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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Kaiser Permanente
Sponsor:
Collaborators:
Group Health Cooperative
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01742065
First received: December 3, 2012
Last updated: October 7, 2014
Last verified: October 2013
  Purpose

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 Intervention Phase
Colorectal Cancer
Other: Auto Plus
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Strategies and Opportunities to Stop Colon Cancer in Priority Populations

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Increased Screening Rates [ Time Frame: up to 4 years (study period) ] [ Designated as safety issue: No ]
    Investigators will determine if the auto and auto-plus interventions increase the rates of screening compared to usual care at FQHC clinics.


Estimated Enrollment: 20000
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

Phase I (Pilot Aims)

  • Aim 1 Conduct preliminary analyses of EHR data at two pilot OCHIN 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.
  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742065

Contacts
Contact: Amanda F Petrik, MS 503-335-2483 amanda.f.petrik@kpchr.org
Contact: Jennifer J Sanchez, MA 503-335-2462 Jennifer.J.Sanchez@kpchr.org

Locations
United States, California
Open Door Health Center Recruiting
Arcata, California, United States, 95521
Contact: Joe Carroll    707-826-8633      
United States, Oregon
Mosaic Medical Recruiting
Bend, Oregon, United States, 97701
Contact: Jaime Crandall    541-383-3005      
Benton and Linn County Health Centers Recruiting
Corvallis, Oregon, United States, 97330
Contact: Melanie Wiens    541-766-6366      
Virginia Garcia Memorial Health Center Recruiting
Hillsboro, Oregon, United States, 97124
Contact: Tanya Kapka, MD       tanya.kapka@kpchr.org   
Sub-Investigator: Tanya Kapka, MD         
Community Health Center Recruiting
Medford, Oregon, United States, 97504
Contact: Jackie Weber    541-773-3863      
La Clinica Health Care Recruiting
Medford, Oregon, United States, 97501
Contact: Simon Parker-Shames    541-535-6239      
Multnomah County Health Department Recruiting
Portland, Oregon, United States, 97214
Contact: Josue Aguirre    503-988-3663      
Oregon Health and Science University Recruiting
Scappoose, Oregon, United States, 97056
Contact: Dawn Hammel    503-418-4222      
Sponsors and Collaborators
Kaiser Permanente
Group Health Cooperative
Investigators
Principal Investigator: Gloria Coronado, PhD The Center for Health Research, Kaiser Permanente Northwest
Principal Investigator: Beverly Green, PhD Group Health Cooperative
  More Information

Publications:
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01742065     History of Changes
Other Study ID Numbers: UH3CA188640, 1UH2AT007782-01
Study First Received: December 3, 2012
Last Updated: October 7, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 22, 2014