Study Designs for Intervention Research in Real-World Settings

Spring 2024 (2 units)

This course provides a foundation for the design of studies that are alternatives to individual participant-level randomization for the evaluation of interventions in real-world settings. An overview of the history of experimental and observational design will set the stage to understand these design variants. For each randomized (e.g., cluster-randomized and stepped-wedge randomized trials) and quasi-experimental design (e.g., pre-post and interrupted time series) presented, students will assess key features, common pitfalls, and possible strategies to improve internal and external validity. Scholars will be also introduced to implications of design decisions for data analysis. Focus will be placed on determining which design is best suited to a range of 'real world' implementation settings.


The objectives for this course are for participants to:

  • Describe the rationale for using common randomized and non-randomized group-level study design alternatives to individual participant-level randomized trials;
  • Understand key characteristics of cluster-randomized trials, stepped-wedge randomized trials, and selected quasi-experimental designs;
  • Identify specific threats to internal validity and strategies to mitigate these threats;
  • Develop design elements that incorporate the implementation process, including hybrid effectiveness implementation designs; and
  • Prepare a plan for discussing issues of sampling, sample size, and analysis with methodologic experts for cluster-randomized trials, stepped-wedge randomized trials, and selected quasi-experimental designs.


Familiarity with basic individual-level study designs.


Course Director:

Margaret Handley, PhD, MPH

Professor, Epidemiology & Biostatistics
email: [email protected]

Course Co-Director:

Starley Shade, PhD

Professor, Epidemiology & Biostatistic
email: [email protected]


Aside from the first class in which a lecture will be delivered by the course director, most of the didactic material will be delivered through a series of videos which students will watch prior to the classroom sessions. Classroom time will mainly be used to have students reflect on the material they viewed prior to class as well as the associated reading.


All course materials and handouts will be posted on the course's online syllabus.


Evaluation of student performance will be based on successful completion of weekly homework assignments, class participation, and attendance.

Students not in full-year TICR Programs who satisfactorily pass all course requirements will, upon request, receive a Certificate of Course Completion.

Only UCSF students (defined as individuals enrolled in UCSF degree or certificate programs) will receive academic credit for courses. Official transcripts are available to UCSF students only. A Certificate of Course Completion will be available upon request to individuals who are not UCSF students and satisfactorily pass all course requirements.

UCSF Graduate Division Policy on Disabilities

To Enroll

ATCR and MAS students use the Student Portal

All other students can find registration information on the Implementation Science website.