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Table 2 Implementation outcomes and other implementation measures for the SCORE project

From: Centralized colorectal cancer screening outreach and patient navigation for vulnerable populations in North Carolina: study protocol for the SCORE randomized controlled trial

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