RESEARCH

MATTERS

DEVOTIONAL & PRAYERCHRISTINA JACKSON

January 19, 2016

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

THANKFULLY, YOU ARE NOT CATS…

WHO PARTICIPATED?

33%

29%

27%

1%10%

Faculty Researcher/Investigator/Scientist Department Director/Manager/Supervisor

Research Coordinator Research Assistant

Regulatory

UNDERSTANDING OF REQUESTOR NEEDS

74%

26%

Met or Above: Below or Poor:

FUNCTIONAL/TECHNICAL EXPERTISE OF STAFF

78%

22%

Met or Above: Below or Poor:

ACCESSIBILITY AND COURTESY OF STAFF

78%

22%

Met or Above: Below or Poor:

UNDERSTANDING AND EXPLANATION OF RESEARCH REQUIREMENTS

67%

33%

Met or Above: Below or Poor:

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

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Clinical Excellence and ResearchSandra Galura

Nurse Research Residency Program

Clinical Excellence and Research

Nurse Research Residency Program

Sandra Galura PhD, RN

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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.

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Integration of Data to Establish a

Standard Operating Procedure for the Diabetic

Patient Undergoing Hyperbaric Oxygen Therapy

Katherine George RN, BSN, CHRN, CWS

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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

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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

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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

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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

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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

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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

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Interventions BGL<100 mg/dL

Comparison of Means Pre-Post

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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

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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

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HBO pilot approved by Nursing Pharmacy Committee 01/14/16; potential to be extended to other procedural areas

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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

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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

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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

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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

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COI UPDATES

1. Updated P&P and SOP

2. SFIs: Helpful Hints…

3. Training Requirements

UPDATED COI P&P AND SOPCan be found on Share Point

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.

INVESTIGATIONAL DRUG SERVICES

Jeff Carrico, Pharm. D., B.C.P.S.

Directory of Pharmacy

THANK YOU FOR YOUR ATTENDANCE AT

RESEARCH MATTERS!