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Bridge Building Workshop for Improving Community Health

Community Engagement in Research

(CEnR) and Comparative Effectiveness

Research (CER)

Welcome

Syed Ahmed, MD, MPH, DrPH, FAAFP

Senior Associate Dean for Community Engagement, Director of the Community Engagement Key Function of the CTSI, Medical

College of Wisconsin

Opening Remarks

Reza Shaker, MD

Senior Associate Dean for Clinical and Translational Research,

Principal Investigator and Director of the CTSI, Medical College of Wisconsin

Host Welcome

Patricia Arrendondo, EdD

Senior Associate Dean for Clinical and Translational Research,

Principal Investigator and Director of the CTSI, Medical College of Wisconsin

Keynote Speaker

Thomas Concannon, PhD

Health Services Researcher, Institute for Clinical Research and Health Policy Studies, Tufts University Medical Center, Boston, Massachusetts

Co-Chair, National Institute’s for Health CTSA Consortium Comparative Effectiveness Research Key Function Committee

Making Research Better with resources from the fields of

community engagement and comparative effectiveness research

Thomas W. Concannon

Tufts CTSI

October 2, 2012

Agenda

1. What is comparative effectiveness research (CER) and who is behind it?

2. CTSA Consortium efforts in CER and community engagement

3. What does the CER Key Function Committee (KFC) do? (With 2 highlights)

4. Insights on the intersection of CER and CE

What is CER and who is behind it?

Comparative Effectiveness Research (CER)

is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels. (IOM, 2009)

Patient-centered outcomes research (PCOR)

…helps people and their caregivers communicate and make informed health care decisions, allowing their voices to be heard in assessing the value of health care options. (PCORI, 2012)

Comparative Effectiveness Research (CER)

• Comparisons

• Effectiveness

• Assist consumers, clinicians, purchasers, and policy makers to make decisions

Patient-centered outcomes research (PCOR)

• Comparisons (relevant comparators)

• Effectiveness (settings where patients typically get care)

• Assist people and their caregivers to make decisions

• Allows their “voices to be heard”

CER & PCOR… Relevance of research questions

• Priorities • Comparators • Settings

Transparency of research activities (“people and their caregivers”)

Adoption of research evidence

helps people make decisions about health care

NIH CTSA program • Speed translation of research discovery into improved patient care • Strategic Goal 4 aims to improve the health of the nation through CER &

Community Engagement

IOM CER is a national priority and viewed as a key strategy for improving

healthcare

ARRA 90% of health research stimulus spent on CER

AHRQ and PCORI: • CER programs to help patients and physicians decide among treatments and

strategies • Emphasis on consumer and stakeholder engagement

NIH FY 2013 Level Request $30.9B

• CTSAs $462M (1%) • Common Fund $445M (1%)

• (Health Care Systems Research Collaboratory: $5M)

• Individual investments by 27 NIH Institutes and Centers ????

AHRQ FY2013 Level Request: $408.8M

• Patient-Centered Health Research $72.4M (18%) • Prevention and Care Management $27.9M (7%) • Value $3.6M (1%) • Health Information Technology $25.6M (6%) • Patient Safety $62.6M (15%) • Other (Cross cutting programs, MEPS) $148.3M (36%) • Program support $68.4M (17%)

PCORI FY 2012 Budget $160M • Approximately 122M (76%) will go to research • The FY2013 budget will increase significantly

CTSA Consortium efforts in CER and CEnR

CTSA Strategic Goal 4 - Mission

Identify and develop effective partnerships between academic

researchers and community stakeholders that allow for participation,

discovery, application, and dissemination of science.

Improve the public's health, reduce health disparities, and promote and

disseminate the translation of results of clinical and translational

research into practice and public policy.

SGC4 Objectives

1. Develop a CTSA Consortium-wide strategy for community-engaged and comparative effectiveness research that leads to improvements in the access, quality, and efficiency of healthcare delivery and the health of diverse communities and the public. (*Metric followed by CCEC).

2. Collaborate and create synergies with a wide range of stakeholders (i.e., communities, health departments, CTSA and other academic medical centers, NIH Institutes and Centers and other DHHS Federal Partners) in planning and implementing community-engaged and comparative effectiveness research and in disseminating the research findings.

3. Facilitate collaborations across CTSA institutions, PBRNs, and a broad cross-section of practice settings that increase the nation’s capacity for innovative community-engaged and comparative effectiveness research leading to the development of novel methodologies for both conducting research and for implementing and disseminating the findings of that research

Community Engagement • Education Scholarship and

Engagement

• Resource Development

• Outcomes of Community Engagement

• Community Partners Integration

• Health Policy

• PBRN Collaboration

• Administrative Supplements

• Translation Position Paper

Comparative Effectiveness Research

• Capacity and Needs Assessment

• Informatics

• Methods

• Education, Training, and Workforce Development

• Dissemination and Implementation Research

SGC4 Key Function Committees (KFCs)

Measures of Success

2011 Develop white papers that articulate strategies for the CTSA Consortium and its partners in community-engaged and comparative effectiveness research.

Identify and prioritize actionable, measurable and high-impact joint research

program opportunities. Identify opportunities for multi-CTSA research infrastructure and studies on

topics of common interest, with appropriate methods and metrics including strategies for measuring community engagement processes.

Measures of Success

2014 Evaluate the existing infrastructure to carry out the consortium-wide strategy in community-engaged and comparative effectiveness research, and ensure that KFC projects continue to be aligned with the mission of the SGC4, “to enhance the health of our communities and the nation.”

Document joint program achievements; develop recommendations for

disseminating research results to all stakeholders and for aligning the NIH grant review process with the translational goals of community-engaged and comparative effectiveness research.

Initiate and coordinate multi-CTSA studies including those that incorporate

an assessment of community engagement processes within the full spectrum of the research process.

Measures of Success

2016 Document the connection between the support for and the accomplishments of the SGC4 in realizing progress toward its mission of “enhancing the health of our communities and the nation.”

Revise and expand priorities for joint program opportunities; influence the

grant review process for community-engaged and comparative effectiveness research to align with the mission of “enhancing the health of communities and the nation.”

Complete, document, evaluate and disseminate findings from multi-CTSA

initiatives and studies.

What does the CER Key Function Committee (KFC) do?

CER KFC Achievements

• 30+ active and completed projects

• Capacity and needs assessment on CER – 2010, 2011, 2012

• Inventory of CER informatics/HIT activities – 2011

• Methods Roadmap – Tunis et al, CTS 2011

• Core Competencies for CER Education & Training – Segal et al, 2012

• A New Taxonomy for Stakeholder Engagement – Concannon et al, JGIM 2012

• Review of Dissemination & Implementation Research – Meissner et al, expected 2013

• Pragmatic Clinical Trials infrastructure (ongoing, jointly with CEnR, Evaluation)

“articulate strategies for the CTSA Consortium”


• Capacity and needs assessment on CER 2010, 2011, 2012

• Inventory of CER informatics/HIT activities





• Pragmatic Clinical Trials infrastructure (ongoing, joint effort of CE, CER, and Evaluation KFCs)

“Initiate and coordinate multi-CTSA studies”









Highlights for this Presentation









Highlight 1: A New Taxonomy for Stakeholder

Engagement

A New Taxonomy for Stakeholder Engagement in Patient-Centered Outcomes Research

Journal of General Internal Medicine

Thomas Concannon, Paul Meissner, Jo Anne Grunbaum, Newell McElwee, Jeanne-Marie Guise, John Santa, Patrick Conway, Denise

Daudelin, Elaine Morrato, Laurel Leslie

Rationale

Stakeholder engagement in research has the potential to • Improve the relevance of research questions

• Increase the transparency of research activities

• Accelerate the adoption of research into practice

Guiding Questions

1. Who are the stakeholders in PCOR?

2. What roles and responsibilities can stakeholders have in PCOR?

3. How can researchers start engaging stakeholders?

Stakeholder – An individual or group who is responsible for or affected by health- and healthcare-related decisions that can be informed by research evidence.

Stakeholder Engagement – A bi-directional relationship between stakeholder and researcher that results in informed decision-making about the selection, conduct and use of research.

Introduces 3 New Items

1. The 7Ps Framework to identify stakeholders

2. The Six Stages Model to identify stages of research

3. A Plan-Do-Study-Act approach to stakeholder engagement

Category Description

Patients and Public Current and potential consumers of patient-centered health care

and population focused public health, their caregivers, families

and patient and consumer advocacy organizations.

Providers Individuals (e.g. nurses, physicians, mental health counselors,

pharmacists, and other providers of care and support services)

and organizations (e.g. hospitals, clinics, community health

centers, community based organizations, pharmacies, EMS

agencies, skilled nursing facilities, schools) that provide care to

patients and populations.

Purchasers Employers, the self-insured, government and other entities

responsible for underwriting the costs of health care.

Payers Insurers, Medicare and Medicaid, state insurance exchanges,

individuals with deductibles, and others responsible for

reimbursement for interventions and episodes of care.

Policy Makers The White House, Department of Health and Human Services,

Congress, states, professional associations, intermediaries, and

other policy-making entities.

Product Makers Drug and device manufacturers

Principal

Investigators

Other researchers and their funders

The 7Ps Framework

The Six Stage Model

A Plan-Do-Study-Act Approach

1. Prioritize engagement and adopt a common taxonomy (plan)

2. Experiment with alternative strategies (do)

3. Evaluate alternative strategies (study)

4. Report on outcomes, implement changes as needed, and iterate (act)

Highlight 2: Pragmatic Clinical Trial infrastructure

Gary Rosenthal, Kathleen Brady, Harry Selker, Tim Carey, Tom Concannon, Lloyd Michener, Sergio Aquilar-Gaxiola, Rosemarie Filart, Iris Obrams, Paul Meissner, Jonathan Tobin, Mark

Helfand, Jerry Krishnan, Peter Neumann, Sean Tunis, Bill Hersh, Joel Saltz, Rowena Dolor, Wilson Pace, Harold Pincus, Arthur Blank, Alecia Fair

Pragmatic Clinical Trial (PCT)

A prospective comparison of a community, clinical, or system level intervention and a relevant comparator in participants who are similar to those affected by the condition(s) under study and in settings that are similar to those in which the condition is typically treated.

Pragmatic Clinical Trial infrastructure (PCT-i)

The resources, systems, and processes needed to prioritize, conduct and use the results of PCTs.

• “Grade” trials on 10 dimensions.

• Connect gradients to create a star-like shape.

• Larger “stars” indicate pragmatic-style trials.

• Pragmatic trials are not always a clear ‘yes/no’ choice.

Pragmatic–explanatory continuum indicator summary (PRECIS)

Objectives

1. Assist in the development of at least 2 large scale PCTs over 2012-2014

2. Learn about building infrastructure for PCTs

Rationale

“Initiate and coordinate multi-CTSA studies” by 2014 • Study healthcare and outcomes in usual settings

• Conduct high priority CER: clinical interventions + healthcare strategies

• Deploy innovative informatics and HIT

• Improve research methods

• Advance community and stakeholder engagement

• Promote D&I in clinical practice

…CTSAs are well positioned

Progress

Development of proposed PCT ideas • 19 proposals submitted

• 7 volunteers reviewed the proposals

• 5 were selected as “use cases” for an upcoming CTSA workshop

Workshop - Monday, November 19, 2012

Registration: https://redcap.ctsacentral.org/surveys/?s=gDpENH

Use Cases

NIcotine replaCement for HOspitaLized Smokers (NICHOLS study), Jerry Krishnan

The Case of Translating and Implementing Evidence-Based Childhood Asthma Interventions in Federally-Qualified Health Centers, Anne Rossier Markus

CER Study for CA-MRSA Treatment, Transmission and Recurrence Prevention, Jonathan Tobin

Chronic Pain Self-Management, Hayden Bosworth and Remy Coeytaux

A Multimodal Intervention to Reduce the Risk for Major Adverse Cardiovascular Events: A Pragmatic RCT to Compare the Effectiveness of Two Implementation Strategies for Primary Care, Karl Hammermeister

Infrastructure Components

1. Informatics

2. Methods

3. Community and Stakeholder Engagement

4. Dissemination and Implementation

5. Evaluation

Insights on the intersection of CER and CE

Where have we been?

