Introduction to Dissemination and Implementation Science.

Cynthia A. Vinson, PhD, MPA Acting Deputy Director for Implementation Science Division of Cancer Control and Population Sciences

November 5, 2014

Objectives

1. Discuss why dissemination and implementation science research is needed

2. Define dissemination and implementation (D&I) research

3. Describe who should be involved

4. Highlight D&I approaches and methods

5. Discuss what makes a good D&I study

Why Do We Need Implementation Science Research?

Most common type of research?

6

Overview Key Features Global Health Discussion IS Applications

T2

T3

T4

T1

Modified from Glasgow RE et al; J Acquir Immune Defic Syndr. 2013;63 Suppl 1:S26-31.

Glasgow, Vinson et al. AJPH 2012.

Discoveries

(e.g. new risk factors,

biomarkers)

Promising Application

(e.g. new vaccine)

Practice and

control programs

Evidence-based

guideline/policy

Reducing the

Burden of Disease

Knowledge Integration

T0

Continuum of Translational Research

Focus of

Implementation

Science – T3 and T4

From: http://kirstyevidence.wordpress.com/2014/09/06/implementation-science/?blogsub=confirming#blog_subscription-2

The Language of D&I

Health Services

Health Services Research

A Sea of Terms (and Circles)

Implementation Science

Implementation

Research

Dissemination

Research

Quality

Improvement

Science

QI

Health

Communication

Research

PEPFAR Definition

• Implementation Science (IS): the study of methods to improve the uptake, implementation and translation of research findings into routine and common practices (the ‘know-do’ or ‘evidence to program’ gap)

• Scope: improve program effectiveness and optimize efficiency, including the effective transfer of interventions from one setting to another

Padian, N. S., C.B. Holmes, S.I. McCoy, R. Lyerla., Bouey, P. D., & Goosby, E. P. (2011).

“Implementation science for the US president's emergency plan for AIDS relief (PEPFAR).” Journal

of Acquired Immune Deficiency Syndromes 56(3): 199-203

Implementation research for the control of infectious diseases of poverty: strengthening the evidence base for the

access and delivery of new and improved tools, strategies, and interventions. World Health Organization, 2011

WHO /TDR Definition

• Implementation involves evidence-supported, systematic, and planned efforts within a system (or organization) to institutionalize an intervention and to ensure its intended effects and impacts.

• Implementation research asks: “What is happening in the design, implementation, administration, operation, services, and outcomes of social programs? Is it what is expected or desired? Why is it happening the way it is?

• Implementation research does not isolate the effects from the context, thus distinguishing itself from clinical trials and impact evaluations.

NIH’s Definitions

– Dissemination: the targeted distribution of information and intervention materials to a specific public health or clinical practice audience. The intent is to spread knowledge and the associated evidence-based interventions.

– Implementation: the use of strategies to adopt and integrate evidence-based health interventions and change practice patterns within specific settings.

The Trans-NIH D&I Funding Announcement (International Investigators Eligible)

• R01 - PAR 13-055 ($500k per annum up to five years)

R03 - PAR 13-056 ($50K per annum up to two years)

R21 - PAR 13-054 ($275K up to two years)

• Participating Institutes: NIMH, NCI, NIDA, NIAAA,

NIAID, NHLBI, NINR, NIDDK, NINDS, NIDCD,

NIDCR, NCCAM, NHGRI*, NIA* & Office of Behavioral

& Social Sciences Research

• Standing review committee, Dissemination and Implementation

Health Research

• Three submission dates per year: February, June, October

*New Institute Added to PAR in 2013

http://cancercontrol.cancer.gov/funding_apply.html#is

Possible Dissemination

Research Topics

Analysis of factors influencing the creation, packaging, transmission and reception of valid health research knowledge

Experimental studies to test the effectiveness of individual and systemic dissemination strategies, focusing on relevant outcomes (e.g., acquisition of new knowledge, maintenance of knowledge, attitudes about the dissemination strategies, use of knowledge in practice decision-making)

Studies testing the utility of alternative dissemination strategies for service delivery systems targeting rural, minority, and/or other underserved populations

Studies on how target audiences are defined, and how evidence is packaged for specific target audiences

Possible Implementation

Research Topics

Studies of efforts to implement prevention, early detection, and diagnostic interventions, as well as treatments or clinical procedures of demonstrated efficacy into existing care systems to measure the extent to which such procedures are utilized, and adhered to, by providers and consumers

