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Table 1 Effectiveness and cost-effectiveness outcomes 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

CRC screening completion

Proportion of participants who completed CRC screening using any of the screening modalities recommended by the United States Preventive Services Task Force (FIT, FOBT, FIT-DNA, colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, CT colonography)

EHR chart review

6 months after randomization (round 1) or FIT mail date (round 2)

Mailed FIT completion

Proportion of participants in the intervention (mailed FIT) arm who return a completed FIT

Commercial laboratory’s online portal,

REDCap database

60 days, 90 days, and 6 months after randomization (round 1) or FIT mail date (round 2)

Follow-up (diagnostic) colonoscopy completion

Proportion of participants with a positive (abnormal) FIT/FOBT result for whom colonoscopy is deemed to be clinically appropriate by the patient's provider who complete a follow-up (diagnostic) colonoscopy

EHR chart review,

REDCap database

6 months after referral for a follow-up colonoscopy

CRCs and advanced adenomas detected

Number of CRCs and advanced adenomas detected among participants who complete a screening or follow-up (diagnostic) colonoscopy

EHR chart review

12 months after referral for a follow-up colonoscopy

Time from CRC diagnosis to the date of evaluation for CRC treatment

Number of days from CRC diagnosis to the date of evaluation for CRC treatment

EHR chart review

Up to 12 months after CRC diagnosis

Referral for cancer treatment

Number of individuals who receive referral for cancer treatment among individuals diagnosed with CRC

EHR chart review

6 months after cancer diagnosis date

Repeat mailed FIT completion

Number of mailed FITs completed (0, 1, or 2) by participants in the intervention (mailed FIT) arm after two rounds of annual FIT outreach

Commercial laboratory’s online portal,

REDCap database

Up to 18 months after randomization