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An automated intervention with stepped increases in support to increase uptake of colorectal cancer screening: a randomized trial.

ABSTRACT: Screening decreases colorectal cancer (CRC) incidence and mortality, yet almost half of age-eligible patients are not screened at recommended intervals.To determine whether interventions using electronic health records (EHRs), automated mailings, and stepped increases in support improve CRC screening adherence over 2 years.4-group, parallel-design, randomized, controlled comparative effectiveness trial with concealed allocation and blinded outcome assessments. (ClinicalTrials.gov: NCT00697047)21 primary care medical centers.4675 adults aged 50 to 73 years not current for CRC screening.Usual care, EHR-linked mailings ("automated"), automated plus telephone assistance ("assisted"), or automated and assisted plus nurse navigation to testing completion or refusal ("navigated"). Interventions were repeated in year 2.The proportion of participants current for screening in both years, defined as colonoscopy or sigmoidoscopy (year 1) or fecal occult blood testing (FOBT) in year 1 and FOBT, colonoscopy, or sigmoidoscopy (year 2).Compared with those in the usual care group, participants in the intervention groups were more likely to be current for CRC screening for both years with significant increases by intensity (usual care, 26.3% [95% CI, 23.4% to 29.2%]; automated, 50.8% [CI, 47.3% to 54.4%]; assisted, 57.5% [CI, 54.5% to 60.6%]; and navigated, 64.7% [CI, 62.5% to 67.0%]; P < 0.001 for all pair-wise comparisons). Increases in screening were primarily due to increased uptake of FOBT being completed in both years (usual care, 3.9% [CI, 2.8% to 5.1%]; automated, 27.5% [CI, 24.9% to 30.0%]; assisted, 30.5% [CI, 27.9% to 33.2%]; and navigated, 35.8% [CI, 33.1% to 38.6%]).Participants were required to provide verbal consent and were more likely to be white and to participate in other types of cancer screening, limiting generalizability.Compared with usual care, a centralized, EHR-linked, mailed CRC screening program led to twice as many persons being current for screening over 2 years. Assisted and navigated interventions led to smaller but significant stepped increases compared with the automated intervention only. The rapid growth of EHRs provides opportunities for spreading this model broadly.

SUBMITTER: Green BB

PROVIDER: S-EPMC3953144 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

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Project description:Background/Aims Screening decreases colorectal cancer (CRC) incidence and mortality, yet almost half of age-eligible patients are not screened at recommended intervals. Our objective was to determine whether interventions using electronic health records, automated mailings, and stepped increases in support increased being current for CRC testing over 2 years. Methods Setting and participants: SOS was a four-arm parallel design randomized controlled comparative effectiveness trial with concealed allocation and blinded outcome assessments (ClinicalTrials.gov registration number: NCT00697047). Patients aged 50–73 at baseline (n = 4674) not current for CRC screening and with no life-threatening illnesses from 21 primary care medical centers were randomized. Interventions: Usual care (UC), Automated mailed (Automated), Automated plus medical assistant telephone assistance (Assisted), or both Automated and Assisted interventions plus nurse navigation until testing was completed or declined (Navigated). Interventions were repeated in year 2. Measurements: Primary outcomes were the proportion current for screening in both years, defined as completion of a colonoscopy or sigmoidoscopy in year 1, or fecal occult blood test (FOBT) in year 1 and either FOBT, colonoscopy, or sigmoidoscopy in year 2. Results Compared to UC, intervention patients were more likely to be current for CRC screening for both years of the study, with incremental increases by intervention intensity (UC 26.5% vs. Automated 50.7%, Assisted 57.7%, or Navigated 64.4% P <.001). Automated interventions increased CRC screening in all patient subgroups compared to UC. The higher-intensity Assisted and Navigated interventions were less effective in patients age ?65, and African American/Blacks and those reporting mixed race. Two-year intervention cost estimates were $57,000 for Automated, $67,000 for Assisted, and $79,000 for Navigated. Inclusion of CRC test costs produced total intervention costs of $314,000, $342,000, and $390,000 for three arms respectively, compared to $339,000 for UC costs for CRC tests alone. Conclusions A low-cost stepped intervention that leveraged automated data and centralized processes led to twice as many people being current for CRC screening over 2 years. The rapid growth of electronic health records provides opportunities for spreading this model broadly.

