Dataset Information

Effect of Sequential or Active Choice for Colorectal Cancer Screening Outreach: A Randomized Clinical Trial.

ABSTRACT:

Importance

Colonoscopy and fecal immunochemical testing (FIT) are considered top-tier tests for colorectal cancer (CRC) screening. Behavioral economic insights about "choice architecture" suggest that participation could be influenced by how people are presented test options.

Objective

To investigate response rates for offering colonoscopy only compared with sequential choice (colonoscopy and then FIT) or active choice (colonoscopy or FIT) through mailed outreach.

Design, setting, and participants

Three-arm pragmatic randomized clinical trial conducted between November 14, 2017, and May 14, 2018. The setting was primary care practices at an academic health system. Patients aged 50 to 74 years with at least 2 primary care visits in the 2-year preenrollment period were included if they were eligible but not up to date on CRC screening.

Interventions

Eligible patients received mailed outreach about CRC screening. Equal numbers of eligible patients were randomly assigned to 3 outreach groups to receive mailings about CRC screening with the following options: (1) direct phone number to call for scheduling colonoscopy (colonoscopy only), (2) direct phone number to call for colonoscopy and a mailed FIT kit if no response within 4 weeks (sequential choice), or (3) direct phone number to call for colonoscopy and a mailed FIT kit offered at the same time (active choice).

Main outcomes and measures

The primary outcome was CRC screening completion (FIT or colonoscopy) within 4 months of initial outreach. The secondary outcomes were CRC screening completion within 6 months of outreach and the choice of colonoscopy as a screening test.

Results

In total, 438 patients were included in the intent-to-treat analysis, with a median age of 56 years (interquartile range, 52-63 years); 55.0% were women. At 4 months, the CRC screening completion rates were 14.4% (95% CI, 8.7%-20.1%) in the colonoscopy-only arm, 17.1% (95% CI, 11.0%-23.2%) in the sequential choice arm, and 19.9% (95% CI, 13.4%-26.4%) in the active choice arm. Neither choice arm achieved a screening rate statistically greater than that in the colonoscopy-alone arm. Among those who completed CRC screening at 4 months, 90.5% (95% CI, 78.0%-103.0%) chose colonoscopy in the colonoscopy-only arm, which was significantly higher than the 52.0% (95% CI, 32.4%-71.6%; P = .005) and 37.9% (95% CI, 20.2%-55.6%; P < .001) in the sequential choice and active choice arms, respectively.

Conclusions and relevance

There was no significant increase in CRC screening when offering sequential or active choice, but there was a lower rate of colonoscopy in the choice arms than in the colonoscopy-only arm. Subtle changes in sequencing or defaults can alter patient decision making related to preventive health.

Trial registration

ClinicalTrials.gov identifier: NCT03246438.

SUBMITTER: Mehta SJ

PROVIDER: S-EPMC6724166 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Importance:Mailed fecal immunochemical test (FIT) outreach is more effective than colonoscopy outreach for increasing 1-time colorectal cancer (CRC) screening, but long-term effectiveness may need repeat testing and timely follow-up for abnormal results. Objective:Compare the effectiveness of FIT outreach and colonoscopy outreach to increase completion of the CRC screening process (screening initiation and follow-up) within 3 years. Design, Setting, and Participants:Pragmatic randomized clinical trial from March 2013 to July 2016 among 5999 participants aged 50 to 64 years who were receiving primary care in Parkland Health and Hospital System and were not up to date with CRC screenings. Interventions:Random assignment to mailed FIT outreach (n?=?2400), mailed colonoscopy outreach (n?=?2400), or usual care with clinic-based screening (n?=?1199). Outreach included processes to promote repeat annual testing for individuals in the FIT outreach group with normal results and completion of diagnostic and screening colonoscopy for those with an abnormal FIT result or assigned to colonoscopy outreach. Main Outcomes and Measures:Primary outcome was screening process completion, defined as adherence to colonoscopy completion, annual testing for a normal FIT result, diagnostic colonoscopy for an abnormal FIT result, or treatment evaluation if CRC was detected. Secondary outcomes included detection of any adenoma or advanced neoplasia (including CRC) and screening-related harms (including bleeding or perforation). Results:All 5999 participants (median age, 56 years; women, 61.9%) were included in the intention-to-screen analyses. Screening process completion was 38.4% in the colonoscopy outreach group, 28.0% in the FIT outreach group, and 10.7% in the usual care group. Compared with the usual care group, between-group differences for completion were higher for both outreach groups (27.7% [95% CI, 25.1% to 30.4%] for the colonoscopy outreach group; 17.3% [95% CI, 14.8% to 19.8%] for FIT outreach group), and highest in the colonoscopy outreach group (10.4% [95% CI, 7.8% to 13.1%] for the colonoscopy outreach group vs FIT outreach group; P?<?.001 for all comparisons). Compared with usual care, the between-group differences in adenoma and advanced neoplasia detection rates were higher for both outreach groups (colonoscopy outreach group: 10.3% [95% CI, 9.5% to 12.1%] for adenoma and 3.1% [95% CI, 2.0% to 4.1%] for advanced neoplasia, P?<?.001 for both comparisons; FIT outreach group: 1.3% [95% CI, -0.1% to 2.8%] for adenoma and 0.7% [95% CI, -0.2% to 1.6%] for advanced neoplasia, P?<?.08 and P?<?.13, respectively), and highest in the colonoscopy outreach group (colonoscopy outreach group vs FIT outreach group: 9.0% [95% CI, 7.3% to 10.7%] for adenoma and 2.4% [95% CI, 1.3% to 3.3%] for advanced neoplasia, P?<?.001 for both comparisons). There were no screening-related harms in any groups. Conclusions and Relevance:Among persons aged 50 to 64 years receiving primary care at a safety-net institution, mailed outreach invitations offering FIT or colonoscopy compared with usual care increased the proportion completing CRC screening process within 3 years. The rate of screening process completion was higher with colonoscopy than FIT outreach. Trial Registration:clinicaltrials.gov Identifier: NCT01710215.

