randomized controlled trials a nd applied informatics at duke

Randomized Controlled Trialsand Applied Informatics at Duke

Martha B. Adams, MD, MAMay 2, 2011

All Rights Reserved, Duke Medicine 2007

RCTs and Informatics

• Randomized Controlled Trials continue to be the backbone of clinical trials.

• Informatics provides the integration of the people, information, and knowledge. Applied Informatics especially relates to the use of IT in clinical effectiveness.

2


Smarter Healthcare Research at Duke

ForRecruitment

Critical Care

DISCERN

NCRI

ForInvestigation

Telegenetics

Risk Modification

Patient Reported Outcomes

3


Critical Care

• Over 200,000 cases of Acute Lung Injury (ALI) occur in the U.S. each year, mortality ARDS 30-40%

• Will it help to identify patients early?• A Lung Injury Prediction Score (LIPS) has been

validated in a multicenter cohort study*• The goal is to ameliorate secondary injury and to

facilitate enrollment into future ALI prevention trials

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*Gajic O et al. Early Identification of Patients at Risk for Acute Lung Injury. Am J Resp Crit Care Med 2011;183:462-470.


Critical Care

• Background: The work resulted from the USCIITG-LIPS,(US Critical Illness and Injury Trials Group, the Lung Injury Prevention Study) demonstrating the multiple hit model of ALI, which led to the validation of CLIP, a checklist for Lung Injury Prevention (LIP).

Multiple hit: aspiration, high tidal volume, sepsis, wrong antibiotics, high FiO2Mechanism: membrane injury and inflammationOnset of ALI: median 2 days

5


Critical Care

• Based on these epidemiologic results, learned that a Lung Injury Prevention Score (LIPS):

>4 results in 10% higher risk of ARDS>20% results in 20% higher risk of ARDS

• Proposing a clinical trial using an iPad app to score illness severity and randomize to Aspirin vs placebo

• Applied for UO1 grant to enroll across 14 institutions; multidisciplinary with ED, Anesthesia and Pulmonary Critical Care

6Principle Investigator: R Bartz, MD


7


Critical Care

Users see the Lung Injury Prevention Score and participants are randomized to Aspirin or placebo

8Principle Investigator: R Bartz, MD


DISCERN – automate eligibility screening

• We have been using DEDUCE which is a retrospective look into the DSR, now we are also using DISCERN to notify of potential enrollees for trials.

• We did this by tapping into the messaging system, for example ADT (admission, discharge and transfer)

• Metrics of success: volume of users, who’s using it and what for; is the use for new grants? How do we compare to other schools?

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The “Duke Integrated Subject Cohort Enrollment Research Network”Lead developer: Jeffrey Ferranti, MD


The NCRI – scaling collaboration

• National Cardiovascular Research Infrastructure• Recognizing clinical research in crisis

– Clinical guidelines founded upon “expert consensus”– Disjoint operations, start and stop, start and stop– Only 10% of sites enroll 40% of patients– Fragmented data collection

10

Funding support: ARRA, the GO initiative, NHLBI Award, $2.6M over 2 years. Principle Investigator is Robert A. Harrington, MD, Duke Cardiovascular Research Institute



• Mission to integrate existing resources to efficiently execute large projects– Site recruitment and education (CTNBP)– Randomization (DCRI)– Data collection (NCDR)– Data standards (CDISC, HL7)– Guideline development (ACC)

• Proof of concept clinical trial – TREATT– TransRAdial Education, Training and Therapy

11



12

ncrinetwork.org


Towards Smarter Healthcare

ForRecruitment

Critical Care

DISCERN

NCRI

ForInvestigation

Telegenetics

Risk Modification


13


Towards Smarter Healthcare

ForRecruitment

Critical Care

DISCERN

NCRI

ForInvestigation

Telegenetics

Risk Modification


14


Telegenetics

• The Problem– Hereditary cancer risk effects approximately 25% of

cancer patients. Genetic counseling is a standard of care particularly because it impacts Rx decisions.

– N.C. has 15 counselors and they are clustered in tertiary care centers

– Access is a health disparity issue– No studies have assessed cost effectiveness, patient

satisfaction with validated surveys, in a RCT design

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Funded by the Susan G. Komen Foundation


Telegenetics

• The Method– Randomized, sample size 139– Surveys to assess the visit and the counselor– Cost measures (travel time, mileage, counselor, labor,

equipment)– Assessed other variables to understand the two

groups, e.g., TM group older, less well educated, less likely to be employed, lower income, and less computer comfort

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Telegenetics

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Telegenetics

• Included college student poster at NCCU Science Day

Freeman Booker with Dean for Science and Technology

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Telegenetics – the results

Cost Satisfaction(max 40)

High Satisfaction(max 30)

In Person $253 37.08 29.13Telemedicine $123 36.66 28.53

• Conclusions– Telemedicine costs less than half of in-person CGC– Satisfaction is equivalent, and high, in both groups– Next steps to test viability without research support

Datta S, Buchanan A, Hollowell G, Beresford H,Marcom P, Adams M. Telemedicine vs in-person cancer genetic counseling: measuring satisfaction and conducting economic analysis. Accepted for publication: Comparative Effectiveness Research.

