Research in an IT Connected World: Building Better Partnerships – NIH and Health Care Systems

August 21, 2013

Building Partnerships

1. Why? The urgent need

2. Concrete examples of partnerships – the Health Care System Collaboratory Demonstration Projects

3. Preliminary thoughts about IT capacities, methods, rules

Cost: personal, institutional, and national

Outcomes

IOM: The Imperative for ActionDrivers of the Problem

Scientific uncertainty

Perverse economic and practice incentives

System fragmentation

Opacity as to cost, quality and outcomes

Lack of patient involvement

Underinvestment in population health

Clinical evidence development is not keeping pace with the emergence of

new diagnostics, treatments and insights into individual variation.

IOM- Learning Health Care System

Mayo Clinic Proceedings: A Breakdown of NEJM Articles Concerning a Medical Practice

Reversals

Examples:

Mortality was higher with recommended glycemic targets as opposed to more permissive standards (ACCORD, NEJM 2008)

Routine use of pulmonary artery catheters worsened ICU outcomes (NEJM, 2009)

Breast cancer survival was not improved by autologous stem cell transplant and intensified chemo compared with standard chemo (Tallman et al NEJM 2005)

Impermeable bedcovers have no benefit for adults with asthma, in spite reduced dust mite exposure (Woodcock, 2003 NEJM

Take home lesson:

We don’t always know what we think we know.

(hence the need to continue to examine standards of care)

What is a Practical Trial?

Defined Practical (pragmatic) Trials as those in which “the hypothesis and study design are developed specifically to answer the questions faced by decision makers”

Decision makers include patients, clinicians, payers,

& health care system policy makers

Pragmatic vs. Explanatory

Broad eligibility

Flexible interventions

Typical practitioners

No follow-up visits

Objective clinical outcome

Usual compliance

Intent-to-treat

Narrow eligibility

Strict instructions

Expert practitioners

Frequent follow-up visits

Surrogate outcomes

Close monitoring

ITT plus per protocol

Thorpe KE et al. J Clin Epidemiol 2009;62:464-75

What is a Pragmatic/Practical Trial?The PRECIS Tool is Developed

Thorpe KE et al. CMAJ 2009;180:E47

Pragmatic Study Elements

Broad eligibility criteriaFlexible interventionsTypical practitionersNo follow-up visitsClinical outcomesUsual complianceIntent-to-treat

Thorpe KE et al. CMAJ 2009;180:E47

The Urgent Need

We need continual improvement in standards of care

To achieve that we need pragmatic trials

We cannot maintain an artificial distinction between research and quality improvement

Building a Partnership

1. Why? The urgent need

2. Concrete examples of partnerships – the Health Care System Collaboratory Demonstration Projects

3. Preliminary thoughts about IT capacities, methods, rules

The overall goal of the Commons Fund’s Health Care System (HCS) Collaboratory is to strengthen the national capacity to implement cost-effective large-scale research studies that engage health care delivery organizations as research partners.

Pragmatic Trial Demonstration Projects

1. Preventing hospital acquired infections: (PI Huang) Do intensified antibacterial bathing measures reduce hospital-acquired infections? Cluster randomized trial - HCA randomizing 50 hospitals – 375,000 patients

“The implications of this study are highly important. The lack of effectiveness of

active detection and isolation should prompt hospitals to discontinue the

practice for control of endemic MRSA in ICUs….”

Pragmatic Trial Demonstration Projects

1. Preventing hospital acquired infections: (PI Huang) Do intensified antibacterial bathing measures reduce hospital-acquired infections? Cluster randomized trial - HCA randomizing 50 hospitals – 375,000 patients.

2. Colorectal cancer screening: (PI Coronado) Does a simple intervention implemented through Federally Qualified Health Centers improve colorectal cancer screening? Cluster randomized trial 18 OCHIN Clinics – 10,000 patients.

3. Suicide prevention: (PI Simon) A pragmatic trial comparing suicide prevention programs. Can patients who admit to suicidal thoughts in a health care encounter be successfully randomized to one of two management strategies and do interventions reduce subsequent suicide attempts? Group Health, Kaiser Colorado – 16,000 patients.

Pragmatic Trial Demonstration Projects

4. Lumbar Spine imaging: (PI Jarvik) Does insertion of epidemiological information into imaging reports reduce subsequent diagnostic and therapeutic interventions? Kaiser, N Ca; Group Health, Mayo, Henry Ford. Cluster randomized 128 clinics,135,000 imaging reports.