Project description:Study questionWhat is the effect of default test offers--opt-in, opt-out, and active choice--on the likelihood of acceptance of an HIV test among patients receiving care in an emergency department?MethodsThis was a randomized clinical trial conducted in the emergency department of an urban teaching hospital and regional trauma center. Patients aged 13-64 years were randomized to opt-in, opt-out, and active choice HIV test offers. The primary outcome was HIV test acceptance percentage. The Denver Risk Score was used to categorize patients as being at low, intermediate, or high risk of HIV infection.Study answer and limitations38.0% (611/1607) of patients in the opt-in testing group accepted an HIV test, compared with 51.3% (815/1628) in the active choice arm (difference 13.3%, 95% confidence interval 9.8% to 16.7%) and 65.9% (1031/1565) in the opt-out arm (difference 27.9%, 24.4% to 31.3%). Compared with active choice testing, opt-out testing led to a 14.6 (11.1 to 18.1) percentage point increase in test acceptance. Patients identified as being at intermediate and high risk were more likely to accept testing than were those at low risk in all arms (difference 6.4% (3.4% to 9.3%) for intermediate and 8.3% (3.3% to 13.4%) for high risk). The opt-out effect was significantly smaller among those reporting high risk behaviors, but the active choice effect did not significantly vary by level of reported risk behavior. Patients consented to inclusion in the study after being offered an HIV test, and inclusion varied slightly by treatment assignment. The study took place at a single county hospital in a city that is somewhat unique with respect to HIV testing; although the test acceptance percentages themselves might vary, a different pattern for opt-in versus active choice versus opt-out test schemes would not be expected.What this paper addsActive choice is a distinct test regimen, with test acceptance patterns that may best approximate patients' true preferences. Opt-out regimens can substantially increase HIV testing, and opt-in schemes may reduce testing, compared with active choice testing.Funding, competing interests, data sharingThis study was supported by grant NIA 1RC4AG039078 from the National Institute on Aging. The full dataset is available from the corresponding author. Consent for data sharing was not obtained, but the data are anonymized and risk of identification is low.Trial registration Clinical trials NCT01377857.

