4-group randomized trial was conducted at 5 US medical centers: Geisinger Health System, Henry Ford Health, Kaiser Permanente Southern California, the University of Pennsylvania Health System (Penn Medicine), and Lancaster General Health, which is affiliated with Penn Medicine but was considered separately for this trial because it used a distinct electronic health record.
During the study’s design phase, the stakeholder advisory committee recommended key strategies to promote cultural relevance of the interventions, maximize engagement of participants, and prevent attrition once enrolled. The 11-member stakeholder advisory committee included individual patients and representatives from patient and health equity advocacy groups, community and government public health services, clinical program leads, and health system and insurance leaders. Additional details on stakeholder advisory committee activities and contributions to the study design have been previously published.43,44
Aligned with the trial’s pragmatic orientation, participants were offered registration via an online study platform (Way to Health).43 Registered patients meeting eligibility criteria via a sociodemographic survey could opt out from participating after reviewing a brief written description and, if desired, a more detailed document. Those who did not opt out underwent randomization. Following 10 months of enrollment, we identified a technologic limitation that prevented true opt-out enrollment because participants were still required to click “continue” to be randomized. Thus, on March 17, 2022, we began sending “last chance” email and text messages to patients who had neither opted out nor clicked “continue,” indicating they would be enrolled in 3 days unless they opted out.