Effectiveness and Cost of Organized Outreach for Colorectal Cancer Screening: A Randomized, Controlled Trial.
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ABSTRACT: Background
Colorectal cancer (CRC) screening remains underused, especially in safety-net systems. The objective of this study was to determine the effectiveness, costs, and cost-effectiveness of organized outreach using fecal immunochemical tests (FITs) compared with usual care.Methods
Patients age 50-75 years eligible for CRC screening from eight participating primary care safety-net clinics were randomly assigned to outreach intervention with usual care vs usual care alone. The intervention included a mailed postcard and call, followed by a mailed FIT kit, and a reminder phone call if the FIT kit was not returned. The primary outcome was screening participation at 1 year and a microcosting analysis of the outreach activities with embedded long-term cost-effectiveness of outreach. All statistical tests were two-sided.Results
A total of 5386 patients were randomly assigned to the intervention group and 5434 to usual care. FIT screening was statistically significantly higher in the intervention group than in the control group (57.9% vs 37.4%, P < .001; difference = 20.5%, 95% confidence interval = 18.6% to 22.4%). In the intervention group, FIT completion rate was higher in patients who had previously completed a FIT vs those who had not (71.9% vs 35.7%, P < .001). There was evidence of effect modification of the intervention by language, and clinic. Outreach cost approximately $23 per patient and $112 per additional patient screened. Projecting long-term outcomes, outreach was estimated to cost $9200 per quality-adjusted life-year gained vs usual care.Conclusion
Population-based management with organized FIT outreach statistically significantly increased CRC screening and was cost-effective in a safety-net system. The sustainability of the program and any impact of economies of scale remain to be determined.
SUBMITTER: Somsouk M
PROVIDER: S-EPMC7017601 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background & aimsClinical guidelines for colorectal cancer (CRC) screening suggest use of either stool-based tests or colonoscopy - modalities that differ in recommended screening intervals, adherence, and costs. We know little about the long-term cost differences in population-health outreach strategies to promote these strategies.MethodsWe conducted a cost-effectiveness analysis to compare 2 mailed outreach strategies to increase CRC screening from a pragmatic, randomized clinical trial: mailed fecal immunochemical test (FIT) kits vs invitations to complete a screening colonoscopy. We built a 10-year Markov chain Monte Carlo microsimulation model to account for differences in screening intervals, adherence, and costs.ResultsMailed FIT kits had a lower 10-year average per-person cost of screening relative to colonoscopy invitations ($1139 vs $1725) but with 10.89 fewer months of compliance and 60 fewer advanced neoplasia detected (37 advanced adenomas and 23 CRC). Incremental cost effectiveness ratios for colonoscopy invitations compared with mailed FIT kits were $55.23, $15.84, and $25.48 per additional covered month, advanced adenoma, and CRC, respectively. Although FIT was the preferred strategy at low willingness-to-pay thresholds, the 2 strategies were equal at a willingness-to-pay threshold of $41.31 per covered month gained.ConclusionMailed FIT or colonoscopy invitations are both options to improve CRC screening completion and advanced neoplasia detection, and the choice of outreach strategy may differ by a health system's willingness-to-pay threshold. Mailed FIT kits are less expensive than colonoscopy invitations but result in fewer months of screening compliance and advanced neoplasia detected.
