Partnering with Patients,

Practices and

Communities in Clinical

Implementation and

Dissemination Research

Ann Bonham, Ph.D.

Chief Scientific Officer

August 2014

1. Setting the context:

The national landscape

2. The “tipping point” for

community engagement and

dissemination?

3. Thoughts on the “how to’s”

4. Peeking over the horizon

5. Opportunities and levers for

CTSA CE

Healt

h m

Set discretionary spending at $1 trillion in FYs 2014-15

($ in billions) FY 2013

FY 2014

w/ seq.

FY 2014

revised1

FY 2015

revised1 FY 2016

Defense $518 $498 $520 $521 $523

Nondefense $468 $469 $492 $492 $493

Total $986 $967 $1,012 $1,014 $1,016

2013 Budget Control Act

Proposals Currently Before Congress

S. 2115, “American Cures Act,” H.R. 4384, “America HEALS Act,”

• Would create mandatory biomedical research trust

fund to increase $ for NIH, others by inflation + 5%

• No “offset” (savings) to pay for bill = no Republican

cosponsor

21st Century Cures Initiative • Energy and Commerce Health Subcomm.’s

bipartisan exploration of ways to accelerate

identification, development of new cures, treatments

• No legislation this year, just study and hearings

Accelerating Biomedical Research Act

• Proposes to lift the budget cap on the NIH without

triggering an offset requirement

• Would allow more predictable, sustainable growth,

restoring agency purchasing power to what it would have

been had it kept pace with inflation since before

sequestration

• No Republican cosponsor

American Compete Reauthorization Act of 2014

• Authorizes stable and sustained increases in

federal research and development funding for

NSF and NIST.

• Addresses agency efforts to increase

participation in STEM fields, including among

women and minorities.

Compelling

health needs

Increasing

calls for data

sharing

Growing

voice of

patients in

research

Emerging Technologies

PCORnet

Expanding science and

workforce needs:

CER,

Informatics

Implementation

Science

Increasing

calls for

outcomes

and metrics

that matter

Affordable

Care Act

1. Setting the context:

The national landscape

2. The “tipping point” for

community engagement and

dissemination?

3. Thoughts on the “how to’s”

4. Peeking over the horizon

5. Opportunities and levers for

CTSA CE

Healt

h m

A convergence of interest

The CTSA Program at NIH:

Opportunities for

Advancing Clinical and

Translational Research

IOM Committee to Review the CTSA

Program at NCATS

AAMC Research Assessment and

Communication Initiative

Health Equity Research Expert Panel

Clinical Outcomes Research Expert Panel

Foundational & Basic Science Research Expert

Panel

What we learned from engaging community

stakeholders on metrics for assessing community-focused research benefits

18 gender, geographic and ethnically-diverse community

members engaged through interviews and focus groups.

Community

based

organizations

Community

advisors

Community

based –

researchers

Other

identified

community

stakeholders

…better engagement in dissemination

“We want information about the outcomes that are

matched to health and wellness priorities we have

identified in our communities, packaged in an

accessible way (language, brevity, linking to local

setting) and easily useable in teaching others (via

clinic, schools, health and social services settings).”

Quote from a community engagement partner

Eder et al: A Logic model:

CTSA Community Engagement

Eder MM, et al. Acad Med. 2013 Oct;88(10):1430-6.

Inputs Short-term

results

Intermediate

results Impact

Better processes and practices

• Infrastructure

• Education

• Improved IRB

• Promotion/tenure

capacity for

dissemination

• Funds/resources

• Bidirectional trust

• Community research

capacity; CBOS,

practices, hospitals

• Stronger

relationships with

communities

• Novel methods

• Ethical framework

• Community

empowerment and

trust of university

• Community and

university PI teams

• Joint questions,

study designs, data,

analysis, publications

• Workforce

• Recruitment/retention

Better science

Better answers

Better population health

• Community leading

Implementation

and Dissemination

• Community leading

Implementation and

Dissemination

(and included)

Gray Bars:

Means criterion scores

across criteria for

knowledge exchange

from 25 exemplar

research grant

proposals

Criteria for assessing knowledge

exchange plans in research

Source: www.implementationscience.com/content/9/1/93

1. Setting the context: The

national landscape

2. The “tipping point” for

community engagement and

dissemination?

3. Thoughts on the “how do you do

implementation research?”

