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Systems intervention to promote colon cancer screening in safety net settings: protocol for a community-based participatory randomized controlled trial.

ABSTRACT: Colorectal cancer is a leading cause of cancer mortality. Screening can be effective but is underutilized. System- or multi-level interventions could be effective at increasing screening, but most have been implemented and evaluated in higher-resource settings such as health maintenance organizations. Given the disparities evident for colorectal cancer and the potential for screening to improve outcomes, there is a need to expand this work to include diverse settings, including those who treat economically disadvantaged patients. This paper describes the study protocol for a trial designed to increase colorectal cancer screening in those 'safety-net' health centers that serve underinsured and uninsured patients. This trial was designed and is being implemented using a community-based participatory approach.We developed a practical clinical cluster-randomized controlled trial. We will recruit 16 community health centers to this trial. This systems-level intervention consists of a menu of evidence-based implementation strategies for increasing colorectal cancer screening. Health centers in the intervention arm then collaborate with the study team to tailor strategies to their own setting in order to maximize fit and acceptability. Data are collected at the organizational level through interviews, and at the provider and patient levels through surveys. Patients complete a survey about their healthcare and screening utilization at baseline, six months, and twelve months.The primary outcome is colorectal cancer screening by patient self-report, supplemented by a chart-audit in a subsample of patients. Implementation outcomes informed by the Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) conceptual framework will be measured at patient, provider, and practice levels.Our study is one of the first to integrate community participatory strategies to a randomized controlled trial in a healthcare setting. The multi-level approach will support the ability of the intervention to affect screening through multiple avenues. The participatory approach will strengthen the chance that implementation strategies will be maintained after study completion and, supports external validity by increasing health center interest and willingness to participate.NCT01299493.

SUBMITTER: James AS

PROVIDER: S-EPMC3674918 | biostudies-literature | 2013 Jun

REPOSITORIES: biostudies-literature

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Systems intervention to promote colon cancer screening in safety net settings: protocol for a community-based participatory randomized controlled trial.

James Aimee S AS Richardson Veronica V Wang Jean S JS Proctor Enola K EK Colditz Graham A GA

Implementation science : IS 20130603

<h4>Background</h4>Colorectal cancer is a leading cause of cancer mortality. Screening can be effective but is underutilized. System- or multi-level interventions could be effective at increasing screening, but most have been implemented and evaluated in higher-resource settings such as health maintenance organizations. Given the disparities evident for colorectal cancer and the potential for screening to improve outcomes, there is a need to expand this work to include diverse settings, includin ...[more]

PMID: 23731594

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Project description:Although brief intervention is effective for reducing problem alcohol use, few data exist on its effectiveness for reducing problem drug use, a common issue in disadvantaged populations seeking care in safety-net medical settings (hospitals and community health clinics serving low-income patients with limited or no insurance).To determine whether brief intervention improves drug use outcomes compared with enhanced care as usual.A randomized clinical trial with blinded assessments at baseline and at 3, 6, 9, and 12 months conducted in 7 safety-net primary care clinics in Washington State. Of 1621 eligible patients reporting any problem drug use in the past 90 days, 868 consented and were randomized between April 2009 and September 2012. Follow-up participation was more than 87% at all points.Participants received a single brief intervention using motivational interviewing, a handout and list of substance abuse resources, and an attempted 10-minute telephone booster within 2 weeks (n?=?435) or enhanced care as usual, which included a handout and list of substance abuse resources (n?=?433).The primary outcomes were self-reported days of problem drug use in the past 30 days and Addiction Severity Index-Lite (ASI) Drug Use composite score. Secondary outcomes were admission to substance abuse treatment; ASI composite scores for medical, psychiatric, social, and legal domains; emergency department and inpatient hospital admissions, arrests, mortality, and human immunodeficiency virus risk behavior.Mean days used of the most common problem drug at baseline were 14.40 (SD, 11.29) (brief intervention) and 13.25 (SD, 10.69) (enhanced care as usual); at 3 months postintervention, means were 11.87 (SD, 12.13) (brief intervention) and 9.84 (SD, 10.64) (enhanced care as usual) and not significantly different (difference in differences, ??=?0.89 [95% CI, -0.49 to 2.26]). Mean ASI Drug Use composite score at baseline was 0.11 (SD, 0.10) (brief intervention) and 0.11 (SD, 0.10) (enhanced care as usual) and at 3 months was 0.10 (SD, 0.09) (brief intervention) and 0.09 (SD, 0.09) (enhanced care as usual) and not significantly different (difference in differences, ??=?0.008 [95% CI, -0.006 to 0.021]). During the 12 months following intervention, no significant treatment differences were found for either variable. No significant differences were found for secondary outcomes.A one-time brief intervention with attempted telephone booster had no effect on drug use in patients seen in safety-net primary care settings. This finding suggests a need for caution in promoting widespread adoption of this intervention for drug use in primary care.clinicaltrials.gov Identifier: NCT00877331.

Project description:Cancer screening rates are suboptimal for low-income patients.To assess an intervention to increase cancer screening among patients in a safety-net primary care practice.Patients at an inner-city family practice who were overdue for cancer screening were randomized to intervention or usual care. Screening rates at 1 year were compared using the chi-square test, and multivariable analysis was performed to adjust for patient factors.All average-risk patients at an inner-city family practice overdue for mammography or colorectal cancer (CRC) screening. Patients' ages were 40 to 74 years (mean 53.9, SD 8.7) including 40.8 % African Americans, 4.2 % Latinos, 23.2 % with Medicaid and 10.9 % without any form of insurance.The 6-month intervention to promote cancer screening included letters, automated phone calls, prompts and a mailed Fecal Immunochemical Testing (FIT) Kit.Rates of cancer screening at 1 year.Three hundred sixty-six patients overdue for screening were randomly assigned to intervention (n?=?185) or usual care (n?=?181). Primary analysis revealed significantly higher rates of cancer screening in intervention subjects: 29.7 % vs. 16.7 % for mammography (p?=?0.034) and 37.7 % vs. 16.7 % for CRC screening (p?=?0.0002). In the intervention group, 20 % of mammography screenings and 9.3 % of CRC screenings occurred at the early assessment, while the remainder occurred after repeated interventions. Within the CRC intervention group 44 % of screened patients used the mailed FIT kit. On multivariable analysis the CRC screening rates remained significantly higher in the intervention group, while the breast cancer screening rates were not statistically different.A multimodal intervention significantly increased CRC screening rates among patients in a safety-net primary care practice. These results suggest that relatively inexpensive letters and automated calls can be combined for a larger effect. Results also suggest that mailed screening kits may be a promising way to increase average-risk CRC screening.

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Systems intervention to promote colon cancer screening in safety net settings: protocol for a community-based participatory randomized controlled trial.

Publications

Systems intervention to promote colon cancer screening in safety net settings: protocol for a community-based participatory randomized controlled trial.

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