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Effectiveness of a Mailed Colorectal Cancer Screening Outreach Program in Community Health Clinics: The STOP CRC Cluster Randomized Clinical Trial

Randomized Controlled Trial

. 2018 Sep 1;178(9):1174-1181. doi: 10.1001/jamainternmed.2018.3629. Effectiveness of a Mailed Colorectal Cancer Screening Outreach Program in Community Health Clinics: The STOP CRC Cluster Randomized Clinical Trial

Affiliations

¹ Kaiser Permanente Center for Health Research, Portland, Oregon.
² Center for Global Health, National Cancer Institute, Rockville, Maryland.
³ OCHIN, Portland, Oregon.
⁴ Kaiser Permanente Washington Health Research Institute, Seattle, Washington.

PMID: 30083752
PMCID: PMC6142956
DOI: 10.1001/jamainternmed.2018.3629

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Randomized Controlled Trial

Effectiveness of a Mailed Colorectal Cancer Screening Outreach Program in Community Health Clinics: The STOP CRC Cluster Randomized Clinical Trial

Gloria D Coronado et al. JAMA Intern Med. 2018.

. 2018 Sep 1;178(9):1174-1181. doi: 10.1001/jamainternmed.2018.3629. Affiliations

¹ Kaiser Permanente Center for Health Research, Portland, Oregon.
² Center for Global Health, National Cancer Institute, Rockville, Maryland.
³ OCHIN, Portland, Oregon.
⁴ Kaiser Permanente Washington Health Research Institute, Seattle, Washington.

PMID: 30083752
PMCID: PMC6142956
DOI: 10.1001/jamainternmed.2018.3629

Item in Clipboard

Erratum in

Error in Table 1.
[No authors listed] [No authors listed] JAMA Intern Med. 2019 Jul 1;179(7):1007. doi: 10.1001/jamainternmed.2019.2186. JAMA Intern Med. 2019. PMID: 31157828 Free PMC article. No abstract available.

Abstract

Importance: Approximately 24 million US individuals receive care at federally qualified health centers, which historically have low rates of colorectal cancer screening. The US Preventive Services Task Force recommends routine colorectal cancer screening for individuals aged 50 to 75 years.

Objective: To determine the effectiveness of an electronic health record (EHR)-embedded mailed fecal immunochemical test (FIT) outreach program implemented in health centers as part of standard care.

Design, setting, and participants: This cluster randomized pragmatic clinical trial was conducted in 26 federally qualified health center clinics, representing 8 health centers in Oregon and California, randomized to intervention (n = 13) or usual care (n = 13). All participants were overdue for colorectal cancer screening during the accrual interval (February 4, 2014 to February 3, 2015).

Interventions: Electronic health record-embedded tools to identify eligible adults and to facilitate implementation of a stepwise mailed intervention involving (1) an introductory letter, (2) a mailed FIT, and (3) a reminder letter; training, collaborative learning, and facilitation through a practice improvement process.

Main outcomes and measures: Effectiveness was measured as clinic-level proportions of adults who completed a FIT, and secondarily, any colorectal cancer screening within 12 months of accrual or by August 3, 2015. Implementation was measured as clinic-level proportions of adults who were mailed an introductory letter and ordered a FIT.

Results: Twenty-six clinics with 41 193 adults (mean [SD] age, 58.5 [6.3] years; 22 994 women) were randomized to receive the direct mail colorectal screening intervention (13 clinics; 21 134 patients) or usual care (13 clinics; 20 059 patients). Compared with usual care clinics, intervention clinics had significantly higher adjusted clinic-level proportion of participants who completed a FIT (13.9% vs 10.4%; difference, 3.4 percentage points; 95% CI, 0.1%-6.8%) and any colorectal cancer screening (18.3% vs 14.5%; difference, 3.8 percentage points; 95% CI, 0.6%-7.0%). We observed large variation across health centers in effectiveness (FIT completion differences range, -7.4 percentage points to 17.6 percentage points) and implementation (proportion who were mailed a FIT range, 6.5% to 68.2%). The number needed to mail to achieve a completed FIT was 4.8 overall, and 4.0 in clinics that mailed a FIT reminder.

Conclusions and relevance: An EHR-embedded mailed FIT outreach intervention significantly improved rates of FIT completion and rates of any colorectal cancer screening. Higher rates of colorectal cancer screening occurred in clinics that successfully implemented the mailed outreach program.

Trial registration: ClinicalTrials.gov identifier: NCT01742065.

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Conflict of interest statement

Conflict of Interest Disclosures: From November 2014 to August 2015, Dr Coronado served as a coinvestigator on an industry-funded study to evaluate patient adherence to an experimental blood test for colorectal cancer. The study was funded by EpiGenomics. From September 2017 to June 2019, Dr Coronado has served as the principal investigator on an industry-funded study to compare the clinical performance of an experimental FIT to an US Food and Drug Administration-approved FIT. The study is funded by Quidel Corporation. No other disclosures are reported.

Figures
Figure 1.. CONSORT Flowchart

Figure 1.. CONSORT Flowchart
Figure 1.. CONSORT Flowchart
Figure 2.. Implementation and Effectiveness of the…

Figure 2.. Implementation and Effectiveness of the STOP CRC Intervention, by Health Center

FIT indicates…

Figure 2.. Implementation and Effectiveness of the STOP CRC Intervention, by Health Center

FIT indicates fecal immunochemical test; HC, health center; STOP CRC, the Strategies and Opportunities to STOP Colon Cancer in Priority Populations study.

Comment in

Promoting FIT Colorectal Cancer Screening.
Redberg RF. Redberg RF. JAMA Intern Med. 2018 Sep 1;178(9):1181. doi: 10.1001/jamainternmed.2018.3654. JAMA Intern Med. 2018. PMID: 30083749 No abstract available.