Collaborative Clinical and Health Research Methods

Course Description

The focus of this course is on providing students with applied knowledge related to conducting pragmatic clinical trials and implementation science studies that involve communities as collaborators in the research process. Communities are broadly defined and can include: physicians, policymakers, state agencies, and patients and their families, among others. Students in this course will focus on:

• Examining the development of patient-centered, pragmatic clinical trials and implementation science studies that engage communities;
• Identifying strategies to form partnerships with communities to address gaps in knowledge around evidence-based interventions; and
• Examining strategies to incorporate patient and other stakeholder preferences and outcomes in clinical research.

Specific examples of community-engaged approaches will be discussed. Because students obtain methods training in other courses throughout the curriculum, the focus of this course is on critical appraisal of the appropriateness of the methods used relative to the study question and the implications of the study design for engaging communities and translating evidence into practice.

Prerequisites

GMS 6851 (Implementation Science Fundamentals)

Student Learning Outcomes

Students who successfully complete the course will be able to:

1. Discuss the major concepts related to engaging communities in the design, implementation, interpretation and dissemination of research;
2. Identify the benefits and barriers to involving community collaborations in pragmatic clinical trials and implementation science studies, as well as strategies for overcoming key barriers;
3. Develop strategies for engaging communities in identifying study topics of importance to them and beginning the process of protocol development;
4. Discuss some sentinel pragmatic clinical trials and implementation science research, their study designs, and strategies for involving community collaborations to build upon and improve those designs;
5. Describe the role of stakeholders and how to involve them in research.
6. Critically evaluate pragmatic clinical trials and other clinical research that have incorporated community engagement by assessing the strengths and limitations of the study design as well as involvement of stakeholders in the study design and selection of outcomes.