Table 1.
Effectiveness and implementation outcomes for the SMARTER CRC study
| Variable | Definition | Population |
|---|---|---|
| Outcomes—effectiveness | ||
| Colorectal cancer screening completion—individual level (primary) | Receipt of any colorectal cancer screening (FIT, sDNA-FIT, colonoscopy, CT-colonography, sigmoidoscopy) within 6 months of the claims list pull dateb (binary) | Enrollees on claims lists (eligible enrollees)a |
| Colorectal cancer screening completion—clinic level | Clinic-level rates of receipt of any colorectal cancer screening (FIT, sDNA-FIT, colonoscopy, CT-colonography, sigmoidoscopy) within 6 months of the claims list pull dateb (proportion) | Enrollees on claims lists (eligible enrollees)a, aggregated by clinic |
| Time to CRC screening | Days from FIT mailing to screening completion, those who do not complete screening are censored at 12 months. Those who are lost to follow-up are censored on date of loss. | Enrollees on claims lists (eligible enrollees)a |
| FIT completion | FIT completed within 6 months of the claims list pull dateb (binary) | Enrollees on claims lists (eligible enrollees)a |
| Completion of screening colonoscopy | Colonoscopy completed within 6 months of the claims list pull dateb (binary) | Enrollees on claims lists (eligible enrollees)a |
| Fecal test result | Receipt of a normal/abnormal FIT test result (binary) | Eligible enrollees who completed a FIT within 6 months of the claims list pull date |
| Follow-up colonoscopy referral | Receipt of a colonoscopy referral within 6 months of the enrollee’s abnormal fecal test date (binary) | Eligible enrollees with an abnormal fecal test result |
| Follow-up colonoscopy completion | Receipt of a colonoscopy within 6 months of the enrollee’s abnormal fecal test date (binary) | Eligible enrollees with an abnormal fecal test result |
| Time to follow-up colonoscopy | Time from abnormal FIT test result to completed colonoscopy (time to event), those who do not complete a colonoscopy are censored at 6 months. Those who are lost to follow-up are censored on date of loss. | Eligible enrollees with an abnormal fecal test result |
| Colonoscopy outcomes | Detection of adenomas, advanced adenomas, or cancer (binary) | Eligible enrollees with a completed colonoscopy |
| Referral to cancer care | Receipt of referral to cancer care within 3 months of cancer diagnosis (binary) | Eligible enrollees with colorectal cancer detected |
| Outcomes—implementation | ||
| Implementation | CCO- and clinic-level rates of program delivery, by core component (mailed FIT, patient navigation) and non-core components (clinic scrub, reminders delivered by clinics/CCOs); (proportion) | Eligible enrollees, by core and non-core intervention components, aggregated by clinic |
| Reach (enrollee level) | Receipt of the program, by component (mailed FIT sent to valid address, at least one patient navigation phone call received) | Eligible enrollees, by component (mailed FIT, patient navigation), aggregated by clinic |
| Adaptations to intervention at CCO and clinic levels, and adaptations to implementation strategies | CCO-clinic-research team level: adaptation, reason, type, who made decision to adapt | CCO staff, clinic staff, research staff |
| Implementation barriers and facilitators and contextual factors at CCO and clinic levels | Barriers and facilitators to implementation (qualitative); contextual factors | CCO staff, clinic staff |
| Reaction to the program/acceptability, at CCO, clinic, and colonoscopy provider/staff levels | Reactions to the intervention and implementation support (for clinics and CCOs), suggestions for improvement | CCO staff, clinic staff, colonoscopy provider and staff |
| Outcome—maintenance | ||
| Maintenance at CCO, clinic, and enrollee levels | CCO/clinic level: implementation in year 2 (by component); enrollee level: CRC screening completion in year 2 (as appropriate) | CCO/clinic level: year 1 CCOs and intervention clinics that implemented the program; enrollee level: eligible enrollees who completed a FIT in year 1c |
| Aim II: Scale-up | ||
| Adoption at the organizational and staff levels | Number of health plan, clinic, or community organization staff that participate in scale-up events, by event; proportion health plans, clinics, or community organizations that adopt the program; characteristics of adopters and non-adopters | Health plans, clinics, organizations that serve rural populations and were approached for participation |
| Implementation | Number of community organizations whose staff have facilitated health plans or clinics to deliver the program, and the number of health plans or clinics who have begun to implement the program, by component | Health plans, clinics, organizations that serve rural populations and were approached for participation |
| Adaptations | Adaptations made to the program; type, reason, who made decision to adapt | Health plans, clinics, organizations that adopt the program |
aEnrollees on claims list are ages 50–75, and overdue for colorectal cancer screening, based on HEDIS criteria
bLists pull dates generally vary by CCO
cEnrollees who completed colonoscopy, sigmoidoscopy, CT colonography, or FIT-DNA in year 1 will be excluded