4. Peeking over the horizon

5. Opportunities and levers for

CTSA CE

nc

e

Translational

Pre-Clinical

Research

Implementation

Research

(CER)

Community-

engaged

research

Basic

Science

Health

system

research

The Research Spectrum

Better processes and

practices

Better

science

Better

answers

Better population

health

Practice

Guidelines

Patient or

group

behaviors

Implementation

Strategy (ies)

Conducting implementation after

completion of the study or intervention

Better processes and

practices

Better

science

Better

answers

Better population

health

Health

system

Intervention

Implementation

Strategy (ies)

Intervention

Simultaneously conducting the

intervention (CER, etc) and implementation

research

Better processes and

practices

Better

science

Better

answers

Better population

health

Health

system

Implementation

Research

Intervention

Health

system

Implementation

Trial 1

Implementation

Trial 2

Comparative Implementation Research

(CIR) in the same community

…”Comparative community engagement

research”

Better processes and

practices

Better

science

Better

answers

Better population

health

Health

system

An Example: “Community Partners in Care” in LA, compared

implementation strategies to help under-resourced

communities to improve their services to clients with

depression

Implementation

Research

Community Engagement

Community agencies brought together to fit the same

quality improvement programs to the needs and

strengths of their communities.

Implementation

Trial 2

Implementation

Trial 1

Expert Consultation

Health experts provide technical assistance to

community groups to adapt quality-improvement

programs proven to work well in improving

depression care.

Implementation

Trial 1

Implementation

Pilot Study

Intervention

Implementation

Scaled Locally

Implementation

Spread to other

Sites

Post

Implementation

Evaluation

Staging the implementation research- from

pilot – to scale – to spread

Better processes and

practices

Better

science

Better

answers

Better population

health

Health

system

Engagement in implementation and

dissemination requires engagement at the

beginning.

1. Setting the context:

The national landscape

2. The “tipping point” for

community engagement and

dissemination?

3. Thoughts on the “how to’s”

4. Peeking over the horizon

5. Opportunities and levers for

CTSA CE

Open Science, Data Sharing,

Reframing of Privacy

“In today’s highly connected world – a discovery

made somewhere is soon known everywhere.”

1.

China

Japan Germany S. Korea Japan

Canada

US

Global Networks:

from “global competition” to “global

collaboration” and engaging communities

across the globe

2.

Increased emphasis on engagement across the spectrum of research

3.

More and “new” partnerships 4.

Greater emphasis on cost and value

Cost

containment in

population

care (beyond

hospital walls):

Cost

containment in

research:

5.

1. Setting the context:

The national landscape

2. The “tipping point” for

community engagement and

dissemination?

3. Thoughts on the “how to’s”

4. Peeking over the horizon

5. Opportunities and levers for

CTSA CE

PCORNet:

A preview of what’s to come

• CDRNs and PPRNs trailblazing the

infrastructure, agreements and proof of

concept studies

• Massive networks for data sharing

• Convergence of partnerships between

PCORI and NIH CTSAs

• Unprecedented capacity-building for community

engagement in implementation and dissemination

1.

Community Health Needs Assessments

(CHNAs)

Source: Preliminary results from AAMC Community Health Needs Assessment (CHNA) member survey 5-30-14

R Expanded requirements under ACA

R Communities engaged every 3 years to prioritize health needs

R CHNAs must include an implementation strategy

AAMC surveyed 501c3 teaching hospitals

(n = 113)

Who played significant roles in conducting

the CHNA?

82%: senior hospital leaders

67%: community leaders

33%: researchers

4%: trainees/residents

RESEARCH

EDUCATION

CHNA

CLINICAL CARE

COMMUNITY

2.

Population health 3. Data sharing

and mining

Comparative community engagement strategies

…in the end…it’s about…

…the social contract and privilege of improving

the dignity, well-being and health of others

through research

©

Engage CTSA

CE lead,

Research Dean,

CHNA lead,

Community

Rep(s)

Inventory/

document all

community-

engaged PIs,

programs &

initiatives & their

connections to

patients & CBOs

Collectively

develop “rules

of the road”

for community

engaged

research

Engage

community in

“kicking the tires”

on current

research

activities, outputs

& impacts

Coordinate

going forward-

generalize the

benefits

Member Capacity Building Advocacy

www.aamc.org/healthequity

“Snapshot” Health equity “virtual site

visit”

Spotlight on disparities-focused HSR

RESEARCH

EDUCATION

CHNA

CLINICAL CARE

COMMUNITY

New ROCC Health Equity Subgroup launched with 25 members

AAMC Commitment to Community

engagement and health equity