Training and evaluation modifications
Modifications to address low treatment initiation focused on additional training of the study staff responsible for screening and consenting OPTIMIZE participants. These modifications are outlined below.The first modification was to be more attentive to financial implications for potential participants. Pragmatic and CER studies typically do not reimburse out-of-pocket expenses encountered by participants in order to reflect real-world circumstances [We modified the role the study staff played in scheduling treatments session with participants. At the start of the study, the OPTIMIZE staff provided participants with contact information for providers but left the responsibility for scheduling to the participant. If scheduled appointments were missed, it was left to the clinic and their usual procedures to contact participants to re-schedule. The onset of COVID exacerbated scheduling challenges due to provider shortages and extended wait times for appointments. Recognition that the overall complexity of scheduling visits was a barrier to treatment initiation and persistence, the OPTIMIZE team modified the training of study staff to adopt a navigator role. Specific changes made included having staff directly connect participants to clinics to schedule the initial session. The staff track the participant’s attendance at the initial session and follow-up with the participant to assist with re-scheduling. When participants encounter long wait times to initiate treatment, the staff contact them intermittently to provide reminders.We modified the staff training in communication with potential participants. The trans-theoretical model of change indicates that some persons may fail to initiate or persist in a CHI based on a lack of readiness or ambivalence about making this type of behavior change [