| S-EPMC9357235 | biostudies-literature
Project description:BackgroundOutreach (i.e., to invite those who do not use, or who under use screening services) and inreach (i.e., to invite an existing population who have already accessed the medical system) approaches may influence people to increase their use of screening test; however, whether their outcomes would be equivalent remains unclear.MethodsA total of 3,363,896 subjects, 50-69 years of age, participated in a colorectal cancer (CRC) screening program using biennial fecal immunochemical tests; 34.5% participated during 2004-2009 when the outreach approach alone was used, and 65.5% participated from 2010-2013 when outreach was integrated with an inreach approach. We compared the outcomes of the two approaches in delivery of screening services.ResultsCoverage rates increased from 21.4% to 36.9% and the positivity rate increased from 4.0% to 7.9%, while referral for confirmatory diagnostic examinations declined from 80.0% to 53.3%. The first period detected CRC in 0.20% of subjects screened, with a positive predictive value (PPV) of 6.1%, and the second detected CRC in 0.34% of subjects, with a PPV of 8.0%. After adjusting for confounders, differences were observed in the PPV for CRC (adjusted relative risk, 1.50; 95% confidence interval [CI], 1.41-1.60), cancer detection rate (1.20; 95% CI, 1.13-1.27), and interval cancer rate (0.72; 95% CI, 0.65-0.80). When we focused on the comparison between two approaches during the same study period of 2010-2013, the positivity rate of fecal testing (8.2% vs. 7.6%) and the PPV for CRC detection remained higher (1.07; 95% CI, 1.01-1.12) in subjects who were recruited from the inreach approach.ConclusionsOutcomes of screening were equivalent or better after integration of outreach and inreach approaches.ImpactThe results will encourage makers of health-care policy to adopt the integration approach to deliver screening services.
| S-EPMC4865222 | biostudies-literature
Project description:OBJECTIVES:METHODS:: RESULTS:: Patients randomized to opt-in agreed to participate 23.1% of the time, and only 2.5% of those in opt-out chose not to participate. FIT kits were mailed to 22.4% and 93% of patients in opt-in and opt-out arms, respectively. In intention-to-screen analysis, patients in the opt-out arm had a higher FIT completion rate (29.1%) than in the opt-in arm (9.6%) (absolute difference 19.5%; 95% confidence interval, 10.9-27.9%; P < .001). Results were similar in subgroup analysis of those sent initial messaging through the EHR portal (9.5% opt-in versus 37.5% in opt-out). CONCLUSIONS:.
| S-EPMC6768589 | biostudies-literature
Project description:Outreach, including patient navigation, has been shown to increase the uptake of colorectal cancer (CRC) screening in underserved populations. This analysis evaluates the cost-effectiveness of triennial multi-target stool DNA (mt-sDNA) versus outreach, with or without a mailed annual fecal immunochemical test (FIT), in a Medicaid population. A microsimulation model estimated the incremental cost-effectiveness ratio using quality-adjusted life years (QALY), direct costs, and clinical outcomes in a cohort of Medicaid beneficiaries aged 50-64 years, over a lifetime time horizon. The base case model explored scenarios of either 100% adherence or real-world reported adherence (51.3% for mt-sDNA, 21.1% for outreach with FIT and 12.3% for outreach without FIT) with or without real-world adherence for follow-up colonoscopy (66.7% for all). Costs and outcomes were discounted at 3.0%. At 100% adherence to both screening tests and follow-up colonoscopy, mt-sDNA costed more and was less effective compared with outreach with or without FIT. When real-world adherence rates were considered for screening strategies (with 100% adherence for follow-up colonoscopy), mt-sDNA resulted in the greatest reduction in incidence and mortality from CRC (41.5% and 45.8%, respectively) compared with outreach with or without FIT; mt-sDNA also was cost-effective versus outreach with and without FIT ($32,150/QALY and $22,707/QALY, respectively). mt-sDNA remained cost-effective versus FIT, with or without outreach, under real-world adherence rates for follow-up colonoscopy. Outreach or navigation interventions, with associated real-world adherence rates to screening tests, should be considered when evaluating the cost-effectiveness of CRC screening strategies in underserved populations.
| S-EPMC9232231 | biostudies-literature
Project description:ImportanceColorectal 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.ObjectiveTo 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 participantsWe 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.InterventionsPatients 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 measuresScreening participation in any CRC test within 1 year after randomization.ResultsMean 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 registrationclinicaltrials.gov Identifier: NCT01191411.
