Research Matters

March 14, 2017

WelcomeRob Herzog, VP Research Operations

Devotion

Lillie Danzy, RACancer Clinical Trials Research

Selflessness

Transparency

Action

Responsiveness

DevotionLillie Danzy, RA

Cancer Clinical Trials Research

Serving Others • Selflessness• Transparency• Action• Responsiveness

Leadership Message

Steven R. Smith, M.D.Chief Scientific Officer

Publ

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Clin

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Impa

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Gra

nts &

Con

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Volu

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nce

Summary of Small Group Discussion from January’s RM

How is research making care at FH• more affordable? • more connected ? • more exceptional?

Summary of Small Group Discussion from January’s RM

Research Enables: • access to potentially life-saving therapies • a better understanding of the molecular

underpinnings of disease • a culture of clinical excellence, “trial effect”

• World-class physician recruitment • Stricter adherence to protocols and standards

How is research making care at FH more affordable?

Near-term • Patient

• Increased access to diagnostics or treatments • Cost of study drug (typically covered during trial)

• Community • Decreased rates of readmission

• Hospital • “Trial Effect” – stricter adherence to protocols and standards

Long-term: • Patient

• Early(ier) interventions from incidental findings • Reduction in time to provide best Tx option (personalized medicine)

• Community • Iterative, incremental and rigorous testing will improve the result of treatment and

reduce the length of stay • Hospital

• Enhanced research “brand” will: • Support recruitment of world-class physician scientists • Drive the procurement of extramural monies for research (sustainability)

Connecting• to clinical teams with study education• with the outside with sponsor and FDA relationships• to our community with recruitment and advertising • to other departments within FH to accomplish better • patients to novel treatment and therapies • to our mission by investing in discovering the best

therapies available

How is research making care at FH more connected?

How is research making care at FH more exceptional?

Exceptional• better research better healthcare better brand• data to knowledge to inform prevention,

coordination, management and action• provide hope, relationships and empowerment• research makes us better clinicians• recruit and retain• learning and development opportunities

About UsResearch Radiology

Radiology Quick Facts• RSF established in 2008• #1 radiology practice in Florida by

volume• 116 radiologists• Division of Advanced Imaging

Research (DAIR) started in December 2015

• 2 research coordinators, 1 research finance manager, 14 research interns, 7 UCF PhD students, 3 UCF FIRE students

• Established research collaborations with

• UCF dept of CS and mechanical engineering, Johns Hopkins University, U of Chicago, High Value Practice Academic Alliance

Research 2016 • Awarded 5 state or foundation

grants• Total: $241,000

• Awarded 10 industry grants• Abbott/St. Jude’s, Medtronic,

Biotronic, Quadrasphere, SureFire

• Published 54 peer-reviewed articles• Presented 64 projects at society

meetings (including all major radiology societies)

• 36 radiologists participated in research projects

• Currently participating in over 100 research projects

About UsGME: Graduate Medical Education

GME Quick Facts• 90 faculty• 186 residents

GME Research • Goal: advance quality of care and patient

related outcomes by providing residents and faculty with the resources, knowledge and infrastructure to plan and conduct transformative biomedical research.

• 38 Studies• 4 Prospective• 12 Retrospective• 1 Registry• 16 Case Studies• 4 Non-Human Subjects• 1 Non-Industry Sponsored

• Research Staff• 1.5 FTEs

• Publications (Peer-reviewed journal articles)

• 24 in 2016

Project TitleProgram

Florida Hospital A-C-E

Affordable Connected Exceptional

Impact of Teaching Service on COPD Exacerbation Management and Outcomes in a Community Hospital

Internal Medicine

Clinical and Financial Implications of Consulting Physicians in the Management of Surgical Patients Surgery

Evaluation of Ascending Thoracic Aorta for Aneurysmal Dilation and Ectasia on Non-Contrast CT Chest

Radiology

Gynecology Procedure Training During Medical Missions Family Medicine

Study of Newborn Screening Report Process - A Quality Improvement Project Pediatrics

Immunizations-Improving Practice Rates Pediatrics

Research Services Updates

• ORI – Christina Jackson• Brief Update

• IRB – Janice Turchin• Common Rule Update

• OSP – Regina Tan• Budget Review

Office of Research Integrity (ORI) Update

Christina Jackson• Research Compliance Oversight Committee

update• Scientific Misconduct Policy

Institutional Review Board (IRB) Update

Janice Turchin• Discussion of the Revised Common Rule

Revised Common Rule

45 CFR 46 Common rule –

established 1991

Advanced notice of Proposed

Rulemaking 2011

(ANPRM)

Notice of Proposed

Rulemaking 2015

(NPRM)

FINAL RULE Issued

1/19/2017

Effective 1/19/18

Revised Common Rule

The revisions seek to update the oversight system to better reflect the current research environment, which HHS noted has

• "has grown in scale”• “become more diverse” • “data has become digital."

