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Trial record 4 of 136 for:    Kaiser Permanente | Recruiting, Not yet recruiting, Available Studies | cancer

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

This study is currently recruiting participants.
Verified August 2017 by Kaiser Permanente
Sponsor:
ClinicalTrials.gov Identifier:
NCT01742065
First Posted: December 5, 2012
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Kaiser Permanente
  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
Colorectal Cancer Other: Auto Plus

Study Type: Interventional
Study Design: 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

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) ]
    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 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 74 Years   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Amanda F Petrik, MS 503-335-2483 amanda.f.petrik@kpchr.org
Contact: Jennifer S Rivilli, MA 503-335-2462 Jennifer.S.Rivilli@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         
La Clinica Health Care Recruiting
Medford, Oregon, United States, 97501
Contact: Simon Parker-Shames    541-535-6239      
Community Health Center Recruiting
Medford, Oregon, United States, 97504
Contact: Jackie Weber    541-773-3863      
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
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
  More Information

Publications:
Coronado GD, Sanchez J, Petrik A, Kapka T, DeVoe J, Green B. Advantages of wordless instructions on how to complete a fecal immunochemical test: lessons from patient advisory council members of a federally qualified health center. J Cancer Educ. 2014 Mar;29(1):86-90. doi: 10.1007/s13187-013-0551-4.
Coronado GD, Vollmer WM, Petrik A, Taplin SH, Burdick TE, Meenan RT, Green BB. Strategies and Opportunities to STOP Colon Cancer in Priority Populations: design of a cluster-randomized pragmatic trial. Contemp Clin Trials. 2014 Jul;38(2):344-9. doi: 10.1016/j.cct.2014.06.006. Epub 2014 Jun 14.
Coronado GD, Vollmer WM, Petrik A, Aguirre J, Kapka T, Devoe J, Puro J, Miers T, Lembach J, Turner A, Sanchez J, Retecki S, Nelson C, Green B. Strategies and opportunities to STOP colon cancer in priority populations: pragmatic pilot study design and outcomes. BMC Cancer. 2014 Feb 26;14:55. doi: 10.1186/1471-2407-14-55.
Coronado GD, Schneider JL, Sanchez JJ, Petrik AF, Green B. Reasons for non-response to a direct-mailed FIT kit program: lessons learned from a pragmatic colorectal-cancer screening study in a federally sponsored health center. Transl Behav Med. 2015 Mar;5(1):60-7. doi: 10.1007/s13142-014-0276-x.
Coronado GD, Burdick T, Petrik A, Kapka T, Retecki S, Green B. Using an Automated Data-driven, EHR-Embedded Program for Mailing FIT kits: Lessons from the STOP CRC Pilot Study. J Gen Pract (Los Angel). 2014 Jan 5;2. pii: 1000141.
Coronado GD, Petrik AF, Spofford M, Talbot J, Do HH, Taylor VM. Clinical perspectives on colorectal cancer screening at Latino-serving federally qualified health centers. Health Educ Behav. 2015 Feb;42(1):26-31. doi: 10.1177/1090198114537061. Epub 2014 Jun 20.
Coronado GD, Retecki S, Schneider J, Taplin SH, Burdick T, Green BB. Recruiting community health centers into pragmatic research: Findings from STOP CRC. Clin Trials. 2016 Apr;13(2):214-22. doi: 10.1177/1740774515608122. Epub 2015 Sep 29.
Johnson KE, Tachibana C, Coronado GD, Dember LM, Glasgow RE, Huang SS, Martin PJ, Richards J, Rosenthal G, Septimus E, Simon GE, Solberg L, Suls J, Thompson E, Larson EB. A guide to research partnerships for pragmatic clinical trials. BMJ. 2014 Dec 1;349:g6826. doi: 10.1136/bmj.g6826.

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 Submitted: December 3, 2012
First Posted: December 5, 2012
Last Update Posted: August 24, 2017
Last Verified: August 2017

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


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