Systems Intervention to Promote Colorectal Cancer (CRC) Screening

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Washington University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01299493
First received: February 16, 2011
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

Colorectal cancer is the second leading cause of cancer death and one of the most commonly diagnosed malignancies. Screening is effective at reducing incidence and mortality from colorectal cancer. This study will evaluate the effectiveness of implementing systems-changes in community health centers that facilitate screening.


Condition Intervention
Carcinoma
Other: Systems-level intervention to promote colon cancer screening

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Systems Intervention to Promote Colorectal Cancer Screening/ Program for the Elimination of Cancer Disparities

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Practice-level colon cancer screening rate [ Time Frame: 12-months post baseline ] [ Designated as safety issue: No ]
    Colorectal cancer screening will be assessed as the proportion of screening-eligible patients who are adherent to national screening guidelines for colorectal cancer.


Estimated Enrollment: 18
Study Start Date: June 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interventional
Access to systems-level interventions to increase colorectal cancer screening.
Other: Systems-level intervention to promote colon cancer screening
Intervention practices will receive access to, and assistance in implementing, evidence-based strategies for increasing colorectal cancer screening rates.
No Intervention: Usual Care
Practices will receive access to intervention components after outcomes data collection is complete.

Detailed Description:

Colorectal cancer (CRC) is one of the cancers that our community partners have identified as a priority. It is the second leading cause of cancer death in the United States, and one with significant disparities in screening, stage of diagnosis, and survival. Underinsured and uninsured adults are less likely to be screened, more likely to have their cancer diagnosed at a late stage, and less likely to survive CRC. In this project we will work with "safety-net" health centers serving Medicaid and uninsured patients in St. Louis City and St. Louis County in Missouri, and in East St. Louis/St. Clair County in Illinois. Working with our Colorectal Cancer Community Partnership we planned a cluster-randomized delayed start trial to test the effectiveness of offering community health centers a "Menu" of evidence-based systems interventions for increasing rates of CRC screening. The strategies included in the Menu will be drawn from evidence-based interventions. The control condition will be usual care, but in concordance with our partners' wishes, we will offer all participating health centers access to state-of-the-art evidence-based patient education materials. The primary outcome will be CRC screening adherence as measured by self-report surveys of a random sample of health center patients. Our evaluation will also be informed by a chart audit to assess screening referral and completion, surveys of physicians and staff at intervention sites to assess implementation outcomes, and exit interviews with administration of intervention health centers to assess maintenance of the intervention strategies. We developed and will conduct our study adhering to the principles of community-based participatory research (CBPR). The specific aims are: (1) Working with community partners, we will select and refine the evidence-based intervention strategies for the trial; (2) Using a CBPR approach, we will collaborate with our partners to implement and evaluate the systems-level intervention for its effectiveness in increasing CRC screening rates. (3) Using the RE-AIM framework, we will work with our partners to evaluate implementation and maintenance of systems changes by intervention health centers and adoption of the changes by control centers. Compared to traditional clinics and healthcare providers, safety-net health centers face additional challenges in implementing evidence-based strategies for increase screening uptake; yet rigorously testing such strategies in this context is novel. Allowing health centers to select from a menu of strategies will provide a practical test of effectiveness, and will increase buy-in and representativeness of participating health centers. As a practical clinical trial with good external validity, this project has the potential for significant impact on CRC screening rates with promise for substantial impact on disparities in CRC burden. This study is responsive to community concerns about CRC and about no-intervention control groups, and is responsive to the RFA by proposing a CBPR randomized controlled trial to increase access to and utilization of CRC screening procedures.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Community health center in the Saint Louis Metropolitan Area, including Southern Illinois
  • Participant in Partnership Planning Process
  • Affiliated with the Washington University Program for the Elimination of Cancer Disparities

Exclusion Criteria:

  • Primary patient population has private health insurance.
  • Not in an medically underserved area.
  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: NCT01299493

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Aimee S James, PhD, MPH    314-454-8300    jamesai@wustl.edu   
Contact: Victoria Anwuri, MPH    314-747-1189    anwuriv@siteman.wustl.edu   
Sub-Investigator: Graham A Colditz, MD, DrPH         
Sub-Investigator: Jean Wang, MD         
Sub-Investigator: Yan Yan, PhD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Aimee S James, PhD, MPH Washington University School of Medicine
  More Information

Additional Information:
No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01299493     History of Changes
Other Study ID Numbers: 10-1131, U54CA153460
Study First Received: February 16, 2011
Last Updated: November 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Washington University School of Medicine:
carcinoma
colorectal cancer
community health centers
cluster-randomized
health behavior

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 22, 2014