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The Division of Research & Scholarship Activity Report 2nd Quarter, Fiscal Year 2016 January 1 March 31, 2016

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Page 1: The Division of Research & Scholarship Activity Reporthsc.ghs.org/wp-content/uploads/2016/09/The... · Orthopaedics Pediatrics Womens 77% 9% 14% Interventional Clinical Trials by

The Division of Research & Scholarship

Activity Report

2nd Quarter, Fiscal Year 2016

January 1 – March 31, 2016

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FY16Q2Department of Research & Scholarship Activity Report 1

37%

48%

5% <1%

2%

8%

Active Studies per Review Type

Full Board

ExpeditedReview

FacilitatedReview (USOStudies)

HSSC(CooperativeReview)

31%

19%

3% 4%

38%

5%

Active Studies per Funding Source

Federally Funded

IndustrySponsored

Private Non-Profit

Internal Funding

No Funding

Other

I - Office of Human Research Protection 2nd Quarter, Fiscal Year 2016

IRB-A Categories: Cardiology, Vascular Surgery, Plastic Surgery, General Surgery, Orthopedics, Rehabilitation, Neurology, Nursing, Women’s, Internal Medicine, Pharmacy, Infectious Disease, General (non-pediatrics/non-oncology) IRB-B Categories: Pediatrics (all), Women’s, Cardiology, Orthopedics, Internal Medicine, Infectious Diseases, Neurology, General (non-adult oncology) IRB-C Category: Adult Oncology Other: Chart reviews, questionnaires, pilot studies, feasibility studies, biology, Humanitarian Device Exempt (HDE) and Humanitarian Use Device (HUD) studies, specimen storage, Comparative Effectiveness Research, Social Behavioral Research, curriculum development, etc.

Full Board 326 Federally Funded 270

Expedited Review 420 Industry Sponsored 163

Facilitated Review (USO Studies) 40 Private Non-Profit 31

HSSC (Cooperative Review) 0 Internal Funding 36

Exempt 16 No Funding 335

NCI CIRB 73 Other 40

Total 875 Total 875

Active Studies per Review Active Studies per Funding Source

IRB Review Type and Funding Source

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FY16Q2Department of Research & Scholarship Activity Report 2

326

420

40 0

16

73

Active Studies per Review Type

QR2 FY2016

270

163

31 36

335

40

Active Studies per Funding Source

QR2FY2016

706 763

808 827 866 895 875

Total # studies opened in IRB

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FY16Q2Department of Research & Scholarship Activity Report 3

7.30%

15.60%

35.90%

4.60%

2.50%

1.60%

10.40%

9.40%

2.10%

0.50%

0.50%

0.90%

0.90%

1.80%

2.40%

4.00%

Women’s Medicine

Pediatrics/Peds Hem/Onc

Adult Oncology

Medicine

Cardiology

Nursing

Surgery

Orthopaedics

Vascular

Psychology

Anesthesia

Pharmacy

Rehabilitation

Clemson University

USC

Other

Active Studies per Specialty

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FY16Q2Department of Research & Scholarship Activity Report 4

3% 1%

74%

2% 12%

6%

2%

Interventional Clinical Trials by Department

Cardiology

Internal Medicine

Oncology

Orthopaedics

Pediatrics

Surgery

Womens

77%

9%

14%

Interventional Clinical Trials by Study Type

Drug

Device

Other

II - GHS Clinical Trials Report 2nd Quarter, Fiscal Year 2016

1 Clinical Trial: For the purpose of this report, a clinical trial is defined as a prospective, biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, biologics, treatments, devices, or new ways of using known drugs, biologics, treatments, or devices). This definition incorporates the major points of the term as defined by the NIH, DHHS, ICMJE, ICH GCP E6, FDA, WHO and the clinicaltrials.gov website. 2 Other types of clinical trials include prevention, treatment, vitamin, symptom management and radiation.

