Study Designs for Intervention Research in Real-World Settings (IMS 241)

At the end of the course, scholars will be able to:

1. Describe the key characteristics of - and rationale for choosing among - common non-randomized quasi-experimental study designs (e.g., pre-post, interrupted time series) and randomized study designs (e.g., pragmatic, cluster, stepped wedge, factorial, MOST, SMART, and choice/preference) used in real-world implementation research.
2. Identify key threats to internal validity across study designs " including confounding, mediation, effect modification, selection bias, information and reporting bias, and random error - and propose design or analytic strategies to mitigate each threat.
3. Design hybrid implementation-effectiveness studies and define appropriate implementation and effectiveness outcomes for each study design.
4. Create clear visual diagrams for each study design for inclusion in protocols, presentations, and grant proposals.

5. Develop a plan for discussing sampling strategy, sample size determination, and analytic approach with a biostatistician for each study design.

   Optional 1-unit Analysis Lab, in addition to the objectives above:

6. Identify appropriate analytic methods for each study design covered in the course. Methods reviewed include regression, segmented regression, autoregressive  integrated moving average (ARIMA) models, generalized estimating equations, and mixed effects models.
7. Calculate and interpret sample size estimates for each study design using STATA software.
8. Conduct and interpret analyses in STATA using example datasets and code provided for each study design.

For Core Design Course, training or experience in public health, epidemiology, quality improvement or health care organization leadership.  For Analysis Lab, it is also essential that you have training or experience in regression analysis using STATA or other statistical software. Exceptions to these prerequisites may be made with the consent of the Course Director.

This course is taught fully remotely (online) with both synchronous and asynchronous components. Learners engage with content organized into 10 weekly modules. Each week, learners view recorded lectures, assigned readings, and submit written assignments in an online forum. Weekly synchronous meetings occur over Zoom. When scheduling meetings, faculty strive to accommodate the schedules of busy professionals across multiple time zones. Synchronous meeting attendance is recommended but not required. 

IMS 241 is offered as a 2-unit Design course, with an optional 1-unit Analysis Lab. 

Completing this Core Design course will take approximately 4-8 hours per module. Those in the optional Analysis Lab will have an additional 2-4 hours per module.

The Design course constitutes the core curriculum and is required for all learners. Each week, learners will be asked to watch online lectures, review case studies, apply study designs to their own research questions and settings, and provide supportive written feedback on peer assignments. 

At the start of the term, learners may elect to enroll in the optional Analysis Lab, which provides hands-on experience applying analytic methods to the study designs covered in the course. Each week, learners enrolled in the Analysis Lab compute sample size estimates and analyze real or simulated data sets, generating and interpreting results aligned with the weekly design topics.

Note for UCSF Graduate Division Students: The core Design course is worth 2 units, and the optional Analysis Lab is worth 1 additional unit. The Analysis Lab may only be taken in conjunction with the core course.  Students are responsible for managing their enrollment  (e.g., 2 vs. 3 units) with the registrar's office. 

This course requires learners to have a stable internet connection and access to the Zoom platform for synchronous meetings.

All learners who meet the minimum course requirements will receive a formal letter documenting their successful completion of the course, its objectives, and requirements. Only learners who are matriculated in a UCSF Graduate Division program (e.g., Masters, PhD) may receive a letter grade on their UCSF transcript. UCSF graduate students should complete the ImS enrollment form (see below) and enroll via the UCSF Office of the Registrar – Student Portal.

Learners are expected to view assigned video lectures, complete required readings, submit weekly homework assignments (Modules 1-9), provide constructive peer feedback via small group forums, submit the grant proposal excerpt, and compete course evaluations. 

Module 10 (pragmatic trials) does not include a weekly homework assignments and is intended to support completion of the final assignment. 

Completing this Core Design course will take an estimated 4-8 hours of work per module. Those in the optional Analysis Lab will have an additional 2-4 hours per module. 

In order to receive a letter of course completion, learners must:

• Abide by course Ground Rules and Community Norms (see course website)
• Turn in weekly assignments by the designated due date and time each week (Modules 1-9).
• Provide substantive feedback on at least two peers’ assignments during each assigned week.
• Submit the final assignment by the designated deadline. 

Pass/No Pass vs. Letter Grade

Success in this course is determined as Pass/No Pass unless a letter grade is required for a UCSF Graduate Division Program. Successful learners will receive a letter of course completion following the end of the term.

Leaners taking the course Pass/No Pass, may miss up to two weeks of weekly homework assignments and required peer feedback. 

Learners taking the course for a letter grade must submit all weekly homework and provide peer feedback for each of the nine weeks in which homework is assigned.

All learners must submit the Final Assignment.

Students who do not turn in weekly assignments on time or do not provide required feedback to peers in more than two weeks will have the option of auditing or dropping the course. In either case, course fees will not be refunded.

Academic Year 2025-2026: The fee for each course is $2,900. A reduced fee of $2,250 is available for individuals affiliated with UCSF, individuals based in countries designated as low- or lower-middle-income-economies (LMIC), and individuals based in areas of ongoing armed conflict. Applicants seeking the reduced fee will be asked to provide support for their status. UCSF affiliation is defined as concurrent enrollment in a UCSF–sponsored residency or postdoctoral fellowship program; or a registered student in one of the UCSF professional schools or graduate programs; or individuals who hold full-time salaried UCSF faculty, academic, or staff positions.

Fees do not include books, supplies, or software. (These costs are minimal as most readings are from open-access journals.)