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Interventions to Improve Colon Cancer Screening in Poor Rural Iowa Counties

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ClinicalTrials.gov Identifier: NCT01477814
Recruitment Status : Completed
First Posted : November 23, 2011
Last Update Posted : April 24, 2017
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Barcey T. Levy, University of Iowa

Tracking Information
First Submitted Date  ICMJE November 18, 2011
First Posted Date  ICMJE November 23, 2011
Last Update Posted Date April 24, 2017
Study Start Date  ICMJE July 2008
Actual Primary Completion Date April 27, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2011)
colorectal cancer screening [ Time Frame: 15 months ]
The main outcome measure is the percentage of subjects who complete colorectal cancer screening by any of the accepted methods
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2011)
cost-effectiveness of various strategies for screening [ Time Frame: 15 months ]
cost-effectiveness of the various interventions for colorectal cancer screening
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interventions to Improve Colon Cancer Screening in Poor Rural Iowa Counties
Official Title  ICMJE Randomized Clinical Trial to Improve Colon Cancer Screening in Poor Rural Iowa Counties
Brief Summary 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?
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • 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
    Other Name: chart reminder
  • Behavioral: chart reminder, educational mat'ls, 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
    Other Name: chart reminder, mailed education, FIT
  • Behavioral: CR,ed mat'ls, FIT, phone 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
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Physician chart reminder
  • 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
    Interventions:
    • Behavioral: Physician chart reminder
    • Behavioral: chart reminder, educational mat'ls, FIT
  • Active Comparator: CR, ed mat'ls, FIT, phone call
    physician chart reminder (CR) 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.
    Interventions:
    • Behavioral: Physician chart reminder
    • Behavioral: CR,ed mat'ls, FIT, phone call
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2011)
743
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 16, 2015
Actual Primary Completion Date April 27, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 52 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01477814
Other Study ID Numbers  ICMJE 200805728
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Written request from an appropriate researcher to the PI
Responsible Party Barcey T. Levy, University of Iowa
Study Sponsor  ICMJE Barcey T. Levy
Collaborators  ICMJE American Cancer Society, Inc.
Investigators  ICMJE
Principal Investigator: Barcey T Levy, PhD, MD University of Iowa
PRS Account University of Iowa
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP