Approximately 10,000 sq. ft. in the IOA-CTRB are dedicated to clinical research space. That space includes 1,000 sq. ft. of physical performance laboratory and 15 dedicated interview, assessment, and examination rooms, and a 25-meter corridor specially dedicated to performing walking testing. The facility has a street address, dedicated parking lot in front of the building and a direct entrance to facilitate access of research participants, a reception and waiting area, exam and interview rooms, meeting rooms, procedures rooms, a biological specimens processing laboratory, data entry stations, study coordinators offices, a study drugs storage room, and several secured storage areas for study documents and areas for freezers for biological specimens.
Biodex–Cybex: The Biodex dynamometer provides resistance throughout a joint’s range of motion to assess isometric, isokinetic, and isotonic muscle strength. The resistance is provided using an electric or hydraulic servo-controlled mechanism at a user-defined constant velocity for isokinetic measures. With the interfacing of Biodex isokinetic dynamometers, objective measures of human muscle function on variables related to torque, power, and endurance can be obtained. The system is designed with two output analog outputs to allow integration with the Biopac system for 1000 Hz temporal resolution.
Dual-energy X-ray Absorptiometry (DXA): A Hologic Discovery QDR Series (2011 Discovery Model, Hologic Inc. Bedford MA), is dedicated to research studies at the IOA-CTRB. All DXA operations are performed by a technician holding a Basic X-ray Operator License from the State of Florida. The technician has also received DXA-specific training from the manufacturer and follow-on training through the International Society for Clinical Densitometry, the latter leading to designation as a Certified Densitometry Technologist.
2008 Honda Odyssey Touring Elite Mini-van. The IOA and OAIC own and operate a van to service participants with transportation needs. Transportation will be available for all participants enrolled in the proposed study.
Health Promotion Research Center
The Institute on Aging UF OAIC hosts the Health Promotion Research Center, a 6,400 sq. ft. facility that is dedicated to lifestyle intervention studies (physical activity and counseling programs), contains a walking track area with adjacent space for counseling sessions (please see floor plan below). The participants have free parking located in the hospital visitor parking lot that is approximately 100 yards from the intervention facility. The participants are greeted in an aesthetic atmosphere containing appropriate pictures and magazines prior to the intervention session. There are two separate waiting rooms and two changing/shower rooms for research study participants. Restroom facilities are located in three locations within a 50 ft radius. Interventionists, staff, and faculty have offices located on-site with access to computers and phones. Staff will have offices located on-site including a dedicated track office with access to computers, phones, two AED’s, and first aid equipment for monitoring adherence and safety of participants.
The track is a cushioned surface with two walking lanes. The walking distance is 200ft/lap just under 1/27th of a mile. The track area is also equipped with various strength, balance training equipment and space for conducting a wide variety of physical activities. A balance bar is bolted to the walls at a height of 1 meter and stretches across (8 meters) of floor to ceiling mirrors to aid in balance for studies on compromised older adults. The facility also has a large conference area (25 x 15 feet) equipped with a kitchen and audio/video equipment for holding focus groups and team meetings. The educational room is highly versatile. Rolling tables can be arranged in numerous ways to promote group interaction or 1:1 collaboration with participants and staff. The equipment can be easily transitioned into storage for when classrooms need additional space for stretching and mobile activities such as yoga or dance class. A portable projector (Dell Liquid Crystal Display) and laptop (Dell Precision) are provided for healthy aging presentations and guest speakers. A demonstration kitchen is used for classes on nutrition, healthy eating, and meal preparation. Three 4’ x 8’ dry erase boards are available to promote classroom discussion (please see floor plan below).