Revised Common Rule

Final Rule adopted from the NPRM

• New and revised definitions• Revised exemptions • Single IRB review for cooperative research

(effective 2020)• Revised requirements for informed consent• Changes to expedited procedures

Revised Common Rule

Final Rule adopted from the NPRM• New and revised definitions• Revised exemptions

• Single IRB review for cooperative research (effective 2020)• Required for all cooperative research studies.

• Applies only to U.S. research sites, unless single IRB review is required by law, including tribal law.

• Revised requirements for informed consent• Changes to expedited procedures

Revised Common RuleFinal Rule adopted from the NPRM• New and revised definitions• Revised exemptions • Single IRB review for cooperative research (effective 2020)

• Revised requirements for informed consent• New requirement that consent begins with a presentation of key

information.• Calls for streamlining consent forms to include an upfront, "concise

explanation" of the research's purpose, risks and benefits, and potential alternative treatments

• Additional required and additional elements of consent.• New broad consent option for some research.• New requirement for public posting of clinical trial consent forms.• Minor revisions to documentation requirements

• Changes to expedited procedures

"Over the years, many have argued that consent forms have become these incredibly lengthy and complex documents that are designed to protect institutions from lawsuits, rather than providing potential research subjects with the information they need in order to make an informed choice about whether to participate in a research study,"

Jerry Menikoff, MD. , HHS Office for Human Research Protections

Revised Common RuleFinal Rule adopted from the NPRM

Challenges! • Informed Consent – “Key Information”

• Final rule does NOT strictly specify what is appropriate “key information.”

• Broad Consent – Separate set of elements• New Exempt categories – “Retraining our minds”• Single IRB Requirement

• Identified by funding department/agency• Funding department/agency can determine that single IRB is not

appropriate with rationale• Rationale must be documented

Office of Sponsored Programs (OSP) Update

BUDGET REVIEW PROCESSIn an effort to move towards more effective budget development and negotiations, the Office of Sponsored Programs is moving its internal budget review from POST-negotiation to PRE-negotiation.

Office of Sponsored Programs (OSP) Update

Why the change?• Better Budget• Streamlined Sponsor Negotiation• CTMS Ready (ish)

Effective Date: April 1, 2017

Questions?

BUDGET REVIEW2016

Average Turnaround1

From Budget Received Q1 Q2 Q3

Review Started 33.32

Initial Review Sent 42.50 42.00 37.00

Budget Approved 76.56 67.21 48.60

Q4

10.05

13.32

18.91

Jan Feb2

4.20 -

6.60 3.00

15.80 7.33

2017

1Metrics are based on Calendar Days (including weekends/holidays)2Review Start occurred same day as Budget Received

Additional Notes:Other variables that impact turnaround time for budget review:

• Volume• Study complexity• Sponsor Responsiveness

Aug

Stretch Break

Lindy Moore, MSTranslational Research Institute for Diabetes & Metabolism

Study SpotlightFH-Sponsored Research

Makes a Difference

“Impact of a Discharge Nurse Standard Operating Procedure on the Efficiency

and Effectiveness of Patient Throughput in a Cardiovascular PCU”

Theresa Munroe BSN, RN, PCCN

Current State/Problem

• How to improve surgical throughput– (OR ICU PCU DC)

• Discharge Nurses (RNs)– Extra-staffed RN– Piloted first in October 2014 on CVPCU– Proactive

Discharge RNs

Background/Scientific Rationale

• Limited research on Discharge RNs• Search terms

– Patient navigator, nurse discharge advocate, (discharge) nurse specialist, admission and discharge (nurse) team

• 4 Studies used

Literature ReviewStudy Design Readmission Length of Stay

(LOS)(Balaban et al., 2015) RCT.

