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RePORTER |
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PM/MPI |
Briana Mezuk |
Linda M. Collins |
Corrine Voils |
Debra Haire-Joshu Ross Brownson |
Vivek Shetty |
Joe Gallo |
David B. Allison Kevin Fontaine Andrew W. Brown |
Chris Coombe Barbara Israel |
Sylvie Naar |
May Wang Michael Lee Prelip Hua Zhou |
Ali Mirzazadeh Sean Arayasirikul David Glidden William McFarland |
Vivek Kumar Ishmail John Abdus-Saboor |
D&I |
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The Summer Institute on Innovative Approaches to Randomized Behavioral Clinical Trials trains fellows to incorporate implementation-related considerations into every phase of translational research on health-related behavioral interventions.
Competency: Provide a defensible rationale in RCT grant proposals for why implementation-related considerations will be on the front or back burner in the proposed trial. |
The IS2 program will train scholars to facilitate the D&I of BSSR in the context of community and clinical settings to eliminate chronic disease disparities. Furthermore, scholars will create realistic action plan for transforming research questions on D&I into NIH grant proposals.
IS2 competency:
Create a clear, rationale and realistic action plan for transforming research questions on D&I grant proposals. |
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The short course and online learning forums include guidelines, case studies, and experiential learning activities for dissemination and implementation using a CBPR approach.
Learning objective/competency
Participants will be able to
discuss the role of partners and the methods involved to interpret, implement, disseminate, and translate research results to improve health using a CBPR approach to create a clear, rational, and realistic action plan for transforming research questions on D&I grant proposals. |
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RCT/Study Design |
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The Summer Institute covers the goals, design, and conduct of Phase I, III, and III studies and introduces Phase IV intervention research. It addresses both well-established approaches and newer designs, e.g., for tests of adaptive or personalized intervene-tions. Strategies for planning and conducting rigorous, informative, high-impact trials are discussed.
Competency: Carefully define the study’s primary purpose and design it accordingly. |
The IS2 training will provide an overview of established (e.g., group randomization trials) and emerging (e.g., dynamic wait-listed designs, hybrid designs) approaches for D&I research with specific attention to designs and analyses useful for addressing BSSR-related health disparities in chronic diseases.
IS2 competency:
Identify and articulate trade-offs between different study designs for D&I research. |
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Strengths, limitations, implementation issues, analytical concerns, and causal interpretations of study designs along the causal spectrum from ordinary observational studies to randomized controlled trials are discussed. |
The short course includes presentations, case studies, and experiential learning activities for research design using a CBPR approach.
Learning objective/competency
Participants will be able to:
- present and analyze innovative research designs that complement randomized controlled trial (RCT) designs (e.g., lagged designs, natural experiments)
- discuss statistical issues involved in using innovative research designs |
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Intervention |
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The Summer Institute examines the short- and long-term goals of health-related behavioral intervention and refinement research and the types of preliminary studies that are needed to pave the way for successful RCTs.
Competency: Develop a provisional plan for a programmatic series of studies that culminate in Phase III-IV trials. |
During the IS2 program scholars will become proficient with the range of D&I models and frameworks to design intervention to eliminate chronic disease disparities. Scholars will also be introduced to designing for dissemination (i.e., planning for adoption, implementation, and sustainability during the intervention development stage).
IS2 competency:
Identify core elements of effective interventions and recognize risks of making modifications to these. |
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Strengths, limitations, implementation issues, analytical concerns, and causal interpretations of study designs along the causal spectrum from ordinary observational studies to randomized controlled trials are discussed. |
The short course and online learning forums include presentations, case studies, and experiential learning activities for developing interventions using a CBPR approach.
Learning objective/competency
Participants will be able to:
- explain the definition of CBPR and the rationale for its use for addressing major public health problems and reducing health inequities
- discuss the role of partners and the methods involved to feed back, interpret, implement, disseminate, and translate research results to improve health |
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Team Science |
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The Summer Institute places a strong emphasis on the roles of team science, research networks, and multicenter collaboration in health-related behavioral intervention research.
Competency: Develop a provisional plan for a programmatic series of studies that culminate in Phase III-IV trials. |
During the IS2 program scholars will become proficient with the range of D&I models and frameworks to design interventions to eliminate chronic disease disparities. Scholars will also be introduced to designing for dissemination (i.e., planning for adoption, implementation, and sustainability during the intervention development stage).
IS2 competency:
Plan a series of collaborative projects that will help to pave the way for a major multicenter trial. |
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The entire CBPR training program enhances competency for using a collaborative, equitable partnership approach to research.