Investments in infrastructure

• Informatics, HIT, methods development, evaluation

• Community and stakeholder engagement

“Articulate strategies for the CTSA consortium”

• Needs assessments, roadmaps, taxonomies, white papers

“The era of white papers is over”

Where do we want to go?

We want to make research better

• Improve the relevance of research questions

• Increase the transparency of research activities

• Accelerate the adoption of research into practice

Where do we want to go?

“Initiate and coordinate multi-CTSA studies”

High quality, community and stakeholder engaged CER and PCOR, including PCTs

PCTs will be assessed by their impact on

the relevance, transparency and adoption

of research evidence

Contact

Thomas Concannon

Tufts CTSI

617-794-9560

[email protected]

After December 10, 2012:

[email protected]

Level 1 Criteria:

We would like each of the 4 use cases to meet all of the following criteria:

• Is championed by a CTSA investigator who can lead further project development

• Is championed by an experienced research network

• Was identified as a priority through a local or national stakeholder and consumer

engagement process

• Uses prospective data and evaluates a clinical intervention, system, prevention

or policy change (may supplement with retrospective data)

• Is conducted in usual care settings (not exclusively in academic settings)

• Is comparative in nature (placebo comparator acceptable if justified as an

effectiveness study)

• Demonstrates some key aspect of consumer and stakeholder engagement

• Demonstrates some key aspect of dissemination and implementation

Level 2 Criteria:

• Uses EHR infrastructure for at least part of the data collection (YES or NO)

• Addresses patient‐reported outcomes as a key outcome of interest (YES or NO)

• Addresses pediatric medicine or health care (YES or NO)

• Compares or evaluates experimental methods

Uses randomization in the intervention assigned (YES or NO)

Quasi‐experimental in intervention assignment (YES or NO)

Observational studies may be considered comparative in a situation where an

intervention can only be examined through observation of a natural experiment

(YES or NO)

Highlight 3: Review of Dissemination & Implementation

Research

Elaine Morrato, Thomas Concannon,

Paul Meissner, Nilay Shah, Barbara J. Turner

Rationale

From the CER capacity and needs assessment of CTSAs in 2011: • 64% reported moderate/extensive D&I efforts

• 43% reported plans to increase D&I activity over the next 3 years

What are CTSAs doing in this area?

Objectives

• Case examples of CTSA D&I efforts

• Challenges in disseminating CER evidence

• Opportunities for improvement

• How can the CER Key Function Committee help?

Methods

Blocked convenience sample (N = 18) of CTSAs

• Self-reported level of D&I activity (hi-mod-low)

Structured telephone interviews with CER contact or desginee(s) (Aug 2011 – Feb 2012)

Synthesis and review of findings

Finding 1: All CTSAs are engaged in CER D&I

Who: CER researchers, investigators with D&I research funding, and health care providers and systems (QI activity)

What: investigator-generated evidence

Primary audience: clinical practices in the CTSA’s community engagement network.

Secondary audience: administrators/policy makers and other academic researchers.

Goals: education; knowledge transfer; Adoption.

Communication Channels: Primarily mass media (e.g., digital media, newsletters, publications). Some interpersonal channels within the local academic setting.

Evaluation: Most did not have a formal CER D&I evaluation process, outside of what would be funded for a D&I grant

Finding 2: CTSAs do not typically engage in D&I of research conducted elsewhere

AHRQ Effective Healthcare Program

I am not aware of this as our CTSA responsibility… dissemination occurs through

applied CER/QI teams.

Yes, we do this because we are a funded AHRQ center or have individual

investigators funded to disseminate evidence.

Landmark Clinical Trials

We don’t disseminate… research unless there was a local involvement in the trial.

Potentially yes… but only if it fits with the particular quality improvement need of a

care network partner.

Finding 3: Challenges

Lack of CTSA leadership awareness/support

Limited funding for D&I

Lack of established methods for D&I

Making CER evidence relevant to our audience

“CER is important to us, but is it high on the radar for our clinical partners?”

Finding 4: Opportunities

Clearinghouse Share D&I strategies and resources across CTSA organizations.

Infrastructure Develop a national infrastructure for D&I which activates existing CTSA networks.

Participating CTSAs

Albert Einstein-Montefiore Institute for Clinical and Translational Research

Colorado Clinical and Translational Sciences Institute

Indiana Clinical and Translational Sciences Institute

The Institute of Translational Health Sciences at the University of Washington

The Johns Hopkins Institute for Clinical and Translational Research

Mayo Clinic Center for Translational Science Activities

The North Carolina Translational and Clinical Sciences Institute

Oregon Clinical and Translational Research Institute

Tufts Clinical and Translational Science Institute

UAB Center for Clinical and Translational Science

University of California San Diego Clinical and Translational Research Institute

University of California Davis Clinical and Translational Science Center

University of Florida-Clinical and Translational Science Institute

University of Illinois at Chicago Center for Clinical and Translational Science

University of Massachusetts Center for Clinical and Translational Science

University of Texas Medical Branch Institute for Translational Sciences

University of Wisconsin Institute for Clinical and Translational Research

Yale Center for Clinical Investigation

Community Engagement at the Medical College of Wisconsin




Translational Research Community Engagement and Clinical Research

The National Committee on Vital and Health Statistics (NCVHS). The Community as a Learning System: Using local data to improve

local health. December 2011. Available:http://www.ncvhs.hhs.gov/111213chip.pdf.