Project description:BackgroundScreening over many years is required to optimize colorectal cancer (CRC) outcomes.ObjectiveTo evaluate the effect of a CRC screening intervention on adherence to CRC screening over 9 years.DesignRandomized trial.SettingIntegrated health care system in Washington state.ParticipantsBetween August 2008 and November 2009, 4653 adults in a Washington state integrated health care system aged 50-74 due for CRC screening were randomized to usual care (UC; N =1163) or UC plus study interventions (interventions: N = 3490).InterventionsYears 1 and 2: (arm 1) UC or this plus study interventions; (arm 2) mailed fecal tests or information on scheduling colonoscopy; (arm 3) mailings plus brief telephone assistance; or (arm 4) mailings and assistance plus nurse navigation. In year 3, stepped-intensity participants (arms 2, 3, and 4 combined) still eligible for screening were randomized to either stopped or continued interventions in years 3 and 5-9.Main measuresTime in adherence to CRC testing over 9 years (covered time, primary outcome), and percent with no CRC testing in participants assigned to any intervention compared to UC only. Poisson regression models estimated incidence rate ratios for covered time, adjusting for patient characteristics and accounting for variable follow-up time.Key resultsCompared to UC, intervention participants had 21% more covered time over 9 years (57.5% vs. 69.1%; adjusted incidence rate ratio 1.21, 95% confidence interval 1.16-1.25, P<0.001). Fecal testing accounted for almost all additional covered time among intervention patients. Compared to UC, intervention participants were also more likely to have completed at least one CRC screening test over 9 years or until censorship (88.6% vs. 80.6%, P<0.001).ConclusionsAn outreach program that included mailed fecal tests and phone follow-up led to increased adherence to CRC testing and fewer age-eligible individuals without any CRC testing over 9 years.Trial registrationSystems of Support (SOS) to Increase Colon Cancer Screening and Follow-up (SOS), NCT00697047, clinicaltrials.gov/ct2/show/NCT00697047.

Project description:Importance:Colorectal cancer screening rates are suboptimal, particularly among sociodemographically disadvantaged groups. Objective:To examine whether guaranteed money or probabilistic lottery financial incentives conditional on completion of colorectal cancer screening increase screening uptake, particularly among groups with lower screening rates. Design, Setting, and Participants:This parallel, 3-arm randomized clinical trial was conducted from March 13, 2017, through April 12, 2018, at 21 medical centers in an integrated health care system in western Washington. A total of 838 age-eligible patients overdue for colorectal cancer screening who completed a questionnaire that confirmed eligibility and included sociodemographic and psychosocial questions were enrolled. Interventions:Interventions were (1) mail only (n = 284; up to 3 mailings that included information on the importance of colorectal cancer screening and screening test choices, a fecal immunochemical test [FIT], and a reminder letter if necessary), (2) mail and monetary (n = 270; mailings plus guaranteed $10 on screening completion), or (3) mail and lottery (n = 284; mailings plus a 1 in 10 chance of receiving $50 on screening completion). Main Outcomes and Measures:The primary outcome was completion of any colorectal cancer screening within 6 months of randomization. Secondary outcomes were FIT or colonoscopy completion within 6 months of randomization. Intervention effects were compared across sociodemographic subgroups and self-reported psychosocial measures. Results:A total of 838 participants (mean [SD] age, 59.7 [7.2] years; 546 [65.2%] female; 433 [52.2%] white race and 101 [12.1%] Hispanic ethnicity) were included in the study. Completion of any colorectal screening was not significantly higher for the mail and monetary group (207 of 270 [76.7%]) or the mail and lottery group (212 of 284 [74.6%]) than for the mail only group (203 of 284 [71.5%]) (P = .11). For FIT completion, interventions had a statistically significant effect (P = .04), with a net increase of 7.7% (95% CI, 0.3%-15.1%) in the mail and monetary group and 7.1% (95% CI, -0.2% to 14.3%) in the mail and lottery group compared with the mail only group. For patients with Medicaid insurance, the net increase compared with mail only in FIT completion for the mail and monetary or the mail and lottery group was 37.7% (95% CI, 11.0%-64.3%) (34.2% for the mail and monetary group and 40.4% for the mail and lottery group) compared with a net increase of only 5.6% (95% CI, -0.9% to 12.2%) among those not Medicaid insured (test for interaction P = .03). Conclusions and Relevance:Financial incentives increased FIT uptake but not overall colorectal cancer screening. Financial incentives may decrease screening disparities among some sociodemographically disadvantaged groups. Trial Registration:ClinicalTrials.gov identifier: NCT00697047.