Drug Device Other 2TOTAL

Cardiology 2 11 0 13

Internal Medicine 2 0 2 4

Oncology 236 2 42 280

Orthopaedics GHS 0 1 0 1

Hawkins Foundation 2 1 2 5

Sub-Total 2 2 2 6

Pediatrics Regular 7 0 2 9

Hem/Onc 36 0 0 36

Sub-Total 43 0 2 45

Surgery 1 17 4 22

Womens 4 3 2 9

TOTAL 290 35 54 379

Active Interventional Clinical Trials 1

Study Type

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FY16Q2Department of Research & Scholarship Activity Report 5

14%

31% 54%

1%

Interventional Clinical Trials by Phase

Phase I

Phase II

Phase III

Phase IV

35%

62%

3%

Interventional Clinical Trials by Funding Source

Industry

FederalFunding

Other

3 Other types of funding include foundation and departmental.

Phase I Phase II Phase III Phase IV IndustryFederal

FundingOther 3

Cardiology 0 0 1 0 11 1 1

Internal Medicine 0 1 1 0 2 2 0

Oncology 43 88 128 0 86 191 3

Orthopaedics GHS 0 0 0 0 0 1 0

Hawkins Foundation 0 0 1 1 2 0 4

Sub-Total 0 0 1 1 2 1 4

Pediatrics Regular 0 0 5 1 6 2 1

Hem/Onc 0 9 26 0 1 35 0

Sub-Total 0 9 31 1 7 37 1

Surgery GHS 0 0 3 0 19 2 1

Womens 0 0 3 0 6 2 1

TOTAL 43 98 168 2 133 236 11

Active Interventional Clinical Trials per Phase and Funding Source

Phases Funding Source

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FY16Q2Department of Research & Scholarship Activity Report 6

7 1

13

0 0 0

41

57

46

2

10 3 2 0 0

12 11 5 4 7

1

Jan Feb March

Subjects Enrollment / month

Cardiology Internal Medicine Oncology

Orthopaedics Pediatrics Surgery

Womens

277

31 42

280

32 53

286

33 52

290

35 54

Drug Device Other

Interventional Clinical Trials per Study type

QR3 FY 2015 QR4FY2015

QR1FY2016 QR2 FY 2016

41

85

159

42

95

162

43

96

165

43

98

168

Phase I Phase II Phase III

Interventional Clinical Trials per Phase

QR3 FY 2015 QR4FY2015 QR1FY2016 QR2 FY 2016

124

218

8

129

228

8

131

233

7

133

236

11

Industry Federal Others

Interventional Clinical Trials per Funding Source

QR3 FY 2015 QR4FY2015

QR1FY2016 QR2 FY 2016

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FY16Q2Department of Research & Scholarship Activity Report 7

Jan Feb March Total

Cardiology $14,028.00 $88,782.11 $6,308.50 $109,118.61

Internal Medicine IM NA NA NA NA

Endoc $0.00 $37,667.20 $25,272.60 $62,939.80

Total $0.00 $37,667.20 $25,272.60 $62,939.80

Oncology Cancer Institute NA NA NA $0.00

ITOR $70,635.00 $146,752.40 $13,997.20 $231,384.60

Total $70,635.00 $146,752.40 $13,997.20 $231,384.60

Orthopaedics GHS NA NA NA $0.00

Hawkins Foundation NA NA NA $0.00

Total $0.00 $0.00 $0.00 $0.00

Pediatrics Regular $3,883.10 $22,318.27 $12,023.50 $38,224.87

Hem/Onc $0.00 $0.00 $1,000.00 $1,000.00

Total $3,883.10 $22,318.27 $13,023.50 $39,224.87

Surgery $46,170.00 $15,675.50 $80,190.00 $142,035.50

Womens $1,950.00 $20,256.48 $6,065.33 $28,271.81

TOTAL $136,666.10 $331,451.96 $144,857.13 $612,975.19

Clinical Trial Revenue (ALL)

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FY16Q2Department of Research & Scholarship Activity Report 8

III - Sponsored Programs Extramural Funding Requests 2nd Quarter, Fiscal Year 2016

PR

IME

SU

B

TO

TA

L

Direct Cost Indirect Cost Cost Share Total Requested

Obstetric and Gynecology 1 1 38,600$ 2,482$ -$ 41,082$

Surgery (General) 5 5 140,629$ -$ -$ 140,629$

Family Medicine 0 -$

Surgery (Orthopaedics/RCP) 4 4 249,685$ 3,704$ 20,000$ 273,389$

Internal Medicine 2 2 976,045$ 38,810$ -$ 1,014,855$

Pediatrics 6 4 10 2,178,180$ 380,945$ 15,750$ 2,559,125$

Psychiatry/Behavioral Medicine 0 -$

Pathology 0 -$

Radiology 1 1 157,066$ 88,586$ -$ 245,652$

Nursing 1 1 2 1,694,566$ 665,673$ -$ 2,360,239$

Emergency Medicine 1 1 31,968$ 18,032$ -$ 50,000$

Child Life 1 1 8,900$ -$ -$ 8,900$

Clinical Integration 3 3 327,814$ 26,786$ -$ 354,600$

Clinical University 2 2 134,000$ 47,376$ -$ 181,376$

Conscious Leadership 1 1 107,605$ 16,141$ -$ 123,746$

TOTAL 26 7 33 6,045,058$ 1,288,535$ 35,750$ 7,333,593$

Total Proposal Activity

Research Other Sponsored Activity Instruction Fed Pass Through Federal State Foundation Industry

