Outcome | Operational definition | Data source(s) | Timing |
---|---|---|---|
Implementation outcomes | |||
 Reach | Number, proportion, and representativeness of eligible patients who are exposed to mailed FIT and do not opt out Number, proportion, and representativeness of patients with a positive FIT who participate in at least one navigation call | REDCap database | End of trial round 1 and round 2 |
 Acceptability | Perception that the SCORE intervention is agreeable or satisfactory [40] | Clinician stakeholder interview, Patient interview | Clinician stakeholder interview: No earlier than 6 months after start of trial Patient interview: As FIT+ patients are identified; no earlier than 2 weeks after final contact with patient navigator |
 Appropriateness | Perception that the SCORE intervention is relevant to and compatible with provider’s practice and setting [40] | Provider survey, Clinician stakeholder interview, Patient interview | Provider survey and clinician stakeholder interviews: No earlier than 6 months after start of trial Patient interview: As FIT+ patients are identified; no earlier than 2 weeks after final contact with patient navigator |
 Cost | The overall cost of the SCORE project; process flow diagrams will serve as a foundation for capturing resource inputs (labor and material costs) for each CRC screening activity | REDCap database, Usual care survey, TAM observation, Patient interview | REDCap database: End of program Usual care survey: No earlier than 6 months after start of trial TAM observation: No earlier than 6 months after start of trial Patient interview: As FIT+ patients are identified; no earlier than 2 weeks after final contact with patient navigator |
 Cost-effectiveness | Cost per person reached and cost per person screened, compared to usual care | TAM observation, Usual care survey, Administrative data | Up to 36 months after randomization |
 Feasibility | Perception that the SCORE intervention can be carried out successfully in the CHCs [40] | Clinician stakeholder interview, REDCap database, Patient interview | Clinician stakeholder interview: No earlier than 6 months after start of trial REDCap database: End of program Patient interview: As FIT+ patients are identified; no earlier than 2 weeks after final contact with patient navigator |
 Fidelity,  Adaptations | Fidelity: degree to which the SCORE intervention is delivered as intended [40] Adaptations: adaptations made to the SCORE intervention and reasons for the adaptations | Fidelity: Clinician stakeholder interview, REDCap database, Patient interview Adaptations: Periodic reflection | Clinician stakeholder interview: no earlier than 6 months after start of trial REDCap database: End of program Patient interview: as FIT+ patients are identified; no earlier than 2 weeks after final contact with patient navigator Periodic reflection: ongoing |
Other implementation measures | |||
 Multilevel implementation determinants | Barriers and facilitators to SCORE implementation at the level of the • Intervention: evidence strength and quality (CRC screening), relative advantage (centralized mailed FIT and navigation) • Outer setting: patient needs and resources, external policy and incentives • Inner setting: structural characteristics, implementation climate • Individual provider: knowledge and beliefs • Process: engaging/involving team members as champions, reflecting and evaluating | Provider survey, Contextual determinants survey, Clinician stakeholder interview, Periodic reflection | Provider survey, contextual determinants survey, and clinician stakeholder interview: no earlier than 6 months after start of trial Periodic reflection: ongoing |