Project description:BackgroundThere is limited evidence on how implementation of peer support interventions influences effectiveness, particularly for individuals with diabetes. We conducted a cluster randomized controlled trial to compare the effectiveness of a peer-led health education package versus usual care to increase uptake of screening for diabetic retinopathy (DR).MethodsOur process evaluation used a mixed-method design to investigate the recruitment and retention, reach, dose, fidelity, acceptability, and context of implementation, and was guided by the Consolidated Framework for Implementation Research (CFIR). We reviewed trial documents, conducted semi-structured interviews with key informants (n = 10) and conducted four focus group discussions with participants in both arms of the trial. Three analysts undertook CFIR theory-driven content analysis of the qualitative data. Quantitative data was analyzed to provide descriptive statistics relevant to the objectives of the process evaluation.ResultsThe trial had positive implementation outcomes, 100% retention of clusters and 96% retention for participants, 83% adherence to delivery of content of group talks (fidelity), and 78% attendance (reach) to at least 50% (3/6) of the group talks (dose). The data revealed that intervention characteristics, outer setting, inner setting, individual characteristics, and process (all the constructs of CFIR) influenced the implementation. There were more facilitators than barriers to the implementation. Facilitators included the relative advantage of the intervention compared with current practice (intervention characteristics); awareness of the growing prioritization of diabetes in the national health policy framework (outer setting); tension for change due to the realization of the vulnerability to vision loss from DR (inner setting); a strong collective sense of accountability of peer supporters to implement the intervention (individual characteristics); and regular feedback on the progress with implementation (process). Potential barriers included the need to queue at the eye clinic (intervention characteristic), travel inconveniences (inner setting), and socio-political disruption (outer setting).ConclusionsThe intervention was implemented with high retention, reach, fidelity, and dose. The CFIR provided a valuable framework for evaluating contextual factors that influenced implementation and helped to understand what adaptations may be needed during scale up.Trial registrationPan African Clinical Trials Registry: PACTR201707002430195 registered 15 July 2017.

Project description:BackgroundColorectal cancer (CRC) screening rates are lower in Appalachian regions of the United States than in non-Appalachian regions. Given the availability of various screening modalities, there is critical need for culturally relevant interventions addressing multiple socioecological levels to reduce the regional CRC burden. In this report, we describe the development and baseline findings from year 1 of "Accelerating Colorectal Cancer Screening through Implementation Science (ACCSIS) in Appalachia," a 5-year, National Cancer Institute Cancer MoonshotSM-funded multilevel intervention (MLI) project to increase screening in Appalachian Kentucky and Ohio primary care clinics.MethodsProject development was theory-driven and included the establishment of both an external Scientific Advisory Board and a Community Advisory Board to provide guidance in conducting formative activities in two Appalachian counties: one in Kentucky and one in Ohio. Activities included identifying and describing the study communities and primary care clinics, selecting appropriate evidence-based interventions (EBIs), and conducting a pilot test of MLI strategies addressing patient, provider, clinic, and community needs.ResultsKey informant interviews identified multiple barriers to CRC screening, including fear of screening, test results, and financial concerns (patient level); lack of time and competing priorities (provider level); lack of reminder or tracking systems and staff burden (clinic level); and cultural issues, societal norms, and transportation (community level). With this information, investigators then offered clinics a menu of EBIs and strategies to address barriers at each level. Clinics selected individually tailored MLIs, including improvement of patient education materials, provision of provider education (resulting in increased knowledge, p = .003), enhancement of electronic health record (EHR) systems and development of clinic screening protocols, and implementation of community CRC awareness events, all of which promoted stool-based screening (i.e., FIT or FIT-DNA). Variability among clinics, including differences in EHR systems, was the most salient barrier to EBI implementation, particularly in terms of tracking follow-up of positive screening results, whereas the development of clinic-wide screening protocols was found to promote fidelity to EBI components.ConclusionsLessons learned from year 1 included increased recognition of variability among the clinics and how they function, appreciation for clinic staff and provider workload, and development of strategies to utilize EHR systems. These findings necessitated a modification of study design for subsequent years.Trial registrationTrial NCT04427527 is registered at https://clinicaltrials.gov and was registered on June 11, 2020.

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An automated intervention with stepped increases in support to increase uptake of colorectal cancer screening: a randomized trial.

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