Learning objective/competency
Participants will be able to:
- explain the definition of CBPR and the rationale for its use for addressing major public health problems and reducing health inequities;
- identify and explain the phases and core principles of CBPR and the application of these principles to develop, maintain, sustain, and evaluate community-academic research partnerships;
- identify and discuss the benefits of and challenges involved in applying a CBPR approach to research, and the facilitating factors for overcoming these challenges; and
- describe the purpose and methods for evaluating the process and impact of CBPR partnerships. |
By encouraging Fellows to forge links with basic behavioral and social science, and with clinical medicine, and then pursue an integrated program of research in behavioral treatment development characterized by innovation, creativity, flexibility, and versatility in methodologic approaches, the course aims to build the evidence base for the value of behavioral treatments for the prevention and management of cancer. |
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mHealth |
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mHealth is not a primary focus of the Institute, but it comes up frequently in presentations and discussions. |
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mHealth is not specifically addressed, but if there are participant teams who conduct mHealth as their applied project, they will present their work to the cohort. |
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Causal Methods |
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Causal inference in RCTs and in preliminary intervention research is addressed; other approaches to causal modeling are not emphasized. |
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Strengths, limitations, implementation issues, analytical concerns, and causal interpretations of study designs along the causal spectrum from ordinary observational studies to randomized controlled trials are discussed. |
Causal methods are discussed in the context of study designs and statistical analysis:
- present and analyze innovative research designs that complement randomized controlled trial (RCT) designs (e.g., lagged designs, natural experiments)
- discuss statistical issues involved in using innovative research designs |
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Generalizability/External Validity |
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The Summer Institute examines questions about generalizability and external validity that are especially important in behavioral interven-tion research, such as differences in the aims and methods of relatively explanatory vs. relatively pragmatic trials.
Competency: Evaluate the relative importance of generalizability and external validity across different phases of intervention research. |
IS2 competency: Describe the core components of external validity and relevance to D&I research. |
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Strengths, limitations, implementation issues, analytical concerns, and causal interpretations of study designs along the causal spectrum from ordinary observational studies to randomized controlled trials are discussed. |
Generalizability and external validity are discussed in the context of the following competencies:
- explain the definition of CBPR and the rationale for its use for addressing major public health problems and reducing health inequities;
- describe and analyze the separate and integrated use of quantitative, qualitative, and mixed methods in the context of a CBPR approach;
- present and analyze innovative research designs that complement randomized controlled trial (RCT) designs (e.g., lagged designs, natural experiments);
- discuss statistical issues involved in using innovative research designs; and
- discuss the role of partners and the methods involved to feed back, interpret, implement, disseminate, and translate research results to improve health. |
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Translation |
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The Summer Institute examines a variety of intervention development and translational research models. The overall structure of the program corresponds to the phases of translational research on health-related behavioral interventions.
Competency: Determine which model(s) best fit the needs and objectives of the investigator’s research program. |
The IS2 program will emphasize translation and the complexity of integrating and adapting evidence-based practices to real-world community and clinical settings, to support the development of more effective strategies to assure all populations benefit from BSSR discoveries.
IS2 competency: Identify a process for adapting an intervention and how the process is relevant to D&I research. |
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The short course includes presentations, case studies, and experiential learning activities for translating research findings to interventions and policies to improve health and equity.
Learning objective/competency
Participants will be able to discuss the role of partners and the methods involved to interpret, implement, disseminate, and translate research results to improve health. |
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Mixed Methods |
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Mixed methods come up in presentations and discussions of topics such as stakeholder engagement and intervention acceptability, but mixed methods are not a major focus of the course. |
IS2 competency: Scholars will explore the application and integration of mixed-methods (quantitative and qualitative) approaches in D&I research. |
Mixed methods are the focus, but most of the other topics come up as applications of mixed methods. |
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Participants will be able to describe and analyze the separate and integrated use of quantitative, qualitative, and mixed methods in the context of a CBPR approach. |
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CBPR/Participatory Research |
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CBPR is one of the first topics discussed in the course. It is not covered in depth but is presented as an important approach for shaping research goals and improving enrollment, adherence, and retention in RCTs. |
The IS2 program will address community engaged D&I, focusing on research involving D&I of evidence-based health interventions within clinical or community-based settings using community-engaged processes or partnerships, including but not limited to community-based participatory research.
IS2 competency:
Identify and apply techniques for stakeholder analysis and engagement when implementing evidence-based practices. |
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The entire training program aims to enhance the skills, knowledge, and competency of academic and community partners – participating in pairs – to conduct research using a CBPR approach. |
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Data Collection/Study Design |
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Considerable time is spent on key data collection, management, and analysis issues in intervention research and in randomized trials.