Studies on the fidelity of implementation efforts, including the identification of components of implementation that will enable fidelity to be assessed meaningfully

Longitudinal and follow-up studies on the factors that contribute to the sustainability of research-based improvements in public health and clinical practice

Possible D&I Research Topics

Studies of the capacity of specific care delivery settings (e.g., primary care, schools, community health settings) to incorporate D&I efforts within current organizational forms

Studies that focus on the development and testing of theoretical models for D&I processes

Development of outcome measures and suitable methodologies for D&I approaches that accurately assess the success of an approach to move evidence into practice (i.e., not just clinical outcomes)

What do these have in common?

TRUTH

BEAUTY

INSANITY

PORNOGRAPHY

CONTACT LENSES

D&I RESEARCH

…in the eye of the beholder

Adapted from Melissa Brouwers (KT Canada)

Q3. Is this a D&I Research Project?

• Chemotherapy: The objective of this study is to

determine the most effective chemotherapy

regimen (as measured by overall survival) for

individuals with stage III colon cancer who have not

been previously treated.

Q3. Is this a D&I Research Project?

• Tool for Health Systems Guidance: The

objective of this study is to develop a measurement

instrument designed to evaluate the methodological

quality of health systems guidance documents.

Q3. Is this a D&I Research Project?

• AF+Media vs. Media alone cRCT: The

objective of this cluster randomized control trial is to

determine if small media combined with audit &

feedback are superior to small media alone at

increasing primary care providers' rates of flu

vaccination of their elderly patients in their practice.

Do differences exist as a function of type of primary

care provider (physician, nurse practitioners vs.

others)?

• # Patients Using ER: Using clinical databases, the

objective of this study is to examine the proportion

of patients who visit the emergency department

within 2 weeks of death and to compare patterns of

practice across 14 local health integrated networks

(i.e. health regions).

Q3. Is this a D&I Research Project?

…And The Survey Said…

Ch

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Green = no Blue = yes Orange = not sure

Interpretation

• Even amongst the old-timers, differences of opinion (…in the eye of the beholder)

• Benefit: Likely an appetite for a broad range of ideas

• Challenge: Variety of opinions on your review committees (funding, publication)

Who Should be Involved in D&I Research?

“Successful implementation research begins and ends with successful

collaborations”

Community

Overview of D&I Methods/Approaches

What Approaches are Appropriate

• “Question is King”

• Examples of types approaches:

– Pragmatic Trials

– Effectiveness-Implementation Hybrid Trials

– Quality Improvement Studies

– Participatory Action Research

• Qualitative, Quantitative and Mixed Methods

Pragmatic (Practical) Trials: Key Contextual

Characteristics

• Multiple, heterogeneous settings

• Representative populations

• Comparison conditions are real-world alternatives

• Multiple outcomes important to decision and policy makers

Thorpe KE et al., Can Med Assoc J, 2009, 180: E47-57

Tunis SR et al. Practical clinical trials…JAMA 2003;290:1624-1632

Glasgow RE et al. Practical clinical trials…Med Care2005;43(6):551-557

31

Key differences between Traditional Randomized Control

Trials (RCT) & Pragmatic Controlled Trials (PCT)

Traditional RCT tests a

hypothesis under ideal

conditions

PCT compares treatments

under everyday clinical

conditions

GOALS To determine causes and

effects of treatment

To improve practice and inform

clinical & policy decisions

DESIGN Tests the intervention against

placebo using rigid study

protocols & minimal variation

Tests two or more real-world

treatments using flexible

protocols & local customization

PARTICIPANTS Highly defined & carefully

selected

More representative because

eligibility criteria are less strict

MEASURES Require data collection

outside routine clinical care

Brief and designed so data can be

easily collected in clinical

settings

RESULTS Rarely relevant to everyday

practice

Useful in everyday practice,

especially clinical decision

making

Hunter, C. “Dissemination and Implementation Research in Diabetes and Obesity”

TIDIRH 2014 July 2014.

Effectiveness-Implementation Hybrid Trials

Efficacy

Studies

Effectiveness

Studies

Implementation

Research

Improved

processes,

outcomes

Hybrids

“go” in

here

Types of Hybrids

Clinical Effectiveness

Research

Implementation Research

Hybrid Type I

Hybrid Type II

Hybrid Type III

Test clinical intervention, observe/gather information on implementation

Test clinical intervention, study implementation intervention

Test implementation intervention, observe/gather information on clinical intervention outcomes.

