cctsi.ucdenver.edu

Clinical and Translational Research Center Network, MicroGrants

Program, etc

Wendy M Kohrt, PhD

Associate Director, CTR Resources & Services

cctsi.ucdenver.edu

Governance

CTR RESOURCES & SERVICES

Kohrt

Study

Implementation

Population-based Translational

Research Programs

Study Design

and Analysis

Lab Analysis and

Technology

CTRC NetworkEckel

Child and Maternal HealthHay

BERDCarlson

CTRC Core LabsAccurso, Maier

Community EngagementNease

Research Data

Management

and IntegrationKahn

NeTTGeraci

Pragmatic Trials and

Dissemination/ImplementationMorrato

cctsi.ucdenver.edu

Governance

CTR RESOURCES & SERVICES

Kohrt

Study

Implementation

Population-based Translational

Research Programs

Study Design

and Analysis

Lab Analysis and

Technology

CTRC NetworkHiggins, Kohrt

Child and Maternal HealthHay

BERDCarlson

CTRC Core LabsAccurso, Maier

Community EngagementNease

Research Data

Management

and IntegrationKahn

NeTTGeraci

Practical Trials and

Dissemination/ImplementationMorrato

cctsi.ucdenver.edu

Specific Aims for the CTR R&S Program

1. Develop and implement a Program Income System and an evaluative process for cost-effective allocation of resources that supports planning, conduct, analysis, and dissemination of research results.

2. Optimize the infrastructure for implementing and tracking research and support services.

cctsi.ucdenver.edu

Specific Aims for the CTR R&S Program

4. Provide a network of services to support investigators in designing, conducting and disseminating the highest quality research.

3. Integrate and expand our distinctive cross-cutting population-based translational research programs to facilitate research with diverse communities and populations.

cctsi.ucdenver.edu

Specific Aims for the CTR R&S Program

5. Strengthen our integrated Network of Translational Technologies (NeTT) and laboratories that provide state-of-the-science services for comprehensive clinical and translational research.

cctsi.ucdenver.edu

Approach1. Develop and implement a Program Income System

and an evaluative process

cctsi.ucdenver.edu

Approach1. Develop and implement a Program Income System

and an evaluative process

• Conducted cost analyses for all revenue-generating components of the CTR R&S (CTRC Network and Core Labs, BERD, NeTT)

• Established Service Centers

• Evaluation team conducted R&S Needs Assessment Survey in Fall 2014

cctsi.ucdenver.edu

Approach1. Develop and implement a Program Income System

and an evaluative process

• Have undergone gradual transition to fee-for-service model, with final transition to occur in July 2015

• Established the MicroGrants Program to offset the cost of CTRC services (at CHCO and UCH) for junior investigators– Based on need, scientific merit, availability of funds– Priority to junior investigators with investigator-initiated

CTRC protocols– Up to 3 years of support (up to $10,000/y)

cctsi.ucdenver.edu

Approach2. Optimize the infrastructure for implementing and

tracking research and support services

• Have maintained the operation of all CTRC units– UCH inpatient and outpatient units– CHCO inpatient and outpatient units– Perinatal unit– NJ outpatient unit– CU-Boulder outpatient unit

• Continue to fully subsidize facility fees

cctsi.ucdenver.edu

Approach2. Optimize the infrastructure for implementing and

tracking research and support services

• UCH inpatient unit was downsized (15 to 7 beds) and may need to be further downsized

• Continued support of the metabolic chamber and sleep lab on this unit will pose financial challenges

• CHCO eliminated dedicated inpatient unit; use clinical beds on as-needed basis

cctsi.ucdenver.edu

Approach

• Covered by Don Nease, Elaine Morrato, and Bill Hay

3. Integrate and expand our distinctive cross-cutting population-based translational research programs to facilitate research with diverse communities and populations.

cctsi.ucdenver.edu

Approach

• Covered by Nichole Carlson

4. Provide a network of services to support investigators in designing, conducting and disseminating the highest quality research.