Competency: Incorporate contemporary strategies for increasing the rigor of behavioral RCTs. |
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Strengths, limitations, implementation issues, analytical concerns, and causal interpretations of study designs along the causal spectrum from ordinary observational studies to randomized controlled trials are discussed. |
The entire short course and online forums include instruction, case studies, and interactive activities on data collection and study design using a CBPR approach. |
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Secondary Data Analysis/Data Linkage |
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There is some discussion of secondary analyses and meta-analyses of trial data. However, most of the emphasis is on primary analyses of RCT data. |
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Strengths, limitations, implementation issues, analytical concerns, and causal interpretations of study designs along the causal spectrum from ordinary observational studies to randomized controlled trials are discussed. |
During the short course there is some mention of the use of secondary data analysis but it is not a focus of the course. |
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Grant Writing |
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Although relatively little time is spent on grant-writing issues per se, much of the material covered in the course is directly relevant for grant proposals for preliminary intervention research or behavioral RCTs. |
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Grant writing and sources of funding for CBPR is a full session of an online forum. |
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Training Modality |
Mentoring |
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Time is set aside on all but the first and last days of the program for individual and group mentorship. Fellows have opportunities to meet with a variety of faculty members. |
The IS2 mentoring approach will establish expectations and a mentoring plan for each fellow. Additionally, the program will maintain effective mentee-mentor communication. |
We match the scholar with a mixed methods expert to focus on their proposal. |
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Each community-academic pair is matched with an expert community-academic mentor team, most of whom are also instructors in the short course. Mentors review partnership grant proposals and mentoring meetings are held periodically throughout the year. |
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Ongoing Membership |
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The Summer Institute encourages fellows to develop colleagial relationships, coalesce around shared interests and goals, and look for opportunities to work together in research networks or multicenter collaborations. Email and social media are used to facilitate communication within and across Summer Institute cohorts. Fellows and faculty are asked to identify conferences that they often attend in order to facilitate ongoing interactions and to continue building a sense of community. |
The IS2 program includes clear mentor-mentee matching criteria based upon prior experience. Mentors and scholars will be cross-matched based upon key mentoring categories to ensure mentor-mentee success. A key principle of our mentorship is the focus on ongoing mentorship over the two-year life of the program. Additionally, a second phase of ongoing mentorship will involve regular evaluation. In brief, the evaluation of mentorship will occur twice per year including a quantitative (online) evaluation, and tracking the products of mentoring including mentor-mentee publications and presentations, grants submitted/funded, and other collaborative products. |
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An ongoing component of the course involves attendees and faculty identifying strong examples of causal inference in the published literature as part of the “RIGorous inference in Obesity Research” (RIGOR) Prize Contest. |
The core cohort program is a year long. An ongoing scholars network composed of participants and instructors from all cohorts is conducted electronically to share resources, funding opportunities, and the results of their work. A networking social is held during the American Public Health Association annual meeting for those attending. |
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Train the Trainer |
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Train-the-trainer activities are a core component of the Summer Institute. Fellows develop individual and/or group plans for dissemination of course materials and lessons learned; e.g., several fellows might collaborate on a plan to propose a workshop on a specific aspect of RCT design. The plans are presented on the final day of the course, and follow-ups are conducted to evaluate the imple-mentation of the plans. |
The IS2 program will feature a train-the-trainer program to disseminate IS2 methods and materials. Scholars will complete the train-the-trainer modules during the Summer Course. During the course of their two-year experience, scholars will have the opportunity to complete two train-the-trainer activities at their home institution. |
We emphasize leadership and bringing mixed methods to their institutions. |
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A train-the-trainer program will be developed in year three to extend the reach of the curriculum model and modules. |
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Online |
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Video recordings of many of the lectures and discussions are posted on the Summer Institute’s YouTube channel. Slides and other course materials are posted on the Open Science Framework’s Meeting website. |
Online platforms will be used to maintain constant communication with mentors and scholars. Additionally, an online mentor (refresher) training session each year for mentors to reconvene, discuss mentoring challenges, and share solutions. |
We have some material presented on interactive webinars given by faculty, and we put the recorded webinars on our web site. |
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Each year’s course is video recorded and made available online. |
An online course management system will be used throughout the year for each cohort. Monthly online forums are recorded and archived. All materials are available on the program website. National webinars will be hosted and co-presented by Community Campus Partnerships for Health. |
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In-Person |
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The annual Summer Institute is held at a conference center near Bethesda, MD. It is a nine-day, intensive course; it starts in the afternoon on Day 1 and ends around noon on Day 9. The faculty are recognized experts in various aspects of behavioral intervention research and clinical trial methodology. Multiple faculty members are present every day. The course includes a mixture of formats such as lectures, panel discussions, and workshop-style sessions, in addition to individual and group meetings. |
The cornerstone of the IS2 program is the Annual Course. To be held each year in St. Louis, the Annual Course brings together Core Faculty, Expert Faculty, and Scholars in a five-day active, intensive, adult learning environment. Fellows attend the Annual Course twice during their time in the program. |
We have an annual three-day retreat in Baltimore with some didactic, but mostly small groups and one-on-one sessions to discuss the projects of scholars. |
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The course consists of five days of in-person training. Locations include the host institutions (Indiana University-Bloomington, University of Alabama at Birmingham) and external sites depending on year. |
The foundation of the CBPR Partnership Academy is a weeklong in-person course held at the University of Michigan, Ann Arbor. Because participants are academic-community pairs, the intensive co-learning experience provides a unique opportunity to establish and strengthen their partnership, while developing future plans. The week includes a site visit to Detroit led by Detroit URC community partner organizations to highlight the impact of their longstanding work to address health inequities in their communities, and to exemplify CBPR in action. |
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