br Table br STOP CRC intervention activities
STOP CRC intervention activities.
Data organization and management
Updating claims data (e.g., historical colonoscopies)
Initial EHR training
Testing EHR tools Training of additional staﬀ (e.g., MA)
Execution of lab interface agreements
Lab Fulvestrant (ICI 182,780) tracking
Results pool tracking Staﬀ training
On-going training/meetings On-boarding of new staﬀ
Adapting/approving mailed materials
Mailing introductory letter
Mailing FIT kits
In-clinic FIT kit distribution
Introductory letters with envelope
Conducting a PDSA
Provider engagement meetings
Processing of returned FITs
Reimbursement for returns from insured
Responding to patient phone calls
EHR: electronic health record.
MA: medical assistant.
FIT: fecal immunochemical test.
meetings. Intervention activities reported by the clinics were based on the project workplan and were reviewed by the research team for va-lidity and completeness. The cost of colonoscopy with polypectomy or biopsy is adapted from Naber et al., 2018 and reported in 2018 US dollars ($1897) (Naber et al., 2018; US Bureau of Labor Statistics, 2018). Costs are reported in 2018 US dollars and are not discounted because of the limited time horizon. Confidence intervals are calculated applying Fieller's theorem (Willan and O'Brien, 1996).
3. Trial results
3.1. Primary dataset
three organizations the proportion of completed FITs among SEPs in their intervention clinics was lower than in their usual care clinics, with diﬀerences ranging from −2.0% to −11.7%.
3.3. Economic results
Table 3 presents delivery costs and baseline ICERs, both in total and by organization. Delivery costs totaled $305 K, ranging from $10.2 K to $110 K across organizations. Overall delivery cost per SEP was $14.43 and varied from $10.37 (HC6) to $19.10 (HC2) across organizations. The overall ICER across all eight organizations was $483 per SEP-ad-justed completed FIT; however, this overall value includes three orga-nizations for which their intervention clinics generated fewer SEP-ad-justed completed FITs than their usual care clinics. (One organization reported fewer absolute, but a higher proportion of, FITs in its inter-vention clinics.) For the five organizations reporting more SEP-adjusted completed FITs in their intervention clinics, ICERs ranged from $96 to $1021 per SEP-adjusted completed FIT. Using the lagged results (Table 4), three organizations produced fewer SEP-adjusted completed FITs in intervention clinics than in usual care clinics. The overall ICER was $441 per SEP-adjusted completed FIT, although organization-level ICERs ranged from $97 to $534.
Per-clinic delivery costs, averaging $23.3 K across organizations, ranged from $8.4 K (HC8) to $36.7 K (HC2). Per-clinic delivery costs for HC2 were somewhat higher than for other organizations because HC2 reported 300 h of full-time staﬀ training in preparation for intervention start-up, which were substantially higher than for any other organiza-tion. Fig. 1 presents STOP CRC's per-clinic activity categories by orga-nization. Regardless of the magnitude of overall costs, the largest re-ported cost category for each organization was implementation, specifically mailing preparation, which included printing letters, af-fixing labels on tubes or cards and envelopes, and placing lab orders.
The ICERs reported earlier do not include costs of follow-up colo-noscopy for abnormal FITs; however, potential implementers of a screening program such as STOP CRC are presumably interested in its implications for limited colonoscopy resources. Table 3 also presents primary data on the number of SEP-adjusted completed FITs per or-ganization that were judged abnormal and the number receiving follow-up colonoscopy. This is a conservative cost estimate for colo-noscopy because many colonoscopies do not involve polypectomy or biopsy. Adding the cost of colonoscopies for abnormal FITs decreases the overall incremental cost per returned FIT to $409. This counter-intuitive result arises because 45.3% of abnormal FITs in usual care clinics were followed up with colonoscopy versus 35.7% in intervention clinics. However, spleen phenomenon is not observed in the lagged data (Table 4); follow-up colonoscopies increase the cost per SEP-adjusted completed FIT by 4.3% to $460.