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RESEARCH ENTERPRISE UPDATE FROM RESEARCH
LEADERSHIP
Steven SmithChief Scientific Officer
Rob HerzogVice President
FHRI UPDATES
PI Forum
Tuesday, February 2nd 7:00 a.m. – 8:00 a.m.
CTMS Clinical Conductor
Launch Meeting with BioOptronics last Friday
CREATION Health - 2016 Tour de Cure for the American Diabetes Assoc.
March 13th
Ride 10 miles or more…
RESEARCH SERVICES, SURVEY RESULTS
OVERALL FEEDBACK – ROB H.
Purpose of Survey
To obtain a baseline snapshot in time of feedback from Clinical Research teams regarding the key
services within Research Services
Who Participated
Overall results with % that met or exceeded and % that were below expectations
WHO PARTICIPATED?
33%
29%
27%
1%10%
Faculty Researcher/Investigator/Scientist Department Director/Manager/Supervisor
Research Coordinator Research Assistant
Regulatory
OVERALL SATISFACTION WITH THE PROCESS OF REVIEW AND
CLEARANCE/APPROVAL
65%
35%
Met or Above: Below or Poor:
OVERALL SATISFACTION - GRANTS
Overall Satisfaction - Average
NA Excellent Above Meet Below Poor
64% 36%
OVERALL SATISFACTION - GRANTS
Understanding Needs
NA Excellent Above Meet Below Poor
60% 40%
Functional/Technical Expertise of Staff
NA Excellent Above Meet Below Poor
66% 34%
Accessibility and Courtesy of Staff
NA Excellent Above Meet Below Poor
72% 28%
Timeliness of Response/Problem Resolution
NA Excellent Above Meet Below Poor
66% 34%
OVERALL SATISFACTION - GRANTS
Consistent Application of Policy/Pocedures
NA Excellent Above Meet Below Poor
62% 38%
Understanding and Explanation Research Administration Requirements
NA Excellent Above Meet Below Poor
61% 39%
Communication
NA Excellent Above Meet Below Poor
64% 36%
Process
NA Excellent Above Meet Below Poor
59% 41%
RESEARCH SERVICES – SURVEY RESULTS
GRANTS
Summary
On average, satisfaction % are consistent for each area
Lowest scoring area is with regards to PROCESS
Grants Team has been in the process of developing new / updating old procedures prior to and in
response to survey results.
The Team anticipates that once procedures have been implemented / refined and communicated
effectively to customers, understanding of these processes will increase overall satisfaction
Strategies
Develop training materials
Increase transparency in the grants administration process
Continue to keep abreast of new policy requirements / updates
OFFICE OF RESEARCH ADMINISTRATION (ORA)
SURVEY RESULTS
94 Respondents, but 8 consistently responded “n/a” to ORA Qs
N = 86 (94 Respondents, but 8 consistently responded “n/a”)
30.8 % Faculty
29.8 % Directors/Managers/Supervisors
26.6 % Coordinators
1.2 % Regulatory
ORA - STRENGTHS
Understanding of Requestor's NeedsN/A Excellent Above Ex Mtg Ex Below Ex Poor
77.9% 22.1%
Functional/Technical Expertise of StaffN/A Excellent Above Ex Mtg Ex Below Ex Poor
86.0% 14.0%
Accessibility and courtesy of staffN/A Excellent Above Ex Mtg Ex Below Ex Poor
86.0% 14.0%
Consistent Application of policy/proceduresN/A Excellent Above Ex Mtg Ex Below Ex Poor
72.1% 27.9%
ORA – OPPORTUNITIES
Classes/Workshops/TrainingN/A Excellent Above Ex Mtg Ex Below Ex Poor
63.5% 36.5%
Timeliness of Response, problem resolution,
or other servicesN/A Excellent Above Ex Mtg Ex Below Ex Poor
68.6% 31.4%
Understanding/explanation of
ORA requirementsN/A Excellent Above Ex Mtg Ex Below Ex Poor
68.6% 31.4%
Overall satisfaction with communication
relating to research and scholarly activityN/A Excellent Above Ex Mtg Ex Below Ex Poor
69.8% 30.2%
Overall satisfaction with the process of
