Table 2.
Stepwise procedures.
| Contact/visit | Intervention period | Follow-up period | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week | −1 | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | … | 21 | 22 | … | 34 | 35 |
| Visit number | 1 | 2 | 3 | 4 | ||||||||||||||
| ENROLLMENT | ||||||||||||||||||
| Screening (inclusion/exclusion) | X | X | ||||||||||||||||
| Informed consent | X | X | ||||||||||||||||
| BASELINE ASSESSMENT | X | |||||||||||||||||
| Standard smoking care | X | |||||||||||||||||
| Randomization | X | |||||||||||||||||
| INTERVENTION* | ||||||||||||||||||
| Referral to Quitline | X | |||||||||||||||||
| Contacted by Quitline and smoking cessation initiated | X | |||||||||||||||||
| Quitline determines preferred oral NRT for second 4-week supply | X | |||||||||||||||||
| NRT dispensing | X | X | ||||||||||||||||
| Smoking cessation program | X | X | X | X | X | X | X | X | ||||||||||
| FOLLOW-UP ASSESSMENTS | X | X | X | |||||||||||||||
| Blinded follow up assessment conducted (all participants) | X | X | X | |||||||||||||||
| Potential qualitative interviewees identified** | X | X | X | |||||||||||||||
| Qualitative interviews conducted** | X | X | X | |||||||||||||||
| CO monitoring (on reported abstainers) | X | |||||||||||||||||
| ADVERSE EVENTS | ||||||||||||||||||
| Unprompted (serious/severe) | X | X | X | X | X | X | X | X | ||||||||||
| Prompted (all) | X | X | X | |||||||||||||||
*
Intervention group only.
**
Participants will be purposely selected at each of the assessment timepoints (2, 5, and 8 months) to be invited for interview.