Clinical & Translational Science Institute (CTSI): Recruitment and Retention Resources. SCORE October 8, 2015
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1 Clinical & Translational Science Institute (CTSI): Recruitment and Retention Resources SCORE October 8,
2 Accessing Available Resources and Services Carrie Dykes, PhD Research Engagement Specialist 2
3 Research Services and Resources Connect. Learn. Get Help. Support Provided Through the CTSI: ClinicalTrials.gov Registration Customized Action Plan Education and Training erecord for Research FDA Regulatory Compliance Mentoring Research Ethics Research Subject Advocacy Funding sources CTSI-Associated Centers: Center for Community Health Center for Human Experimental Therapeutics (CHET) Clinical Research Center Center for Research Implementation and Translation UR Resources: Biostatistics Biomedical Informatics Comparative Effectiveness Epidemiology Human Behavior Assessment Physical Exercise Activity Kinesiology (PEAK) Lab URMC Labs Shared Resource Laboratories External Resources: Peer Institutions UNYTE CTSAs Government Agencies Contract Research Organizations Others Identified to meet needs Consultations Research Help 3
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7 CTSI Resources Bioinformatics Clinical Research Center ClinicalTrials.gov Registration and Reporting Data Access and Management Developing an Informed Consent Process Data and Safety Monitoring Plan Development Clinical Material Services Unit (CMSU) Clinical Trials Coordination Center (CTCC) Investigational Drug Service (IDS) 7
8 CTSI Resources - continued erecord for Researchers Guidance for FDA Regulatory Compliance Research Coordinators Group (SCORE) UR Connected Research Subject Advocacy URMC Labs 8
9 Recruitment and Retention Consultations Feasibility analysis Developing and writing recruitment plan Greater Rochester Practice-Based Research Network (Karen Vitale) Community Engagement (Gail Newton) Emergency Department Research ROC Health Website ResearchMatch.org Marketing (flyers, brochures, TV, radio, web, social media) 9
10 Recruitment and Retention Forteresearch.com SCORE listserv Commercial contact lists 10
11 Examples of request for help I am interested in learning more about how to market a research study to help with recruitment. Carrie provided information from other investigators who have used radio and TV. IHeartRadio and TV producers Rose Films was provided. She is also meeting with Heather Doyle in graphics and will get internal film production contacts from her. I wanted to inquire about commercial lists that could be purchased to send out letters to potential interested participants for research studies. Carrie contacted investigators who have used this service and provided that info to requester We need to enroll up to 20 typically developing children for a comparison group for a study we are conducting examining the socioemotional skills of children with fetal alcohol spectrum disorders. Research connected requester with recruitment consultant, community engagement consultant, GR-PBRN, and participant registries Do you know if anyone here at UR is doing social media advertising (e.g. Facebook, Twitter) for clinical research studies? I d love to reach out to them to find out what specifically they are doing/have done and what steps they ve taken with RSRB process. Connected requester with group that uses social media
12 Research Help Desk Submit questions and general requests: (585) All requests will receive a response within 2 business days of submission Connect. Learn. Get Help. Research teams work faster and better with the CTSI. 12
13 How the CRC Assists in the Retention of Research Volunteers Ann Miller, BSN, MS, CCRC Nurse Manager, Clinical Research Center (CRC) 13
14 Administration Giovanni Schifitto, MD, MS Medical Director Kathleen Jensen, MHSA Executive Director of Finance for the Clinical and Translational Science Institute Ann Miller, BSN, MS, CCRC Nurse Manager 14
15 Sponsor The Clinical Research Center is a component of the NIH-Funded Clinical & Translational Science Institute (CTSI) 15
16 What Do We Do? The CRC provides professional support for patient research We strive to create a positive and consistent experience for all participants A Positive Experience = Subject Retention! 16
17 What Kind of Support? Dedicated inpatient & outpatient research unit Professional clinical nurses Bionutrition services Specimen collection, processing, and storage Coordination services DEXA on-site Have a question please call! Our nurses are happy to answer any clinical research related question. 17
18 Nursing experience: Nursing Personnel Medical/Surgical & Pediatrics Ann Miller, RN, BSN, MS Susan Haefner, RN, BSN Nancy Gillam, LPN Lisa Ryan, RN Maureen Costanza, RN, BSN Jacquelyn Felker, RN, BSN Advocates for Good Clinical Practices (GCP) for all study volunteers 18
19 Nurse Coordinator Susanne Heininger, BS, RN, BSN Provides knowledge and support of the research process and planning Tailors coordination services based on project needs, (temporary, short-term) Fee-for-service 19
20 Bionutrition 20
21 250 Crittenden Blvd. 21
22 Parking Reserved parking First come basis 22
23 Location Room # G-5035 Main Entrance Waiting Room 23
