Strategies and Opportunities to Stop Colon Cancer in Priority Populations

NCT01742065 | Completed Results DMC

• 2 other identifiers: UH3CA1886401UH2AT007782-01
• Study Type: interventional
• Target: 62,155
• Locations: 1 country
• Sites: 8

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.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer Screening; Cancer Screening; Pragmatic Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Any CRC Screening

  Any CRC screening complete within 12 months

Study Arms (2)

Usual Care

NO INTERVENTION

Clinics in usual care will go about clinic practices to complete recommended screening for colorectal cancer.

Auto Plus

ACTIVE COMPARATOR

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

Interventions

Auto Plus OTHER

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.

Auto Plus

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• End Stage Renal Disease (ESRD)
• Hospice/Nursing Home

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (8)

Open Door Health Center

Arcata, California, 95521, United States

Location

Mosaic Medical

Bend, Oregon, 97701, United States

Location

Benton and Linn County Health Centers

Corvallis, Oregon, 97330, United States

Location

Virginia Garcia Memorial Health Center

Hillsboro, Oregon, 97124, United States

Location

La Clinica Health Care

Medford, Oregon, 97501, United States

Location

Community Health Center

Medford, Oregon, 97504, United States

Location

Multnomah County Health Department

Portland, Oregon, 97214, United States

Location

Oregon Health and Science University

Scappoose, Oregon, 97056, United States

Location

Related Publications (23)

• 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.

  PMID: 24057692 BACKGROUND

• 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.

  PMID: 24937017 BACKGROUND

• 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.

  PMID: 24571550 BACKGROUND

• 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.

  PMID: 25729454 BACKGROUND

• 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;2:1000141. doi: 10.4172/2329-9126.1000141.

  PMID: 25411657 BACKGROUND

• 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.

  PMID: 24952378 BACKGROUND

• 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.

  PMID: 26419905 BACKGROUND

• 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. No abstract available.

  PMID: 25446054 BACKGROUND

• Coronado GD, Petrik AF, Vollmer WM, Taplin SH, Keast EM, Fields S, Green BB. Effectiveness of a Mailed Colorectal Cancer Screening Outreach Program in Community Health Clinics: The STOP CRC Cluster Randomized Clinical Trial. JAMA Intern Med. 2018 Sep 1;178(9):1174-1181. doi: 10.1001/jamainternmed.2018.3629.

  PMID: 30083752 BACKGROUND

• Coronado GD, Nielson CM, Keast EM, Petrik AF, Suls JM. The influence of multi-morbidities on colorectal cancer screening recommendations and completion. Cancer Causes Control. 2021 May;32(5):555-565. doi: 10.1007/s10552-021-01408-2. Epub 2021 Mar 9.

  PMID: 33687606 DERIVED

• Petrik AF, Keast E, Johnson ES, Smith DH, Coronado GD. Development of a multivariable prediction model to identify patients unlikely to complete a colonoscopy following an abnormal FIT test in community clinics. BMC Health Serv Res. 2020 Nov 10;20(1):1028. doi: 10.1186/s12913-020-05883-2.

  PMID: 33172444 DERIVED

• Petrik AF, Green B, Schneider J, Miech EJ, Coury J, Retecki S, Coronado GD. Factors Influencing Implementation of a Colorectal Cancer Screening Improvement Program in Community Health Centers: an Applied Use of Configurational Comparative Methods. J Gen Intern Med. 2020 Nov;35(Suppl 2):815-822. doi: 10.1007/s11606-020-06186-2. Epub 2020 Oct 26.

  PMID: 33107003 DERIVED

• Schneider JL, Rivelli JS, Gruss I, Petrik AF, Nielson CM, Green BB, Coronado GD. Barriers and Facilitators to Timely Colonoscopy Completion for Safety Net Clinic Patients. Am J Health Behav. 2020 Jul 1;44(4):460-472. doi: 10.5993/AJHB.44.4.8.

  PMID: 32553027 DERIVED

• O'Connor EA, Vollmer WM, Petrik AF, Green BB, Coronado GD. Moderators of the effectiveness of an intervention to increase colorectal cancer screening through mailed fecal immunochemical test kits: results from a pragmatic randomized trial. Trials. 2020 Jan 15;21(1):91. doi: 10.1186/s13063-019-4027-7.