Obstetric and Gynecology 1 1

Surgery (General) 1 4 5

Family Medicine

Surgery (Orthopaedics/RCP) 2 2 4

Internal Medicine 2 1 1

Pediatrics 4 6 4 2 1 3

Psychiatry/Behavioral Medicine

Pathology

Radiology 1 1

Nursing 1 1 2

Emergency Medicine 1 1

Child Life 1 1

Clinical University 2 2

Clinical Integration 3 3

Conscious Leadership 1 1

TOTAL 11 22 0 6 5 1 20 1

Percent of Total 33% 56% 0% 18% 15% 3% 61% 3%

Proposal Activity by Project Type

Sponsored Program Classification Sponsor Type

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FY16Q2Department of Research & Scholarship Activity Report 9

The Office of Sponsored Programs reports that the following 33 proposals, requesting a total of $7,333,593, were submitted to external agencies by GHS faculty and staff members during the second quarter of fiscal year 2016.

Department of Obstetrics and Gynecology Dr. Bruce Lessey: AbbVie The Effect of 3 Months of Lupron on Inflammatory Cytokine Expression after Surgery for Endometriosis This proposed research project hypothesizes that GnRH agonists and newer generation oral GnRH antagonists such as Elagolix may have better profiles for systemically treating inflammatory changes associated with endometriosis compared to surgery alone. The purpose of this study is to compare inflammatory cytokine levels in women treated with surgical intervention alone to women with surgical intervention followed by 3 months of GnRH agonist (Lupron®) therapy. It is expected that Lupron® will be superior at reducing circulating levels of inflammatory cytokines compared to surgery alone at 3 months after surgery. Project Dates: 07/01/2016 – 06/30/2017 Request: Total: $41,082 Direct: $38,600 Indirect: $2,482

Department of Surgery Dr. Alfredo Carbonell: Foundation for Surgical Fellowships MIS Fellowship Grant This request to the Foundation of Surgical Fellowships will be used to support the GHS Surgery Fellowship program and is awarded based on criteria of excellence. Project Dates: 08/01/2017 – 07/31/2018 Request: Total: $62,629 Dr. Alfredo Carbonell: W.L. Gore and Associates MIS Fellowship Grant This request to W.L. Gore & Associates, Inc. will be used to support the GHS Surgery Fellowship program and is awarded based on criteria of excellence. Project Dates: 08/01/2016 – 07/31/2017 Request: Total: $33,000 Yonge Jones: SC MedTransTech Department of Surgery Student Summer Internship Program, June 2016 The Program provides undergraduate and medical students from the Upstate of South Carolina with experiences that will stimulate them to consider pursuing a career in medicine in general and in academic surgery in particular. Project Dates: 06/06/2016 – 07/01/2016 Request: Total: $10,000 Yonge Jones: SC MedTransTech Department of Surgery Student Summer Internship Program, July 2016 This grant requests additional funding for the second summer program. Project Dates: 07/04/2016 – 07/29/2016 Request: Total: $10,000

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FY16Q2Department of Research & Scholarship Activity Report 10

Dr. Jeremy Warren: Americas Hernia Society Prospective Randomized Control Trial of Open versus Robotic REtrOmuscucular Ventral Hernia Repair [ORREO Trial] This proposed research project hypothesizes that the robotic retromuscular ventral hernia improves the clinical composite outcome, which includes surgical site occurrence requiring procedural intervention, surgical site occurrences excluding simple seroma, surgical site infection, hernia recurrence, and hospital readmission, in higher risk patients compared to open ventral hernia repair. Project Dates: 04/01/2016 – 03/31/2017 Request: Total: $25,000