24 Resources Inpatient & Outpatient Rooms 4 unit wireless telemetry monitoring Dedicated room for muscle testing Proper equipment for accurate collection of research data Skilled research staff collect, process, and document data 24
25 Inpatient Rooms 4 private inpatient rooms Cable television Wireless internet 25
26 Outpatient Rooms 3 rooms with stretcher or bed 5 exam rooms Rooms have the flexibility for short or long study visits. One exam room is pediatric themed. 26
27 Specimen Processing Room Serial and non-serial specimen collection and processing Short-term refrigeration and freezer storage 27
28 Investigator-Coordinator Office Dedicated Space Computers, Copier & Fax 28
29 Dual-energy X-ray absorptiometry (DEXA) Infant through adult DEXA scans and analysis collaborative arrangement with Imaging Services 29
30 Patient Satisfaction Survey Results Would you volunteer for another research study that utilized the Clinical Research Center? Yes % No 0 0% Totals % 2015 Spring results 30
31 Patient Satisfaction Survey Results What can we do to improve the experience of research volunteers? Everyone is very helpful, always on track! Everyone was so nice and helpful. It made the time here so nice. Everything was good. I cannot think of any improvements that would be required. I can't imagine working with a nicer group of people! The staff here is wonderful. Thank you to all of them. It was all great!! Made my stay pleasant and would not hesitate to come again. Good professional people. 31
32 Patient Satisfaction Survey Results continued More CRC specific parking, especially in bad weather. The employees at the CRC are always helpful and caring. They go above and beyond to accommodate any needs I might have. They deserve a lot of credit for making research patients feel comfortable at all times. Personally I have seen the great strides made in research over the last 25 years. I would like to thank everyone who is working so hard to make a difference for those who have FSH muscular dystrophy. Very nice staff. The only thing that is needed is a little stronger Internet at times would be helpful. Thank you. 32
33 Application Process Consult with the CRC team during the study feasibility process to discuss and identify project requirements and CRC-related costs for budget completion Obtain IRB approval o Investigator-initiated studies, submit your RSRB online application via (ROSS System). o Industry sponsored or previously approved RSRB studies now utilizing the CRC, submit CRC application found on the CRC web page: Obtain CRC Team approval Forms/Application: 33
34 Clinical Research Center We welcome your feedback. Ann Miller, BSN, MS, CCRC Nurse Manager
35 Bionutrition Department Clinical Research Center Nellie Wixom, RD
36 Mission To contribute to the field of nutrition by assisting investigators in planning, developing, implementing, analyzing and evaluating the nutrition aspects of their clinical research protocols to produce quality grant applications and publications. 36
37 Staff The Bionutrition Department is managed by a PhD- level dietitian, and staffed by a full-time lead diet technician with over 25 years of research experience and a part time research dietitian. Patricia Stewart, PhD, RD Robin Peck, DTR Nellie Wixom, RD 37
38 Specialized Nutrition Services Nutrient Analysis/Assessment of Food Intake Identification and review of selected nutrition tools for interventions Dietary data collection using 24 hour recalls, 3 day food records, and food frequency questions Data input and nutrient analysis using NDS-R, a comprehensive nutrition research software Customized nutrition assessments using a specialized nutrient analysis tool called SNAC that can be used for individualized counseling 38
39 SNAC: Simple NDSR Analysis Comparison Tool Visual display that provides a nutrient/energy intake summary Allows for individual comparison to the DRIs in a visually appealing format including the Upper Limit (UL) Estimates energy expenditure Calculates BMI Nutrition assessment easily translated to study subjects Lists the top nutrient contributors 39
40 40
41 41
42 Specialized Nutrition Services Consultation services regarding: Protocol design Budgets Data analysis and interpretation Grant and manuscript preparation Nutrition Interventions: Study specific- development and implementation of nutrition interventions for individuals or groups including staff support Curriculum/educational material development Nutrition lifestyle counseling for individuals or groups based on customized dietary assessments Development of manual of operations for nutrition interventions 42
43 Standardized Diets Metabolic Kitchen: design, produce and deliver diets for controlled feeding studies Constant diet Controlled nutrient diet Control of timing for meal service Estimated diet Formula diet Metabolic balance diet Micro and macro nutrient control Observed monitoring of intake 43
44 Recruitment and Retention Services Nutrition assessment: SNAC Tool Nutrition counseling Standardized meal quality 44
45 Summary Whether nutrition is a small component or a major component of your study, the Bionutrition Department provides trained professionals who deliver specialized nutrition services in addition to providing quality foods with a high level of customer service which can be significant in recruitment and retention. 45
46 For more CTSI information &id=65bec3c724 Web ?trk=myg_ugrp_ovr
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