Dataset Information

A stepped randomized trial to promote colorectal cancer screening in a nationwide sample of U.S. Veterans.

ABSTRACT:

Background

Colorectal cancer (CRC) screening (CRCS) facilitates early detection and lowers CRC mortality.

Objectives

To increase CRCS in a randomized trial of stepped interventions. Step 1 compared three modes of delivery of theory-informed minimal cue interventions. Step 2 was designed to more intensively engage those not completing CRCS after Step 1.

Methods

Recruitment packets (60,332) were mailed to a random sample of individuals with a record of U.S. military service during the Vietnam-era. Respondents not up-to-date with CRCS were randomized to one of four Step 1 groups: automated telephone, telephone, letter, or survey-only control. Those not completing screening after Step 1 were randomized to one of three Step 2 groups: automated motivational interviewing (MI) call, counselor-delivered MI call, or Step 2 control. Intention-to-treat (ITT) analyses assessed CRCS on follow-up surveys mailed after each step.

Results

After Step 1 (n = 1784), CRCS was higher in the letter, telephone, and automated telephone groups (by 1%, 5%, 7%) than in survey-only controls (43%), although differences were not statistically significant. After Step 2 (n = 516), there were nonsignificant increases in CRCS in the two intervention groups compared with the controls. CRCS following any combination of stepped interventions overall was 7% higher (P = 0.024) than in survey-only controls (55.6%).

Conclusions

In a nationwide study of Veterans, CRCS after each of two stepped interventions of varying modes of delivery did not differ significantly from that in controls. However, combined overall, the sequence of stepped interventions significantly increased CRCS.

SUBMITTER: Vernon SW

PROVIDER: S-EPMC8172445 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A stepped randomized trial to promote colorectal cancer screening in a nationwide sample of U.S. Veterans.

Vernon Sally W SW Del Junco Deborah J DJ Coan Sharon P SP Murphy Caitlin C CC Walters Scott T ST Friedman Robert H RH Bastian Lori A LA Fisher Deborah A DA Lairson David R DR Myers Ronald E RE

Contemporary clinical trials 20210403

<h4>Background</h4>Colorectal cancer (CRC) screening (CRCS) facilitates early detection and lowers CRC mortality.<h4>Objectives</h4>To increase CRCS in a randomized trial of stepped interventions. Step 1 compared three modes of delivery of theory-informed minimal cue interventions. Step 2 was designed to more intensively engage those not completing CRCS after Step 1.<h4>Methods</h4>Recruitment packets (60,332) were mailed to a random sample of individuals with a record of U.S. military service d ...[more]

PMID: 33823295

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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:BackgroundScreening decreases colorectal cancer (CRC) incidence and mortality, yet almost half of age-eligible patients are not screened at recommended intervals.ObjectiveTo determine whether interventions using electronic health records (EHRs), automated mailings, and stepped increases in support improve CRC screening adherence over 2 years.Design4-group, parallel-design, randomized, controlled comparative effectiveness trial with concealed allocation and blinded outcome assessments. (ClinicalTrials.gov: NCT00697047)Setting21 primary care medical centers.Patients4675 adults aged 50 to 73 years not current for CRC screening.InterventionUsual 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.MeasurementsThe 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).ResultsCompared 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%]).LimitationParticipants were required to provide verbal consent and were more likely to be white and to participate in other types of cancer screening, limiting generalizability.ConclusionCompared 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.

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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.

Dataset Information

A stepped randomized trial to promote colorectal cancer screening in a nationwide sample of U.S. Veterans.

Background

Objectives

Methods

Results

Conclusions

Publications

A stepped randomized trial to promote colorectal cancer screening in a nationwide sample of U.S. Veterans.

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