Department of Orthopaedics (Roger C Peace Rehabilitation Hospital) Dr. Sheldon Herring: SC Developmental Disabilities Council UCAN: Community Persons with either acquired or developmental disabilities frequently experience decreased social connectedness and community participation secondary to perceptions that sensory, cognitive/intellectual, or behavioral difficulties preclude their participation in everyday recreational activities. UCAN: Community is designed to increase social connectedness using a two pronged approach. First, persons with disabilities will be provided an increased number of adaptive recreational activities that will allow them to participate in a broad range of sports and social activities using adaptive recreational strategies and programs. The second approach will be to use the model of social capital to increase our ability to identify community-based gatekeepers as a way of integrating individuals with disabilities into existing recreational and social opportunities. Project Dates: 07/01/2016 – 06/30/2017 Request: Total: $20,000 Cost Share: $20,000 Elizabeth Dubose: SC Spinal Cord Injury Research Fund Lower-Limb (Ankle) Stretching via the Vittori Device The proposed study investigates the use of an innovative spasticity treatment device that is able to apply ankle stretching motions in a more controlled, precise, and safe manner. The Vittori lower-limb stretcher is a device that allows a therapist to handle and maneuver a SCI patient’s foot affected by spasticity with ease, precision, and safety. The device design originated from a project by a team consisting of students in the Clemson University Bioengineering Department and a Greenville Health System clinician (Principal Investigator). Significant design improvements were made by a team of engineers (SC TAO and Spark Innovations), in consultation with experienced therapists. The overarching goal of this study is to determine if controlled use of the Vittori significantly improves the ROM of SCI patients with lower-limb spasticity. Project Dates: 06/01/2016 – 05/31/2018 Request: Total: $150,000 Tracie Hawkins: Paralyzed Veterans of America Education Foundation Making SCI Education Effective: Improving access with animation and the web In order to increase the quality of life of SCI patients, RCPRH seeks to identify needs/problems and provide education and intervention to maximize functioning and quality of life along a continuum of care. Services are aimed at increasing patient independence and prevention of long term problems associated with SCI injury or disease. The goal of this project is to create an online SCI education program for patients, families and caregivers. Project Dates: 06/01/2016 – 05/31/2017 Request: Total: $150,000

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FY16Q2Department of Research & Scholarship Activity Report 11

Dr. Kevin Kopera: SC Spinal Cord Injury Research Fund Prospective Study Registry of Individuals in South Carolina with Spinal Cord Injuries The purpose of this project is to develop a prospective Registry Database of patients with SCI. Demographic and Injury Related Common Data Elements will be collected from spinal cord injury (SCI) patients and their clinicians from Roger C. Peace Rehabilitation Hospital. Project Dates: 05/15/2016 – 05/14/2017 Request: Total: $33,389

Department of Internal Medicine Dr. Meenu Jindal: SAMHSA An Interdisciplinary and Collaborative Approach to SBIRT Training: Curricular Integration and Application for Health Professions Students Greenville Health System proposes to develop, implement and assess training programs to teach health professions students the skills necessary to provide screening and brief intervention and refer patients who are at risk for a substance use disorder (SUD) to appropriate treatment. By integrating SBIRT, an evidence-based approach, into existing pharmacy, counseling, nursing, nurse practitioner, paramedic, medical student and residency training programs, GHS and partners will train 350 students and faculty/trainers annually in SBIRT and its integration into practice. Project Dates: 10/01/2016 – 09/30/2019 Request: Total: $859,963 Direct: $821,153 Indirect: $38,810 Dr. Andrea Bryant: AstraZeneca Women's Heart Health The program goal is to diagnose, treat and prevent cardiovascular disease in women through 1) improved access to cardiovascular health education (on both risk and preventive factors) for at least 300 women and 2) screenings and care for at least 100 underserved women at increased risk for cardiovascular disease due to race and/or socio-economic barriers. Project Dates: 11/01/2016 – 10/31/2017 Total: $154,982

Department of Pediatrics Dr. Nancy Powers: Greenville Women Giving South Carolina Medical-Legal Partnership (SC MLP) This proposal seeks to establish a broader spectrum of support for the SC MLP, a pilot program established between the Greenville Health System, South Carolina Legal Services, and Furman University. The SC MLP was established in 2015 with the focus of identifying and remedying the unmet legal needs of adolescents and young adults with Autism Spectrum Disorders and Related Neurodevelopmental Disabilities. Project Dates: 06/01/2016 – 07/31/2017 Total: $100,000 Dr. Nancy Powers: SC Developmental Disabilities South Carolina Medical-Legal Partnership (SC MLP) This proposal seeks to establish a broader spectrum of support for the SC MLP, a pilot program established between the Greenville Health System, South Carolina Legal Services, and Furman University. The SC MLP was established in 2015 with the focus of identifying and remedying the unmet legal needs of adolescents and young adults with Autism Spectrum Disorders and Related Neurodevelopmental Disabilities. Project Dates: 07/01/2016 – 06/30/2017 Total: $29,250 Direct: $24,788 Indirect: $4,462 Cost Share: $15,750