cctsi.ucdenver.edu

Approach

• Initiated the implementation of a Core Laboratory Management System (iLab Solutions) in 2014 to improve a) efficiency of lab operations, b) access by investigators, c) financial management, and d) tracking and reporting of utilization

5. Strengthen our integrated Network of Translational Technologies (NeTT) and CTRC core laboratories

• Establishing an -Omics Working Group to facilitate a more coordinated delivery of proteomics and metabolomics services

cctsi.ucdenver.edu

AccomplishmentsCTRC Network – active protocols

CU-B NJH UCH CHCO Perinatal UCH CTO

Nu

mb

er

of P

roto

co

ls

0

20

40

60

80

100

120

140

160 Y1 Y2 Y3 Y4 Y5 Y6 Y7 projected

cctsi.ucdenver.edu

AccomplishmentsCTRC Network – new protocols

CU-B NJH UCH CHCO Perinatal UCH CTO TOTAL

Num

ber

of P

roto

cols

0

20

40

60

80

100

120

140

160

180Y1 Y2 Y3 Y4 Y5 Y6 Y7 Projected

cctsi.ucdenver.edu

AccomplishmentsCTRC Network – outpatient visits

Ou

tpa

tie

nt V

isits

0

4000

8000

12000

16000

20000

24000

Y1

Y2

Y3

Y4

Y5

Y6

Y7 Projected

CU-B NJH UCH CHCO Perinatal UCHCTO

CHCOCTO

cctsi.ucdenver.edu

AccomplishmentsCTRC Network – inpatient days

UCH CHCO TOTAL

Inp

atient D

ays

0

400

800

1200

1600Y1

Y2

Y3

Y4

Y5

Y6

Y7 projected

cctsi.ucdenver.edu

AccomplishmentsCTRC Network – assays performed by core labs

NJH CHCO UCH

Assa

ys P

erf

orm

ed

0

20000

40000

60000

80000

100000

Y4

Y5

Y6

Y7 projected

cctsi.ucdenver.edu

AccomplishmentsCTRC Network – protocols supported by core labs

NJH CHCO UCH

Pro

tocols

Support

ed

0

20

40

60

80

100

120

140

160

180Y4

Y5

Y6

Y7 projected

cctsi.ucdenver.edu

AccomplishmentsCTRC Network - nutrition core support

Meals Provided Hours of Support

Num

ber

of U

nits

0

3000

6000

9000

12000

15000 Y4

Y5

Y6

Y7 projected

cctsi.ucdenver.edu

AccomplishmentsMicroGrants Program

CHCO UCH TOTAL

Applications 14 28 42

awarded 11 18 29

pending 2 4 6

denied 0 5 5

withdrawn 1 1 2

cctsi.ucdenver.edu

Accomplishments

MicroGrants Program

CHCO UCH TOTAL

Encumbered $198,869 $371,000 $569,869

Awarded $154,869 $293,000 $447,869

Pending $44,000 $78,000 $122,000

Avg award $14,079 $16,277 $15,178

cctsi.ucdenver.edu

AccomplishmentsMicroGrants Program

CHCO UCH TOTAL

Departments/Divisions 7 11 14

Endocrinology 4 6 10

Pulmonary Science 3 4 7

Ob/Gyn 1 2 3

Infectious Diseases 0 2 2

Geriatric Medicine 0 2 2

Gastroenterology 1 1 2

Cardiology 2 0 2

PM&R, Immun, Anesth, Rheum, Neuro, Nutrition, Pharm 1 each

cctsi.ucdenver.edu

Accomplishments

Core Laboratory Management System (iLabs Solutions)

