Recently in Research Services Category

The Clinical and Translational Science Institute (CTSI) has awarded funds to support 15 research projects that will be conducted by U of M investigators and their collaborators. Funding from three CTSI grant programs will support a wide range of projects, from early-stage, translational research to clinical research to community-engaged research. Congratulations to our newest awardees!

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Translational Grant Program
This funding program helps drive the highest quality early stage translational research through the complex process of translating basic science discoveries into patient benefit. The overarching goal is to positively impact human health in Minnesota and the nation. Following are the program's 2014 awardees:

Conrado Aparicio, PhD, School of Dentistry
Project Title: GL13K Antimicrobial Peptide Coatings with Strong Resistance to Degradation and Sustained Activity for Preventing Dental Peri-implant Infection

Shai Ashkenazi, PhD, College of Science & Engineering
Project Title: Depth-resolved Tissue Oxygen Needle Sensor

Arthur Erdman, PhD, College of Science & Engineering
Project Title: Acoustic Modulation of the Phrenic Nerve for Treatment of Ventilator Induced Diaphragmatic Dysfunction

Benjamin Hackel, PhD, College of Science & Engineering
Project Title: Molecular PET Imaging of MET with Small Protein Ligands

Alexander Khoruts, MD, Medical School
Project Title: Development of Immunoregulatory Microbiota to Suppress Gut Inflammation

Jayanth Panyam, PhD, College of Pharmacy
Project Title: A Novel Marker for Isolation and Characterization of Circulating Tumor Cells from Patients with Metastatic Cancer

Srinand Sreevatsan, BVSc, MVSc, MPH, PhD, College of Veterinary Medicine
Project Title: Point-of-care Detection and Monitoring System for Tuberculosis

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Research Services Pilot Funding Program
This funding program supports focused clinical research pilot projects and is designed to poise U of M researchers for future success. Funded investigators can access a wide range of services for planning, implementing, conducting, and analyzing studies, from consultations and support to clinical facilities, staff, and procedures. The program's newest awardees are:

Peter Karachunski, MD, Medical School
Project Title: New Tools Used to Study Effects of Growth Hormone Therapy on Bone Health and Muscle Function in Boys with Duchenne Muscular Dystrophy

Suma Konety, MD, Medical School
Project Title: Chemotherapy Induced Cardiomyopathy and Associated Genetic Variants

Erin Osterholm, MD, Medical School
Project Title: The Impact of Breast Milk-Acquired Cytomegalovirus Infections on Clinical Outcomes in Premature Infants

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Community Collaborative Grants Program
This funding program supports community-university pilot research projects that address important health issues identified by Minnesota communities. Awards are designed to stimulate high-impact research, while building and sustaining long-term partnerships between U of M researchers and community representatives. The program has awarded funding to the following community-University research teams:

Mary Williams, RN, Everyday Miracles
Katy Kozhimannil, PhD, MPA, School of Public Health
Project Title: Improving Maternal and Child Health by Increasing Doula Support for Diverse Minnesota Women

Teri Verner, RN, DNP, Hennepin County Medical Center
Pamela Jo Johnson, PhD, Academic Health Center
Project Title: Impact of Complementary and Integrative Healthcare on Health and Wellbeing for Adults with Chronic Disease

Angela Lewis-Dmello, MSW, Domestic Abuse Project, Inc.
Lynette Renner, PhD, MSW, School of Social Work
Project Title: Exploring Mental and Behavioral Health Outcomes Among Children Exposed to Intimate Partner Violence

Joan Cleary, MM, Minnesota Community Health Worker Alliance
Elizabeth Rogers, MD, MAS, Medical School
Project Title: The Health Care Home in Supporting Chronic Disease Management: Understanding Team Member Roles and the Integration of Community Health Workers

Kathleen Culhane-Pera, MD, MA, West Side Community Health Services
Robert Straka, PharmD, College of Pharmacy
Project Title: Genomic Guided Assessment of Drug Therapy Effectiveness in Managing Hmong Adults with Hyperuricemia and Gout


By receiving the Clinical and Translational Science Award, the University of Minnesota is now required by NCATS and NIH to ensure an acknowledgment of the CTSA in any publications that result from UMN CTSI assistance with a project.

