Who will take informed consent? {26a}
The study is approved by the KPWA Institutional Review Board (IRB). Due to the pragmatic and educational nature of the intervention, the KPWA IRB granted a waiver of informed consent for eligible participants consistent with the requirements outlined in 45 CFR 46.116 Part F.3.Intervention participants are mailed an invitation letter and information sheet informing them of their enrolment in the study because they may be taking a medication that increases fall risk. They are informed that participation in the research study does not affect their insurance coverage. Their PCPs receive a staff message via the electronic medical record (EMR), alerting them of their patient’s enrollment in the study, including general information on the study and next steps, and that they are under no obligation to act on any of the research materials or alter medical care in any way. All materials and communications to both participants and PCPs include information on how to contact the study team by email or telephone.