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FY16Q2Department of Research & Scholarship Activity Report 12

Jane Witowski: Mary Black Foundation Help Me Grow South Carolina (HMG SC) The goal of this project is to support the school readiness work of Spartanburg County organizations, particularly Spartanburg Academic Movement (SAM), by increasing the quantity and quality of developmental screenings for children under the age of 5, and therefore increase early identification of children at risk of developmental delays. Project Dates: 04/01/2016 – 03/31/2019 Total: $371,944 Dr. Desmond Kelly: Fullerton Foundation Expanded Collaborative Services Initiative for Autism Spectrum Disorder This project will expand the reach and impact of Autism Spectrum Disorder (ASD) services with evaluation and expansion of services and the establishment of a collaborative partnership initiative. The goal of the project is to improve the lives of individuals with ASD and their families in South Carolina. Project Dates: 05/01/2016 – 04/30/2019 Total: $351,410 Lorraine Cragan-Sullivan: Centers for Disease Control Learn the Signs. Act Early. (LTSAE) Ambassadors Program The overarching objective in applying as a LTSAE Ambassador is to integrate the work of LTSAE and Help Me Grow SC (HMG SC); enhance developmental promotion, early detection, and linkage to services. HMG SC is poised to become a state-wide system within the next three years, which will allow HMG SC to reach the most vulnerable children. Project Dates: 05/01/2016 – 04/30/2018 Total: $8,000 Lorraine Cragan-Sullivan: Centers for Disease Control Developmental Monitoring within State Systems The overall goal of this project is to improve home visitation workforce development and increase home visitors’ capacity to attend to developmental milestones, engage parents in developmental screening, and connect families to the appropriate early intervention services. Project Dates: 04/01/2016 – 03/31/2018 Total: $9,852 Dr. Desmond Kelly: HRSA via USC Virtual Reality and psychophysiological monitoring system for enhancement of social skills and joint attention training in autism The proposal describes Oculus-Rift and Unity software-based virtual reality applications and real-time psychophysiological monitoring system with biofeedback elements for facilitation of social skills and joint attention initiation and responsiveness in children with autism spectrum disorder. Project Dates: 12/01/2016 – 11/30/2018 Total: $52,936 Direct: $33,847 Indirect: $19,089 Dr. Anne Kinsman: HRSA via MUSC Leadership Education in Neurodevelopmental and Related Disabilities (LEND) The goals of this project are to provide and evaluate a statewide, comprehensive, interdisciplinary leadership training program for the development of culturally competent leader Project Dates: 07/01/2016 – 06/30/2021 Total: $808,325 Direct: $749,305 Indirect: $59,020

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FY16Q2Department of Research & Scholarship Activity Report 13

Dr. Desmond Kelly: NIH via USC Combined neuromodulation treatment for autism spectrum disorder This project will investigate effects of novel integrated neuromodulatory therapy that combines repetitive transcranial magnetic stimulation with neurofeedback. Therapeutic effects on this innovative neurotherapy will be assessed using clinical and behavioral evaluations and outcomes like electrocortical and behavioral responses during performance on cognitive tests. Project Dates: 12/01/2016 – 11/30/2021 Total: $661,292 Direct: $422,821 Indirect: $238,471 Dr. Desmond Kelly: HRSA via USC Gamma Oscillations as Biomarker in Autism Spectrum Disorder This project proposes using high frequency brainwaves as an indicator of the possible effect of a treatment that uses pulsating magnetic fields on autistic patients. The proposed research will test the specificity, sensitivity, persistence and reproducibility of this marker. Using this, indicator clinicians treating autistic patients will be able to assess the most likely response to treatment with pulsating magnetic waves. Project Dates: 12/01/2016 – 11/30/2021 Total: $166,116 Direct: $106,213 Indirect: $59,903

Department of Radiology Dr. Lee Madeline: NIH via USC Reducing Disparity in the Care of Acute Ischemic Stroke: Analysis of Brain Structural Signs on Stroke Treatment and Outcome in a Telestroke Network This project will provide in-depth understanding of the effects of early ischemic and pre-existing signs in stroke treatment and outcome in a telestroke network. Results will provide new knowledge on the best use of imaging variables in view of their strong independent prognostic value, and in making decisions when clinical ambiguity occurs about the potential use of rt-PA. Findings will have implications for guiding the diagnosis of acute ischemic stroke where every second counts to make a difference in a stroke patient recovery, and to provide equitable access to high-quality stroke care. Project Dates: 10/01/2016 – 09/30/2019 Request: Total: $245,652 Direct: $157,066 Indirect: $88,586

