Amy Kilbourne, PhD, MPH

Director, VA Quality Enhancement Research Institute (QUERI)

“Let’s Get Real: Planning Rigorous Pragmatic Health Services Research for Equitable, Real-World Care”

Learning Objectives

• Define pragmatic research, how it can be rigorous, and key aspects of pragmatic research planning
  • Frameworks and designs
  • Working with community partners
  • Implementation planning processes
  • Selecting outcomes measures (e.g., using EHR data)
• Describe the QUERI implemntation roadmap and how it can help guide planning pragmatic research
• Describe the ways in which pragmatic research supports health equity goals of getting more communities involved in research

Abstract:

There is increased demand from consumers, providers, health systems, communities, and policymakers for effective health care innovations that make a substantial public health impact and can be readily adopted in real-world settings. However, even in the 21st Century, it can still take decades for a fraction of effective clinical innovations to be successfully adopted in routine health care settings. Moreover, many of these innovations are tested in small, select populations using clinical trial methods that have not adapted to the changing needs of patients and the providers and communities who care for them. The National Academy of Medicine, in their groundbreaking report on the Future of Health Services Research strongly suggests the need for more timely and pragmatic research that addresses the practical issues facing health systems and communities. This presentation provides a novel strategy for applying pragmatic research methods in health services research in order to enhance the real-world impact of health care innovations and health equity, incorporating lessons learned from the Learning Health System and QUERI implementation frameworks. We also outline the use of pragmatic research methods across the different research lifecycle stages (e.g., prioritization, discovery, validation, scale-up) that can be used to accelerate the substantial real-world impact of research at multiple levels (e.g., consumer, provider, practice, system, policy) and provide examples of how implementation science employs pragmatic research methods to accelerate the adoption of effective innovations ad reduce health disparities in real-world settings.

Elva Arredondo, PhD 

Professor,

San Diego State University

"Translating research evidence into practice to improve health equity: Lessons from a faith-based physical activity intervention"

Learning objectives

• Design studies that collect data relevant to community stakeholders. 
• Discuss lessons learned and opportunities to translate evidence-based faith-based interventions into practice.
• Identify opportunities and strategies to advance health equity in community settings.

Abstract

Physical inactivity is prevalent and chronic diseases impact racial/ethnic minorities at a disproportionate rate.  Evidence-based approaches for increasing physical activity (PA) and reducing obesity such as Faith in Action exist, but few PA interventions go to scale. Implementation strategies that enhance the capacity of faith-based organizations (FBO) leaders to implement EBIs can facilitate their uptake.

Research that addresses health disparities may need to consider dissemination plans in the early developmental phases of the study.  Several lessons to successfully scale up PA interventions in FBOs will be discussed including: 1) adapting the program to different contexts/denominations, 2) tailoring the messages to fit the context, 3) engaging key stakeholders in the implementation and scale-up process while considering costs, 4) shifting focus to organizational level outcomes, and 5) collecting data relevant to stakeholders (e.g., health outcomes).

Amy Huebschmann, MD, MS, FACP

Associate Professor, Clinician-Investigator, Division of General Internal Medicine University of Colorado

“Planning Pragmatic Research and the Value of Frameworks: using PRECIS-2 as a case example”

Learning Objectives:

To understand how frameworks are beneficial for pragmatic research, including study design, planning, and evaluation

To recognize the use of frameworks in grant applications to support the planning and/or evaluation of the proposed work

To specifically describe the benefits of using the PRECIS-2 framework for planning pragmatic research

Abstract

Frameworks are used for pragmatic research to assist with the study design, planning and evaluation of research projects.  Implementation science frameworks have been developed based on implementation theories, empirical data, or stakeholder input on factors necessary for optimal implementation of effective programs.  Frameworks benefit researchers in planning pragmatic research in several ways: 1. Designing for real-world context and stakeholders; 2. Incorporating implementation science methods that accelerate the potential for dissemination; 3. Assist with efficiently describing one’s approach to grant reviewers;  4. Allow prioritization of pragmatic constructs or implementation outcomes that are part of current frameworks.  This talk will introduce these aspects of frameworks and focus specifically on the PRECIS-2 framework.  PRECIS-2 was designed with input from multiple community, research, and policy stakeholders as a framework that assesses to what extent a trial is intended to be pragmatic with a priority on generalizability or how much it intends to be explanatory or efficacy-focused.  It includes a simple visual display to show the level of pragmatism visually in several domains.

