Table 2.
Description of implementation outcomes and measurement for Smokefree Support Study 2.0
| Implementation Outcome | Description | Measurement | Data Source | Time Point |
|---|---|---|---|---|
| Acceptability | Site staff perceived acceptability of tobacco treatment intervention (e.g., met needs, provided cessation assistance wanted, helpfulness and quality of assistance.) | Site staff surveys | NCORP Site Staff | Baseline (before trial enrollment), 12 months, 24–36 months follow-up |
| Open-ended questions about aspects of the program most/least helpful, challenges faced to participation, and topic and program recommendations | Site staff focus group interviews | NCORP Site Staff | Following completion of trial enrollment | |
| Patient satisfaction with content/delivery of their randomly assigned tobacco treatment | Participant 6-month follow up survey | Study participants | Patient 6-month follow-up | |
| Program engagement (recruitment video, reasons for enrolling), intervention (counseling components and medication), remote delivery and assessments, tobacco counselor, and oncology team support | Post-treatment participant exit interview | VIT participants | Following completion of patient 6-month follow up survey | |
| Organizational Readiness | Site program uptake, Site engagement in implementation facilitation activities |
Patient Screening Log Study administrative data |
NCORP Site Staff MGB research staff |
Weekly Monthly |
| Appropriateness | Perceived fit and relevance of the VIT and EUC interventions from the perspective of representative site staff | Site staff surveys | NCORP Site Staff | Baseline (before trial enrollment),12 months, 24–36 months follow-up |
| Site staff focus group interviews | NCORP Site Staff | Following completion of site participant enrollment | ||
| Treatment Fidelity | Delivery of all components of the Smokefree 2.0 Study Treatment Interventions (EUC and VIT) | Tracking of NCI Quitline sessions and NRT dispensed (EUC) | NCI Quitline, EUC participants | Twice yearly |
| Collection of data at follow up timepoints regarding whether participants were advised to quit/referred to NCI Quitline by oncology providers | EUC participants | Patient 3-month and 6-month follow -up surveys | ||
| Tracking of number of contacts, session content and completion, NRT dispensed, and any intervention modifications (e.g., counselor adherence to the VIT manual, medication changes) (VIT) | MGB research staff, VIT participants | Weekly | ||
| Cost | Incremental cost per quit of the VIT intervention relative to the EUC control over the 6-month follow-up period | Tracking of local staff effort (time x base salary) related to eligibility screening, recorded in the Patient Screening Log | NCORP Site Staff | Weekly |
| Counseling delivery costs and NRT delivery costs recorded in MGB database | MGB research staff | Weekly | ||
| Feasibility | Ease of delivery and suitability for routine care of the VIT and EUC interventions | Site staff surveys | NCORP Site Staff | Baseline (before trial enrollment),12 months, 24–36 months follow-up |
| Site staff focus group interviews | NCORP Site Staff | Following completion of site participant enrollment | ||
| Penetration/Reach | Patient participation rate at each site, reasons for study ineligibility and refusal, comparison of sociodemographic and cancer variable characteristics of enrollees and refusers of the study | Patient Screening Log, NCORP Admin data | NCORP Site Staff | Weekly |
| Sustainability | Resources needed and preference for a site-based centralized tobacco treatment program | Site staff surveys | NCORP Site Staff | Baseline (before trial enrollment),12 months, 24–36 months follow-up |
| Site staff focus group interviews | NCORP Site Staff | Following completion of site participant enrollment |