| S-EPMC5228201 | biostudies-literature
Project description:ImportanceMailed 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.ObjectiveCompare 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 participantsPragmatic 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.InterventionsRandom 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 measuresPrimary 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).ResultsAll 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 relevanceAmong 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 registrationclinicaltrials.gov Identifier: NCT01710215.
| S-EPMC5648645 | biostudies-literature
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.
| S-EPMC6142956 | biostudies-literature
Project description:Efforts to boost colorectal cancer (CRC) screening rates in underserved populations have been limited by effectiveness and scalability. We evaluate the impact of adding a lottery-based financial incentive to a text messaging program that asks patients to opt-in to receive mailed fecal immunochemical testing (FIT). This is a two-arm pragmatic randomized controlled trial at a community health center in Southwest Philadelphia from April to July 2017. We included CRC screening-eligible patients between ages 50-74 years who had a mobile phone, active health insurance, and at least one visit to the clinic in the past 12 months. Patients received a text message about CRC screening with the opportunity to opt-in to receive mailed FIT. They were randomized 1:1 to the following: (1) text messaging outreach alone (text), or (2) text messaging with lottery for a 1-in-5 chance of winning $100 after FIT completion (text + lottery). The primary outcome was the percentage of patients completing the mailed FIT within 3 months of initial outreach. 281 patients were included in the intent-to-treat analysis. The FIT completion rate was 12.1% (95% CI, 6.7%-17.5%) in the text message arm and 12.1% (95% CI, 6.7%-17.5%) in the lottery arm, with no statistical difference between arms. The majority of post-intervention interview respondents found text messaging to be acceptable and convenient. Opt-in text messaging is a feasible option to promote the uptake of mailed FIT screening, but the addition of a lottery-based incentive did not improve completion rates. Trial Registration: clinicaltrials.gov (NCT03072095).
| S-EPMC7251946 | biostudies-literature
Project description:ImportanceColonoscopy 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.ObjectiveTo 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 participantsThree-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.InterventionsEligible 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 measuresThe 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.ResultsIn 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 relevanceThere 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 registrationClinicalTrials.gov identifier: NCT03246438.
| S-EPMC6724166 | biostudies-literature
Project description:BackgroundRoutine screening reduces colorectal cancer mortality, but screening rates fall below national targets and are particularly low in underserved populations.ObjectiveTo compare the effectiveness of a single text message outreach to serial text messaging and mailed fecal home test kits on colorectal cancer screening rates.DesignA two-armed randomized clinical trial.ParticipantsAn urban community health center in Philadelphia. Adults aged 50-74 who were due for colorectal cancer screening had at least one visit to the practice in the previously year, and had a cell phone number recorded.InterventionsParticipants were randomized (1:1 ratio). Individuals in the control arm were sent a simple text message reminder as per usual practice. Those in the intervention arm were sent a pre-alert text message offering the options to opt-out of receiving a mailed fecal immunochemical test (FIT) kit, followed by up to three behaviorally informed text message reminders.Main measuresThe primary outcome was participation in colorectal cancer screening at 12 weeks. The secondary outcome was the FIT kit return rate at 12 weeks.Key resultsFour hundred forty participants were included. The mean age was 57.4 years (SD ± 6.1). 63.4% were women, 87.7% were Black, 19.1% were uninsured, and 49.6% were Medicaid beneficiaries. At 12 weeks, there was an absolute 17.3 percentage point increase in colorectal cancer screening in the intervention arm (19.6%), compared to the control arm (2.3%, p < 0.001). There was an absolute 17.7 percentage point increase in FIT kit return in the intervention arm (19.1%) compared to the control arm (1.4%, p < 0.001).ConclusionsSerial text messaging with opt-out mailed FIT kit outreach can substantially improve colorectal cancer screening rates in an underserved population.Trial registrationclinicaltrials.gov ( https://clinicaltrials.gov/ct2/show/NCT03479645 ).
| S-EPMC8298623 | biostudies-literature