Clinical Research Resources Office ReSPECT Registry & StudyFinder at BU/BMC
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1 Clinical Research Resources Office ReSPECT Registry & StudyFinder at BU/BMC Farrah Belizaire, BS R. Joshua Reynolds, BM Mary-Tara Roth, RN, MSN, MPH Clinical Research Resources Office (CRRO) November 14, 2012
2 Many, MANY thanks to.. BUMC Information Technology Application Services Adam Kozaryn Peter Flynn Karim Kabbara Christopher Dorney Khaled Khattar from the IRB BU Data Coordinating Center Ajay Sequeira Alice Bisbee Christine Chaisson And funding/support from CTSI, OCR, and DOM
3 Clinical Research Resources Office Supported by the BU CTSI, OCR, and DOM Serving all BUMC Clinical Researchers Regulatory Service and Education Program Consultation services Study implementation IRB application submission Tools and Resources (web- based) Education programs for all levels of the research team Support for sponsor-investigators of FDA-regulated research Quality Assurance Reviews Recruitment Services Program Consultation services Recruitment plans & materials ReSPECT Registry Resources Templates, tools, plans, etc. Community Outreach StudyFinder See our website: 3
4 Recruitment Services Program ReSPECT Registry The Recruitment Services Program of the Clinical and Translational Science Institute maintains a registry that serves as a way to connect potential research participants with clinical research investigators who are conducting studies in and around Boston University, Boston Medical Center, and affiliated community health centers. 4
5 Recruitment Services Program How can people join the Registry? 5
6 Recruitment Services Program Print Advertising Distributing card brochures throughout the city Ad in the Boston Metro Ad in The Bay State Banner Online Online survey Craigslist The Word Boston Boston Metro Website 6
7 Recruitment Services Program 7
8 Recruitment Services Program Recruitment at Information Tables BU/BMC Sites Community Health Centers Community events (health fairs, community breakfasts, etc.) 8
9 Recruitment Services Program 13,348 (6.9%) 8,045 (4.2%) 1,288 (0.7%) 7,267 (3.8%) 1,155 (0.6%) 445 (0.2%) 116 (0.1%) 66,078 (34.4%) Boston Medical Center Patient Profile WHITE BLACK/ AFRICAN-AMERICAN HISPANIC/ LATINO OTHER 33,815 (17.6%) ASIAN DECLINED / NOT AVAILABLE MIDDLE EASTERN BLANK 60,539 (31.5%) AMERICAN INDIAN/ NATIVE AMERICAN NATIVE HAWAIIAN/ PACIFIC ISLANDER 9 Source: Provided to Kimberly Russell by Clinical Data Ware house Manager, Linda Rosen, Boston Medical Center, May 2010 Recruitment Services Program of the Clinical And Translational Science Institute: ReSPECT
10 Recruitment Services Program ReSPECT Registry Race Demographics Asian or Pacific Islander 4% Native American 3% Hispanic 15% Other 7% White (not Hispanic) 30% Black (not Hispanic) 41% 10 Roughly 70% of Registry members have information linked to the CDW
11 People Recruited Recruitment Services Program Recruitment Totals May 2010 to October
12 How Can Investigators Connect? Using the Registry Investigators contact the Registry with basic information, their inclusion/exclusion criteria, and their IRB Protocol # (if study is already approved). Registry staff review inclusion/exclusion criteria to search the database for potential volunteers (Example: Black females, age 55 and up, who have diabetes). Health information can be searched via the Clinical Data Warehouse To move forward, investigators can then create a contact message and submit either with the IRB application or with an amendment to use the Registry Registry staff contact Registry members via , postal mail, or phone to inform them about the study. Registry members can contact the investigator themselves or Registry staff can have the research team contact them individually. 12 Consultations By appointment
13 13 How Can Investigators Connect?