A community is an

interdependent group of

people who share a set of

characteristics and are joined

over time by a sense that what

happens to one member

affects many or all of the

others.

What do we mean by Community?

What do we mean by Community Engagement in Research (CEnR)?

Source: Ahmed, SM and Palermo, AS. (2010) Community Engagement in Research: Frameworks for Education and Peer Review. American

Journal of Public Health, 100(8): 1380-1387.

CEnR is a process of inclusive

participation that supports mutual

respect of values, strategies, and

actions for authentic partnership of

people affiliated with or self-identified

by geographic proximity, special

interest, or similar situations to

address issues affecting the well-being

of the community or focus.

Rationales for Community Engagement: National, Institutional, and Community Driven

As commitment to community becomes more visible, community engagement helps bi-directional dialogues with communities and it enhances our ability to communicate all academic missions.

Needing the support of an infrastructure with adequate local data and analytic capacities and an overarching privacy and security framework.*

Opening the door to the community to knowledge, information, networks, resources, there by increasing its social capital.

*National Commission on Community Health Services , Health Is a Community Affair, 1966 (called the Folsom Report after its Chair). See also Dean W. Roberts, MD, “Health is

a Community Affair: Preview of the Final Report of the National Commission on Community Health Services,” Journal of the American Medical Association, April 25, 1996, Vol.

196, No. 4.

**Rosenstock L, Hernandez L, Gebbie K, eds. Who Will Keep the Public Healthy? Educating Public Health Professionals for the 21st Century. Washington, DC: National

Academies Press; 2003.

Need to address health disparities using Community Engagement.**

Community Engagement at MCW

Healthier Wisconsin

Partnership Program

Advancing a Healthier Wisconsin

Research & Education


Key Functions

Clinical & Translational

Science Institute

Partners Froedtert Hospital

(as partner)

Children’s Hospital of Wisconsin

(as partner)

Center for Healthy

Communities & Research

Departmental Programs

Center for

AIDS Intervention

Research

Center for the

Advancement of

Underserved

Children

Institute for Health & Society


Mission

MCW CTSI Community Engagement Framework

Current

Approach

Unidirectional

Engaged Partner

Approach

Bidirectional

Bench to

bedside to

community

and back

Co

llab

ora

tion

Co

lla

bo

rati

on

Transformation

Transformation

Disconnect

between

bench/

bedside and

community

Vehicles for

Meaningful

Engagement

Community Resources Communities Engage as Scientific

Citizens

Academics Engage as Citizen

Scientists Academic Resources

Trust and Genuineness

Negotiation

and Conflict

Resolution

Evaluation and

Feedback

Communication

Clinical

Research

Education


Community Engagement activities provide an opportunity to integrate across all missions of the Medical College

Mutually Reinforcing Missions

Improving Community Health: UW-Milwaukee Initiatives

Rachel F. Schiffman, PhD, RN, FAAN

Professor and Associate Dean for Research, College of Nursing

Director, CON Self-Management Science Center

Director, UWM Clinical and Translation Research Support Office

Sustained Community Engagement in Genetics and Genomics Research to

Improve Health and to Increase Health Equity

Principal Investigators:

Aaron Buseh and Sandra Underwood, College of Nursing

Focus: African American and African Immigrants attitudes and beliefs related

to health, research, and genetics/genomics

Methods: Focus Groups (10) and In-depth Interviews conducted (N = 70)

Population-based surveys for each group (N = 426)

Findings: Data analysis is in process and community forums are being held to

review. Although there are some seeming similarities, the underlying

perspectives from the two groups differ.

Funding: Wisconsin Genomics Initiative

Stories to Tell: Etiology of Sexual Risk, Substance Abuse, & Trauma: A Bioecological

Systems Model

Principal Investigator:

Laura Otto-Salaj, Helen Bader School of Social Welfare, Center for Applied

Behavioral Health Research

Focus: A prospective study of African American women living in urban housing

developments to understand the dynamics and complexity of sexual risk behavior,

substance use and trauma history.

Methods: Multiple assessments of individual, interpersonal, community and sociocultural

factors with 6 and 12 month follow-up.

Findings: We have conducted a preliminary test of one of several hypothesized models

using structural equation modeling; directions of all significant relationships, as

well as some non-significant ones, are as predicted. Although the model fits,

psychiatric symptoms related to previous trauma appears to be a key construct

influencing current victimization, substance use, and coping self-efficacy.

Funding: National Institutes of Health, National Institute on Drug Abuse, Eunice

Shriver National Institute of Child Health and Human Development, and National

Institute of Mental Health (R01DA023858)

Community-Based Behavioral Activation for Latinos with Depression

Principal Investigator:

Jonathan Kanter, College of Letters and Science, Department of

Psychology, Center for Applied Behavioral Health Research

Focus: Culturally and linguistically adapting Behavioral Activation for

depressed Latinos.

Methods: Focus groups and a pilot randomized trial comparing BA-Latino to

standard care in a community clinic.

Findings: Preliminary findings suggest improved session attendance and

improved depression outcomes at the end of 12 weeks of treatment for

the culturally adapted approach.

Funding: National Institutes of Health, National Institute of Mental Health

(R34MH085109)

Resources at UW-Milwaukee connected to Community Health

College of Nursing

Institute for Urban Health Partnerships

Community Nursing Centers

Self-management Science Center

School of Freshwater Science

Great Lakes WATER Institute

College of Health Sciences

Speech & Language Clinic

Community Audiology Services

Center for Urban Population

Health

Older Adult Fitness

Zilber School of Public Health

Public Health Impact Initiative

Institute for Urban Health Partnerships

The IUHP is one of only a few programs nationally that link the expertise of

university faculty and staff with the expertise of public and private

organizations and residents to develop more effective solutions to pressing

health care issues. The IUHP has provided surrounding neighborhoods with

innovative health delivery programs for more than 20 years through

community-based nursing centers.