Kate Guastaferro, PhD

Associate Research Professor,  Methodology Center Pennsylvania State University

"Using multiphase optimization strategy (MOST) for developing, optimizing, and evaluating multicomponent interventions"

Learning Objectives

• Describe the ways in which the MOST framework differs from the traditional intervention development and evaluation process

• Explain why MOST is a good approach for pragmatic research (ensuring fit to context)

• Describe the three phases of MOST

• Understand how to identify and select experimental designs to be used in the Optimization phase of MOST (e.g., factorial designs, SMART)

• Identify relevant examples for the application of MOST across the health research spectrum

Abstract

The majority of behavioral and biobehavioral interventions in use today have been evaluated as a treatment package using a two-arm randomized controlled trial (RCT). This approach is an excellent way to determine whether an intervention is effective; however, it is less helpful in providing empirical information that can be used to optimize the intervention to achieve improved effectiveness and efficiency while maintaining a desired level of economy, and/or scalability. In this presentation, an innovative framework for optimizing behavioral interventions, the multiphase optimization strategy (MOST), will be introduced. MOST is based on ideas inspired by engineering methods, which stress the careful management of research resources and ongoing improvement of intervention products. MOST is a comprehensive strategy that includes three phases: preparation, optimization, and evaluation. MOST can be used to build a new intervention or to improve an existing intervention. Using MOST it is possible to engineer an intervention that meets an a priori specified optimization criteria such as a particular effect size, level of cost-effectiveness, or any other implementation-related constraint.

Matthew Wynia, MD, MPH

Director, Center for Bioethics and Humanities University of Colorado

"Pragmatic Challenges of Engaging Stakeholders in Pragmatic Trials" 

Learning Objectives

• Define key terms and concepts related to stakeholder engagement

• Describe the purposes, value, and evidence for stakeholder engagement in pragmatic research

• Describe ethical considerations related to the importance of conducting research with real-world relevance

Abstract

Effective stakeholder engagement can be critical to the success of pragmatic clinical research, not least to ensure the results of the research are meaningful to its intended audiences. Yet, researchers intending to carry out stakeholder engagement activities should be aware of several practical challenges that can arise. A number of these are well-recognized, but a few are less commonly acknowledged, in part because they pose provocative questions about the priorities, values, and ethics of pragmatic research. This talk will provide core concepts and definitions in stakeholder engagement and then explore how notions of therapeutic misconception, advocacy, representation, and bias can play out in stakeholder-engaged pragmatic trials.

Ross Brownson, PhD

Lipstein Distinguished Professor

Washington University St. Louis

"Desigining for Dissemination: Beginning with the End in Mind"

Learning Objectives

• Describe core principles of designing for dissemination (D4D).

• Learn about progress in conducting D4D.

• Describe D4D methods.

• Learn how to incorporate D4D principles in your work to make it more pragmatic.

Abstract

Designing for dissemination (D4) is an active process that helps to ensure that public health and clinical interventions, often developed by researchers, are implemented in ways that match well with adopters’ needs, assets, and time frames. Data from the United States and Canada has shown considerable room for improvement in D4D. The lack of effective D4D is due in part to differing priorities and incentives between researchers, practitioners, and policymakers. A range of methods (e.g., user panels, advisory committees) may improve D4D yet vary widely in their use. This presentation will frame key issues related to D4D and describe a set of actions designed to speed up the process of D4D and enhance the impact of research. Actions include processes (e.g., stakeholder engagement), outcomes (e.g., data segmentation), and products (e.g., user-friendly summaries). Many of these themes fit closely and are complemented by pragmatic research methods and frameworks.