Project description:IMPORTANCE:Colorectal cancer (CRC) screening saves lives, but participation rates are low among underserved populations. Knowledge on effective approaches for screening the underserved, including best test type to offer, is limited. OBJECTIVE:To determine (1) if organized mailed outreach boosts CRC screening compared with usual care and (2) if FIT is superior to colonoscopy outreach for CRC screening participation in an underserved population. DESIGN, SETTING, AND PARTICIPANTS:We identified uninsured patients, not up to date with CRC screening, age 54 to 64 years, served by the John Peter Smith Health Network, Fort Worth and Tarrant County, Texas, a safety net health system. INTERVENTIONS:Patients were assigned randomly to 1 of 3 groups. One group was assigned to fecal immunochemical test (FIT) outreach, consisting of mailed invitation to use and return an enclosed no-cost FIT (n?=?1593). A second was assigned to colonoscopy outreach, consisting of mailed invitation to schedule a no-cost colonoscopy (n?=?479). The third group was assigned to usual care, consisting of opportunistic primary care visit–based screening (n?=?3898). In addition, FIT and colonoscopy outreach groups received telephone follow-up to promote test completion. MAIN OUTCOME MEASURES:Screening participation in any CRC test within 1 year after randomization. RESULTS:Mean patient age was 59 years; 64% of patients were women. The sample was 41% white, 24% black, 29% Hispanic, and 7% other race/ethnicity. Screening participation was significantly higher for both FIT (40.7%) and colonoscopy outreach (24.6%) than for usual care (12.1%) (P?<?.001 for both comparisons with usual care). Screening was significantly higher for FIT than for colonoscopy outreach (P?<?.001). In stratified analyses, screening was higher for FIT and colonoscopy outreach than for usual care, and higher for FIT than for colonoscopy outreach among whites, blacks, and Hispanics (P?<?.005 for all comparisons). Rates of CRC identification and advanced adenoma detection were 0.4% and 0.8% for FIT outreach, 0.4% and 1.3% for colonoscopy outreach, and 0.2% and 0.4% for usual care, respectively (P?<?.05 for colonoscopy vs usual care advanced adenoma comparison; P?>?.05 for all other comparisons). Eleven of 60 patients with abnormal FIT results did not complete colonoscopy. CONCLUSIONS AND REVELANCE: Among underserved patients whose CRC screening was not up to date, mailed outreach invitations resulted in markedly higher CRC screening compared with usual care. Outreach was more effective with FIT than with colonoscopy invitation. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01191411.

Project description:ImportanceApproximately 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.ObjectiveTo 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 participantsThis 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).InterventionsElectronic 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 measuresEffectiveness 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.ResultsTwenty-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 relevanceAn 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 registrationClinicalTrials.gov identifier: NCT01742065.

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Project description:IMPORTANCE:Colorectal cancer is a major health burden. Screening is recommended in many countries. OBJECTIVE:To estimate the effectiveness of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality in a population-based trial. DESIGN, SETTING, AND PARTICIPANTS:Randomized clinical trial of 100,210 individuals aged 50 to 64 years, identified from the population of Oslo city and Telemark County, Norway. Screening was performed in 1999-2000 (55-64-year age group) and in 2001 (50-54-year age group), with follow-up ending December 31, 2011. Of those selected, 1415 were excluded due to prior colorectal cancer, emigration, or death, and 3 could not be traced in the population registry. INTERVENTIONS:Participants randomized to the screening group were invited to undergo screening. Within the screening group, participants were randomized 1:1 to receive once-only flexible sigmoidoscopy or combination of once-only flexible sigmoidoscopy and fecal occult blood testing (FOBT). Participants with positive screening test results (cancer, adenoma, polyp ?10 mm, or positive FOBT) were offered colonoscopy. The control group received no intervention. MAIN OUTCOMES AND MEASURES:Colorectal cancer incidence and mortality. RESULTS:A total of 98,792 participants were included in the intention-to-screen analyses, of whom 78,220 comprised the control group and 20,572 comprised the screening group (10,283 randomized to receive a flexible sigmoidoscopy and 10,289 to receive flexible sigmoidoscopy and FOBT). Adherence with screening was 63%. After a median of 10.9 years, 71 participants died of colorectal cancer in the screening group vs 330 in the control group (31.4 vs 43.1 deaths per 100,000 person-years; absolute rate difference, 11.7 [95% CI, 3.0-20.4]; hazard ratio [HR], 0.73 [95% CI, 0.56-0.94]). Colorectal cancer was diagnosed in 253 participants in the screening group vs 1086 in the control group (112.6 vs 141.0 cases per 100,000 person-years; absolute rate difference, 28.4 [95% CI, 12.1-44.7]; HR, 0.80 [95% CI, 0.70-0.92]). Colorectal cancer incidence was reduced in both the 50- to 54-year age group (HR, 0.68; 95% CI, 0.49-0.94) and the 55- to 64-year age group (HR, 0.83; 95% CI, 0.71-0.96). There was no difference between the flexible sigmoidoscopy only vs the flexible sigmoidoscopy and FOBT screening groups. CONCLUSIONS AND RELEVANCE:In Norway, once-only flexible sigmoidoscopy screening or flexible sigmoidoscopy and FOBT reduced colorectal cancer incidence and mortality on a population level compared with no screening. Screening was effective both in the 50- to 54-year and the 55- to 64-year age groups. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00119912.

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