The Westlawn Partnership for a Healthier Environment, Milwaukee,

Wisconsin: A Level II CARE Cooperative Agreement

To implement solutions proposed by the Ranked Community Profile Action Plan

based on the Westlawn Partnership's vision of Environmental Health. This Action

Plan, developed by the Westlawn Partnership during the Level I funding period, is

being implemented using a multimedia, holistic approach to reduce environmental

risks in the community.

Level II CARE funding focuses on three overarching goals:

a) Long-term sustainability of the Westlawn Partnership;

b) Healthy Homes; and

c) Healthy Day Cares.

PI: Anne Dressel

Funding: Environmental Protection Agency

Center for Applied Behavioral Health Research

Based in the UW-Milwaukee Helen Bader School of Social Welfare, the

Center for Applied Behavioral Health Research (CABHR) is a consortium of

public and private organizations led by academic scientists with broad interest

in the addictions and behavioral health. Our interdisciplinary team conducts

cutting edge epidemiological, intervention, and clinical research, and provides

treatment resources to Milwaukee residents in the process.

Self Management Science Center

The purpose of the N Self Management Science Center (SMSC) at the

University of Wisconsin-Milwaukee College of Nursing is to expand programs of

research aimed at enhancing the science of self-management in individuals

and families.

• UWM has broad range of programs of research that promote community health.

• There are venues at UWM for scientists across disciplines and across institutions to collaborate.

Rachel Schiffman

414-229-3991 [email protected]

Engaging the Community: Marquette University

Katherine Durben, Executive Director

Office of Research and

Sponsored Programs

Marquette University

Marquette University Facts

– 8,400 undergraduate and 3,600 graduate and professional students

– 77 majors and 65 minors and pre-professional programs in dentistry, law and medicine

– 50 doctoral and master's degree programs, 37 graduate certificate programs, and a School of Dentistry and Law School

– More than 1,100 faculty; almost 700 full-time

– Catholic, Jesuit institution

University Mission

Marquette University is a Catholic, Jesuit university dedicated to serving God by serving our students and contributing to the advancement of knowledge. Our mission, therefore, is the search for truth, the discovery and sharing of knowledge, the fostering of personal and professional excellence, the promotion of a life of faith, and the development of leadership expressed in service to others.

A university becomes a social project. Each institution

(Jesuit Schools) represented here, with its rich resources of

intelligence, knowledge, talent, vision, and energy, moved

by its commitment to the service of faith and promotion of

justice, seeks to insert itself into a society, not just to train

professionals, but in order to become a cultural force

advocating and promoting truth, virtue, development, and

peace in that society.

Adolfo Nicolas, Superior General of the Society of Jesus

Mexico City; April 23, 1010

Strategic Planning Priorities

• Pursuit of Academic Excellence for Human Well-being

• Research in Action

• Service, Social Responsibility, and Civic Engagement

Other Community Engagement Efforts

• Task Force on Community Engagement

• Task Force on Interdisciplinary Research

and Community/Civic Engagement

Units Involved with Health Research

• College of Arts & Sciences oBiological Sciences

oChemistry

oMathematics, Statistics and Computer Science

oPhilosophy

oPolitical Science

oPsychology

oSocial and Cultural Sciences

oTheology

Units Involved with Health Research

(cont.)

• College of Business Administration

o Economics

• College of Education

oCounselor Education and Counseling

Psychology

• College of Nursing

Units Involved with Health Research (cont.)

• College of Health Sciences

o Biomedical Sciences

oClinical Laboratory Sciences

o Physical Therapy

o Physician Assistant

o Speech Pathology and Audiology

• School of Dentistry

Specific Efforts

• Department of Psychology

• School of Dentistry

• College of Nursing

• Physical Therapy

414-288-7200

[email protected]

Julie A. Panepinto, MD, MSPH

Medical College of Wisconsin

Children’s Hospital of Wisconsin

Children’s Research Institute

Comparative Effectiveness Research: Does it Work?

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1

2

3

4

5

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Infant Mortality Rates by Country - 2010

How are we doing?

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$2,000

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Given what we are spending?

Basic

biomedical

science

T

1

T

2

Clinical

effectiveness

knowledge

T

3

Key T1 activity to test

what care works

Clinical efficacy

research

Key T2 activities to test

who benefits from

promising care

Outcomes research

Comparative

effectiveness research

Health sciences

research

Improved health

care quality and

value and

population health

Basic

biomedical

science

T

1

Clinical

efficacy

knowledge

T

2

Clinical

effectiveness

knowledge

T

3

Key T1 activity to test

what care works

Clinical efficacy

research

Key T2 activities to test

who benefits from

promising care

Outcomes research

Comparative

effectiveness research

Health sciences

research

Key T3 activities to test how to

deliver high-quality care reliably

and in all settings

Measurement and

accountability of health care

quality/cost

Implementation of:

-interventions

-redesign health system

Scaling/spread of effective

interventions

Research in above domains

The 3 T’s Roadmap

Dougherty, D. et al. JAMA 2008;299:2319-2321

Can it

work?? Does it work?

Is it valuable?

• Children’s Hospital of Wisconsin

Family Services

– Family Advisory Committee

– Parents as Partners’ registry

• Think Tank Meetings

– Patients/parents as research team members

• Community involvement

Patient/Stakeholder Involvement What Matters to the Patient?