How to acknowledge CTSA support

All publications resulting from the use of CTSI resources are required to credit CTSA by using the text below.

Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health Award Number UL1TR000114. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

When to acknowledge CTSA support
Please note that assistance is not limited to monetary support (e.g., pilot grant funds), but also includes use of CTSI space, consultation with CTSI faculty or staff, and use of any CTSI Internal Service Organization services (Project Management, Clinical Research Coordinators, Nursing and Nutritional Services, Biostatistical support, and Regulatory assistance such as IND/IDE support, clinical trial monitoring, or ClinicalTrials.gov support).

Beginning Monday, March 11th, 2013 new hours of operation will be implemented in the Masonic Clinical Research Unit (MCRU) and Delaware Clinical Research Unit (DCRU).

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Masonic Clinical Research Unit (MCRU)
Under the new schedule all visits at MCRU must be scheduled at least one week in advance so that we can make sure that appropriate staffing is available to meet your needs. If for some reason you cannot schedule a week in advance, please contact MCRU staff at 612-624-0104 to see if we can accommodate your request.

Monday-Friday      7:00 AM - 7:00 PM
Saturday               7:00 AM - 12:00 PM
Sunday                 Closed

Delaware Clinical Research Unit (DCRU)
Contact DCRU staff at 612-624-4423.

Monday-Friday      7:30 AM - 4:00 PM

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These changes are being made in an effort to develop a sustainable financial model of operation for the CTSI units without significantly affecting customer research programs. Currently, the vast majority (>95%) of all work in the clinical research units fall within the new scheduled hours of operation.

If your research visits are absolutely unable to fit within our revised hours of operation, please contact Clinical Research Implementation Services (CRIS) Manager Jeanne Eull at 612-624-8475 a minimum of 2 weeks prior of your expected needs to discuss.

We are sorry for any inconvenience that this may cause.


Frequently Asked Questions

Q: How were these hours of operation selected?
A: We have analyzed the appointment volume in our facilities over the past few years. The new proposed hours cover 95% of the appointment hours scheduled over the last 6 months. Therefore, we can ensure coverage for the most customers by ensuring we are open & staffed during these hours.


Q:
Why is this change being made at this time?
A: We are making this change for several reasons:

  • In our effort to operate in a more efficient model, we are seeking opportunities to optimize staffing and operational costs. By reducing the hours of operation, we both decrease the staffing required to operate our facilities and increase the coverage/staffing during our busiest times (hopefully resulting in decreased wait times, more back-up coverage, and improved customer service/quality).
  • We are currently experiencing some unanticipated staff leaves. This provided us with the momentum and opportunity to make changes to our operational structure.

Q: Are your rates changing as a result of these operating model changes?
A: No, service rates will not be changing. Rates changes occur on a fiscal year basis (next rate changes will occur July 2013). We are continuing to seek opportunities to improve our rates and rate structure, along with our overall CTSI financial operating structure. If you have questions specific to CTSI rates and the ISO rate structure, please reach out to Lisa Johnson, Senior Operations Officer (lisaj@umn.edu, 612-624-9159) or David Bremseth, Clinical Research Integration Officer (dbremset@umn.edu, 612-624-4759).


Q: My study requires evening/overnight or weekend appointments, what do I do?
A:

  • If your study requires special accommodations outside our normal hours of operations, please contact the CRIS Clinical Manager, Jeanne Eull (jeull@umn.edu, 612-624-8475) at least 2 weeks in advance so that we can review the request and determine if we will be able to accommodate your service needs.
  • For existing studies, with appropriate notice, we will honor our commitments for any appointments that must occur outside normal operating hours. However, we would ask you to help us assess if there are options that would enable your appointment to occur within our normal hours of operation.
  • For new studies, we will be reviewing service needs outside the normal hours of operation based on your CTSI Request for Services.


Q: Why am I now required to schedule appointments 1 week in advance at MCRU or go through the MCRU Clinic Desk Staff?
A: Controlling the schedule 1 week in advance allows us to better manage our staff capacity and schedule between our facilities and offsite obligations. We can shift staff between hours and facilities based on where we have the heaviest volume and based on the complexity of the services. Based on our review of staff scheduling processes, we feel that the 1 week window provides us with the appropriate time frame to adjust our resources.