• Purchased by CCTSI and UCCCC in April 2014

• 1st wave of 3 cores started development in Sept 2014, went live Jan 2015

• Plan to roll out 3 more waves in 2015

• Can accelerate implementation, if feasible

• Up to 30 cores under site license

cctsi.ucdenver.edu

Accomplishments-Omics Working Group

• 2 CU-AMC proteomics/metabolomics cores, 1 CU-B proteomics/metabolomics core, 1 CSU proteomics/metabolomics core, 1 CU-AMC NMR metabolomics core

• 1st meeting of working group – Dec 2014

• Goals – match capabilities with investigators needs, capitalize on unique strength of each lab, minimize unnecessary duplication across labs, maximize utilization of current vs older generation technology

cctsi.ucdenver.edu

Accomplishments

Impact of circadian misalignment on energy metabolism during simulated nightshift work

McHill AW, Melanson EL, Higgins J, Connick E, Moehlman T, Stothard ER, Wright KP Jr. Proc Nat Acad Sci 111:17302-7, 2014

• Utilized the CU-B outpatient CTRC, UCH inpatient CTRC, UCH metabolic chamber, Nutrition Core, research nursing staff

• Simulated nightshift work reduced total daily energy expenditure, representing a contributing mechanism for weight gain and obesity

cctsi.ucdenver.edu

cctsi.ucdenver.edu

AccomplishmentsDelayed skeletal muscle mitochondrial ADP recovery in youth with type I diabetes relates to muscle insulin resistance

Cree-Green M, Newcomer BR, Brown MS, Baumgartner AD, Bergman B, Drew B, Regensteiner JG, Pyle L, Reusch JE, Nadeau KJ. Diabetes 2015 in press

• Utilized CHCO outpatient and inpatient CTRC, Nutrition Core, research nursing staff, C-TRIC (CO-pilot, MG awards)

• Using MR spectroscopy, demonstrated that youth with T1D have skeletal muscle mitochondria dysfunction that is associated with tissue-level insulin resistance.

cctsi.ucdenver.edu

Clamp Study Design

racwerBasal 10 16 80

6,6 D2 Glucose & 1-C13 GlycerolIsotope Tracer

Insulin (mU/m2/min)

Time (hours) 0 2h 3.5h 5h 6.5h

Clamp Preparation:

• 3 days weight maintenance diet

• 3 days inactivity

• 12-hour monitored fast

• Overnight variable insulin

infusion to achieve glucose goal

of 90-105 mg/dL

Blood Sample* * * * * * * * * * * * * * * **

cctsi.ucdenver.edu

cctsi.ucdenver.edu

National CTSA Consortium Participation

Participation in CTSA Consortium Working Groups •Kohrt – Methods & Processes DTF•Hammack - GCP training•To be assigned – new competency working groups

CTSA Consortium collaborations

•Kohrt – proposed UC Irvine Institute for Clinical and Translational Science Clinical Research Expert Committee for Terminology Harmonization in Exercise Medicine and Science (THEMES)

•Kohrt - National Exercise Trials Network (NExTNet)

cctsi.ucdenver.edu

Response to EAC Critiques

CTRC Network outpt visits, inpt days, and active protocols show a consistent and continued reduction.

• Number of active protocols, outpt visits, and inpt days have plateaued

– Result of downsizing (inpatient units)

– Shift in research focus (fewer intensive intervention trials)

• Number of new protocols is down

– Driven primarily by decrease in CTO protocols

– Unfunded/underfunded protocols not being accepted by COMIRB

cctsi.ucdenver.edu

Response to EAC Critiques

EAC is favorable toward MicroGrant program but concerned that program income estimates are high … graduated fees and monitoring will be crucial to “steering the ship” into the appropriate spot.

• Implementation of re-charge for nursing support in July 2015 is a particular concern for ongoing sponsored projects

– Expand MicroGrants program to support these protocols?

cctsi.ucdenver.edu

Questions for EAC

• Unique resources (metabolic chamber, sleep lab) on the UCH inpatient CTRC will generate financial stress in coming years. Does the scientific value outweigh the financial liability?

• Is there a recommended approach for evaluating the cost sensitivity for R&S services?