Interventions to Improve Colon Cancer Screening in Poor Rural Iowa Counties

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Iowa.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Barcey T. Levy, University of Iowa
ClinicalTrials.gov Identifier:
NCT01477814
First received: November 18, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  Purpose

The goal of the study is to conduct a randomized clinical trial to test several office-based strategies for improving colon cancer screening among individuals who are regular patients at 16 family practice physician offices in the state of Iowa. These offices are members of the Iowa Research Network (IRENE), a rural practice-based research network. The interventions to be tested are increasing in intensity from the usual care provided in the office, to physician chart reminders, mailed educational materials to patients, a fecal immunochemical test with postage-paid return envelope, and a telephone call designed to determine attitudes and barriers to screening, and to motivate subjects to get screened. Our main research questions are: 1)do attitudes toward CRC screening change after providing educational materials about CRC screening? 2)do mailed educational materials and a FIT, with or without a telephone reminder, result in increased rates of CRC testing with the FIT?


Condition Intervention
Colorectal Cancer
Behavioral: Physician chart reminder
Behavioral: usual care
Behavioral: chart reminder, mailed education, FIT
Behavioral: chart reminder, mailed education, FIT, telephone call

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening
Official Title: Randomized Clinical Trial to Improve Colon Cancer Screening in Poor Rural Iowa Counties

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • colorectal cancer screening [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    The main outcome measure is the percentage of subjects who complete colorectal cancer screening by any of the accepted methods


Secondary Outcome Measures:
  • cost-effectiveness of various strategies for screening [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    cost-effectiveness of the various interventions for colorectal cancer screening


Enrollment: 743
Study Start Date: July 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: usual care
usual medical care
Behavioral: usual care
usual care
Other Name: usual medical care
Active Comparator: physician chart reminder
either a paper or an electronic reminder placed on the subject's medical record to remind the physician to screen for colorectal cancer
Behavioral: Physician chart reminder
Subjects randomized to this intervention will have paper or electronic chart reminders placed on their medical records alerting their physicians to the need for colorectal cancer screening
Active Comparator: chart reminder, educational mat'ls, FIT
physician chart reminder plus mailed educational materials, including the Centers for Disease Control CRC Screen for Life, the ACS DVD on CRC screening, a fecal immunochemical test with postage-paid return mailer, a magnet reminding individuals to get screened, and a CRC screening preference sheet where subjects could indicate their preferred CRC test
Behavioral: Physician chart reminder
Subjects randomized to this intervention will have paper or electronic chart reminders placed on their medical records alerting their physicians to the need for colorectal cancer screening
Behavioral: chart reminder, mailed education, FIT
Subjects randomized to this group will have a physician chart reminder, mailed educational packet which includes the CDC Screen for Life materials, a FIT with return envelope, a magnet to remind the subject about CRC screening and a CRC screening preference sheet
Active Comparator: chart reminder, educational mat'ls, FIT, telephone call
physician chart reminder plus mailed educational materials, including the Centers for Disease Control CRC Screen for Life, the ACS DVD on CRC screening, a fecal immunochemical test with postage-paid return mailer, a magnet reminding individuals to get screened, and a CRC screening preference sheet where subjects could indicate their preferred CRC test, and a motivational telephone call designed to elicit barriers and preferences and motivate individuals to complete a CRC screening test.
Behavioral: Physician chart reminder
Subjects randomized to this intervention will have paper or electronic chart reminders placed on their medical records alerting their physicians to the need for colorectal cancer screening
Behavioral: chart reminder, mailed education, FIT, telephone call
Subjects randomized to this group will have a physician chart reminder, mailed educational packet which includes the CDC Screen for Life materials, a FIT with return envelope, a magnet to remind the subject about CRC screening and a CRC screening preference sheet. Subjects will also receive a telephone call from project staff to assess barriers to screening and to encourage CRC screening

Detailed Description:

Colorectal cancer is the second leading cause of cancer death in the U.S. yet approximately half of eligible adults are not up-to-date with colon cancer screening and the rates of screening are lower among those with lower incomes and who lack insurance. A physician's recommendation for screening has consistently been show to be one of the most powerful predictors of CRC screening. Relatively few studies of CRC screening have been conducted in primary care. Disparities in CRC screening rates are seen in low socioeconomic and rural individuals who often lack resources and access to screening. Most intervention studies have been conducted in managed care settings, community health centers, Veteran's Administration or academic practices. Few studies have looked at interventions in rural medical practices. This research will address screening issues for rural patients and those residing in communities designated as medically underserved. The interventions tested in the study will focus on two key areas: educating the patient about the importance of screening, and reminding the physician about the need to discuss screening during the patient's visit.

The original goal of the study was to enroll 1500 unscreened patients aged 52 to 79 years from 16 family physician practices located in poor, rural Iowa counties. This study will test a combination of patient and physician reminder strategies designed to ensure that the patient is educated about CRC screening and receives a recommendation for CRC screening from their physician. The main outcome is colorectal cancer screening by any of the accepted methods. Rates of screening will be compared across intervention groups. We will also determine how much the interventions cost per person screened.

Patients due for screening within each practice (based on their self-report) (never screened or not up to date with screening) will be randomized to one of four groups that will receive office reminder system strategies of increasing intensity: 1) Usual care, 2) Physician chart reminder alone, 3) Physician chart reminder plus multifaceted mailed patient education, including a postage paid fecal immunochemical test, a reminder magnet, and returnable CRC screening test preference sheet, or 4) Physician chart reminder + multifaceted mailed patient education/FIT/magnet/preference sheet + telephone reminder to encourage screening and address barriers.

Our central hypothesis is that providing offices with one or more CRC screening support systems based on the Chronic Care Model will significantly increase CRC screening rates in comparison with usual care, and that such interventions will be cost-effective and accepted in practice.

  Eligibility

Ages Eligible for Study:   52 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients not up-to-date with CRC screening guidelines based on their responses to baseline survey
  • patients with a positive personal history of CRC

Exclusion Criteria:

  • patients with personal history of CRC or inflammatory bowel disease
  • patients with a family history of hereditary conditions that put them at high risk for CRC (familial adenomatous polyposis or hereditary, nonpolyposis CRC)
  • inability to read and comprehend the Informed Consent or written survey
  • patients who are up-to-date with CRC screening guidelines based on their response to the baseline survey
  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: NCT01477814

Locations
United States, Iowa
Iowa Research Network, University of Iowa
Iowa City, Iowa, United States, 52242-1097
Sponsors and Collaborators
University of Iowa
American Cancer Society, Inc.
Investigators
Principal Investigator: Barcey T Levy, PhD, MD University of Iowa
  More Information

No publications provided by University of Iowa

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barcey T. Levy, Professor, IAFP Chair in Rural Medicine, University of Iowa
ClinicalTrials.gov Identifier: NCT01477814     History of Changes
Other Study ID Numbers: RSGT-08-148-01-CPPB
Study First Received: November 18, 2011
Last Updated: November 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
colorectal cancer
screening
colonoscopy
fecal immunochemical test
clinical guidelines

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

ClinicalTrials.gov processed this record on August 20, 2014