Hi, friend! I know that the most rigorous and credible way to develop a counterfactual is to randomize practices interested in participating in the intervention to an intervention or control group. The control group will then provide a good proxy of what would have happened to intervention practices had they not adopted the model. However, our team all believes that we cannot conduct a randomized trial for ethical and also fairness reasons. In such cases, may I ask if there is any possible solution?

My pleasure.

Many thanks for the introduction.

Yes. There are two pragmatic ways to randomize practices are available—both of which provide a strong randomized design to study the effects of a primary care intervention. The first approach to selecting practices to participate is to conduct a lottery among all practices that volunteer. A lottery is a randomized controlled trial in which practices selected by lottery receive the intervention, and practices that are not selected serve as a control group. Another approach is to allow all practices that volunteer to participate but stagger the rollout of implementation across them. This is called a staggered randomized or stepped wedge design. The late starters serve as a control group—before they begin the intervention—for the early starters.