study review and clearanceN/A Excellent Above Ex Mtg Ex Below Ex Poor
63.5% 36.5%
OFFICE OF RESEARCH ADMINISTRATION (ORA)
SURVEY RESULTS
Summary
Expertise and accessibility of ORA Staff are seen as strengths
Stakeholders may not understand the “why” behind ORA processes and requests – ORA needs to provide more
information/education
Continued improvement with the process of study review & clearance as well as other problem resolution is
needed
2015 & 2016 Strategies
Continue development of Onboarding Education
Monitor and publish metrics for contract review and budget review
IRB - STRENGTHS
Understanding of Requestor's NeedsN/A Excellent Above Ex Mtg Ex Below Ex Poor
71.0% 25.0%
Functional/Technical Expertise of StaffN/A Excellent Above Ex Mtg Ex Below Ex Poor
74.0% 22.0%
Timeliness of Response, problem resolution,
or other servicesN/A Excellent Above Ex Mtg Ex Below Ex Poor
75.0% 21.0%
Understanding/explanation of
IRB requirementsN/A Excellent Above Ex Mtg Ex Below Ex Poor
71.0% 25.0%
IRB – OPPORTUNITIES
Classes/Workshops/TrainingN/A Excellent Above Ex Mtg Ex Below Ex Poor
66.0% 23.0%
Overall satisfaction with the process of study review and clearance
N/A Excellent Above Ex Mtg Ex Below Ex Poor66.0% 29.0%
Consistent Application of policy/proceduresN/A Excellent Above Ex Mtg Ex Below Ex Poor
64.0% 31.0%
Accessibility and courtesy of staffN/A Excellent Above Ex Mtg Ex Below Ex Poor
68.0% 25.0%
INSTITUTIONAL REVIEW BOARD (IRB)
SURVEY RESULTS
IRB - Key Take-Aways
Strengths
• Timeliness of Response/Resolution to Problems
• Staff Expertise
Opportunities for improvement (OFI’s)
• Communication
• Education
• Timeliness for review of minimal risk studies
2016 Strategies
• Continue development of educational offerings and investigator guidances
• Monitor review times for expedited/exempt review
• Random monthly surveys
Nurse Research Residency
Purpose: To support clinical nurses and facilitate the development and implementation of
nursing research that aligns with Florida Hospital’s Strategic Innovation Agenda.
Objectives: Upon completion of Nursing Research Residency Program, residents will:
1. Develop skills necessary for clinically relevant research project.
2. Identify and utilize Florida Hospital research support services.
3. Integrate the research process into clinical nursing practice.
4. Disseminate research findings internally & externally to professional organizations.
25
Integration of Data to Establish a
Standard Operating Procedure for the Diabetic
Patient Undergoing Hyperbaric Oxygen Therapy
Katherine George RN, BSN, CHRN, CWS
26
Introduction
Hyperbaric oxygen therapy:
• Adjunct clinical therapy used to treat multiple medical conditions
including diabetic foot infections and wounds
• Patient placed in a full body pressurized chamber
• Atmospheric pressure> 1.5 to 3 times normal
• Patient breathes 100% oxygen
– Normally we breathe ~21% @ sea level
• Benefit: increases oxygen available to tissues for healing
27
Problem
• No HBO Standard Operating Procedure for diabetic population
• Safe minimal BGL pre-HBO > 100 mg/dL
• HBO glycemic management, no standard protocol
• HBO nutritional options, not standardized
• Risk of seizures
• Risk of operational delays
• Documentation in electronic health record, inconsistent
28
Background/Scientific Rationale
Glycemic Physiology
• Hyperbaric environment reduces blood glucose
levels (BGL) in all patients undergoing HBO therapy
• Hypoglycemia increases the risk of oxygen induced
seizures associated with HBO therapy