Resources for Research Study Participant Recruitment
The IOA-CTRB also houses the “screening and recruitment suite”. The OAIC recruitment program combines the resources of the IOA, the Department of Aging and Geriatric Research, the Division of Geriatric Medicine, the College of Public Health and Health Professions at UF, the North Florida/South Georgia Veterans Health System and its Geriatrics Research, Education, and Clinical Center (GRECC), and the UF Health Shands Hospital and Health Care System. The screening suite occupies four cubicles, a coordinator office, and a small meeting/ whiteboard area. Each cubicle and the coordinator’s office is equipped with an IP telephone (with multi-line, caller-ID, mail forwarding, and voice mail capability). Each phone is also equipped with a wired or wireless headset. The phones are connected in a “rollover phone bank”, so that if a particular phone in the tree is busy, calls are immediate to the next available line. Only when all five phones are busy or unattended (e.g., after business hours) does voicemail capture the caller’s information. When a participant is reached, initial screening occurs using a CATI (Computer Assisted Telephone Interview) framework. Using a web-enabled interface, the present study will be selected and data entry will occur in real-time so that accrual reports can be generated. The Recruitment Program has several display stands for use in community health fairs and other screenings, as well as an LCD projector and laptop computer for computerized public presentations and slide shows. The recruitment facility also possesses a high-resolution scanner, a digital camera, and a color printer dedicated to the production of high-quality recruitment material such as brochures, flyers, and letters.
The RC1 Core of the UF OAIC is tasked with ensuring (a) a steady flow of prospective participants to supported studies, (b) that participants are diverse and heterogeneous with respect to disability status and race/ethnicity, and (c) that affiliated investigators (especially REC Scholars) have access to necessary information regarding feasibility, participant availability, and strategies for communicating with prospective participants. A key goal of the RC1 Core is to support the generalizability and external validity of study findings. To ensure adequate representation of low functioning older persons in its studies investigators have developed substantial experience with the recruitment of older adults, especially minorities, both in the Gainesville/Alachua County region and in the more general North Central Florida catchment area of the center.
The RC1 Core directly provides services to support recruitment, including the development and implementation of recruitment strategies, monitoring and reporting recruitment progress, and development of recruitment materials. The RC1 Core also helps OAIC-affiliated studies and investigators, especially REC Scholars, to develop strategies for monitoring and improving participants’ adherence and retention in clinical research studies. This core also facilitates enrollment of women, ethnic minorities, and elders with disabilities, all of whom have often been under-represented in both observational and intervention studies. The RC1 Core in partnership with Investigators to evaluate the real-time progress of each study, and ensure integration of recruitment, screening, and data acquisition/randomization. The RC1 Core continuously evaluates the success of strategies to facilitate participation, retention, and adherence in OAIC-associated research and seeks to identify the most effective and efficient RC1 strategies. In both the services provided and studies conducted by the RC1 Core, a particular emphasis is on the participation of ethnic minorities and persons in research on aging.
Real-time communication between faculty/staff of the Health Promotion Center and IOA-CTRB is facilitated by (a) shared web-enabled calendars, which are updated in real-time; (b) direct-line telephone contact and between all staff members and study coordinators; (c) e-mail and fax; (d) video conferencing using iPads (FaceTime application) provided to faculty and staff (d) daily in-person “mail runs” to ensure that paper correspondence (e.g., reply cards from prospective participants) is in the hands of screening staff; transportation of materials is rendered HIPAA compliant by being placed in locking hi-denier canvas bags (as used for transport of financial securities in the banking industry); (e) shuttling of materials and persons by the Institute on Aging driver on an as-needed basis.
The following resources are utilized by the RC1 Core to facilitate participant recruitment.