Q: I enrolled a subject at the last minute or just had an appointment cancellation or rescheduling, but I'm within the 1 week window to use MCRU. What do I do?
A: Please contact the CRIS Clinic Desk Staff (MCRU 612-624-0104). Our staff will be able to help identify available appointment times, reschedule appointments and provide alternate options if there is no available capacity during your proposed time. We expect that we will still be able to accommodate most requests within the 1 week window provided they fall within our normal hours of operation.

Medical School Assistant Professor Aaron Kelly, PhD, and Jennifer Abuzzahab, MD, Children's Hospitals and Clinics of Minnesota, received a Community Collaborative Grant from CTSI in 2010 to study the effects of the drug exenatide on extreme pediatric obesity. On Monday, February 4, the encouraging results of that study were published online in JAMA Pediatrics. 

Exenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist currently approved for adults with type 2 diabetes. Dr. Kelly and his team conducted a three-month, placebo-controlled trial followed by a three-month open-label extension where medication was offered to all participants. 22 individuals between 12 and 19 years of age completed the trial. Participants who received exenatide experienced a greater reduction in BMI compared with placebo (-2.7 percent), and a further reduction in BMI during the open-label period (cumulative reduction of 4 percent). The team also observed a reduction, though not statistically significant, in systolic blood pressure. 

The authors conclude that "...data from the current study provide evidence that GLP-1 receptor agonist treatment reduces BMI and elicits a potentially meaningful reduction in SPB in adolescents with severe obesity." Kelly's team collaborated with Kyle Rudser, PhD, of the CTSI Biostatistical Design and Analysis Center to complete the analysis and interpretation of the data; Rudser is also an author of the JAMA Pediatrics article. 

The CTSI Community Collaborative Grants are meant to generate pilot data for further research and funding. The authors discussed future directions for this line of research, concluding that future clinical trials should be conducted over a longer duration and should look at other health outcomes, beyond BMI and systolic blood pressure. The study was covered by Reuters and U.S. News and World Report, among others.

REDCap, or Research Electronic Data Capture, has taken off at the University of Minnesota. REDCap is a software application that provides secure, web-based data entry for clinical studies and a user-friendly interface to create online surveys and databases. 

REDCap was created at Vanderbilt University and is now being used by 549 institutions in 50 countries including the University of Minnesota Clinical and Translational Science Institute (CTSI). Within the University and CTSI, there are now almost 600 users taking advantage of REDCap's innovative features, compared to 188 just one year ago.

"I switched to REDCap from Microsoft Access and Infopath and have been wishing I had done it sooner," said Lynda Polgreen, M.D., M.S., Assistant Professor of Pediatrics. "REDCap is a user friendly database system. I can more easily review data, develop reports for a regulatory agencies, import and export data. REDCap has saved me a lot of time that used to be spent developing and trouble shooting Access and Infopath. In addition, I save time because my study coordinator was able to quickly learn to use REDCap and I anticipate she will be the primary database manager soon."

Not only does REDCap make it easier to adopt innovative practices, but it is fully supported by the CTSI's Biostatistical Design and Analysis Center and Biomedical Informatics teams. Use of REDCap is available at no cost to research teams, and additional assistance from a database developer is available at an hourly rate. Database programmer and analyst Sue Lowry provides bi-weekly introduction sessions to REDCap and is available to provide ongoing support. 

"CTSI staff were very willing and available to train my project staff who actually used the program," Kola Okuyemi, M.D., M.P.H. said. "They were readily available for trouble shooting, and Sue Lowry was great!"

Lowry and CTSI team members guide users through application upgrades. In 2012 these included a new randomization module, automated approval of changes to production projects, and new display options for survey answers. REDCap continues to evolve with an upgrade scheduled for later this year.

REDCap is used across a broad range of research studies at the University of Minnesota and around the globe.  If you are interested in learning more, register to attend a REDCap demonstration held the first Thursday and third Wednesday of every month.