• Google:

– “center for clinical effectiveness research” to

get to our web page

• Email

– [email protected]

– [email protected]

Center for Clinical Effectiveness Research

Vision and Goals: Today’s Workshop and Future




Vision

Identify philosophical, methodological and differences and common ground between these two disciplines

Gain a deeper understanding of the each other’s basic framework, principles and methods for conducting research

Networking and future collaboration among scientists and research organizations within Southeastern Wisconsin

Begin dialogue to effectively work together to advance knowledge, produce practical outcomes and leverage

resources

Format and Desired Outcomes

Le

arn

ing

La

nd

sca

pe

Keynote and Local Institutional Representative Presentations

This

Morn

ing

Review a case example,

Use example as springboard for identifying:

PROBLEMS and NEEDS in CEnR and CER

In the

Aftern

oon

Based on the morning session,

Explore opportunities for collaboration by identifying:

Recommended STRATEGIES towards BRIDGE BUILDING

Housekeeping Reminders

• Designations for Workgroup Rooms is on your NAME BADGE

• Parking Validation is available at the Reception Desk at elevator entrance

• WiFi Access is complimentary. Use the network named “Classroom”, no Login or Password required

• Refreshments are available throughout the day outside on the Credenza

• Lunch is in the Dining Room at 12 noon

“When facing a difficult task, act as if

it is impossible to fall. When going

after Moby Dick, bring along the

tartar sauce.”

Anon

Bridge Building Workshop for Improving Community Health

Community Engagement in Research

(CEnR) and Comparative Effectiveness

Research (CER)

BREAK

Information/Metrics/Tracking • Access to Existing Population Data • Investigator Training on Community

and Population • Database Management

Perceptions • Grassroots Buy-in • Population Motivation • Population Trust

Research/Study Design • Sample Size • Subject Recruitment • Access to Populations • Institutional Review Board • Best Study Design?

Support/Funding/Policy

Information/Metrics/Tracking • Measuring Success • Who Measures and How is it

Communicated? • Database Management • Understanding Built Environment and

other Social Determinants of Health

Perceptions • What the Community “Needs” versus

What we Think the Community “Needs” • Population Trust

Research/Study Design • Length of Study (Short Term Success

versus Long Term Follow-up) • Population Engagement • Institutional Review Board

Support/Funding/Policy

CEnR Problems/Needs CER Problems/Needs

• Understanding the disease

• Environmental settings

• Sustainability

• Who measures outcomes

and how are they

communicated

• Stakeholder adherence to

recommended therapy

• Peers

• Information source

• Best study design

• Engage community and

parents

• Defining study population

• Sustainability

• Representativeness and

generalizability

• Who measures outcomes

and how are they

communicated

• Stakeholder adherence to

recommended therapy


• Partnerships between

providers and schools

• Trust between parents,

providers and schools

• Time and money

(resources)

• Understanding outcomes

that matter

• Engagement of those with

the experience of the

disease

• Involvement of child/patient

with respect to outcomes

Parking Lot

List…

….

Recommended Strategies Towards Bridge Building

• Involving community and stakeholders in retrospective studies • Review available analytic and research designs in conjunction with

partners/stakeholders • Methods to engage stakeholders • Stakeholders identify benefits • Engaging early and co-identifying the problem and goals • Incentives or pay for time commitment • Use grassroot support • Acknowledge that communities have assets/recognize value that

stakeholders bring • Use a content expert from the stakeholder group (co-PI) • Identifying barriers to lack of interest or previous negative

experience • Identifying a place within a larger initiative or nesting within other

studies • Involve advocacy groups • Adopt other roles in community separate from your research role • Research staff with personal story/experience with the disorder • Communication, appropriate literacy and transparency • Sustainability – what’s left after study • Acknowledge and respect expertise of each other (CER and CEnR)

Next Step Suggestion(s)

Continuing to invest in Milwaukee Community Engaged Research Network

(MCERN)

Find non-healthcare and non-academic strategic partners

Expand outside Milwaukee

Apply clinical scholars network model to engage strategic partners, community

partners - those with shared goals to improve community health

What do you suggest as potential next steps

for the CTSI and CEnR-CER Leadership?


• What does “success” look like?

• Involvement with key community

stakeholders – from the beginning

• Look at long term changes in the

community – fresh grocery access and

utilization, options for physical activity

• Elevate the awareness of the

community (after 30 years of inertia)

• Some WIC parents – already believe

their children are eating “healthy” when

they may not be

• Recommend small/incremental

changes

• The measure that is decided upon

needs to be translated back to the

community being served

• BMI monitoring and tracking

• Due to transient population, use

cross-sectional data

• Lack to access to larger data sets /

lack of training to use.

• Metrics - are they available? Are

they the correct measures?

• Socially desirable bias

• Clinician training needs to emphasize

realistic lifestyle changes.

• Need to develop trust with

populations being served


• Populations being served – high

mobility; cultural and language diversity

• Employees of community agencies

have limited hours - use job as a

“stepping stone”; some full time staff

• “Needs”: are they of the community OR

what we THINK the community needs;

Are we asking? And continuing to

monitor over the timeline of the project.

• Political issues related to access to

food, parks, etc.

• Need to be developmentally

appropriate in providing education to

children – simple, basic statements.

Provided through 3 small steps they

can accomplish and repeat.

• How the issue is perceived by different

populations – may not be perceived by

the population as relevant

• 1 solution does not fit all /heterogeneity

• Confounders

• Access to resources – especially

refugees; inadequate knowledge

• Parents’ knowledge of information

provided to them in caring for children

• Sociological change – cultural change,

need for quick prep

• Not having the knowledge of food prep

• “relationship” development before the

research can begin

• Need to know the “motivation” of the

population being served

Recommended Strategies Towards Bridge Building • Develop a relationship before developing a strategy; let populations of people

know that the conversation is happening (invite participation). • Community HAS to be recognized as a full partner and equal in the project. • CTSI develops a research workforce program that partners with MPS, MATC, and

the MKE Area Workforce Development Board. • Don’t re-invent the wheel. Check with learnings/successes of other disciplines

working in the community of interest. Build a database of faculty and community organizations with current efforts that are in place.

• Building bridges – training, mentorship, how to get more faculty and staff interested in the field

• Sharing best practices in community organizations – Affinity Groups at UNCOM (monthly meeting of similar staff people sharing ideas/solutions)

• Ensuring cultural and language competencies among providers working with community members. Interpretation and translation available.

• Training to work as part of a group without power and balance issues. Institutions – based on rank and tenure; community-based work may take away from “regular” requirements. Community based organizations – also takes away from regular work.