Department of Nursing Academics Susan Bethel: National Institutes of Health (NIH) MAST: Medication Adherence, Self-Care and Technology This innovative project addresses current gaps in research and involves the use of novel advanced technology, addresses how patients use technology in the home and their learning behavior, and can lead to promotion of self-care and reliable medication treatment. The significance of this contribution is in addressing self-care during transition from hospital to home, as well as how the evolving use of technology can impact self-care and outcomes. Project Dates: 12/01/2016 – 11/30/2019 Total: $1,725,951 Direct: $1,107,262 Indirect: $618,689 Dr. Joy Green-Hadden: HRSA via Clemson University Expanding Nurse Practitioner Primary Care Expertise for Underserved and Rural Populations in South Carolina The purpose of this project is to expand the capacity and diversity of the nurse practitioner (NP) workforce in South Carolina (SC) by educating master’s prepared NPs to provide clinical management within a primary care model focusing on population health and diversity in underserved and rural settings. The cohort will begin with 24 students in 2016 and expand to 48 students in 2017 and 2018. Project Dates: 07/01/2016 – 06/30/2019 Total: $634,288 Direct: $587,304 Indirect: $46,984

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FY16Q2Department of Research & Scholarship Activity Report 14

Department of Clinical Integration Anne Marie Maertens: Greenville Women Giving AccessHealth Greenville County (AHGC) Assessment Tools AccessHealth Greenville County (AHGC) seeks to spark sustainable health system changes that result in better health outcomes, lower system costs, and comprehensive access to effective, efficient, and equitable healthcare throughout Greenville County for underserved populations. The purchase and implementation of Community Health Assessment Software will increase our ability to complete accurate and relevant patient assessments, ensuring we meet the needs of our clients and community. Project Dates: 07/01/2016 – 06/30/2017 Total: $44,600 Jennifer Snow: Robert Wood Johnson Foundation A Medical Neighborhood Approach to Improving Community Health Using Community Health Workers Support from RWJ’s TCC grant would allow GHS to further develop and expand its community health worker (CHW) program to deliver the appropriate level of care in designated PCMNs. Accountable Communities creates the platform for the community-led innovation needed to improve overall health and develop new, innovative care models to deliver care and resources to these areas. Collaborators in this endeavor include GHS academic partners (for training, education and evaluation), health care partners, including safety-net providers and others. Additional collaborations with community service agencies and organizations are anticipated as the program grows and partners identify community needs. Project Dates: 05/15/2016 – 05/14/2018 Total: $250,000 Direct: $223,214 Indirect: $26,786 Jennifer Snow: Robert Wood Johnson Foundation Invest Health The Invest Health team will help GHS identify how and where to place resources for easy access, be it clinics in neighborhoods, mobile clinics, community paramedics or other methods. Greenville itself will be able to better identify service providers that can perhaps locate in the neighborhoods, as well as obtain more buy-in for expanded transportation options from the overall community. The team's other members will represent voices that often go unheard, like the target population, smaller funders, etc. The evidence of and potential solutions to the transportation/access problems will be produced by a team with the ability to influence community decisions. Project Dates: 05/01/2016 – 10/31/2017 Total: $60,000

Department of Emergency Medicine Dr. Phillip Moschella: NSF via Clemson University Studying the Effects of Multimedia Content in a Social-Based Healthcare Question and Answer System The goal of this project is to test the possible deployment of a smartphone based application using real patients in the ED. The project will begin with ED based demonstrations and deploy the system with 100 patients to establish a network to share information and experiences. Project Dates: 09/01/2016 – 08/31/2018 Total: $50,000 Direct: $31,968 Indirect: $18,032

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FY16Q2Department of Research & Scholarship Activity Report 15

George Maynard (Office of Institutional Advancement): Sanders Family Foundation University of South Carolina School of Medicine Greenville - Paladin Scholarship GHS is requesting funds on behalf of the USCSOM Greenville for a medical student scholarship designated for a Furman University graduate. A three-member panel will select a Furman student who has been accepted into the USC School of Medicine Greenville (USCSOMG). The panel will be comprised of one representative from Greenville Health System, one from Furman University and another from the Sanders Family Foundation. A majority vote will approve the student to be selected for the Furman graduate USCSOMG Paladin scholarship. Project Dates: 05/01/2016 – 04/30/2017 Total: $50,000 Brenda Thames: Wells Fargo MedEx Academy This grant will fund scholarships, stipends, and other costs for deserving students from throughout South Carolina to participate in all tiers of the GHS MedEx Academy. The funding will not only provide educational benefits to individual students, but it will also serve to strengthen developing partnerships between GHS and Historically Black Colleges and Universities (HBCUs). Students from HBCUs have been represented 40 times in Tiers 1-4 since 2011 and GHS plans to dramatically increase that amount through our partnerships. In addition, it will build on the support that Wells Fargo has provided in the past to USC and Clemson academics by strengthening the pathway to health professions for their students. Project Dates: 05/01/2016 – 04/30/2017 Total: $131,376 Direct: $84,000 Indirect: $47,376