• Problem is exacerbated in the diabetic patient
29
Objectives & Research Design
• Objectives
– Determine impact of blood glucose
• Seizure events
• Nutritional interventions
• Operational delays
• Research Design
– Retrospective, descriptive review
• Electronic health records
• Department logs
• January 1-May 31, 2015
30
Population/Sample
• Population/Sample– All diabetic patients
undergoing HBOT
– Convenience sample
– 100 patients
– 1175 dives
• Inclusion– Admitted between January 1,
2015 and May 31, 2015
– Age, all inclusive
– Gender, all inclusive
• Exclusion– Did not receive HBOT
31
Blood Glucose Levels
Pre-HBO
• N=1175 dives
• Range = 53 - 439
• Mean = 178
• <100 = 43
Post-HBO
• N=1162 dives*
• Range= 56 - 414
• Mean= 165
• <100 = 91
* No BGL
documentation =13
32
Interventions BGL<100 mg/dL
Comparison of Means Pre-Post
33
4= Combination of food &
hypoglycemic med kept patients
most stable, without decline of BGL
HBO Practice Change
Study Recommendations
• Utilize Florida Hospital Hypoglycemic Protocol BGL <120 mg/dL
• Employ American Diabetic Association snack options post medication
• Eliminate routine use of fruit juices as snack during HBO therapy
• Ensure HBO documentation of interventions in the EHR
34
Post Study/Current State
• Increased minimal BGL from 100 mg/dL to <120 mg/dL
• Drafted HBO Standard Operating Procedure specific to diabetic population
• Modified HBO power plan to include a standard meal time (not concierge)
• Added Glycemic Management Intervention tab to HBO Procedure Form
• Linked HBO documentation to Glycemic Management in I-net
• Process improvement for documentation in Electronic Health Record, ongoing
35
HBO pilot approved by Nursing Pharmacy Committee 01/14/16; potential to be extended to other procedural areas
36
Pilot Project: Standard Operating Procedure (draft)
Acknowledgements
• Glycemic Management Program
– Mary Gaines, Director
– Damon Tanton MD
• Hyperbaric Medicine and Wound Care Center
– Maria Dominico BSN, RN, CWCN, CHRN
– Robin Ortega MS, RN, CWCN, CHRN, Nurse Manager
• Office of Research Administration
– Julie Pepe PhD
• Clinical Excellence and Research
– Sandra Galura PhD, RN, CPAN
– Dianne Ross PhD, RN
– Lynn Rowe PhD, RN
– Hong Tao PhD, RN
37
American Diabetes Association (2015). American Diabetes Association Standards of Medical Care in Diabetes, 39(1), Supplement
1, pages S1-S94. Retrieved from http://professional.diabetes.org/admin/UserFiles/0%20-
%20Sean/Documents/January%20Supplement%20Combined_Final.pdf.
Baromedical Nurses Association (2015). Retrieved from http://hyperbaricnurses.org/about-us/standards-of-care/.
Florida Hospital (2014). Glycemic management plans. Orlando, FL. Florida Hospital System.
Hanson, R. (2015). Diabetes bedtime snack options. Orlando, FL. Florida Hospital System.
Harch, P.G., Andrews, S.R., Fogarity, E., Lucarini, J., Aubrey, C., Staab, P.K., et al. (2011). Preliminary report on hyperbaric oxygen
treatment (HBOT) of U.S. military veterans with traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD); The
LSU IRB #7051 Pilot Trial. Retrieved from http://www.hbot.com/us-veteran-pilot-trial-lsu-irb-7051-hbot-tbiptsd-preliminary-
data.
Heyboer, M., Jennings, S., Grant, WD, Ojevwe, C., Byrne, J., Wojcik, SM. (2014). Seizure incidence by treatment pressure in
patients undergoing hyperbaric oxygen therapy. Undersea Hyperbaric Med, Sep-Oct; 41(5):379-85.
Lenth, R. V. (2006-9). Java Applets for Power and Sample Size [Computer software]. Retrieved March 17, 2011, from
http://www.stat.uiowa.edu/~rlenth/Power.