Since July 2007, the OAIC has maintained a participant registry. There are currently nearly 3,000 participants in the OAIC registry. This is an IRB-approved database containing contact information and minimal demographics (age, race, sex, ethnicity) for persons who consent to be contacted with recruitment opportunities. The registry contains no information regarding health or functional status (since these are labile phenomena, and need to be rescreened by each individual study at the time of recruitment). Registrants are recruited at the time they consent to participate in individual studies; they are also recruited if they fail to qualify for an OAIC-supported study. Registrants have also been identified through a direct-mail campaign (10,000 pieces sent to elders in the catchment area), community presentations as well as persons screened for various studies. Unsolicited inquiries from elders seeking to participate in research are also directed to the registry. Each registrant receives a consent form (which is reviewed with a member of the RC1 staff prior to signing), and then a contact record (name, address, phone, email), and a demographic questionnaire. The contact information is entered and stored separated from the demographic information. The registry contains 2700 older persons. Regular communication with registrants is an essential element of retention. When specific studies are recruiting, registrants are contacted in one of three ways: (1) the quarterly newsletter, THRIVE, highlights specific studies and also includes summary “blurbs” for individual studies; (2) direct mail of flyers to eligible registrants; and (3) follow-up phone calls to eligible registrants.
JAX-ASCENT Registry. Starting in 2017, JAX-ASCENT has maintained a participant registry. In 3 short years, over 2,000 have enrolled in the JAX-ASCENT registry. This is an IRB-approved database containing contact information and minimal demographics (age, race, sex, ethnicity, education, SES) for persons who consent to be contacted with recruitment opportunities. Registrants are recruited directly from the local community by outreach conducted by Community Health Workers or at the time they consent to participate in individual studies. They are also recruited if they fail to qualify for other supported studies.
Minority Outreach Program (Church and Community Communicators). We have established several efforts to achieve minority recruitment goals for trials conducted within RC1. The strategy here is to build a presence in the community through outreach efforts. This presence is expected to build trust in the community and enhance minority recruitment. We will leverage several existing contacts including (a) the University of Florida Health Disparities Initiative, managed by Dr. Carolyn M. Tucker; in combination with this office, the Institute on Aging recently held nine “Relationship Building” luncheons at African American churches and community centers throughout Gainesville and can leverage these relationships to hold additional recruitment meetings; (b) the UF/Shands Eastside Community Outreach office, which maintains a corps of “Church Communicators” who can bring recruitment messages to most of the major churches in the Gainesville/Alachua County area; (c) the “Health Street” initiative, directed by Dr. Linda Cottler, which is the UF community engagement effort of the Clinical and Translational Science Institute, is a model that utilizes community health workers to assess needs and concerns of the population in order to link them to medical and social services as well as opportunities to participate in health research. The reach of HealthStreet has been North Central Florida, with a database of over 6500 persons. HealthStreet is described further below; (d) the Gainesville Guardian, a weekly newspaper for the African American community, which has previously been receptive to feature stories on OAIC studies. We can also pursue targeted advertising on local Gospel and Smooth Jazz radio stations, which are relatively popular with the local older African American audience. We have also identified, in our direct mailing lists, using data from the 2010 Census, census blocks that have a particularly high representation of African American residents. These blocks can be scheduled to receive repeated mailings, often using customized (IRB-approved) marketing materials. Local events (e.g., church/community talks) can also be targeted for the areas surrounding these census blocks.
UF Consent2Share. Data previously collected during clinical inpatient and outpatient care has tremendous retrospective and prospective value for planning studies, studying usage patterns, understanding comparative effectiveness, matching phenotypic and genotypic results, matching phenotypic and therapeutic approaches, and much more. We have the ability to store and track medical, encounter, genome, pharmaceutic, and other information and associate this information to outcomes is being created through the UF Health Integrated Data Repository (IDR). Patients under UF care can consent to be contacted about opportunities to participate in research. Over 66,000 individuals have consented to this option. The UF Consent2Share initiative was launched to develop, pilot, and expand such a consent process at UF Health. This effort is led by Peter Iafrate, Chairman of the UF Institutional Review Board.
The UF Consent2Share project has developed a large group of potential research participants who have consented to be re-contacted for future research studies. Having this consent data available in combination with the other data in the IDR will make it much faster and more feasible to identify potentially willing research participants who meet the study criteria. Creating a consent process with tracking will create new opportunities for our ability to study and improve human health.
