Dataset Information

Advanced Notification Calls Prior to Mailed Fecal Immunochemical Test in Previously Screened Patients: a Randomized Controlled Trial.

ABSTRACT:

Background

Phone calls as part of multimodal fecal immunochemical test (FIT) outreach are effective but resource-intensive. Previous studies of advanced notification calls before FIT mailing have not differentiated patients' prior screening status.

Objective

To determine the effectiveness of a phone call preceding mailing of a FIT kit on test completion rate for patients who have completed a prior FIT.

Design

Randomized controlled trial nested within a larger study. All patients were assigned to receive organized mailed FIT outreach in the larger study.

Participants

Patients in a safety-net health setting ages 50-75 years old with a previously negative FIT.

Interventions

Patients were assigned to either receive an advanced notification phone call or no phone call preceding a mailed FIT kit. Both groups received an informational postcard prior to the mailed FIT.

Main measures

The primary outcome was FIT completion rate at 1 year. The secondary outcomes were FIT completion rates at 60, 90, and 180 days, rates stratified by demographic subgroups, and rates according to outcome of the phone call.

Key results

A total of 1645 patients were assigned to advanced notification calls and 1595 were assigned to no call preceding the FIT mailing. Although FIT completion rate was higher at day 60 (55.5% vs. 50.8%, p < 0.01), an advanced notification call did not significantly improve FIT completion at 1 year (70.9% vs. 69.9%, p = 0.52). Of the patients assigned to receive an advanced notification call, 90.5% were spoken with or left a voicemail; patients who were spoken with were more likely to complete a FIT at 1 year compared with patients who were only left a voicemail or could not be left a voicemail (79.9% vs. 69.2% vs. 49.6%, p < 0.01).

Conclusions

Advanced notification phone calls prior to FIT mailing did not improve rates at 1 year for patients with a previously negative FIT.

SUBMITTER: Lee B

PROVIDER: S-EPMC7572934 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND & AIMS:The fecal immunochemical test (FIT) is an alternative to colonoscopy and can increase overall screening for colorectal cancer (CRC). However, little is known about the frequency of and reasons for mishandled FIT samples. METHODS:We performed a prospective study, nested within a randomized controlled trial of patients, recruited from December 2015 through August 2017, who were not up to date with colorectal cancer screening (50-75 years old). The patients were randomly assigned to usual care or outreach groups that received a mailed FIT with low literacy level instructions or a reminder call, or both. We examined frequency of and reasons for mishandled FIT samples, including absence of collection date; time from collection to laboratory receipt of more than 14 days; or mishandling of stool, buffer, or cap. The outcomes were the frequency of mishandled FIT samples, effects of outreach on mishandling, and positive results from the FIT among proper and mishandled samples. RESULTS:FIT samples were returned from 1871 patients assigned to usual care and 3045 who received the low literacy level instructions and a reminder call. In total, 19.8% of samples were mishandled; most of these (93.7%) had not labeled the date of stool collection but were still processed. Of the received samples, 1.2% of were not processed because the time from patient collection to laboratory receipt was more than 14 days. Outreach was associated with a lower proportion of mishandled samples (16.5% vs 25.0% for usual care; P < .0001). The proportion of mishandled samples was lowest among patients who received the low literacy level instruction and a reminder call (12.8%, P < .0001). There was no significant difference in proportions of positive results between properly processed samples (7.5%) and improperly processed samples (6.2%) (P = .14). CONCLUSION:In a prospective study of patients who were not up to date with colorectal cancer screening, we found that almost 20% of FIT samples were mishandled, with most patients missing the stool collection date. Patient outreach was associated with a lower proportion of mishandled samples, but there was no difference in proportions of positive results between properly and improperly handled samples. Our findings indicate that routine processing of undated FIT samples is associated with similar rates of positive results. There are limited data on test characteristics for FIT samples beyond the 14 days of stool acquisition. The inclusion of low literacy level instructions with reminder calls was associated with improved patient handling of the FIT sample. ClincialTrials.gov no: NCT02613260.

Project description:ImportanceFecal immunochemical tests for hemoglobin are widely used for colorectal cancer (CRC) screening. Observational studies suggested that sensitivity of fecal immunochemical tests for detecting advanced neoplasms could be increased by acetylsalicylic acid (aspirin), especially among men.ObjectiveTo evaluate the potential to increase sensitivity of fecal immunochemical tests by administering a single 300-mg oral aspirin dose 2 days before stool sampling.Design, setting, and participantsA randomized, placebo-controlled, double-blind trial was conducted in 14 gastroenterology practices and 4 hospitals in Germany, and included 2422 men and women aged 40 to 80 years scheduled for colonoscopy, with no recent use of aspirin or other drugs with antithrombotic effects (enrollment from June 2013 to November 2016, and final follow-up January 27, 2017).InterventionsAdministration of a single tablet containing 300 mg of aspirin (n = 1208) or placebo (n = 1214) 2 days before fecal sampling for fecal immunochemical test.Main outcome and measuresThe primary outcome was sensitivity of a quantitative fecal immunochemical test at 2 predefined cutoffs (10.2 and 17-μg Hb/g stool) for detecting advanced neoplasms (colorectal cancer or advanced adenoma).ResultsAmong 2422 randomized patients (mean [SD] age, 59.6 [7.9] years; 1219, 50%, men), 2134 were included in the analysis (78% for primary screening colonoscopy, 22% for diagnostic colonoscopy). Advanced neoplasms were identified in 224 participants (10.5%), including 8 participants (0.4%) with CRC and 216 participants (10.1%) with advanced adenoma. Sensitivity was 40.2% in the aspirin group and 30.4% in the placebo group (difference 9.8%, 95% CI, -3.1% to 22.2%, P = .14) at cutoff 10.2-μg Hb/g stool and 28.6% in the aspirin and 22.5% in the placebo group (difference 6.0%, 95% CI, -5.7% to 17.5%, P = .32) at cutoff 17-μg Hb/g stool.Conclusions and relevanceAmong adults aged 40 to 80 years not using aspirin or other antithrombotic medications, administration of a single dose of oral aspirin prior to fecal immunochemical testing, compared with placebo, did not significantly increase test sensitivity for detecting advanced colorectal neoplasms at 2 predefined cutoffs of a quantitative fecal immunochemical test.Trial registrationDeutsches Register Klinischer Studien Identifier: DRKS00003252; EudraCT Identifier: 2011-005603-32/DE.