• Principles of Partnership – time of effort vs. monetary values associated with that time. May not be viewed as equitable.

Next Step Suggestion(s) • IRB – has to be focused on federal regulations; more collaboration between CTSI CEKF and

Regulatory Knowledge (RK) Key Function; consents are way too long; health literacy of parents may be less than the children; assents are typically only one page long; CEKF needs to be aware of regulations that MUST be there for community-based research; there are IRBs that differ in their approach – may be “okay” with one IRB, but may not be with another.

• Online CITI training for community-based members (and across all institutions) is challenging to complete. RK is investigating alternative options to provide that training to community-based members. CEKF needs input – what works and what does not work.

• Ensure target participant driven needs, program strategies and outcomes. Leadership can translate this message by a mandate. Challenge is to operationalize.

• Leadership workshop/training series – learn how to build teams and networks to conduct the leadership and research. Make the training affordable. Similar to Healthy Wisconsin Leadership Institute (HWLI).

• CTSI Faculty collaboration database – expand to include community based organizations and a catalog of current/previous community based research efforts.

• Write a mandate that individuals of one research type must include at least one individual from more than one research background be included in the proposed project.



• Parking lot…

• Such as: speak in communities you want to work with; ads in the paper; walking group (meet in a situation where everyone is “equal”; start relationship as a person, not a researcher); develop relationships with key community members and then reach to additional community members through those people (can use neighborhood trust and appropriate language). Can use “block watch” leaders or other leadership roles within a neighborhood. Doing something WITH somebody is helpful; not doing something for them. When you invite community members, provide a purpose for them in the meeting and how to proceed forward – better engaged community members.


• Research is expensive

• Individuals within control group want same benefits as those

who are within the intervention group

• IRB issues

• Relationship issues are antithetical to some of the goals of

CER (“what can you do anywhere?”); because of

dependence on relationships/time/etc, it can be very difficult

to claim that CEnR is generalizable

• Volunteers are held to a higher standard, despite not being

able to pay them (opportunity with the soon-to-retire baby

boomer generation)

• Research question: “How to identify a good volunteer?” Dr

Whittle could not answer this during the recruitment

• Identification of a population

• Is the identification of a research question community-initiated or

investigator-initiated?

• Necessary to have buy-in from community; need liaison to the community

(has to be mutually beneficial for all involved. Have to leave the community

with something that is sustainable.)

• Urban areas have more structures (health systems, public health depts –

neutral ground); this is a challenge in rural communities

• Relationships have to be ongoing – requires an investment in the

relationship over time; relationships/trust over the long-haul regardless of

funding

• Research is expensive – priorities of funders has to match the priorities of

community (lack of concordance)

• Power and influence are not the same thing – need delegate

• Identifying and getting support of opinion leaders are important

• IRB concerns – community members don’t understand the ethical issues

underlying research

• Providing feedback from the researcher to the community (at what point

within urban and rural settings, how many subjects are too many? How to

share results without betraying confidentiality?)

• Attrition rates; long-term followup is necessary, but sustaining the study

over a long time can be difficult

• Trust issues related to funding - Funding for the trial – but once the funding

is gone, the relationship dissolves

• Competitiveness across sites –

• Being able to inspire others to get engaged with your own sense of social

responsibility; individuals within the community are now trained to take a

role within the community

• Difficult to be transparent with the control group – do we tell the control

group EVERYTHING that the intervention group would be receiving

• Community Advisory Board (for POWER Project) was very researcher

friendly


• They saw effective adoption of BP cuff; but difficult to

find money to provide BP cuffs after the intervention

had completed

• Making it easy to manage chronic conditions

• Need more funding, more training for investigators

• Effective/accurate translation – is it always clear to

the community what they are really going to get; they

are contributing to generalized knowledge that is

contributing to the greater good. Our communication

needs to be channeled through community members

• How do you engage the providers (e.g., individuals

who went to their providers with information about

their BP);

• Partnering well with insurance providers

• Uninsured individuals cannot afford medications to

manage their chronic illness

• Medication adherence

• Literacy issues and language barriers

• Needs assessments help to identify barriers

• Free meds no longer available from physicians

• Need more funding, more training for

investigators

• Similar conversation necessary for funders;

• How to convince funders of the importance –

longterm benefit to the funder

• Policy makers need to be involved with

allocating resources to true health promotion

and self-management; impact on the bottom

line might be sooner than later.

• “Report cards” might be a natural experiment

providing support for effective interventions

• Need grassroots buy-in for sustainability

Parking Lot

List…

….


List of strategies here • IRB training for community members • Understanding of ethics by community organization – the principles of protection (example of the tension between ethics and

reality – if you take only volunteers, there’ll be more effectiveness – therefore it is not necessarily generalizable. CER – more generalizable to the “real world” if results are from a wider group that includes those who want to participate as well as those who DON’T want to participate.)

• Ethical issues around who gets to see data; we have incredible technical capability to know about everybody, but who has a right to know?

• Privacy activists are so powerful; research activists are not political; researchers (and representatives major organizations) could got together and coordinated efforts to loosen up HIPAA regulations related to privacy. The fact that community members find IRB issues to be barriers, maybe we have a case to reduce these barriers.