Patient Navigator (n = 585) vs. control (n = 925).

No difference in 30-day readmission.

< 60 y.o. vs. > 60 y.o. patients = significant 4.1% decrease in readmission.

(Dawes et al., 2006) RCT.

Nurse specialist (n = 52) vs. standard care (n = 54).

No difference in control vsintervention groups.

Nurse specialist group had shorter hospital stay by an average of 1.34 days.

(Jack et al., 2009) RCT.

Discharge Nurse Advocate using the Reengineered Discharge services (n = 376) vs. standard care (n = 373).

Discharge Nurse Advocate decreased readmissions by 30%(with an included multidisciplinary approach).

(Kwan et al., 2015) Retrospective, cohort study.

Patient Navigator (n = 4,592) vs. no Navigator (n = 1,920).

No difference between the 2 groups.

Patient navigator decreased LOS by 21%,or 1.3 days.

36

• Evaluate the effects of a Discharge RN Standard Operating Procedure (SOP) on:– Length of stay (LOS)– Discharges before 1:00pm– 30-day Readmission rates– Unit savings

Hypotheses

• The effects of a Discharge RN SOP will:– Reduce LOS– Increase patient discharges before

1:00pm– Reduce 30-day readmission rates– Provide unit savings

Study Design• Develop DC RN SOP and Work

Instructions • Quasi-experimental design• Use prospective and retrospective data

with 3 data collection points– Phase I: Before DC RN implementation– Phase II: DC RN Pilot Program (10/2014)– Phase III: After DC RN SOP implementation

Discharge RN SOP

Dis

char

ge R

N W

ork

Inst

ruct

ions

Population/Sample

• Population– CABG and

valve patients discharged from CVPCU

• Sample– Minimum of 176

patients for each Phase

– n = 530

• Inclusion Criteria – All post-CABG and/or heart

valve patients on CVPCU– Admitted between May

2014 -August 2016 (Phase I – III)

– Age, all inclusive

• Exclusion Criteria– All other post-

cardiothoracic surgical patients (aneurysm repairs, thoracotomies, etc.)

– Admitted before May 2014– Discharged after August

2016

Study Measures

• CVPCU LOS (interval, # of days)• Discharge before 1:00pm (yes/no)• Readmission within 30-days (yes/no)• Unit savings (dollars)

– Cost of DC RN program– Estimated value of spending 1 day in the hospital on

CVPCU– Estimate value of savings from DC RN program– Unit savings on CVPCU

• Demographics– Age (year)– Gender (male/female)

Study Measures• Demographics (cont’d)

– Race– Insurance (none or self-pay/Medicare/private)– Comorbidities (Ordinal, # of)

• Barriers (reason discharged after 1:00pm) – Unknown– Practitioners, Bedside RN, Discharge RN– Personal transport, Skilled nursing facility (SNF)

transport– Change in condition– Insurance authorization– SNF bed availability – RxExpress– Lunch

Data Analysis• Patients LOS was 0.714 days

shorter in Phase III than in Phase I (p = 0.028).

• No significance found in the increase of discharges before 1:00pm in Phase III vs. Phase I. (Phase II discharges before 1:00pm were significantly decreased compared to Phase I (p < 0.001).

• No significance found in the decrease of readmission in Phase II or III vs. Phase I.

Discussion

Variable B Beta t Statistic p Value

Phase III CVPCU LOS

-0.714 -0.110 -2.197 .028

• For Phase III, a decrease of 0.714 equates to 17.1 less hours

• No increased in readmission• Increasing the discharges before 1:00pm

Cost Effectiveness

• Cost of the a Discharge RN during Phase III (July – Aug 2016) = $17,857.51– $62,748 - $17,857.51= $44,890.49 saved– $44,890.49/178 patients = $252.19 saved

per patient in Phase III

# of Patients

AverageLOS

reduction per case

Estimated LOS days

saved

EstimatedValue of Day on CVPCU

EstimatedValue of Savings

178 17.1 hrs 126 $498 $62,748

Study Limitations/Future Research

• Limitations– One site study– Sample limited to

CABG/valve patients

– Uncontrollable physiological variables

• Future Research – Benchmark of

1:00pm Discharges

– Barriers– Discharge RN for

other patient populations

References

Balaban R. B., Galbraith, A. A., Burns, M. E., Vialle-Valentin, C. E., Larochelle, M. R., & Ross-Degnan, D. (2015). A

patient navigator intervention to reduce hospital readmission among high-risk safety-net patients: A randomized

controlled trial. Journal of General Internal Medicine, 30(7), 907-915.