14 How Can Investigators Connect? 14
15 How Can Investigators Connect? 4083: Total # in Registry as of 10/31/ : Total # participants recruited into the Registry in 2012 (as of 10/31/12) Separately # people recruited via internet: 416 # phone: 115 # in person: : # investigators recruiting from Registry in : Number of Registry members enrolled into studies 15
16 How Can Investigators Connect? Results of using the Registry 16
17 How Can Investigators Connect? Case Study: Dr. Jack & the Preconception Care Study Preconception Care Study ing Results November 5, 2012 Bounced Back (12) Registry Member Replied to Express Interest (8) No Reply from Registry Member (70) Preconception Care Study Cold Calling Results November 5, 2012 Number Not in Service (28) Registry Member Not Interested (8) 13% 9% Unreachable - Staff Left Voice Message or Mailbox Unavailable (47) Registry Member Agreed to be Contacted by Study (22) 21% 27% 78% 45% 7% 17
18 How Can Investigators Connect? Case Study: Dr. Wang & the Tools to Collect Family Health History Study Return Rate of Letters Sent in June 2012 for Family Health Study Return Rate of s Sent in September 2012 for Family Health Study Total Letters Returned as Undeliverable 14% Total s bounced back 18% Total Letters Delivered 86% Total s Delivered 82% 18
19 How Can Investigators Connect? Consultation Services Common Barriers to Recruitment Concerns about personal safety and loss of confidentiality Consents are getting longer and more complex Goals of research are not well understood Subjects often do not get results from the study Cultural competence and sensitivity Unprepared study staff 19
20 Community Outreach & Education To provide a better understanding of what the community needs in healthcare To relay some of the community s current concerns regarding health and safety about a study. 20 Diverse participation in research studies can improve the community s understanding of certain diseases or conditions that exist in the community Study results and/or examples shared with a community may help individuals to take personal action and change behavior to improve their health.
21 Community Outreach & Education 21
22 Community Outreach & Education 22
23 Community Outreach & Education Attendance BU/BMC Sites Annual Health Fairs Community meetings Massachusetts Research Subject Advocacy Group 23 Presentations Community sites and academic forums
24 24 Thank You
25 What is StudyFinder? Medical Campus website Lists BUMC research studies for public view, for purposes of: general publicity/collaboration and/or recruitment
26 What is StudyFinder? The StudyFinder website is about to go live. Currently, accessible for searching via the CRRO- Community website: Will be posted on various BU/BMC websites Current StudyFinder listings: 427 General Publicity 21 Recruitment
27 What is StudyFinder? Listings are approved administratively by the CRRO. Per OHRP guidance, the listing itself will not require IRB approval. However, your protocol must be approved by the IRB for the listing to go live on the StudyFinder website.
28 General Publicity Listings Study title, the Study Summary (from the Summary in INSPIR Section 8), PI name and .
29 General Publicity Listings Expanded view (with Summary)
30 Recruitment Listings List view: title, purpose
31 Recruitment Listings Expanded view: title, purpose, eligibility, payment, contact, PI name and From INSPIR Study Summary (optional)
32 Looks great! How do I get one? If you have a new protocol, then in INSPIR.. Check whether or not you want the general publicity listing in Navigation Section Check whether or not you want the recruitment listing in Recruitment section of INSPIR. If you only want general publicity listing, that is all you have to do! If you want a recruitment listing, you must complete a simple form within the Submissions Forms in INSPIR.
33 Looks great! How do I get one? If you have an already submitted, or already approved protocol or if you want a recruitment listing, complete the StudyFinder Form in Submissions Forms in INSPIR. Full tutorial on completing the SF form available on the CRRO website (and as a link in INSPIR). What follows are a few of the slides from the tutorial.
34 Under Submission Forms, click on StudyFinder Form.
35 Click Add New Form.
36 For a General Publicity listing only: Complete Section 1 (1.2 should be yes and 1.3 should be no ) ; click Save and Continue to the Next Section. For a Recruitment listing plus General Publicity: Complete Section 1 (1.2 should be yes and 1.3 should be yes ); click Save and Continue to the Next Section.
37 Complete Section 2 (items ). Then click Save and Continue to the Next Section.
38 This is the sign-off screen. Click Notify PI to Sign off, or if you are the PI click Sign off and Submit (as in this example). You can also click here to go to the CRRO website for information about StudyFinder. The form will be routed to the CRRO for review, and once approved will appear in the StudyFinder website (as long as there is initial IRB approval for the protocol). These listings do NOT require an amendment to the IRB.
39 Helpful Hint in Creating your Listing If you decide to include your INSPIR Study Summary in your Recruitment listing, read it to make sure it is in SIMPLE LAY LANGUAGE.
40 Accessing StudyFinder From CRRO-Community Website:
41 Accessing StudyFinder From CRRO-Investigator website: (Click Recruitment and then StudyFinder) Coming soon.. Link to StudyFinder from other BMC/BU patient-related web-pages
42 Thank you!! Any questions?
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