Skip to main content

Table 1 Effectiveness and implementation outcomes for the SMARTER CRC study

From: Mailed fecal testing and patient navigation versus usual care to improve rates of colorectal cancer screening and follow-up colonoscopy in rural Medicaid enrollees: a cluster-randomized controlled trial

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
  1. aEnrollees on claims list are ages 50–75, and overdue for colorectal cancer screening, based on HEDIS criteria
  2. bLists pull dates generally vary by CCO
  3. cEnrollees who completed colonoscopy, sigmoidoscopy, CT colonography, or FIT-DNA in year 1 will be excluded