Bobay, K., Bahr, S.J., Weiss, M.E., Hughes, R., & Costa, L. (2015). Models of discharge care in magnet hospitals.

Journal of Nursing Administration, 45(10), 485-491.

Dawes, H. A., Docherty, T., Traynor, I., Gilmore D. H., Jardine, A. G., & Knill-Jones, R. (2006). Specialist nurse

supported discharge in gynecology: A randomized comparison and economic evaluation. European Journal of

Obstetrics and Gynecology and Reproductive Biology, 130, 262-270. doi:10.1016/j.ejogrb.2006.02.002.

Florida Hospital Cardiovascular Institute. (2015). 8800 discharge pilot [PowerPoint slides]. Presented to Florida

Hospital Cardiovascular Institute RN administration on August 19th, 2015.

Jack, B. W., Chetty, V. K., Anthony, D., Greenwald, J. L., Sanchez, G. M., Johnson, A. E., … Culpepper, L. (2009).

A reengineered hospital discharge program to decrease rehospitalization: A randomized trial. Annals of Internal

Medicine, 150(3), 178–187.

Kwan, J. L., Morgan, M. W., Stewart, T. E., & Bell, C. M. (2015). Impact of an innovative inpatient patient navigator

program on length of stay and 30-day readmission. Journal of Hospital Medicine, 00, 1-5. doi: 10.1002/jhm.2442.

Spiva, L. A., & Johnson, D. (2012). Improving nursing satisfaction and quality through the creased of admission and

discharge nurse team. Journal of Nursing Care Quality, 27(1), 89-93.

Impact StoryHow We Make a Difference

Andrew Taussig, MDTracey Purvis, BN, RN, CCRC, CFRN

FH Cardiovascular Research

MitraClip® device“They Didn’t Give Me Long”A Patient Journey in the COAPT Trial

COAPT TrialCOAPT Trial• 1st clinical trial of the

MitraClip® device for• Clinically significant

functional mitral regurgitation in symptomatic heart failure patients

• Patients not appropriate for mitral valve surgery

• Randomized 1:1 to device or medical therapy.

Case Study• 81 year old male

• Prior medical Hx: MI, CAD, CABG x 4(1995), PCI (2009), Pulmonary hypertension, systemic Hypertension, Prior CVA, Stage 3 chronic kidney disease. A-Fib, ventricular tachycardia and Sick Sinus syndrome with ICD placement.

• Severe functional ischemic mitral regurgitation• NYHA functional Class IV EF 35-40%• Past year, 9 admissions for CHF

• Patient alternatives• COAPT• Hospice

Case Study• Thought by both Structural heart and research

team to be a candidate for the COAPT trial• Work Up: TTE, TEE, Cath, Labs, ECG, STS, 6MWT,

Frailty index and questionnaires. • Patient must be presented to COAPT screening

committee

Case Study• Declined by COAPT screening committee 10/2013

• Recommended start anticoagulation (not true allergy) and discontinue IV Milrinone

• CV Research Team believed patient was an excellent candidate for the trial, requested to re-present with recommendations implemented.

• Re-presented to the COAPT screening committee 11/2013

• approved as a roll in subject (not randomized, received device)

Case Study• First implant of a Mitraclip in the Central Florida

Area and was considered successful by the team

Case Study• MitraClip implant

– end of 2013

• 6 months later… Let’s watch

Post Procedure• Original prognosis was significantly altered• ZERO re-admissions for Heart Failure• 1 admission for a non-cardiac related diagnosis• Doing well 2½ years post procedure• Daily activities

• travels • plays golf • walks his dog

TeamworkRob Herzog

• Overview• Group Discussion• Re-cap

Small Group Discussion

Q: What are some ways your team could handle these situations in a way that serves others?

“Whatever it takes”“Red tape”

“Send it out”

Q: Who are you serving in these situations?

Closing RemarksRob Herzog

Thank You for Attending!

Our next Research Matters meeting will be in May…

Details will be released soon!