• Need big name scientists to lead the way • The bridge is about complementary or sequential research questions – e.g., on CeNR side to get baseline data and then apply

CER research methodologies. • Communities as watchdog of privacy issues but also to identify research issues, “What works?”, “What’s fair?” • AIAN Native Americans – they have an IRB to do research with them. They want research done wtihin their community, but they

(community) wants to tell researchers what the research agenda is. • A set of CER and CEnR researchers should convene to talk through their project-specific priorities • People affected by studies should be part of thinking through and determining what ‘s next • This money funds the research, but then additional money needs to be secured to implement (sustain) the intervention. • Health care systems have to do assessments – at first, there were high level execs together at the table, llooked at community

report cards, etc., but within the community priorities had chnaged. “Top-down” priorities are not the same as the grass-roots “bottom-up” priorities. CER could come in at that point to provide resources to assist with this process. Again, starts FIRST at the community level and then, after several steps are complete, academia can come in to assist

• Change in academia – need to think about being embedded in a community and think more about how you interact with a community; so community sees you not just as educational resources, but you have arts, and also you are the entity interacting on a wider level with the community. Vibrancy of a community where academia is genuinely and widely involved in the community

• “The Wisconsin Idea” = taking university to the borders of the state. • Townhall meetings to identify community members’ priorities. Health is always within the top 5. Beaten out by safety, housing,

jobs and poverty (and, increasingly, food safety). But you better not ask those questions, and get those answers and STILL be prepared to respond according to their priorities. E.g., better address violence first (before health) if that is the priority of the community. Better by tending to all needs. You could reframe it according to the discipline you represent. Health might not always equal medicine –

• CEnR – NIH looks more at diseases, chronic issues, medicine, etc. – whereas people look at it differently • EPA and HUD – looking at • Research students – individuals from different disciplines (interdisciplinary) approaches to solve an identified issue. • John McKnight talks about the importance of identifying community assets • Pipeline programs – from middle schools on up; getting students engaged in small studies within their neighborhood

Next Step Suggestion(s) • Lead opportunities for CER and CEnR researchers to convene to talk through community priorities, identify synergies and make a plan for

using both CER and CEnR research methodologies • Teams of researchers that are broader than just health researchers so as community presents more fleshed out package of issues we are

better prepared to provide comprehensive help within our interdisciplinary research efforts • Broaden how we define research (not just medical or not just a laboratory with a microscope). • CTSI could explicitly reach out to do more to engage many more disciplines • Still focused on T1 and T2 end of the spectrum; strengthen community engagement • Notion of basic scientists working with the community is just one aspect; but it goes beyond that – biobehavioral, psychosocial, help the

community members to engage in health promotion (more effective/important than any kind of medication). • More money - $50k might buy a lot in a lab, but doesn’t buy much in the community; more money would advance what we could do for both

CER and CEnR • Bring community members to a venue like this; e.g., a dozen veterans (from POWER) in this room to talk about priorities, talk about

interpretation and dissemination • Bring program evaluation people to the table; work directly with community members who want to know if a program is really working. Inform

them what our statistical results indicate and let them provide the meaning/interpretation. Evaluation people are not researchers in the way that many define researchers; they are more “generalists” than other researchers. Methodologists are not always just biostatisticians.

• Capitalize on interorganizational assets; more interdisciplinary involvement for fuller discourse • Have point people at different institutions who can help to catalogue information (e.g., who is doing what at each institution) • CER at MCW is quantitative and less program evaluation • More opportunities for dialogue abou tinterst areas not just necessarily about “conditions” or disease-specific conversations and more about

broader topics like talking about collaborating around methods, research approaches that one might take that are still robust but different than traditional research

• Reach out and invite more people to network; make CTSI more interdisciplinary. • “Community Grand Rounds” focused on methodologic things – short presentations (e.g., 3 short presentations followed by food and

networking opportunities). • Creative ways to use technology to bring people together (e.g., CTSI has supported video conference room at UWM) • Quarterly in-person face-to-face networking • Not just rotating through partner sites but rotating through community sites as well. Recognition by the community that people care enough to

show up to see what is going on. • Tap into infrastructure of organizations who put on the ethnic festivals (e.g., German fest; Italian fest, etc.)




• Frontline staff turnover

• Need retraining

• Short term objective (pilot)

for Long term condition

• sustainability

• How do we introduce

innovation?

• Data management

(needs/requirements?)

• ETO system at UCC

• Also need Access

Database

• Comparison

group/historical measure?

• Not necessarily hypothesis

driven

• Metrics-How do you

quantify?

• Data management needs

to be scalable (can we use

open source tools e.g.

RedCap?)

• Sample size/power

analysis

• Study design

• Assess each intervention

individually

Are there strategies, technologies, or techniques

that CER uses that might be translatable to CEnR?


• Leave footprint after grant funding

over (plan for dis-engagement)

• Management expectations (from

the outset)

• Writing to “funder” vs. community

served

• Sustainability (take successful pilot

and obtain outside funding to

continue)

• Institution statistical support

• IRB tensions e.g. who owns data

• Technology transfer

• Communication plan

• How do we capture

effort/energy/vitality as well as

data outcomes

• Transparency of the

research project

• Sample size/power

analysis

• Study design

• Comparison group

(historical comparison)

Parking Lot

List…

….


• Community-Academic learning regarding each other’s Institutions

• Mission, challenges, processes • mutual education on constraints

• Conflicts of interest, ethical concerns • Institutions and community should be “open” to readjustments of

processes if needed • Willingness

• Competition and cooperation among research institutions • Different institutions go after different questions

• Negotiation and compromise • Relationship building • Shared workflow (resources such as IT, knowledge management) • Methods to determine cost effectiveness

• What are the most cost effective components (have the most benefit)?

• Need to define metrics that are relevant, cost effectiveness (Does the intervention keep the pt. in the home?)

Next Step Suggestion(s) • Long term academic-community partnerships needed to better serve the communities • More networking opportunities • Change the programmatic funding streams to include more research focus • Multi-site community trials • Transparency • Communication (limitations, barriers, process essential) • Resources, assets (how do we use them) • Think about the future (larger implications, can you look beyond project implications) • Infrastructure (informatics, databases) • Cost effectiveness (multiple roles researcher and payer) • Insured risk model (everyone benefits) • Relate to public health and use • Prioritizing research questions that matter • Funding differences between the two disciplines

– Indirect costs for Academic Institution – Society benefits worth it?

• Community engagement needs to be authentic part of the Academic mission



Keynote Speaker’s Reflections and Assessment

Thomas Concannon, PhD

Closing Remarks

Ted Kotchen, MD

and


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