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Behavioral Health Interventions

• Chronic illnesses contribute to the majority of U.S. health expenditures

• There’s proven value in tailoring interventions to patients’ needs

• General Medicine HSR&D research led by Hayden Bosworth, PhD has demonstrated success with multiple health behaviors combined with intensification of pharmacotherapy and including the provider

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Risk Reduction Using Telemedicine

• Background– Risk factor modification improves patient outcomes yet

often is not achieved because of poor prioritization and failure to change behaviors

• Hypothesis– A telemedicine intervention with tailored patient

education could improve risk factors• Method

– To enroll 450 patients post-MI with hypertension– Measure BP, LDL cholesterol, A1c, weight, BP,

adherance at 12 months

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• A 3-arm, randomized trial with eligible patients to:1. Usual care2. Home BP monitor + nurse tailored education by

phone and enrolled in HealthVault3. Home BP monitor + tailored web based education

and enrolled in HealthVault• Sponsored by the American Heart Association• Besides HealthVault, includes the Heart360 platform

– A disease monitoring tool, not a medical record

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• Nurse intervention

Shah B, Adams M, Peterson E, Powers B, Oddone E, Royal K, McCant F, Grambow S, Linquist J, Bosworth H. Secondary Prevention Risk Interventions Via Telemedicine and Tailored Patient Education (SPRITE): A Randomized Trial to Improve Postmyocardial Infarction Management. Circulation: Cardiovascular Quality and Outcomes 2011; 4: 235-242.

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Patients Reporting Outcomes (PRO)

• A quality healthcare metric• Patients reporting symptoms, performance status,

satisfaction with care, and quality of life (QOL)• e/Tablets pre-programmed with the PACE system

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Abernethy AP, Ahmad A, Zafar Y, Wheeler JL, Reese JB, Lyerly K. Electronic Patient-Reported Data Capture as a Foundation of Rapid Learniing Cancer Care. Medical Care 2010;48:S32-S38.


25Used by permission from AP Abernethy, MD


e/Tablet Results

• Easy to use, navigate, and read• Patients satisfied with e/Tablets, and would

recommend them to other patients.• Help patients recall symptoms to report.• ePRO system can be used to collect research-quality

data using common, validated instruments in an academic oncology clinic.

26Used by permission from AP Abernethy, MD


Roll-out of the eTablet system and Patient Care Monitor (PCM) tool into usual practice in the Duke oncology clinics starting with the GU Oncology clinic in 8/09 with serial roll out to Thoracic Oncology in 11/09, Breast Oncology in 5/10, and GI Oncology sequentially. Other clinics will follow.

Used by permission from AP Abernethy, MD


We are currently averaging 1300-1400 PCM surveys being completed per month, with approximately 300-350 new patients using the system per month.


Oncology Data MartDSR

VariablesClinician Reported Variables

Patient Reported Variables

AbstractedVariables Common

across all disease groups(80%)

Disease Specific

(20%)

Data transferred and feeding into avariety of databases and reports

Tumor Registry

NCCN Databases Quality Clinical

TrialsClinical

CareBasic &

Population Research



Did you see this in the WSJ?

• “ALS Study Shows Social Media’s Value as Research Tool”– An example of patient reported outcomes with patients

themselves taking charge! Findings released online April 24, 2011 in Nature Biotechnology

– Social-networks do have potential in clinical research• Speedy to launch, costs avoided, recruitment easy, and

results transparent in open access publishing

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Future challenges and plans for us in CRI

• Regulatory• Budget planning to include informatics• Data management (already NSF requirement)• More cultural and behavioral intervention studies• Expansion of the global outreach• Increase in the demand for informatics experts

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Thank you!

• Appreciated contributions from Duke colleagues:– Raquel Bartz, MD, Anesthesiology and Critical Care– Robert Harrington, MD and David Kong, MD

Duke Cardiovascular Research Institute– Amy Abernethy, MD, Medical Oncology

33

To find me:@CallingFC on Twitter@mbadams also on [email protected]

http://www.dukehealth.org/

randomized controlled trials a nd applied informatics at duke

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