Corporate Office: Academy of Leadership and Professional Development Tod Tappert: The Physicians Foundation Physician Leadership Certificate Program GHS believes the ideal physician leadership development program is one that focuses on practical and experiential learning through mentoring and coaching as a way of receiving feedback while carrying out difficult tasks. The GHS program will advance physician leadership development as it: 1) Builds a program around a single well-delineated leadership model, 2) Conducts pre-course preparation, 3) Incorporates multiple learning methods such as experiential exercises, reflective methods, as well as traditional classroom methods, 4) Structures learning around extended learning periods and multiple sessions. Project Dates: 05/01/2016 – 04/30/2018 Total: $123,746 Direct: $107,605 Indirect: $16,141

Department of Child Life Lindsey Metz: SC MedTransTech Child Life Council 34th Annual Conference on Professional Issues: Innovation; Imagination; Inspiration Child life specialists are required to obtain 60 professional development units each five year certification period. Attendance at the Child Life Council’s annual conference is the best way to continue their education and development. This proposal seeks funding to send four members of the child life staff to the 34th Annual Conference this year in Orlando, Florida. Project Dates: 04/01/2016 – 10/01/2016 Total: $8,900

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FY16Q2Department of Research & Scholarship Activity Report 16

IV - Sponsored Programs Award Activity 2nd Quarter, Fiscal Year 2016

Total

Awards

New

Awards

Continuation

Awards

Direct Cost

Awarded

Indirect

Cost

Awarded

Total

Awarded

Obstetric and Gynecology 2 2 48,140$ 4,532$ 52,672$

Surgery (General) 1 1 10,000$ -$ 10,000$

Family Medicine -$

Surgery (Orthopaedics) -$

Internal Medicine 1 1 1,124,258$ -$ 1,124,258$

Pediatrics 2 2 72,814$ 27,065$ 99,879$

Psychiatry/Behavioral Medicine -$

Pathology -$

Radiology -$

Anesthesiology -$

Emergency Medicine -$

Roger C. Peace -$

Clinical Integration 1 1 500,000$ -$ 500,000$

TOTAL 7 5 2 1,755,212$ 31,597$ 1,786,809$

Total Award Activity

Research Other Sponsored Activity Instruction Fed Pass Through Federal State Foundation Industry

Obstetric and Gynecology 2 1 1

Surgery (General) 1 1

Family Medicine

Surgery (Orthopaedics)

Internal Medicine 1 1

Pediatrics 2 1 1

Psychiatry/Behavioral Medicine

Pathology

Radiology

Anesthesiology

Emergency Medicine

Roger C. Peace

Clinical Integration 1 1

TOTAL 6 1 0 2 0 0 5 0

Percent of Total 86% 14% 0% 29% 0% 0% 71% 0%

Award Activity by Project TypeSponsored Program Classification Sponsor Type

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FY16Q2Department of Research & Scholarship Activity Report 17

The Office of Sponsored Programs reports that the following 7 awards totaling $1,786,809 were received by Greenville Health System during the second quarter of fiscal year 2016.

Department of Obstetrics and Gynecology Sarah Covington-Kolb: March of Dimes CenteringPregnancy Project aims to decrease rates of preterm birth by increasing access to CenteringPregnancy's group prenatal care model throughout South Carolina, with a focus on geographic areas with the greatest racial disparities in preterm birth. Project Dates: 02/01/2016 – 01/31/2017 Total: $49,847 Direct: $45,315 Indirect: $4,532 Dr. Benjie Mills Act or Not Trial Continued funding for GHS to be a study site in the protocol “Optimal treatment for women with a Persisting Pregnancy of Unknown Location - a Randomized Clinical Trial of Women at Risk for an Ectopic Pregnancy: Active Treatment versus Expectant Management (No Treatment)” (ACTorNOT). Project Dates: 12/01/2015 – 11/30/2016 Total: $2,825

Department of Surgery Dr. David Cull: SC MedTransTech Use of the UCLA/RAND Appropriateness Method Study Data to Develop a Tool for Standardizing/Optimizing Vascular Access Procedure Selection, Educating Surgeons, and Enhancing Provider Communication/Collaboration To develop a mobile application software program that will do the following:

Provide surgeons with a tool that will transform the complex clinical decision-making process of vascular access procedure selection, to a simple process requiring the surgeon only to enter patient characteristics into the program. The procedure recommendation generated by the software will be based on the best available literature and expert opinion.

