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Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOPCRC)

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ClinicalTrials.gov Identifier: NCT01742065
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : February 6, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Auto Plus Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Strategies and Opportunities to Stop Colon Cancer in Priority Populations
Study Start Date : January 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care
Clinics in usual care will go about clinic practices to complete recommended screening for colorectal cancer.
Active Comparator: Auto Plus
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
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.




Primary Outcome Measures :
  1. Increased Screening Rates [ Time Frame: up to 4 years (study period) ]
    Investigators will determine if the auto and auto-plus interventions increase the rates of screening compared to usual care at FQHC clinics.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01742065


Locations
United States, California
Open Door Health Center
Arcata, California, United States, 95521
United States, Oregon
Mosaic Medical
Bend, Oregon, United States, 97701
Benton and Linn County Health Centers
Corvallis, Oregon, United States, 97330
Virginia Garcia Memorial Health Center
Hillsboro, Oregon, United States, 97124
La Clinica Health Care
Medford, Oregon, United States, 97501
Community Health Center
Medford, Oregon, United States, 97504
Multnomah County Health Department
Portland, Oregon, United States, 97214
Oregon Health and Science University
Scappoose, Oregon, United States, 97056
Sponsors and Collaborators
Kaiser Permanente
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Gloria Coronado, PhD The Center for Health Research, Kaiser Permanente Northwest
Principal Investigator: Beverly Green, PhD Kaiser Permanente

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01742065     History of Changes
Other Study ID Numbers: UH3CA188640 ( U.S. NIH Grant/Contract )
1UH2AT007782-01 ( U.S. NIH Grant/Contract )
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kaiser Permanente:
Colorectal Cancer Screening
Cancer Screening
Pragmatic Trial

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases