Strategies and Opportunities to Stop Colon Cancer in Priority Populations

Study Overview
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Brief Summary
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Only an estimated 50 million US adults aged 50-75 are up-to-date on colorectal cancer (CRC) screening according to guidelines set by the federal government. CRC is 90% curable with timely detection and appropriate treatment of precancerous polyps; increased screening could reduce incidence by up to 50%. Groups least likely to undergo screening, those with minimal education, low income, low access to health care, recent immigrants or Hispanics, are the same people who frequently receive care at Federally Qualified Healthcare Center's (FQHCs). The use of fecal occult blood tests (FOBT) and fecal immunochemical tests (FIT) is exceedingly low in FQHCs (7-9% of patients in the past year) and far below national averages and target rates. Our results will provide valuable information on how to use electronic health record (EHR) resources to optimize guideline-based screening in FQHC clinics whose patient populations have disproportionately low CRC screening rates. This project, in conjunction with the research team, will use an advisory panel to direct the research activities. The advisory panel will be made up of clinicians, leaders, researchers, and patients. The panel and team will guide the development of materials, the outreach to patients, and the research protocol to best reach FQHC patients who are due for colorectal cancer screening. This project will be conducted in two phases, Phase I is conducting a pilot at two FQHC's, and Phase II is rolling out the intervention to between 20-30 clinics.

Detailed Description
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Phase I (Pilot Aims) Aim 1 Conduct preliminary analyses of EHR data at two pilot clinics. Aim 2: Use codes and methods developed in Aim 1 to test the feasibility, reach, effectiveness, and cost of an EHR-based CRC screening intervention using a subset of 100 patients at each of two pilot clinics. We will use codes defined in Aim 1 to create a Solutions-based, Epic-integrated system to track CRC screening, mail FIT kits, and track patient test results and receipt of follow-up care. The system will be pilot-tested in two clinics. Aim 3: Use results from the pilot intervention to prepare for a large-scale, cluster-randomized pragmatic trial across 18 OCHIN clinics (see Phase II). Transition from Phase I to Phase II -Changes to our original proposal include going from a three arm to a two-arm pragmatic cluster trial with revised evaluation and power calculation and refinements to the intervention components for both usual care (now described as enhanced usual care) and the intervention (now described as enhanced auto). Phase II (Full trial Aims) Primary Aim 1. Assess the effectiveness of a large-scale, two-arm CRC screening program among diverse CLINIC patients, and assess difference in CRC screening outcomes (overall and by age, sex, insurance status, Hispanic ethnicity/race). The intervention will consist of an automated data-driven, EHR-linked program for mailing FIT kits (with linguistically appropriate pictographic instructions and return postage) to patients due for CRC screening. Primary Aim 2. Assess the costs and long-term cost-effectiveness of the automated program. We have also included two secondary aims: Secondary Aim 1. Assess adoption, implementation, reach and potential maintenance and spread of the program, using a mixed-method rapid assessment process, field notes, and other ethnographic data. Secondary Aim 2. Adapt and pilot-test the adaptation of STOP CRC in an alternate EHR platform, Allscripts, and develop an implementation guide to assist sites in adopting the program.

Official Title
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Strategies and Opportunities to Stop Colon Cancer in Priority Populations

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Auto Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 50-74 with no evidence of a colonoscopy within 9 years or fecal testing within 11 months, and no history of colorectal disease will be eligible to receive a mailed FIT. Exclusion Criteria: End Stage Renal Disease (ESRD) Hospice/Nursing Home

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Clinics in usual care will go about clinic practices to complete recommended screening for colorectal cancer. | |
| Active Comparator: Auto Plus<br>Clinics randomized to the Auto-Plus arm will engage in all activities (send an introductory letter to participants, then a FIT Kit, then a reminder letter encouraging the return of the FIT Kit) in addition to a PDSA (Plan Do Study Act) cycle to refine or improve their process. | Other: Auto Plus<br>* Clinics randomized to the Auto-Plus arm will engage in all activities in the Auto arm (send an introductory letter to participants, then a FIT Kit, then a reminder letter encouraging the return of the FIT Kit) in addition to one other outreach effort.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FIT Completion | Binary indication of FIT completion within 12 months or through August 3, 2015 (when usual care clinics received access to study tools). Proportion of completed FIT is represented below with a confidence interval of the difference in completed FIT. | Completed FIT kits sent back within 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any CRC Screening | Binary indication of any CRC screening (fecal test, sigmoidoscopy, or colonoscopy) during the evaluation interval. | Any CRC screening complete within 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer Screening, Cancer Screening, Pragmatic Trial