Provide surgeons with instructional videos on how to do complex vascular access procedures and “tips and tricks” from experts in the field.

Create a forum both locally and nationally for surgeons, nephrologists, and nurses to communicate and collaborate on patients or vascular access research.

Project Dates: 01/01/2016 – 12/31/2016 Total: $10,000

Department of Internal Medicine (Women’s) Elena Huston: Nurse Family Partnership National Service Office Pay for Success Nurse Family Partnership Pay For Success project to funds Nurse Family Partnership in which SC DHHS, Duke Endowment, Greenville First Steps, and other philanthropic funders worked together to create the first Pay for Success project in South Carolina to funds this home visiting program for first time mothers and their babies. Project Dates: 04/01/2016 – 03/31/2017 Total: $1,124,258

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FY16Q2Department of Research & Scholarship Activity Report 18

Department of Pediatrics Dr. Ransome Eke: American College of Gastroenterology EoE Smoking Exposure Study To provide critical information on SHS exposure on EoE activity in children, this study proposes to conduct a longitudinal study in a cohort of children with EoE at the Children’s Hospital, Greenville Health System (GHS). The objective is to examine whether there is an association between SHS and EoE disease activity among pediatric patients and will be achieved by: 1) Examining for differences in characteristics (e.g. symptoms, demographics) of EoE in children based on SHS exposure; 2) Evaluating the association between urinary cotinine level and Pediatric Eosinophilic Esophagitis Symptom Scores (a validated EoE instrument); 3) Studying the association between urinary cotinine level and the degree of active eosinophilic esophagitis, as measured by eosinophil counts per high powered field (40X) in esophageal biopsies. This study will provide a comprehensive understanding of the association between EoE and SHS exposure. Project Dates: 07/01/2016 – 6/30/2017 Total: $24,826 Dr. Bryce Nelson: NIH via UNC Limited Competition for the Continuation of the SEARCH for Diabetes in Youth Cohort Study This grant request will serve to continue the work of the current Search project here at GHS in which GHS serves as a clinical site with Dr. Nelson serving as the site PI. Project Dates: 09/30/2015 – 09/24/2016 Total: $75,053 Direct: $47,988 Indirect: $27,065

Department of Clinical Integration Heather Goss: Duke Endowment Mountain Lakes Access Health Mountain Lakes AccessHealth works to link low-income, uninsured adults to a medical home for appropriate comprehensive care, medical specialists, dental care, diagnostic testing, social services, and providing intensive case management focused on health education, encouragement, and removing social barriers. Project Dates: 01/01/2016 –12/31/2017 Total: $500,000

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FY16Q2Department of Research & Scholarship Activity Report 19

V- Sponsored Program Expenditures 2nd Quarter, Fiscal Year 2016

The Office of Sponsored Programs reports that Greenville Health Systems’ sponsored program expenditures totaled $1,698,509 during the second quarter of fiscal year 2016.

Q1:FY16 Total Expenditures

$1,698,509

$85,106

$333,268

$418,233

$838,893

$5,717 $17,293

$-

$100,000

$200,000

$300,000

$400,000

$500,000

$600,000

$700,000

$800,000

$900,000

Federal FederalFederal Pass ThroughFoundation Industry State

Q2: FY 16 Expenditures by Sponsored Type

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FY16Q2Department of Research & Scholarship Activity Report 20

VI- USCSOM Greenville Proposals 2nd Quarter, Fiscal Year 2016

Title PI Name Funding Total Amount

LMEd: Integration of Lifestyle Medicine into

Medical School Curricula Trilk, Jennifer

Ardmore Institute of

Health $145,472.00

DHEC Bureau of Community Health and Chronic

Disease Prevention 1422 Egan, Brent

SC Department of

Health &

Environmental

Control (DHEC)/CDC $152,306.00

Pediatric Metrics Egan, Brent

Medical University of

SC (MUSC)/HRSA $56,127.00

A Qualitative Study of Pyramidal Cells and

Interneurons in the Cerebral Cortex of Patients

with Autism Spectrum Disorders Casanova, Manuel

Autism Research

Institute $20,000.00

Total $373,905.00