  PMID: 31941527 DERIVED

• Thompson JH, Schneider JL, Rivelli JS, Petrik AF, Vollmer WM, Fuoco MJ, Coronado GD. A Survey of Provider Attitudes, Beliefs, and Perceived Barriers Regarding a Centralized Direct-Mail Colorectal Cancer Screening Approach at Community Health Centers. J Prim Care Community Health. 2019 Jan-Dec;10:2150132719890950. doi: 10.1177/2150132719890950.

  PMID: 31779517 DERIVED

• Green BB, Vollmer WM, Keast E, Petrik AF, Coronado GD. Challenges in assessing population reach in a pragmatic trial. Prev Med Rep. 2019 May 29;15:100910. doi: 10.1016/j.pmedr.2019.100910. eCollection 2019 Sep.

  PMID: 31198661 DERIVED

• Meenan RT, Coronado GD, Petrik A, Green BB. A cost-effectiveness analysis of a colorectal cancer screening program in safety net clinics. Prev Med. 2019 Mar;120:119-125. doi: 10.1016/j.ypmed.2019.01.014. Epub 2019 Jan 24.

  PMID: 30685318 DERIVED

• Nielson CM, Rivelli JS, Fuoco MJ, Gawlik VR, Jimenez R, Petrik AF, Coronado GD. Effectiveness of automated and live phone reminders after mailed-FIT outreach in a pilot randomized trial. Prev Med Rep. 2018 Oct 17;12:210-213. doi: 10.1016/j.pmedr.2018.10.012. eCollection 2018 Dec.

  PMID: 30364785 DERIVED

• Coronado GD, Rivelli JS, Fuoco MJ, Vollmer WM, Petrik AF, Keast E, Barker S, Topalanchik E, Jimenez R. Effect of Reminding Patients to Complete Fecal Immunochemical Testing: A Comparative Effectiveness Study of Automated and Live Approaches. J Gen Intern Med. 2018 Jan;33(1):72-78. doi: 10.1007/s11606-017-4184-x. Epub 2017 Oct 10.

  PMID: 29019046 DERIVED

• Petrik AF, Le T, Keast E, Rivelli J, Bigler K, Green B, Vollmer WM, Coronado G. Predictors of Colorectal Cancer Screening Prior to Implementation of a Large Pragmatic Trial in Federally Qualified Health Centers. J Community Health. 2018 Feb;43(1):128-136. doi: 10.1007/s10900-017-0395-7.

  PMID: 28744716 DERIVED

• Coury J, Schneider JL, Rivelli JS, Petrik AF, Seibel E, D'Agostini B, Taplin SH, Green BB, Coronado GD. Applying the Plan-Do-Study-Act (PDSA) approach to a large pragmatic study involving safety net clinics. BMC Health Serv Res. 2017 Jun 19;17(1):411. doi: 10.1186/s12913-017-2364-3.

  PMID: 28629348 DERIVED

• Petrik AF, Green BB, Vollmer WM, Le T, Bachman B, Keast E, Rivelli J, Coronado GD. The validation of electronic health records in accurately identifying patients eligible for colorectal cancer screening in safety net clinics. Fam Pract. 2016 Dec;33(6):639-643. doi: 10.1093/fampra/cmw065. Epub 2016 Jul 28.

  PMID: 27471224 DERIVED

• Johnson KE, Neta G, Dember LM, Coronado GD, Suls J, Chambers DA, Rundell S, Smith DH, Liu B, Taplin S, Stoney CM, Farrell MM, Glasgow RE. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 2016 Jan 16;17:32. doi: 10.1186/s13063-016-1158-y.

  PMID: 26772801 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Limitations and Caveats

* FIT samples were not processed if missing collection dates * under-capture of colonoscopy * screening/diagnostic colonoscopy indistinguishable * mailed an introduction letter and having a FIT order served as proxy for having been mailed a FIT.

Results Point of Contact

• Title: Gloria D. Coronado
• Organization: Kaiser Permanente Center for Health Research

Gloria.D.Coronado@kpchr.org

503 335 2427

Study Officials

• Gloria Coronado, PhD

  The Center for Health Research, Kaiser Permanente Northwest

  PRINCIPAL INVESTIGATOR

• Beverly Green, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 5, 2012
• Study Start: January 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: August 1, 2018
• Last Updated: April 23, 2019
• Results First Posted: April 23, 2019

Record last verified: 2019-04

Locations

US (8)