Shooting • Community-based samples and/or open enrollment criteria may require discretion in screening • Word of mouth may make the Registry appealing in the wrong circles • Some essential information may not be able to be verified in medical records • Setting your registry apart from other studies and other registries • Dealing with participants who have had poor UM/UMHS experiences • Over-burdening participants • Monitoring the users of the Registry • Evolving Registry profile

15. Thank you!Clairez@umich.eduHartwigr@umich.edu