Lo T., Moore P., Delamor, N.C., Daher, N. (2009). Glucose fluctuations in diabetic versus non-diabetic patients with chronic wounds
undergoing hyperbaric oxygen therapy. Journal of Wound, Ostomy & Continence Nursing, 2009 May-Jun; 36 (3S):
Supplement: S61-2.
Moghissi E, Korytkowski M, Umpierrez G, et al. American Association of Clinical Endocrinologists and American Diabetes
Association consensus statement on inpatient glycemic control. Diabetes Care [serial online]. June 2009; 32(6):1119-1131.
Available from: CINAHL Plus with Full Text, Ipswich, MA. Accessed February 22, 2015.
References
38
Nwafor, T. S., & Collins, N. (2014). Managing Low Blood Glucose Levels in Patients Undergoing Hyperbaric Oxygen Therapy. Ostomy
Wound Management, 60(4), 12-15.
Peleg, R.K., Fishely, G, Bechor, Y, et al. (2013). Effects of hyperbaric oxygen on blood glucose levels in patients with diabetes mellitus,
stroke or traumatic brain injury and healthy volunteers: a prospective, crossover, controlled trial. Diving Hyperbaric Medicine,
43(4):218-21.
Plafki, C., Peters, P., Almeling, M., Welslau, W., Busch, R. (2000). Complications and side effects of hyperbaric oxygen therapy.
Aviation, Space, and Environmental Medicine. 71(2): 119-24.
Polit, D.E. & Beck, C.T., (2012). Nursing Research Principles & Methods. Philadelphia, PA. Wolters Kluwer Health/Lippincott
Williams & Wilkins.
Shailendra, S. & Gambert, S.R., (2014). Hyperbaric oxygen therapy: A brief history and review of its benefits and indications for the
older adult. Annals of Long-Term Care, 22(7-8). Retrieved from http://www.annalsoflongtermcare.com/article/hyperbaric-oxygen-
therapy-brief-history-and-review-its-benefits-and-indications-older-adult.
Trytko, B., Bennett, MH (2003). Blood sugar changes in diabetic patients undergoing hyperbaric oxygen therapy. Journal of the South
Pacific Underwater Medicine Society. Retrieved from http://archive.rubicon-foundation.org/7773.
Undersea and Hyperbaric Medical Society Blog (UHMSBLOG) (2015). Retrieved from
https://uhmsblog.files.wordpress.com/2014/10/dfu-cpg-public-comment-text1.pdf.
Wilkinson, D., Chapman, I. M., & Heilbronn, L. K. (2012). Hyperbaric oxygen therapy improves peripheral insulin
sensitivity in humans. Diabetic Medicine, 29(8), 986-989. doi:10.1111/j.1464-5491.2012.03587.x.
References
39
Thank you
Katherine George BSN, RN CHRN, CWSHyperbaric Medicine and Wound Care Center
2015 Nurse Research Residency
Clinical Excellence and ResearchFH.Nursing.Research@flhosp.org
40
UPDATED COI P&P AND SOP (CONTINUED)
How is it determined if a management plan is necessary?
• The SFI-related entity is the sponsor of a research study.
• The SFI-related entity provides funding for a research study.
• The SFI-related entity manufactures, makes, or provides an article, device, drug, or service being evaluated or used in a research study.
CHANGES IN CONFLICT OF INTEREST TRAINING EFFECTIVE
JULY 1, 2016.
This affects all researchers
including your
investigators!
COI training certification is good for 4 years.
If you completed your training in 2012, you will need to renew!
Effective July 1, 2016, the COI training requirement will be met by completing the COI Refresher module through CITI Training.
This will take approximately 40 minutes.
After completion, you will scan your completion record to the ORA mailbox at FH.Research.Administration@flhosp.org.
Attendance at an ORA training will satisfy your COI training requirement for the next 4 years.
Sessions will be offered in April, May, and June of this year.
These sessions will run approximately 15 minutes.
ORA can also provide a session in your department if there will be a minimum of 10 people in attendance.
COI training must be current for all study team members on a project.
If it is not, the study must be placed on Administrative Hold.
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