From Curran G., Bauer, M., Stetler, C., Mittman B.

A different view of Hybrids

Focus Implementation?

Clinical

Intervention?

Yes No

Yes Hybrid Type II Hybrid Type I

No Hybrid Type III Observational Research

From Curran G., Bauer, M., Stetler, C., Mittman B.

Plan, Do, Study, Act Cycle

P D Plan Do A S Act Study

PLAN for changes to bring about improvement

• Customer/supplier mapping Flowcharting

• Pareto analysis • Brainstorming • Nominal group techniques • Evaluation Matrix • Cause-and-effect diagrams

DO changes on small scale first to trial them

• Small group leadership skills

• Experiment Design • Conflict Resolution • On-lab training

ACT to get the greatest benefit from changes

STUDY changes to see if they are working and investigate selected processes • Data check sheets • Graphical analysis • Control charts • Key performance indicators

• Process mapping • Process standardization • Control reference

information formal training for standard processes

Peters, D.H., Tran, N.T., Adam, T., Implementation Research in Health: A Practical Guide, 2013.

Quality Improvement Studies

Participatory Action Research

Participatory Action Conventional

What’s the research for? Action Understanding what’s

possible

Who’s the research for? Local People Institutional, personal, and

professional

Whose knowledge counts

most?

Local people’s Scientist’s

Who chooses the topic? Local priorities Funding agency,

institutional agenda,

professional interests

Methodology chosen for

what reason?

Empowerment and learning Disciplinary convention,

“objectivity”, “truth”

Who takes part in the stages of research?

Problem Identification Local people Researcher

Data collection Local people Researcher, data collector

Interpretation Local concepts and

frameworks

Disciplinary theories and

frameworks

Analysis Local people Researcher

Presentation of findings Locally accessible

and useful

By researcher to academics

and funding agency

Action on findings Integral to process Usually separate or may not

happen

Who takes action? Local people, with

or without external

support

External agency

Who owns results? Shared Researcher or funder

Emphasis of process or

outcomes?

Process Outcomes

What Makes a Good D&I Study?

Q1. We asked D&I Scientists:

In your experience as a REVIEWER of D&I

research grant proposals, please identify the

one or two key components you believe

define a stellar D&I research proposal.

Adapted from Melissa Brouwers (KT Canada)

…And The Survey Said…

• Potential to make an impact/real world problem (soon)

• Strong theory, concepts, frameworks

• Well-chosen intervention and/or implementation plan

– sound justification, innovative, tested pragmatically, aimed to change behavior

• Tests an intervention or competing interventions

…And The Survey Said…

Logical step to research enterprise/strong

rationale

Evaluation – process and outcome (e.g.

clinical outcomes) measures contradictions across respondents

Compelling description of performance gap

Pilot data collected to justify request pilot primary data, systematic review, or both

…And The Survey Said…

• Advances Implementation Science

• Rigorous assessment of implementation

strategy

• Good team

– integrated, D&I scientists

• Good fundamental methods

Q2. We asked D&I Scientists:

In your experience as a REVIEWER of D&I

research grant proposals, please identify the one

or two common problems seen in these

proposals.

Adapted from Melissa Brouwers (KT Canada)

…And The Survey Said…

• Applicants simply do not understand D&I

(almost all) – superficial

– not an integrated approach with decision makers

– conference presentation or publication does NOT = D&I

– not embedded in a real world context

– window dressing (use D&I theory but do NOT

understand it)

– no respect for the science of D&I

…And The Survey Said…

• Poor justification

– failure to build on what is already known

– little knowledge of extant literature

– no pilot data

• D&I interventions not designed appropriately

D&I Research Training Opportunities

• Dec. 8-9, 2014 - 7th Annual Conference on the Science

Dissemination & Implementation: Transforming Health Systems

to Optimize Individual and Population Health (Bethesda, MD) –

registration currently open

• June-December 2014- Implementation Science-Principles and

Practice (World Cancer Congress Master’s Course) –

registration closed

• Summer 2015 - Annual Training Institute on Dissemination and

Implementation Research in Health

• Monthly IS Advanced Topic Webinars (see our website)

Questions?