Here’s how the process works: At check-in, trained admissions staff briefly discuss UF Consent2Share with patients, who then receive the research consent form to review. Saying yes to one or both options is completely voluntary and is not required to receive care. Patients are offered a copy of the consent form to keep, and their responses are recorded and managed as part of their Epic electronic medical records. For patients who have questions about or wish to change their consent, a helpline and CTSI research subject advocate are available as resources. The protection of patient privacy and personal health information is of paramount importance. For patients who choose to participate, their related medical information will be stored on a password-protected and encrypted computer server and will only be available to researchers conducting IRB-approved studies. Access to data will be expertly managed by the IDR and CTSI Biorepository staff.
UF StudyConnect. In collaboration with the four UF IRBs, UF Health, and UF research teams, the UF CTSI maintains and promotes UF StudyConnect as a central resource for listing UF clinical research studies that are seeking volunteers. In addition to being displayed on UF StudyConnect, the study listings appear on UFHealth.org Research Studies & Clinical Trials.
How Studies Get Listed on the Site: As part of its ongoing Study Registry project, the UF CTSI has a team of trained individuals collecting data about human research studies approved by the four UF IRBs since 2008. This team identifies studies that may be enrolling participants for inclusion on StudyConnect. In addition, UF research teams can easily request that listings for IRB-approved studies be added, modified, or removed from the site at any time.
The CTSI Study Registry Team gathers the data required for the listings and provides investigators an opportunity to review their study information before publishing it on the site. All that’s required of research teams is to notify the CTSI when they have an actively enrolling study and/ or when enrollment for a study has ended. The CTSI Study Registry Team will update the site accordingly.
ResearchMatch. UF CTSI subscribes to ResearchMatch— a national volunteer research registry that brings together researchers and willing volunteers who want to get involved in research studies. This national registry, developed by institutions affiliated with the Clinical and Translational Science Awards (CTSA) program, provides a secure, web-based approach to address a key barrier to advancing research: finding research participants.
Volunteers register for ResearchMatch at researchmatch.org – it only takes 5 to 10 minutes to register. Volunteers of any age, race, ethnicity, and health status are invited to join. By registering in ResearchMatch individuals are not registering to participate in any study. They are showing interest to be contacted about studies that may be a good ‘match’ for them. The goal of ResearchMatch is to better connect volunteers with potential study opportunities.
Health Street. Health Street is a community-based effort that works every day to reduce disparities in healthcare and research by linking the medically underserved to medical and social services and opportunities to participate in research. Community Health Workers (CHWs) meet residents at health fairs, special events, bus stops, parks, laundromats, grocery stores, Libraries, and other locations in North Central Florida. Community members can also visit HealthStreet to access free services, including health screenings, use of computers, classes, and many more. The aim is to improve relationships between community members, health care providers, community organizations, and researchers in the University of Florida community.
HealthStreet has enrolled 6500 members through the efforts of our Community Health Workers; the model allows us to directly contact individuals in the community and link them to studies based on their primary health concern, medical history, and eligibility criteria. If HealthStreet staff members meet community members who fit the eligibility criteria for ongoing studies, they are referred to the study coordinator for screening. HealthStreet organizers also routinely check our population database for persons who may fit general criteria for ongoing studies and refer them accordingly.
Recruitment through HealthStreet is free and provides opportunities for University of Florida researchers to learn from and improve the health of diverse and underrepresented populations in North Central Florida.
Investigational Drug Service
The Investigational Drug Service (IDS) is provided by the Department of Pharmacy at Shands Hospital and is available to all investigators at Shands. It has been established to provide a safe, effective, and efficient means of delivering investigational drugs to patients. In addition, compliance with federal, state, and JCAHO requirements regarding investigational drug control is ensured. The IDS is staffed by PharmD and residency-trained pharmacists. IDS services investigators of clinical trials in both the inpatient and outpatient settings. Currently, there are approximately 200 clinical trials being supported.