Criterion | Critical feasibility outcome | Green | Amber | Red |
---|---|---|---|---|
(1) Recruitment rate | Feasibility of being able to recruit 84 participants within a 7-month window |  ≥ 80% | 60–79% |  ≤ 59% |
(2) Visiting Data | Percentage of participants with available data on dental visiting via self-report or BSA |  ≥ 80% | 60–79% |  ≤ 59% |
(3) Clinical exam | Percentage of participants completing the dental examination |  ≥ 80% | 60–79% |  ≤ 59% |
(4) Adherence to intervention | Percentage of participants receiving ≥ 1 intervention sessions during 9-month window |  ≥ 80% | 60–79% |  ≤ 59% |
(5) Intervention and trial protocol | Qualitative data to understand the acceptability and feasibility of the procedures, assessments, and intervention to inform a full trial and service delivery | |||
(6) Safety of intervention | Monitoring and review of research related serious adverse events (SAEs). The TSC will oversee SAEs across treatment arms. We will discontinue the trial if the intervention or procedures elevate risk |