5. Nocturnal blood pressure control: (PI Rosenthal) Does taking anti-hypertensive medications at night reduce CV events? U of Iowa and Duke primary care clinics, 6,000 patients.

6. Collaborative care pain management model: (PI Debar) Study impact of integration of psycho-social supports for patients with chronic pain on pain measures and opioid use. 3 Kaiser regions, Georgia, Hawaii, Northwest. Cluster randomized by practice. Several hundred practices, 6,000 patients.

7. Longer dialysis duration: (PI Dember) Does increasing dialysis duration reduce mortality? Partners Fresenius, da Vita, Cluster randomized trial of 402 dialysis units. 7000 patients.

Test and Strengthen Models for Clinical

Research in Partnership with Health Care

Delivery Systems

Develop capacity to leverage resources of major integrated health care systems for large scale clinical research studies

Test and improve methods to extract research quality data from electronic health information systems

Strengthen relevance and translatability of research results to ‘real world’ health practice

Develop and test more cost-effective models for large scale randomized clinical trials

Building a Partnership

1. Why? The urgent need

2. Concrete examples of partnerships – the Health Care System Collaboratory Demonstration Projects

3. Preliminary thoughts about Health IT capacities, methods, rules to facilitate a learning health care system

Myriad Data Types

Other ‘Omic

Imaging Phenotypic

EHR

Genomic

Administrative

Data Steward #1

Authorized user

NIH DRN Secure Network Portal

1

52Data tables

Review & Run Query

3

Review & Return Results

4

6

Datatables

Review & Run Query

3

Review & Return Results

4

1- User creates and submits query (a computer program)

2- Data partners retrieve query

3- Data partners review and run query against their local data

4- Data partners review results

5- Data partners return results via secure network

6 Results are aggregated

Data Steward #2

ONC Query Health

Compliant

Send the question to the data!

The Goal of the IT Approach

Creating secure networking capabilities and analysis tools

Build networking capacity, not a network

Insure that access to data occurs only with data stewards’ permission and active engagement

Leverages existing networks’ data and analysis tools

Can use many data types, e.g., EHR, claims, registries

Can use many data models, e.g., Mini-Sentinel, i2b2, OMOP

Can use existing querying tools, e.g., Mini-Sentinel modular programs

Every use requires the agreement of the data steward

Health Plan 1

Health Plan 2 CTSA 1 Research

Dataset 1

NIH Distributed Research Network Secure Portal

Research Dataset 2CTSA 2 Registry

NIH DRN Secure Portal

Mini-Sentinel Site A

Registry 1Mini-Sentinel

Site B

Medical Practice 1PBRN 1

CTSA 1Hospital

1Research dataset 1

NIH Distributed Research Network Coordinating Center

CTSA 2Health Plan 2

Health Plan 1

Network Managemen

tResearch Support

Query Support

Query Tool Developmen

t

Knowledge DatabaseSoftware

Development

Project Managemen

tData Models & Standards

Consultation

Health System Expertise

Knowledge Management System Cross project lessons learned, query tracking, meta-data capture, search functions, etc

AdministrationQuery ToolsSAS, SQL,

menu-drivenModular Programs

Summary Tables

Project 1PROJECTS

LIRE studyAnalytic ToolsFeasibility study

Query Interface Reporting Tools

Security \ Access ControlFile \ Query Repository

User Administration Workflow Management

Thorny issues

Defining the right questions

Ethical issues surrounding research on standards of care: eg. when is waiver of consent appropriate

Optimum trial design for group or cluster randomized trials

Preserving effective public-private partnerships

https://www.nihcollaboratory.org/

National Center for

Complementary and

Alternative Medicine

Clearinghouse: 1-888-644-6226

Web site: nccam.nih.gov

Twitter: @NCCAM

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Pragmatic Trials

Pragmatic trials should test an intervention, or compare several interventions.

The question should be important – to patients, payers and with health care delivery systems.

The intervention should be reasonable simple and not require a complex structure for implementation.  System level interventions may be particularly suitable.

The trial design should incorporate rigorous controls, prospectively identified, preferable by randomization. 

The monitoring and outcome assessment should be as simple as possible – and potentially utilize electronic health records.