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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